Full Conference Details Inside

"A must-attend conference every year!"
– Rochelle Shapland, Process Development Associate,
Alexion Pharmaceuticals Inc.
"A key forum for all aspects of biopharmaceutical
process development and CMC!"
– Dr. Jens H. Vogel, Global CMC Development Team Leader and
Head, Isolation and Purification, Bayer Healthcare
"This conference gave me the global update of what
the industry is faced with and their challenges to
target the true worth"
ACCESS &
AFFORDABILITY
Matthew B. Walker
Vice President, Operations,
Pfizer Global Supply
PFIZER INC.
– Ronald Eimers, Project Manager, Merck
"A great mix of practical and strategic themes,
with good opportunities for networking with
relevant industry players."
– Sancha Salgueiro, Manager, Novozymes
REGULATION
OF BIOSIMILARS
Emily Shacter, Ph.D.
Consultant, THINKFDA, LLC;
former Chief, Laboratory of
Biochemistry, CDER, FDA
Diamond Sponsor: Platinum Sponsor:
THE Industry Meeting Place to Exchange Real-World Solutions
to Improve Speed, Cost and Quality
Conference: October 8-12, 2012
Exhibition: October 9-11, 2012
Rhode Island Convention Center, Providence, RI
Attendees keep coming back for:
• Increased Efficiency in Manufacturing and Development
• Solutions to Quality and Process Challenges in
Product Lifecycle Planning
• Leveraging Technology and Innovation to Improve
Cell Culture Process Development
• Applying Disruptive Technologies to Streamline
Recovery & Purification
• Developing and Implementing Truly Continuous
Drug Substance Processes
• Optimizing ADC Development and Production –
Approaches to Maximize Efficiency and Speed to the Clinic
• Vaccine and Complex Biologics Development and
Production - New Technologies, QbD, Characterization, and
Single Use Systems
• Formulation and Delivery Strategies for Protein Therapeutics
Industry Visionaries Provide Fresh Perspectives
DRIVING VALUE
Jörg Thömmes, Ph.D.
Vice President, Global
Engineering and Facilities
BIOGEN IDEC
BIOSIMILARS
& QBD
Steven Kozlowski, M.D.,
Director, Office of
Biotechnology Products,
OPS, CDER, US FDA
Gold Sponsors:
www.IBCLifeSciences.com/BPI
PARTNERING &
CO-OPETITION
John Stubenrauch, MBA,
Ph.D., Head of External
Commercialization and
Operations, Biologics,
MERCK & CO., INC.
Organized by:
TARGETED
DEVELOPMENT
Thomas Stangler, Ph.D.,
Development Strategy and
Technology Manager, SANDOZ
BIOPHARMACEUTICALS,
Austria
Founding Publication:

COLLABORATE ... LEARN ... INNOVATE
Experience more perspectives and strategies than any other event of
its kind where every presentation has been carefully selected to offer
new ideas and real-world solutions to improve your processes and
overcome your most pressing challenges.
Expand your knowledge with unparalleled access to new,
unpublished data and exclusive case studies from companies of all
sizes and perspectives at the most comprehensive event for those
directly involved with improving the speed, cost and quality of
developing and manufacturing biotherapeutics.
The Conference... Realize innovation and ensure success with proven strategies
for process and manufacturing excellence
> Debottleneck your processes, reduce cycle time and variability, and avoid cross contamination in
multi-product facilities
> Ensure a reliable supply chain and reduce variability caused by raw material changes
> Plan for integrated, fully continuous bioprocessing platforms
> Implement the new process validation guidance with continuous process verification and
QbD strategies
> Create efficient processes and support sustainable pipelines through collaboration with discovery
and development
> Adopt cost-effective approaches to comparability to enable post approval changes and
biosimilar and biobetter development
Unpublished scientific data from exclusive case studies, novel technical
advances and new modalities
> Develop truly continuous drug substance processes and move towards becoming a more integrated
development organization
> Significantly reduce cycle times with fully automated process workflows for both cell line and
cell culture development
> Implement distruptive technologies to replace centrifugation and remove steps in downstream processing
> Effectively streamline two-column purification processes
> Optimize the research-development interface to improve predictability of molecule manufacturability
> Use continuous downstream processing to maximize yield, product quality and equipment utilization for
compact facilities of the future
> Understand assessment, development and production of antibody drug conjugates, bispecifics, cell
therapies and other novel therapies
> Evaluate disposable centrifuge technologies for cell recovery
Specialized Content...
Quality Content for Quality Groups – New This Year!
If you are a quality professional, find expanded content designed just for you in the Track on
Product Lifecycle Planning: Innovative Solutions to Meet Quality and Process Challenges, including
performance by design, regulatory strategies and using comparability to implement process change.
Many of the Pre-Conference Symposia and Training Courses can also help you with new tools for
your day –to-day work.
Engineered for Engineers – New This Year!
Process engineers will find practical solutions to current challenges in the Track on Enhancing
Manufacturing and Development Efficiency where sessions focus on procedures and technologies to
enable safe, cost-effective and flexible, multi-product biomanufacturing. Learn tools and strategies
for enabling a secure supply chain, and speeding start of manufacturing through rapid process
development and adaptation of new technologies.
2 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

The world’s largest gathering of industry suppliers & collaborators
As you set foot into the exhibit hall, you will be surrounded by a full array of technologies, services
and systems that you need to move your projects forward. Right now more than ever, suppliers and
biopharmaceutical manufacturers are working together to drive innovation in biopharmaceutical
manufacturing. This is your chance to influence and make your mark on that future! See the new and
exciting opportunities that can improve your process during your visit to BPI on pages 14-15.
Networking cocktail receptions, luncheons and refreshment breaks
During our networking functions, you will have the opportunity to mix and mingle with the industry
experts in the field in a more relaxed setting surrounded by all of the new innovations being displayed by
over 150 suppliers and novel scientific data presented in the poster hall.
Your BioProcess International Passport
When you arrive to the conference, you will receive your BPI passport which will bring a lot of fun and
opportunity to you as you visit the exhibit hall. This interactive venture leads you to many exhibitors
that will be donating several useful and exciting prizes. Throughout your journey the more participating
companies you visit the better chances you have to win one of these great prizes.
The Emerging Marketplace
This area of the exhibit hall gives you the opportunity to visit with companies that are new in the market
and/or start-up companies that offer technologies or services that may be the leaders of the future.
The 3rd Annual Best Poster Award Contest
We recognize the cutting-edge science, techniques and expertise that can improve existing methods
and processes while reducing time and cost. The awards are sponsored by BioProcess InternationalTM magazine, in partnership with the BioProcess InternationalTM Conference and Exhibition.
The BioProcess International Awards: Honoring a Decade of BioProcess
Dinner and Ceremony: Tuesday, October 9th from 7:00 pm – 9:00 pm
Four awards will be granted for each of the three pillars of bioprocessing: Upstream
Processing, Downstream Processing, and Manufacturing which include:
Technology of the Decade, Technical Application of the Decade, Collaboration of
the Decade and Thought Leader of the Decade. To attend, a separate fee is required.
To submit your nomination, visit www.bioprocessintl.com/awards
Case Study of a Viral Contamination at Genzyme
and Steps Taken to Mitigate Future Risk
Understand and plan for the most crucial future industry trends.
Kris DeSmet, Ph.D., Lead Cell Culture
Operational Technical Support,
GENZYME, A SANOFI COMPANY, Belgium
Biologics Manufacturing Facility
of the Future
Berthold Boedeker, Ph.D., Chief Scientist;
Head, Cell Culture and Pilot Plants,
BAYER PHARMA AG, Germany
Special Events...
Speed Networking Sessions: Back by Popular Demand!
The Speed Networking session last year was such a big success that we decided to bring it back with two time
options to choose from to better fit your schedule. Attendees told us they liked the opportunity to discuss current
topics, gather best practices and insights from fellow attendees. Come prepared to talk fast, talk best practices,
and make new business connections. Pre-registration is required and is open to all registered attendees.
Thought Leadership Forums
The series of thought-leadership forums in the program provide a unique educational setting for you to discuss, debate
and listen to the best practices of your peers and industry experts on today’s pressing topics such as: Biotech-CMO
partnerships, the future of Single-Use technology, updates on global advances in the development of Biosimilars and
structuring process knowledge to achieve robust processes, simplified technology transfer and regulatory compliance.
Getting Trastuzumab Emtansine(T-DM1)
from the Lab-Bench to the Pharmacy Shelf
Fred Jacobson, Ph.D.,
Principal Scientist,
GENENTECH, INC.
For full abstracts and to register, visit www.IBCLifeSciences.com/BPI 3

Monday, October 8, 2012
Symposium #1: Biosimilars: Defining
Successful Development Strategies in an
Evolving Regulatory Environment
Symposium #5:
Best Practices in Cleaning
and Cleaning Validation
Agenda-at-a-Glance –With So Much Going On, Take Advantage of Group Discounts
Tuesday, October 9, 2012 Exhibit Hall Hours: 3:15 pm - 7:00 pm
Enhancing
Manufacturing and
Development Efficiency
Optimizing Manufacturing
Operations
Product Lifecycle
Planning: Innovative
Solutions to Meet Quality
and Process Challenges
Performance by Design:
Mapping and Controlling
Critical Quality Attributes
Antibody Drug
Conjugate Development
and Production
Keynote from Genentech and
analytical, regulatory and process
development approaches
Analytical Technologies
for Biopharmaceutical
Development
Ensuring Quality, Demonstrating
Comparability and Implementing
Novel Technologies
Formulation Strategies
for Protein Therapeutics
Formulation Strategies for
Biosimilars and Next-Generation
Biologics
Technology Workshops Sponsored by: BD Biosciences, Fujifilm Diosynth Biotechnologies, GE Healthcare Life Sciences and Life Technologies
Impact of Raw Material
Variability and Reliability on
Supply Chain and Development
Process Innovation and
Regulatory Submission
Strategies
Luncheon Presentation Sponsored by: EMD Millipore
Antibody Drug Conjugate Scale up and Transfer,
Facility Design and Formulation
Grand Opening of Poster and Exhibit Hall Refreshments Sponsored by Pall Life Sciences
Keynote Presentations: Successfully Partnering Pharmaceutical Manufacturing Throughout Product Lifecycle
Targeted Development of a Biosimilar Using QbD Concepts
Panel Discussion: Ten Key
Questions for Subvisible
Particle Characterization,
Monitoring and Control
Rational Selection and Design
for Improved Pharmacokinetics
Opening Night Networking Reception in Poster and Exhibit Hall Sponsored by IBC Life Sciences / BioProcess International Award Dinner and Ceremony
(To attend, a separate fee is required.)
Wednesday, October 10, 2012 Exhibit Hall Hours: 9:45 am - 7:15 pm
Product Lifecycle
Enhancing
Planning: Innovative
Manufacturing and
Solutions to Meet Quality
Development Efficiency
and Process Challenges
Achieving Rapid Process
Development and
Novel Technology
Implementation
Sponsored by: Pall Life Sciences
Symposium #2:
Best Practices for Implementation
Challenges with Single-Use Systems
Symposium #6:
Risk Management in
Fill/Finish Operations
Viral Safety
for Biologics
Mixed Mode
Chromatography
Strategies for
Biomolecule Purification
Hosted by Bio-Rad Laboratories
Technology Workshop with Light Continental Breakfast Sponsored by: Thermo Scientific
Advancing the Science
of Comparability: Cost
Effective Approaches for the
Implementation of Process
Change Through the Lifecycle
Latest Regulatory
Perspectives and Novel
Technologies
Maximizing Downstream
Process Method Development
Technology Workshops Sponsored by: GE Healthcare Life Sciences, Life Technologies, Kerry Inc, and Sartorius Stedim
Plenary Session:
Implementation of Quality by Design for a Monoclonal
Antibody Therapeutic
Case Study of a Viral Contamination at Genzyme and Steps
Taken to Mitigate Future Risk
Biologics Manufacturing Facility of the Future
Symposium #3:
Best Practices in Managing Variability
of Raw Materials
Symposium #7:
CMC Project Management throughput
the Product Development Life Cycle
Networking Luncheon in Exhibit and Poster Hall with Dedicated Poster Viewing
Recovery & Purification
Improving Predictability with Developability Assessments and
Speed with High Throughput Screening Methods
Keynote Presentations: Regulatory Challenges for Biologics: Biosimilars, Characterization & QbD
Driving Value through Biopharmaceutical Manufacturing
Improving Access and Affordability to Biopharmaceuticals in Emerging Markets through Partnerships
Networking Reception in Poster and Exhibit Hall
Symposium #4:
Regulatory Requirements
in Preclinical CMC Development
Symposium #8:
Microbial Protein
Production Systems
Formulation
Strategies for Protein
Therapeutics
Quality by Design for Drug
Product Development
Product Characterization for
Formulation Development
Predictive Methods in
Formulation Development
4 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

Agenda-at-a-Glance –With So Much Going On, Take Advantage of Group Discounts
Thursday, October 11, 2012 Exhibit Hall Hours: 9:45 am - 1:40 pm
Cell Culture & Upstream
Processing
Case Studies and Lessons Learned in
Cell Culture Process Development
Effect of the Cell Culture Environment
on Product Quality
Friday, October 12, 2012
Cell Culture & Upstream
Processing
Cell Culture Process Development for
Novel Molecules and Next Generation
Protein Therapeutics
__________________
Keynote Presentation:
The Evolution of QbD Implementation
in Cell Culture at Genentech and
Lessons Learned
__________________
Early Process Development
and Cell Line Engineering
Eliminating Bottlenecks – Impact
of New Tools on Cell Culture
Development
__________________
Disposables in Cell Culture
Recovery & Purification
Delivery Strategies
for Biologics
Technology Workshop with Light Continental Breakfast Sponsored by: Repligen
Expanding the Toolbox – Disruptive
Technologies in Harvest and Recovery
Sponsored by: Novasep
Delivery Strategies for High Viscosity
and High Concentration Drug Products
Technology Workshops Sponsored by: 3M, Life Technologies, TAP Biosystems and SAFC
Networking Luncheon & Last Chance to Visit the Exhibit and Poster Hall
Streamlining Downstream Processes to
Improve Cost and Time to Clinic
Plenary Session: Developing Truly Continuous Drug Substance Processes
Recovery & Purification
Technology Workshop Sponsorship Still Available
Understanding Sources of Process
Variability
__________________
Impact of Disposable Technologies
and Flexible Platforms/Manufacturing
on Downstream Processing
__________________
Keynote Presentation:
Implementation of a QbD Approach
for a Monoclonal Antibody BLA - A
Downstream Purification Case Study
Technology Workshop Sponsorship Still Available
Lunch on Your Own
Developing Downstream
Processes for Next Generation and
Novel Molecules
Co-Development Strategies for
Biologic-Device Product Combinations
Delivery Strategies for
Biologics
Localized and Targeted Delivery
of Biologics
Next Generation Routes of
Administration for Biologics
Vaccine and Complex
Biologics Development and
Production
Improving Vaccine Technologies
Quality by Design and Analytical
Technologies for Vaccines
Thought Leadership
Forums
Smart Solutions for Early
Development & Manufacturing of
Biopharmaceuticals: How CMO’s
Can Help Product Companies be
Successful
Tuesday 1:30 pm – 3:15 pm
Co-Sponsored by BioAlta, Boehringer
Ingelheim, DSM Biologics,
Rentschler Biotechnologie
Reducing the Risk of a
Contamination Event Due to Raw
Materials
Wednesday 10:30 am – 12:00 pm
Sponsored by BD Biosciences
Update on Global Advances in the
Development and Regulation of
Biosimilars
Thursday 10:30 am – 12:00 pm
Structuring Process Knowledge
to Achieve Robust Processes,
Simplified Technology Transfer
and Regulatory Compliance
Friday 10:15 am – 11:45 am
Co-Sponsored by BioPharm Services
5 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

Symposium #1: Biosimilars: Defining
Successful Development Strategies in an
Evolving Regulatory Environment
The global biosimilars sector continues to gain
momentum with the emergence of significant new
commercial partnerships and the continued evolution
of the global regulatory environment over the past year.
Recent advances in the global regulatory framework for
biosimilar products include the publication of the first
three draft guidance documents related to biosimilars
by the US FDA in February and an update to the
overarching guideline for biosimilar medicinal products
and new product-specific guidelines by the European
Medicines Agency. Both originator and biosimilar
companies are refining their strategies to enter and
compete in this dynamic new market. This symposium
will discuss overall business trends and biosimilar
development and manufacturing strategies.
Agenda to include:
• What is the emerging competitive landscape and what
will be the keys to success in this space?
• What technical and regulatory challenges are
presented by alternative development and
manufacturing strategies?
• What are the opportunities for innovation in this area?
Co-Chairpersons:
Thomas Stangler, Ph.D., Development Strategy and
Technology Manager, Biopharmaceuticals, Sandoz,
Austria
Thomas J. Vanden Boom, Ph.D., Vice President,
Global Biologics R&D, Hospira, Inc.
1:00 Co-Chairperson’s Remarks
Thomas Stangler, Ph.D., Development Strategy
and Technology Manager, Biopharmaceuticals,
Sandoz Biopharmaceuticals, Austria
Thomas J. Vanden Boom, Ph.D., Vice President,
Global Biologics R&D, Hospira, Inc.
1:15 A Global Update on the State of
Biosimilars in the Highly Regulated
Markets: A Regulatory and Policy
Perspective
Gillian Woollett, D. Phil, Vice President,
Avalere Health
1:45 Update on US Regulation
of Biosimilars
John M. Pakulski, R.Ph., Head US Biopharmaceutical
Regulatory Affairs, Sandoz Inc. a Novartis company
2:15 How to Leverage Resources for
Biosimilar CMC Activities: Hindsight
is 20/20
Nadine M. Ritter, Ph.D., Senior CMC Consultant,
Biologics Consulting Group
2:45 Networking Refreshment Break
3:15 Biosimilar Development –
An Emerging Market Perspective
Cyrus Karkaria, Ph.D., President, Biotech Division,
Lupin Ltd., India
3:45 The Potential Role of Network
Strategies in the Emerging
Biosimilars Space
Thomas J. Nikolai, Senior Director, Global
Biologics R&D, Hospira Corp.
4:15 Audience Interactive Panel
Discussion with all presenters
5:00 Close of Pre-Conference Symposium
Pre-Conference Symposia • Monday, October 8, 2012 • 1:00 pm - 5:00 pm
Symposium #2:
Best Practices for Implementation
Challenges with Single Use Systems
This session will focus on addressing challenges when
implementing single use systems. Single use systems
have become critical components of many processes,
so an understanding of potential risks and challenges
is critical to developing successful control strategies
when implementing processes which utilize single
use systems. This session will discuss the challenges,
risks and potential control strategies that can be
implemented throughout the supply chain.
1:00 Chairperson’s Remarks
Robert Repetto, M.S., MBA., Research
Fellow, External Affairs, Pfizer BioTherapeutics
Pharmaceutical Sciences; Chair, PDA Single-Use
System Task Force
1:15 Evolution and Sustainability of
Single Use Systems
Robert Repetto, M.S., MBA., Research
Fellow, External Affairs, Pfizer BioTherapeutics
Pharmaceutical Sciences; Chair, PDA Single-Use
System Task Force
1:45 Economics of Single Use Operations
and Loss Risk
Andrew Sinclair, Managing Director, BioPharm
Services Ltd., United Kingdom
2:15 Material Understanding and
Supplier Partnerships
Duncan Low, Ph.D., Scientific Executive Director,
Amgen Inc.
2:45 Networking Refreshment Break
3:15 Using Single-Use Technologies
to Improve Speed to Clinic:
A Case Study Looking at Scalability as
Well as Leachables and Extractables in a
Fully Disposable Downstream Process
Joshua Hayes, Field Marketing Manager – Single Use
Processing Systems, Biopharm Process Solutions,
EMD Millipore
3:45 Global Adoption of Single Use
Technologies: Perspectives from an End
User
Jeffrey C. Johnson, New Technology Lead, Sterile
Technology and Commercialization, Merck & Co.,
Inc.
4:15 Audience Interactive Panel
Discussion with all presenters
5:00 Close of Pre-Conference Symposium
12:00 pm Registration
Symposium #3:
Best Practices in Managing Variability
of Raw Materials
Managing raw material variability is becoming
an increasingly important topic within the
biopharmaceutical industry. This symposium will discuss
best practices within process development, clinical and
commercial manufacturing, supply chain and quality to
ensure that the impact from raw material variability to
process performance and product quality is minimized.
1:00 Symposium Introduction and
Overview: Current Challenges in
Managing Raw Material Variability –
From Development to Commercial
CASE STUDY
UNPUBLISHED
DATA
The impact of lot-to-lot variability of raw materials on
process performance and product quality has gained
increased attention. This talk will provide an overview
of the strategies one can incorporate to effectively
manage the impact of raw material variability.
Examples will include development approaches to
minimize variability, as well as data analysis and
supply chain tools to manage variability.
Niall Carolan, Ph.D., Director of Manufacturing
Sciences, Human Genome Sciences, Inc.
1:30 Amgen’s Supplier Excellence Program
Ran Zheng, Ph.D., Executive Director, Plant Manager,
Amgen Inc.
2:00 Development of a Novel Chemically-
Defined Growth Media for CHO Cell
Applications: Coupling Raw Material
Quality and a Design of Experiments
Approach to Optimize Cell Culture
Media Performance
Michael A. Cunningham, Ph.D., Senior Research
Scientist, EMD Millipore
2:30 Networking Refreshment Break
3:00 Single Use Systems and the
Challenges They Present Regarding Raw
Material Quality and Management
Melissa Morandi, Vice President Quality,
Acceleron Pharma Inc.
3:30 Joint Presentation: How Can
Industry and Suppliers Work Together
to Identify Critical Raw Material
Attributes to Ensure More Consistent
and Reliable Performance?
David Radspinner, Ph.D., Director of Global Marketing
and Customer Applications, Thermo Fisher Scientific
and end-user to be announced
4:00 Audience Interactive Panel Discussion
sponsored by
How Can Industry and Suppliers Work
Together to Identify Critical Raw
Material Attributes to Ensure More
Consistent and Reliable Performance?
Panelists will discuss the potential for integration of
suppliers’ and end-users’ quality systems including
product safety data, change control and change
control notification and related topics.
Moderator:
Niall Carolan, Ph.D., Director of Manufacturing
Sciences, Human Genome Sciences, Inc.
Panelists:
Industry End-User to be named
Melissa Morandi, Vice President Quality,
Acceleron Pharma Inc.
David Radspinner, Ph.D., Director of Global Marketing
and Customer Applications, Thermo Fisher Scientific
Ran Zheng, Ph.D., Executive Director, Plant Manager,
Amgen Inc.
Additional End-users and providers to be identified
5:00 Close of Symposium
Symposium #4:
Regulatory Requirements in
Preclinical CMC Development
This symposium provides a comprehensive overview
of the FDA regulatory requirements applicable to
pharmaceutical research organizations during the
preclinical stages of drug development and the
preparation of an IND (Investigational New Drug)
application. The CMC (Chemistry, Manufacturing
and Controls) section of the IND application will be
reviewed in detail, and a short preview will be provided
of the regulatory process during clinical development.
The course is intended to provide participants from
all facets of the pharmaceutical and biotech industry
with a broad understanding of what is required from a
regulatory standpoint in early drug development.
Agenda to include:
• FDA structure and function
• The product development timeline from R&D to IND
• Good Laboratory Practice (GLP)
• Preclinical studies required throughout drug
development
• Good Manufacturing Practice
• GMP compliance throughout drug development
• The CMC section of the initial IND
• Regulatory compliance in CMO relationships
Instructor:
Bruce K. Burnett, Ph.D., RAC, Director of
Regulatory Affairs, Duke Translational Medicine
Institute, Duke University School of Medicine
Early Registration and Group Discounts are Available (see page 27) 6

Symposium #5: Best Practices in
Cleaning and Cleaning Validation
A Science-based and Integrated Approach
for Biopharmaceuticals
Room ???
In this symposium we will identify the elements of a
robust cleaning program for biopharmaceuticals. we will
then see how each element is systematically developed
and integrated to ensure successful implementation.
The symposium will cover current regulatory
expectations, science-based methodologies for cleaning
characterization, and the lifecycle approach to cleaning
validation and monitoring.
In addition to the fundamentals of cleaning,
this symposium will also cover the following
advanced topics:
Agenda to include:
• Unique cleaning challenges for multiproduct
bioprocesses equipment.
• Effective strategies for addressing these challenges
through planned small-scale studies.
• Degradation/inactivation studies and how they can
be used to eliminate product-specific assays and the
traditional MAC approach.
• Acceptance limits for degraded/inactivated product.
• Cleaning tenacious residues in bioreactors and media
tanks.
• The use of master soils to streamline and
provide flexibility for scheduling cleaning validation
activities.
Instructor:
Rizwan Sharnez Ph.D., Principal Engineer, Process
Engineering,
Amgen Inc.
Pre-Conference Symposia • Monday, October 8, 2012 • 1:00 pm - 5:00 pm
12:00 pm Registration
Symposium #7:
CMC Project Management
throughout the Product
Development Life Cycle
Room ???
The session will provide a comprehensive overview of
phase-dependent CMC activities and the role of CMC
teams in integrating development plans and facilitating
progress. Talks will cover different models for managing
CMC projects that are tied to company’s resources,
number of products, and phase of development.
Best practices in CMC PM be discussed in detail. The
symposium is intended to provide participants with a
broad understanding of the drug development process
from discovery to commercialization and how CMC-
PM can help integrate the strategic vision with tactical
implementation.
• Overview of Integrated Phase Dependent CMC
Development
• Best Practices in CMC Project Management
• CMC structure: One Size Does Not Fit All
• Bridging Discovery to Human Proof of Concept and
Commercialization
• CMC PM as a Career Path
Talks will be followed by a panel discussion which will
cover topics of interest to the audience and the speakers.
Agenda to include:
• Understand Product Development Life Cycle from a
CMC perspective
• Models for managing CMC activities throughout
development life cycle
• CMC PM organizational structures and functional
roles
• Risk Management processes to maneuver through
development hurdles
• CMC PM business processes, tools and templates
• Managing in-licensed products, partnerships, and
CROs
• Interactive discussions with peers and experts in
managing CMC development
Co-Chairpersons:
Seshu Tyagarajan, Ph.D., Associate Director, CMC
Project Management, ImClone Systems, a whollyowned
subsidiary of Eli Lilly and Company
Zahra Shahrokh, Ph.D., Biotech Product Development
Consultant, ZDev Consulting
Symposium #8:
Microbial Protein
Production Systems
Room ???
Microbial systems are being used to express a growing
number of early stage protein products, circumventing
issues such as viral clearance associated with CHO and
other mammalian platforms, offering lower media costs
and much shorter bioreactor run times. Virtually every new
“antibody-like” scaffold is selected for efficient microbial
expression, thereby facilitating discovery and manufacture.
While almost all approved antibodies and most of those
in clinical development rely on mammalian cell culture for
production, a rapidly growing number of smaller antibody
fragments, scaffold-based therapeutics and other proteins
are produced in microbial systems. These production
platforms include various bacterial hosts, several species of
yeasts, and other small eukaryotes. This session focuses on
recent advances and improvements to microbial systems
and case studies of protein production and manufacture.
Agenda to include:
• Gain an overview of microbial production systems.
• Understand key advantages and challenges of
bacterial and eukaryotic microbial hosts.
• Insights into the latest improvements to established
and novel microbial expression platforms.
• Learn from case studies of current protein products
manufactured by microbial process.
• Be prepared for increasing applications of microbial
systems for new products.
Chairperson:
David Bramhill, Ph.D.,
Research Corporation Technologies and
Bramhill Biological Consulting, LLC.
7 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

8:00
8:15
8:45
Optimizing Manufacturing
Operations
Chairperson’s Opening Remarks
Greg Liposky, Vice President and General
Manager, Site Operations, MedImmune
Operational Excellence - A Transformational
Culture Focused on Performance
OPEX activities focused on team performance and
process cycle time enabled debottlenecking of the
production critical path permitting the facility to
meet supply plan needs for multiple commercial
and clinical products. Approaching improvements
with a focus on learning from others coupled
with the speed of sharing to accelerate learning
is driving a positive transformational shift in the
manufacturing facility’s culture.
Chris N. Pacheco, Director Manufacturing,
Amgen Inc.
Flexible Manufacturing Solutions in
Multi-Product Facilities
Manufacturing facilities have to deal with a wide range
of processes (low-titer legacy and high-titer state of
the art) and tech transfer projects where each project
has its own set of priorities regarding speed, project
cost, COGs and risk. The situation in multi-product
drug substance plants producing multiple approved
products and handling multiple tech transfers per year
will be analyzed and examples of typical challenges
and the corresponding solutions will be given.
Markus Wollenberg, Ph.D., Director,
Manufacturing Sciences and Technology,
Biopharma Operations, Boehringer Ingelheim
Pharma GmbH & Co. KG, Germany
Risk-Based Approaches to Cross
Contamination Prevention in
Multi-Product Facilities
Contemporary biopharmaceutical multiproduct
facilities are continuing to advance new flexibilities
in layouts and in the combinations of products,
product classes, host-cell types, and product
hazards within those facilities. The presenters
will share their proven practices for selecting
different quality risk management tools in order
to successfully identify and control crosscontamination
hazards across a variety of facility
designs and multiproduct operating schemes.
Stephen Reich, Director, Quality Systems, and
Kristin Murray, Associate Director, Global CMC
Regulatory Affairs, Pfizer Inc.
Tuesday, October 9, 2012
7:00 Registration and Coffee
9:15
Enhancing Manufacturing
and Development Efficiency
Product Lifecycle Planning:
Innovative Solutions to Meet
Quality and Process Challenges
Performance by Design:
Mapping and Controlling Critical
Quality Attributes
Chairperson’s Opening Remarks
Sarah Thomas, MBA, Vice President, Quality,
Human Genome Sciences, Inc.
Roadblocks in CMC: Improving your
Quality Submissions throughout the
Product Lifecycle
While the outcome of a clinical trial is never
certain, the quality of the therapeutic protein in
that clinical trial should be under the complete
control of the sponsor. Too often the quality
submission is lacking data or clarity resulting in
an IND hold, a delay in approval of a BLA or a
post-marketing change. This presentation will
highlight roadblocks and speed bumps that occur
throughout the product lifecycle
Marjorie A. Shapiro, Ph.D., Chief, Laboratory
of Molecular and Developmental Immunology,
Division of Monoclonal Antibodies, US FDA
From QbD to Control Strategy
The development of a product control strategy is
not a new concept but should be the culmination
CASE
of the product development lifecycle. The ICH
quartet (Q8, Q9, Q10 and Q11) along with
STUDY
the recently issued FDA guidance on process
validation stress the importance of linking the
product development life cycle with control strategy.
The linkage of product development to ultimate
commercial control strategy is achieved through a
series of structured risk assessments. This talk will
focus on risk management approaches including
examples used in Pfizer and how the output of this
leads to definition of a product control strategy.
Paul B. McCormac, Ph.D., Senior Manager,
Bio-manufacturing Sciences Group,
Pfizer Global Supply, Pfizer Inc.
Advanced Process Modelling
Tools for Innovative Technology
Assessment at Merck & Co, Inc
CASE STUDY
This presentation will examine the use of
advanced process modelling tools to support
critical decision making in the evaluation of
innovative technologies. This will be illustrated
through a case study based on functionalized porous
media chromatography platforms (membrane and
structured hydrogels). Presentation will conclude
with forward looking process modelling techniques
to describe novel unit operations such as continuous
porous media chromatography.
James Velez, Senior Process Engineer, Global
Engineering Services, Merck & Co., Inc.
Miriam Monge, Vice President,
Biopharm Services Ltd, United Kingdom
Chairperson’s Opening Remarks
Nadine M. Ritter, Ph.D., Senior CMC
Consultant, Biologics Consulting Group
Paradigms for Biotech/Biosimilar
Product Characterization and
Comparability
Comprehensive characterization has long been a
key feature of biotechnology product development.
Advances in process design coupled with orthogonal
analytical technologies enhance understanding
of process consistency and product quality.
Characterization methods are also used to show
‘developmental continuity’ through appropriate
comparability studies from early development through
commercialization. Post-market comparability studies
also utilize analytical characterization tools to support
implementation of further process improvements.
And now, the emergence of biosimilars requires
challenging analytical characterization strategies as
one part of assessing similarity between products.
This presentation will illustrate the biotechnology
product characterization and comparability paradigm
for each of these applications. It will highlight
emerging analytical tools for characterization, and
share common mistakes made in process and product
comparability studies.
Nadine M. Ritter, Ph.D., Senior CMC
Consultant, Biologics Consulting Group
Applying Quality by Design
Principles to Analytical Development
Quality by design principles are often used in
vaccine manufacturing to understand process
steps that influence final product quality. Similar
principles can also be applied to analytical
development with the goal of minimizing method
variation and increasing method robustness.
Examples of an assay target profile, risk analysis,
selection of assay design space and design of
experiments will be presented.
Marc Thorsteinsson, Ph.D., Research Fellow,
Merck and Co., Inc.
Process Validation by NMR –
Detection and Qualification
of Process Impurities in
Complex Solutions
9:45 Networking Refreshment Break
Analytical Technologies
for Biopharmaceutical
Development
UNPUBLISHED
DATA
Detection of a broad range of process
impurities in protein containing process pools
is challenging due to interference from protein,
buffer components, and water. Using a CPMG
sequence to attenuate protein signals, we are able
use NMR as a general method to quantify organic
impurities in protein based biopharmaceutical
products. This approach works for both expected
and unexpected impurities.
Ken Skidmore, M.S., Associate Scientist,
Genentech, Inc.
Antibody Drug Conjugate
Development & Production
Chairperson’s Opening Remarks
Deborah Meshulam, M.S., Director, Contract
Manufacturing, ImmunoGen, Inc.
Keynote Address
Getting Trastuzumab Emtansine
(T-DM1) from the Lab-Bench to the
Pharmacy Shelf
Fred Jacobson, Ph.D., Principal Scientist,
Genentech, Inc.
Bioassays for ADCs with
Antibodies having Inherent
In Vitro and In Vivo Cell
Killing Activity
CASE STUDY
UNPUBLISHED
DATA
All antibody-maytansinoid conjugates
have antibody binding activity
and cytotoxic activity from the conjugated
maytansinoid. Some conjugates have additional
activities such as ADCC, CDC, and inherent
apoptosis-inducing activity from the antibody.
Examples of antibody-maytansinoid conjugates
having various activities will be presented
with proposals for release, stability and
characterization testing.
Xiangyang Xu, Ph.D., Principle RA, Translational
Research, ImmunoGen, Inc.
Analytical Approaches to
Support Development of Antibody
Drug Conjugates
Samadhi Vitharana, Senior Scientist, Takeda
(invited)
Early Registration and Group Discounts are Available (see page 27) 8

10:15
10:45
11:15
Enhancing Manufacturing
and Development Efficiency
Single Use and Simplicity – Three Years
in at Shire HGT
Paul Slaman, Associate Director, Manufacturing
Technical Services, Shire Human Genetic Therapies
Cleaning Validation Challenges
for Bioprocesses: Leveraging
Cleaning Characterization to
Streamline New Product Launches
Tuesday, October 9, 2012
CASE STUDY
UNPUBLISHED
DATA
Strategies for addressing cleaning validation
challenges for bioprocesses will be presented. The
strategies are rooted in systematic and proactive
approaches to cleaning. Several approaches, including
performing small-scale cleanability studies to minimize
at-scale cleaning validation studies, the use of master
soils to streamline and provide flexibility for scheduling
cleaning validation activities, and leveraging inactivation
studies to obviate the need for product-specific assays
and MAC assessments, will be discussed.
Rizwan Sharnez Ph.D., Principal Engineer,
Process Engineering, Amgen Inc.
Co-authors: Michelle Monk, Laura Klewer,
Chris Flint, Arun Tholudur Ph.D., Amgen Inc.
Optimizing Changeover in a Large
Scale Multi Product Bioprocess Plant
MedImmune’s Manufacturing Center in Frederick,
Maryland recently transitioned from a steady,
single product facility to a fast-paced, clinical/
commercial multiproduct facility. Senior
leadership challenged the site to optimize change
over from its early cycle time of 28 days to 14 days
or less. Join us to review the cross-functional work
and operational excellence tools that successfully
drove change over optimization.
Chad Briggs, Senior Manufacturing Manager,
MedImmune
Product Lifecycle Planning:
Innovative Solutions to Meet
Quality and Process Challenges
Life Cycle Management - A Case
Study Using a Novel Protein
Eli Lilly has built, qualified and validated a new
state of the art facility in Kinsale, Ireland. The
subject of this presentation is a novel protein that
was the first molecule validated in this facility. The
talk will highlight the approach taken to incorporate
the new FDA guidance document and current
European perspectives and the business drivers of
global supply chain on process validation, the quality
systems for lifecycle management and discuss the
approach being taken for continuous verification.
Graham McCartney, Ph.D., Technical Services Lead
Biotechnology, Eli Lilly S.A., Ireland
Considerations and Challenges
when Evaluating Vials and
Stoppers as Part of Parenteral
Product Container Closure System
Selecting vial and stopper combinations
with optimal fit can be challenging. Issues during
manufacturing can negatively impact process
productivity and timelines, and proper closure
integrity is of utmost importance. Data will be
shown which demonstrates such challenges and
recommendations will be made on how to evaluate
material attributes and dimensions in order to
implement proper control strategies.
Melissa D. Perkins, Ph.D., Senior Director,
Drug Product Sciences, Human Genome Sciences, Inc.
Strategies for Continued Process
Verification – A Lifecycle Approach
to Quality by Design (QbD) and
Process Validation
CASE STUDY
CASE STUDY
UNPUBLISHED
DATA
CASE STUDY
UNPUBLISHED
DATA
As per the new FDA process validation guidance, the
third validation stage describes a lifecycle approach to
continually assure that the process remains in a state
of control (the validated state) during commercial
manufacture. This presentation will describe strategies
and approaches to implementing a continuous
monitoring and continuous improvement program
consistent with QbD principles applied to earlier stages
such as process design.
Kumar Dhanasekharan, Ph.D., Associate
Director, Process Sciences and Technology,
Genzyme, a Sanofi company
Analytical Technologies
for Biopharmaceutical
Development
Developing an Extractable/
Leachable Program
E&L studies are a required part of license
pplications, but can be challenging for biotech
companies due to lack of infrastructure and
experience. In addition to testing of container
closure materials, the evaluation process at HGS
included a risk assessment for contact materials of
the manufacturing and filling processes to determine
which additional components required testing.
Studies were performed utilizing a combination of
external services and a buildup of internal capabilities.
Helmut Schneider, Ph.D., Principal Scientist,
Analytical Sciences, Human Genome Sciences, Inc.
CASE STUDY
Automated Analytics, Data
Reduction, and Data Management
In order to meet the demands of high sample
numbers and large amounts of data in short
periods of time produced in the Automated
Analytical laboratories, we have developed, and
are evolving, a work stream for sample submission
and tracking, analytical quality, and data
management that requires less "hand-on" time to
allow analysts to focus more time in the labs.
Kristine M. Kearns, Senior Research Biochemist,
Vaccine Analytical Development,
Merck and Co., Inc.
Preliminary Characterization
of a Novel Class of Multi-Specific,
Multi-Valent Therapeutic
Zybodies are a novel class of multi-specific
antibodies that consist of short molecular
recognition domains fused to the termini
of mAbs. The presentation will discuss the
expected attributes and behavior of Zybodies,
the analytical approaches and challenges used
to monitor them, along with a comparison to
mAbs and other bispecific molecules.
Rajesh Krishnamurthy, Ph.D., Director,
Pharmaceutical Development, Zyngenia, Inc.
Antibody Drug Conjugate
Development & Production
Antibody Drug Conjugate Process
Development Considerations
Mark Itterman, Senior Manager, Process
Development, Millennium Pharmaceuticals, Inc.
Approaches to Improve Efficiency
and Speed to the Clinic for Antibody
Drug Conjugates
John Moscariello, Ph.D., Principal Scientist,
Purification Process Development, Amgen Inc.
Regulatory Considerations for the
Manufacture, Characterization and
Quality Assurance of Antibody-Drug
Conjugates
Since the first IND for an antibody-drug conjugate
(ADC) was submitted almost 20 years ago,
only two ADCs have been approved; Mylotarg
in 2000 and Adcetris 2011. During that time,
improvements in the conjugation chemistry result
in ADCs with improved serum stability. New and
improved analytical methods allow a more precise
characterization of the ADC. This presentation
will focus the regulatory approach to ADCs from
the drug and biologics review perspectives.
Marjorie A. Shapiro, Ph.D., Chief, Laboratory
of Molecular and Developmental Immunology,
Division of Monoclonal Antibodies, US FDA
11:45 Concurrent Technology Workshops
What’s Next in
Meeting Marketplace
Single-Use Vs.
Early Process Development
Fed-Batch Cell Culture?
Needs - Rapid
Multi-Use Equipment:
Integrating Chemically
The history of fed-batch as a method of producing Development of Robust
An Environmental Life Cycle Assessment Defined Supplements and Feeds
proteins in CHO cells is remarkable with respect to
the progress made in a relatively short period of time.
Within the past decade we have progressed from
IgG titers in the milligram per liter range to current
routine yields of multiple grams per liter. The latter
have been achieved by both sophisticated feeding
strategies and cell line engineering. This workshop
will provide data related to recent improvements in
the various elements that impact fed-batch culture
and how one can maintain flexibility in scale-up
Peggy Lio, Senior Process Science Fellow, Gibco®
PD-Direct Bioprocess Services, Life Technologies
Manufacturing Processes
As the biopharmaceutical industry matures,
outsourcing has become an integral part of production
strategies including a shift towards the outsourcing
of research and process development activities. For
contract manufacturing organizations, innovation and
providing custom solutions has become ever more
important. We will outline aspects of our current
process and analytical development activities to meet
the needs of the biomanufacturing market.
Greg Adams, Ph.D., Section Leader, Analytical
Development, Fujifilm Diosynth Biotechnologies
of an Entire mAb Production Process
This cradle-to-grave environmental study compares
single-use vs. traditional process equipment for
the production of monoclonal antibodies at 100L,
500L and 2000L scales. The study results show
that, for the conditions explored in this study,
the single-use process technology exhibits lower
environmental impact by reducing or eliminating
the need for large quantities of steam, process
water, and water for injection.
Jeffrey Carter, Ph.D., Director of Research &
Development, GE Healthcare Life Sciences
Elizabeth C. Dodson, Ph.D., Advanced
Bioprocessing, BD Biosciences
12:15 Luncheon Presentation
“Open Sourcing” – Increasing Options to Meet the Challenges of Drug Development and Manufacturing
Developing and implementing a manufacturing process for clinical scale material involves many steps, requiring knowledge, expertise and resources. In this presentation we introduce the concept
of “Open-Sourcing,” an alternative view of how such knowledge, expertise and resources can be accessed and delivered to speed the journey to the clinic. This presentation will highlight through a
case study how a solutions-based approach enabled the development of a clinical manufacturing process for a new drug in parallel with the construction of a new clinical manufacturing facility.
Richard Pearce, Director of Strategy Development, BioPharm Process Solutions, EMD Millipore
Sponsored by:
9 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

Tuesday, October 9, 2012 (continued)
1:30 Thought Leadership Forum Co-Sponsored by:
1:30
1:45
2:15
2:45
Smart Solutions for Early Development & Manufacturing of Biopharmaceuticals: How CMO’s Can Help Product Companies be Successful (See more details on p.21)
Enhancing Manufacturing and
Development Efficiency
Impact of Raw Material Variability and
Reliability on Supply Chain and Development
Chairperson’s Remarks
Ran Zheng, Ph.D., Executive Director, Plant Manager, Amgen Inc.
Mitigating Risk in the Raw Material
Supply Chain
A raw material supply issue can take down your supply
chain resulting in lost production days, increased COGS,
scrapped inventory, product recall, and in extreme
situations result in your product not being available for sale to
the market. How well do you understand your supply base and
relative risks from one part and one supplier to the next and
what are you doing to mitigate this risk? A holistic approach to
assessing risk, developing appropriate and feasible mitigations,
and dynamic monitoring of emerging risks is essential.
Craig Malzahn, Director, Supply Chain, Human Genome Sciences, Inc.
CASE STUDY
UNPUBLISHED
DATA
Applying Process Analytics towards Controlling Raw
Material Variation: Strategic Directions at Suppliers
and in the Biologics Manufacturing Industry
Challenges in identifying, monitoring and control of raw
material variability exist in biopharmaceutical industry. Insightful
strategies focusing on process analytics applied to raw materials
variation monitoring and control will be provided. Approaches at
the supplier’s end and at the manufacturing end are summarized.
Cenk Undey, Ph.D., Director of Process Development, Amgen Inc.
Understanding Supply Chain Complexities for Raw
Materials and Single Use Systems
Bob Repetto, M.S., MBA, Research Fellow, External Affairs,
Pfizer BioTherapeutics Pharmaceutical Sciences and Chair,
PDA Single-Use Systems Task Force
Product Lifecycle Planning:
Innovative Solutions to Meet Quality
and Process Challenges
Process Innovation and Regulatory
Submission Strategies
Chairperson’s Remarks
Joanne T. Beck, Ph.D., Vice President, Process Development,
Shire Human Genetic Therapies
Process Innovation and Regulatory
Submission Strategies
Even though we work in a very regulated industry it doesn’t
mean we can’t be innovative in our manufacturing environment,
supply chain and regulatory filings. During my talk I will discuss
tools and techniques which can be used to foster an innovative
environment as well as examples where innovation has been
demonstrated in our industry in manufacturing, supply chain and
regulatory dossiers.
Robert O'Hagan, Director Quality Operations,
Abbott Bioresearch Center
Regulatory Considerations for
Implementing Innovation
Biotech innovation, unlike incremental improvements, is
the implementation of a better alternative and represents
change from the norm. In regulated biotech environment,
such advancements are incremental and deliberate that requires
development time and supportive technical data. Whereas
comparability is cornerstone of implementing lifecycle changes, a
sound foundation of process and product knowledge facilitates
regulatory agency approvals. Examples will be discussed.
Andrew Papas, Ph.D., MBA, Director of Regulatory Affairs,
Pharmaceutical and Biologics Practice, Becker & Associates
Consulting, Inc.
A Rapid QBD Based Response to Annual Seasonal
Influenza Vaccine Changes
Protein Sciences Corporation’s platform technology utilizes a
recombinant protein approach for generating vaccines. PSC
leverages a QBD based process for large scale production of
vaccines in less than 50 days from identification of the target virus.
During the presentation, the speaker will discuss a case study
focusing on the rapid modification of the seasonal influenza vaccine
(FluBlok) to accommodate the 2012-2013 virus strain change.
Robert R. Boulanger, Ph.D., Manager, USP Development,
Product Realization, Protein Sciences Corporation
3:15 Grand Opening of Poster and Exhibit Hall with Refreshments Sponsored by:
Keynote Presentations
5:45 Networking Reception in Poster & Exhibit Hall
7:00 BioProcess InternationalTM Award Dinner and Ceremony (see page 14)
CASE STUDY
UNPUBLISHED
DATA
Specialty Focus Track
Antibody Drug Conjugate
Development & Production
Chairperson’s Remarks
Deborah Meshulam, M.S., Director, Contract Manufacturing,
ImmunoGen, Inc.
Characterization of Stress-Related
Degradants in Antibody-Drug Conjugate
Formulation Development
UNPUBLISHED
DATA
Characterization of impurities and degradants for biologics
is an ICH recommendation for New Drug Application.
Characterization of ADC provides a unique analytical challenge
as impurities/degradants can be derived from the protein, the
linker or the drug-linker. Here we present our strategies on the
generation and characterization of these stress-related degradants
for both mAb and ADC during formulation development.
Stanley Kwok, Ph.D., Senior Scientist, Formulations,
Fill/Finish, Seattle Genetics
Complexities Associated with Scale Up and
Transfer of a Conjugated Process
ImmunoGen develops conjugates consisting of one of its
proprietary derivatives of the cytotoxic agent maytansine attached
to tumor-targeting antibodies. The conjugation process is complex
which involves development and transfer of both small and large
molecules. Key process parameters can be identified and controlled
thus minimizing uncertainty in the transfer and scale-up effort.
Deborah Meshulam, M.S., Director, Contract Manufacturing,
ImmunoGen, Inc.
ADC Manufacturing Facility Design – Current
Requirements and Flexibility for the Future
Given that ADC technology is still evolving, collaboration with
customers early and often in the facility design phase is essential
to define requirements. A robust facility design addresses current/
potential customer needs, cGMP facility quality requirements
and safety aspects for high potent compound handling. New
technologies in equipment and instrumentation enable flexibility
for the future.
Bill Seaton, MBA, Vice President, Operations, SAFC
4:00 Chairperson’s Remarks Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
4:15 Successfully Partnering Pharmaceutical Manufacturing
5:00 Targeted Development of a Biosimilar Using Quality
throughout Product Lifecycle
by Design Concepts
In a unique business development deal, MedImmune and Merck have entered into a
The primary goal in biosimilar development is to deliver products which
15-year manufacturing capacity-sharing agreement that initially utilizes MedImmune’s
are highly similar to the originator product. Comparable safety and efficacy
Frederick, Md., facility for Merck Biotech bulk product manufacturing. The agreement
need to be demonstrated in an extensive comparability exercise. This talk
serves to grow MedImmune’s manufacturing capabilities, while providing Merck with world class
will discuss how QbD concepts can serve as key enablers for successful development of a
manufacturing capability and capacity for its novels and biosimilars pipeline. In this presentation we will
biosimilar product. In a systematic approach, development targets are defined based on
highlight both the deal structure and execution as an industry best practice. The platform of the agreement, originator product data with the comparability exercise in mind. A science- and risk-based
which allows for joint capacity planning, represents a strategic long-range solution that addresses capacity approach combined with product and process understanding enable to set the right priorities
issues within the industry. While it is not unusual for bio-pharmaceutical companies to share manufacturing throughout product development in order to finally achieve a highly similar product.
capacity, it is less common for two companies to jointly plan for capacity utilization in a facility built and
owned by one of the parties. The companies are also exploring the suitability of Merck’s facilities in the
production of microbial-based compounds in MedImmune’s pipeline, and other potential manufacturing
opportunities where business strategies intersect.
John Stubenrauch, MBA, Ph.D., Head of External Commercialization and Operations, Biologics,
Merck & Co., Inc.
Thomas Stangler, Ph.D., Development Strategy and Technology Manager,
Sandoz Biopharmaceuticals, Austria
Early Registration and Group Discounts are Available (see page 27) 10

Achieving Rapid Process
Development and Novel
Technology Implementation
Session Sponsored by:
Chairperson’s Opening Remarks
Jon Petrone, Vice President, Technical Services,
Pall Life Sciences
Challenges of Concurrent Multi-
Product Manufacturing of Bulk Drug
Substances in a Ballroom Environment
This presentation will discuss the challenges and
benefits of reduced levels of environmental controls
for concurrent multi-product manufacturing within
a ballroom facility concept. Design, operational,
organizational and testing challenges will be
addressed with solutions to mitigate identified risks.
Mitigation will include quality risk management
approaches and assurance of closed processing via
the integrity of equipment design, procedural and
operational controls. Benefits extend to realizing
facility capacity and reducing operational costs whilst
maintaining product quality and operator safety.
Kenneth D. Green, Ph.D., Director,
Operational Excellence, Pfizer
Simon Chalk, Director, BioPhorum
Operations Group
Electronic Visual Factory: Enhance
Operational Excellence through
Visualization and Mobility
Wednesday, October 10, 2012
7:00 Networking Coffee
7:30 Technology Workshop with Light Continental Breakfast Sponsored by:
8:00
8:15
8:45
Enhancing Manufacturing
and Development Efficiency
CASE STUDY
Electronic Visual Factory is a means
of finding innovative ways of making
information available and useful. Today’s
biopharmaceutical factory produces a vast
amount of data that can be used to make better
process and business decisions. Discover ways to
improve process monitoring, achieve paperless
manufacturing, enhance “purposeful presence
on-the-floor”, improve business communications
and increase efficiency through mobile solutions.
Fernando Nuno Fialho, Senior Manager,
Manufacturing, Amgen Inc.
Product Lifecycle Planning:
Innovative Solutions to
Meet Quality and Process
Challenges
Advancing the Science
of Comparability: Cost-
Effective Approaches for the
Implementation of Process
Change through the Lifecycle
Chairperson’s Opening Remarks
Victor A. Vinci, Ph.D., Chief Scientific Officer
and Vice President, Cook Pharmica
TBA
Comparability Strategies
for Bioproducts
Changes to pharmaceutical processes
or products may be implemented at any
stage of development or post-licensure,
and have the potential to impact product
quality. Regardless of the nature of the change,
quality assessments are always conducted to
demonstrate the comparability of pre- and postchange
material. The purpose of this talk is to
discuss the approaches to establishing analytical
comparability of bioproduct drug substance
and drug product solutions, including risk
assessments, establishing acceptance criteria and
designing the appropriate stability studies for pre
and post change material.
Sarah Demmon, Senior Research Scientist,
Bioproduct R&D, Eli Lilly and Company
UNPUBLISHED
DATA
Specialty Focus Track
Viral Safety for Biologics
Chairperson’s Opening Remarks
Hannelore Willkommen, Ph.D., Regulatory
Affairs and Biological Safety Consulting, Germany
Demonstration of Consistent
and Robust Retrovirus Removal
by Parvovirus Filter...A Co-spiking
Approach to Support Modular
Clearance for IND/CTA Filing
Dayue Chen, Ph.D., Research Advisor,
Process Development, Eli Lilly and Company
UVC Based Viral Inactivation
of Cell Culture Media –
Prototype Design and
Experimental Verification
CASE STUDY
UNPUBLISHED
DATA
UNPUBLISHED
DATA
A novel high-throughput UVC treatment
device for cell culture media was designed using
computational modeling techniques. With
high UV absorbances of cell culture media,
the primary challenge was to accomplish a
sufficiently narrow UVC dose distribution at
high flow rates to allow for media preparation
in a reasonable time for a perfusion culture. A
prototype was built and experimentally verified
using chemical actinometry techniques with
fluorescent microspheres in media that undergo
photobleaching corresponding to UVC dose. The
results indicate a viable device and technology for
successful treating of cell culture media with high
throughput requirements for perfusion culture.
Kumar Dhanasekharan, Ph.D., Associate
Director, Process Sciences and Technology,
Genzyme, a Sanofi company
Mixed Mode
Chromatography
Strategies for
Biomolecule Purification
8:00 am - 12:00 pm
Maximizing Downstream
Process Method
Development
A majority of monoclonal antibodies
are purified using affinity on protein A.
For each non-antibody therapeutic in
today’s pipeline, the lack of an affinity
capture increases the burden on every
step of the downstream process to
achieve final product purity. Mixed mode
media have a significant role in polishing
for monoclonal applications, and are
now being leveraged into capture,
intermediate and polishing steps for new
protein therapeutics.
Case studies and topics to
be presented:
• Mixed mode interactions
• Implications for protein purification
• Strategies for method development
• Application of mixed mode chromatography
in biomolecule purification
This forum will offer detailed
understanding of mixed mode
interaction mechanisms, key benefits in
bioprocessing, applications and how to
develop a robust process using a mixed
mode chromatography media.
Visit www.IBCLifeSciences.com/BPI for
complete session details on case studies
presented by key industry leaders.
Hosted by:
11 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

9:15
10:30
11:00
11:30
Enhancing Manufacturing and
Development Efficiency
Challenges of Managing Multiple Clinical and
Commercial Tech Transfers to an Existing High-Run
Rate Commercial Manufacturing Facility
Introduction of new processes into an established, high run rate
commercial manufacturing facility can pose significant logistical and
technical challenges. In addition to ensuring the success of the new
product introduction, careful consideration is required to ensure the
fidelity of the existing process is maintained and the established plant
capability and run rate is not disturbed. Simultaneous tech transfers
for multiple processes with differing levels of process and scale-up
experience add to the management complexity. This presentation will
summarize these challenges and the approaches taken to mitigate
any potential impact and maximize tech transfer success.
Gregory R. Naugle, Director, Process Development, Amgen Inc
Wednesday, October 10, 2012
9:45 Networking Refreshment Break in Poster and Exhibit Hall Sponsored by:
Product Lifecycle Planning:
Innovative Solutions to Meet Quality
and Process Challenges
10:30 Thought Leadership Forum Sponsored by:
Reducing the Risk of a Contamination Event Due to Raw Materials (See more details on p.21)
Microbial Contaminations:
The Fundamentals of Prevention
Microbial contaminations are a reality for the Biotech
industry. They are costly to an organization in many ways:
financially, lost time in production, unplanned resource
allocations, and elevated compliance risk. This presentation
and interactive discussion will focus on the basic fundamentals
to preventing opportunities for microbial ingress into process
equipment and/or processing environments. The presentation will
cover aspects related to facility design and operation, personnel,
equipment design and operation, and material/process flow. The
discussion will include a case study where data analysis was used
to identify areas where prevention measures were implemented,
resulting in a significant reduction in contamination rates.
Phil McDuff, Director, Global Engineering
and Facilities, Biogen Idec
Volume Reduction Strategies Using Single-Pass
TFF to Accommodate Higher Titers, Multi-Product
Processing, and Tank Volume Limitations
Presenter to be announced
Application of Innovative Technologies to
Develop Disruptive Continuous
Bioprocessing Platform
UNPUBLISHED
DATA
CASE STUDY
UNPUBLISHED
DATA
In the current environment of diverse product pipelines,
rapidly fluctuating market demands and growing
competition from biosimilars, biotechnology companies are
increasingly driven to develop innovative solutions for highly flexible
and cost effective manufacturing. To meet these challenging demands,
integrated continuous processing, comprised of high-density perfusion
cell culture and a directly coupled continuous capture step, can be
used as a universal biomanufacturing platform. This study highlights
the significance of using innovative technologies to develop robust,
disruptive solutions such as continuous bioprocess platform.
Veena Warikoo, Ph.D., Associate Director, Purification
Development, Genzyme, a Sanofi company
Co-authors: Rahul Godawat, Daniel Geoffrey Cummings, Sujit Jain,
Kevin Brower, Mahsa Rohani, Konstantin Konstantinov and
Frank Riske
Comparability and Biosimilarity: Two Sides of the
Same (or a Different) Coin?
Biosimilarity between a follow-on biomolecule and its innovator
counterpart relies upon many of the same principles as does the
demonstration of comparability between pre- and post-change
biotech products by an innovator company; however, there are
important differences. This presentation will address both the
similarity and the differences between the two paradigms. In
addition, the application of QbD principles to drug development
for both paradigms will be discussed.
Stephen C. Hosselet, Ph.D., Director,
Global Analytical Sciences, Amgen Inc.
Understanding the Innovator to Drive Development
of a Biosimilar
Joseph McClellan, MBA, Ph.D., Director, Bio-enhancement
Development Unit, Pfizer Inc.
Featured Presentation
Understanding FDA’s Regulation of Biosimilars
Thinking about developing a biosimilar protein product for the
US market? In February, 2012, the FDA issued draft guidance
delineating some of the regulatory expectations for biosimilars,
covering over-arching scientific considerations as well as
specific analytical, nonclinical, and clinical approaches for the
demonstration of similarity to a US-licensed reference product. This
talk will offer insights into FDA’s overall approach to the regulation
biosimilars with emphasis on the evaluation of molecular similarity.
Emily Shacter, Ph.D., Consultant, ThinkFDA, LLC; former Chief,
Laboratory of Biochemistry, Division of Therapeutic Proteins,
Office of Biotechnology Products, CDER, FDA
Post-Approval Changes of Biosimilar
Products: A Case Study
The global regulatory framework established for the
management of post-approval changes for originator
biologic products is relevant to the management of
these changes for biosimilar products. The foundation of this
regulatory framework is a well-designed comparability exercise
that compares the quality attributes of a biologic product before
and after a change. In this talk, a comparability case study for a
post-approval site and scale change for a biosimilar product will
be discussed.
Goran Valinger, Ph.D., Director, Technical Support,
Hospira Zagreb, Croatia
CASE STUDY
UNPUBLISHED
DATA
Specialty Focus Track
Mixed Mode Chromatography
Approach for Viral Clearance
Dan Bezila, M.S., Senior Associate Scientist,
API Large Molecule Development,
Janssen Research & Development, LLC
UNPUBLISHED
DATA
Risk Mitigation Strategies for Non-Enveloped Viral
Contaminants
Small, non-enveloped viruses represent a critical challenge to the
biologics industry. Recent contamination events with porcine
circovirus, vesivirus 2117 (a calicivirus), and murine minute virus
(a parvovirus) underscore the concern. The challenge is due to
the fact that these viruses are extremely resistant to physical and
chemical inactivation and consequently survive such treatments as
extremes of pH, high temperature, solvent/detergent, and gamma
irradiation that readily result in the inactivation of the more fragile
lipid-enveloped viruses. This presentation will review the clearance
that may be achieved for these viruses using a variety of procedures.
The discussion will also highlight the screening and treatment of
raw materials, facility process flow, and facility cleaning validation
studies as complementary strategies for coping with these viruses..
Jeri Ann Boose, Ph.D., Director of Biopharmaceutical Services,
Eurofins Lancaster Laboratories, Inc.
Regulatory Prospective on New Trends and
Developments
Hannelore Willkommen, Ph.D., Regulatory Affairs and
Biological Safety Consulting, Germany
Dealing with Inconsistent Results from Testing
Labs that are not Comparable – Who Do You
Trust? What Do You Do with Those Results?
What are the Regulatory Implications?
Norbert Schuelke, Ph.D., Director, Millennium Pharmaceuticals Inc.
Early Registration and Group Discounts are Available (see page 27) 12

Wednesday, October 10, 2012 (continued)
12:00 Concurrent Technology Workshops
1:45
2:00
2:30
3:00
“Out of the Box” Thinking for
Process Chromatography
ReadyToProcess TM chromatography solutions provide
a novel and integrated concept for clinical production
campaign use. ÄKTA TM ready’s disposable flowpath
and ReadyToProcess pre-packed columns ensure that
a clean, verified, complete chromatography solution is
“out of the box” ready for operation. This workshop will
focus on usability, quality, flexibility, and the scalable
performance of the systems and columns including
recently added gradient chromatography capabilities.
Fredrik Lundstrom, Manager, ReadytoProcess
Chromatography, GE Healthcare Life Sciences
Plenary Session
Evolving Paradigms in
Cell Culture Media
Chairperson’s Remarks
Thomas Seewoester, Ph.D., Executive Director, Clinical Drug Substance Manufacturing, Amgen Inc.
Implementation of Quality by Design for a
Monoclonal Antibody Therapeutic
Andrew Kosky, Ph.D., Associate Director, Purification Development,
Genentech, Inc. – A Member of the Roche Group
John F. Menton, PhD.
Global Cell Culture Applications Manager,
Kerry Inc.
Case Study of a Viral Contamination at Genzyme and
Steps Taken to Mitigate Future Risk
Manufacture of biological therapeutic products is associated with the potential
risk of process and product contamination by adventitious viruses and other
microbial agents. Manufacturers typically control for this risk by careful raw
material selection, vendor qualification, raw material and cell bank testing, raw material treatment for
viral clearance, and risk assessment. This presentation will review Genzyme’s vesivirus case and discuss
viral remediation approaches as a means to mitigating the risk due to adventitious agents.
Kris DeSmet, Ph.D., Lead Cell Culture Operational Technical Support, Genzyme, a Sanofi
Company, Belgium
Biologics Manufacturing Facility of the Future
Recent advances in disposable technologies using closed systems in addition to
high titer yields and personalized medicine have changed mammalian cell culture
technology and plant design leading to simple, inexpensive plant set-up and low
cost of goods manufacturing of protein drugs. The presentation will describe
concepts, design as well as operation of disposables based standard as well as ballroom like, low
segregated, flexible facilities based on single use bioreactors as well as discuss the technical and
regulatory requirements for implementation.
Berthold Boedeker, Ph.D., Chief Scientist; Head, Cell Culture and Pilot Plants,
Bayer Pharma AG, Germany
CASE STUDY
CASE STUDY
Optimize Downstream Purification
Processes: New Approaches and Benefits
to Bioprocess Chromatography
Learn how high capacity, high resolution and salt
tolerant ion-exchange resins can help revolutionize
your approach to bioprocess chromatography. We
will discuss the benefits of IEX resins to downstream
purification processes, including increased process
flexibility and productivity while providing high
impurity clearance. Applications data and process
modeling will be used to demonstrate the benefits
of POROS® chromatography resins.
Shelly Cote Parra, MSc., Senior Field Application
Scientist, Bioproduction/POROS, Life Technologies
12:30 Networking Luncheon in Exhibit and Poster Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their posters for discussion.
Improving Predictability with Developability Assessments and
Speed with High Throughput Screening Methods
Chairperson’s Remarks
Thomas Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.
The Use of Miniaturization and High Throughput Screening for
Purification Process Development – A Case Study Comparison of
Different Techniques and Formats
Recovery & Purification
Innovative Concepts and Technologies
in Virus and Contaminant Clearance
The essential role of bioseparation can be
reframed to the task that all process- and
product-derived contaminants are removed
below specified values. Today's polishing
operations represent high-end technologies and
integrated concepts that allow for reliable virus
and contaminant clearance combined with high
productivity and favourable process economics.
Case studies of modern polishing platforms
and new strategies will be discussed during the
presentation.
Juan Pablo Martinez, Ph.D., Project Manager,
Polishing Operations, Sartorius Stedim Biotech
CASE STUDY
UNPUBLISHED
DATA
Several different microscale methods are available for high throughput protein purification
applications. These methods offer the potential for decreased time and material required for
process development. In this study, batch incubations, micropipette tips, and miniature columns were
compared with each method evaluated in the context of both platform purification adaptability and
fermentation support. Recommendations are provided for the appropriate utilization of each technique.
John Welsh, Ph.D., Senior Research Biochemical Engineer, Merck & Co., Inc.
Using Robotics and High Throughput Screening to Develop
Purification Processes
We have developed high throughput screens using 96-well plates to develop our chromatography
processes and to assess the stability of our antibodies during purification. The simultaneous screening of
a large number of conditions allows us to identify operating conditions for antibodies with a variety of
characteristics. The screens can be used to accelerate the development of purification processes for
therapeutic antibodies at various stages of development, ranging from an initial molecular assessment to
the development of commercial manufacturing processes.
Paul McDonald, Associate Scientist, Bioprocess Development, Genentech, Inc.
CASE STUDY
UNPUBLISHED
DATA
Developability Assessments of Antibodies and
Antibody Drug Conjugates
Developability analysis of antibodies and ADCs forms together with cell line productivity
and cost-of-goods analysis it determines the manufacturing feasibility of a drug candidate. A
thorough biochemical & biophysical characterization together with DSP and analytics platform
compatibility check are performed to analyze intrinsic stability and technical robustness of clinical
candidates. Early formulation buffer screening is performed for accelerated formulation development.
Lars Linden, Ph.D., Senior Scientist, GDD-GB Cell and Protein Science,
Purification & Research Analytics, Bayer Pharma AG, Germany
13 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI
UNPUBLISHED
DATA

4:00 Regulatory Challenges for
Biologics: Biosimilars,
Characterization and QbD
Ensuring pharmaceutical performance is
of critical importance to public health.
Quality by Design (QbD) manufacturing and advances in
analytical characterization can enhance pharmaceutical
quality. The appropriate characterization of protein
products is also very important for the development of
biosimilar biological products. The agency has recently
published three draft guidances on biosimilars. FDA intends
to use a risk-based “totality-of-the-evidence” approach
to evaluate the information submitted in support of a
determination of biosimilarity of the proposed product to
the reference product.
Steven Kozlowski, M.D., Director, Office of Biotechnology
Products, OPS,CDER, US FDA
Wednesday, October 10, 2012 (continued)
3:30 Networking Refreshment Break in Poster and Exhibit Hall Sponsored by:
Keynote Presentations
Chairperson: Thomas Seewoester, Ph.D., Executive Director, Clinical Drug Substance Manufacturing, Amgen Inc.
4:40 Driving Value through
Biopharmaceutical
Manufacturing
Over the last 30 years, the Biopharma
Industry has had remarkable successes
delivering tremendous value to our society. The
manufacturing side of our industry has also matured, driven
by dramatic improvements in productivity over the past
decade coupled with the development of robust platforms.
We’ve seen an industrialization of biologics manufacturing,
which makes manufacturing capacity a most valuable
asset. By introducing innovation in manufacturing facilities,
operation, and process understanding we can have a
remarkable impact on our ability to utilize manufacturing
capacity optimally. We will show how focused innovation
can further improve manufacturing efficiency and turn
biotech manufacturing into a powerful value driver.
Jörg Thömmes, Ph.D., Vice President, Global Engineering
and Facilities, Biogen Idec
6:00 Networking Reception in Poster and Exhibit Hall
Best Poster Award Sponsored by:
The BioProcess International Awards: Honoring a Decade of BioProcess
Posters provide cutting-edge scientists with unique, educational vehicles to
introduce and educate the industry on how their science, techniques, and expertise
can improve existing methods and processes while reducing time and cost.
BioProcess InternationalTM magazine, in partnership with the BioProcess
InternationalTM Conference, are proud to present the 3rd Annual Best Poster
Award at the 2012 BioProcess InternationalTM Conference & Exhibition.
How to submit your poster: To submit your poster and for additional details on
the poster size and regulations, please visit
www.IBCLifeSciences.com/BPI/poster.xml
Important Poster Deadlines (Abstract and full payment of conference and poster
fees must be received by this date):
Submit your poster by the following dates to be included in:
• BPI Conference Preview Issue (Published September 2012): July 15, 2012
• On-Site Agenda and Conference Documentation: September 10, 2012
(After September 24th on-site posters are on a space available basis.)
About the Award: All posters abstracts received by September 24, 2012 and
In 2012 BioProcess InternationalTM Magazine will celebrate its 10th year
of publication. During this decade, BPI has annually provided more than
30,000 readers with the opportunity to read, learn and implement the
biopharmaceutical industry’s most impactful scientific breakthroughs and
process improvements.
Today’s Upstream, Downstream and Manufacturing processes look
completely different than they did ten years ago.
To celebrate BioProcess InternationalTM Magazine’s 10-year anniversary
and recognize the outstanding products, services, partnerships and
people that have had the greatest positive impact on the “three pillars” of
bioprocessing, BioProcess International has created the 2012 BioProcess
InternationalTM Awards: Honoring a Decade of BioProcess.
Gain Recognition from your Peers and Present a Poster
presented at the 2012 BioProcess International TM Conference and Exhibition
are automatically eligible. Posters will be reviewed and judged by BioProcess
International TM magazine's Editor-in- Chief and BioProcess International
magazine’s Scientific Advisory Board. Two winning posters, one academia/
industry and one supplier, will be announced at the conference.
The two winning posters will be published in BioProcess International TM
magazine's November 2012 Interactive Poster Hall Supplement and BPIMobile,
BPI’s new mobile app. Posters, complete with pre-recorded audiocast
presentation, will also be posted on bioprocessintl.com/posters for a full year.
The BioProcess International
Dedicated Poster Viewing
Wednesday, October 10, 2012 • 12:30 pm - 1:45 pm
Poster & Exhibit Viewing Hours
Tuesday, October 9, 2012 • 3:15 pm - 7:00 pm
Wednesday, October 10, 2012 • 9:45 am - 7:15 pm
Thursday, October 11, 2012 • 9:45 am - 1:40 pm
TM Conference Preview Issue will be published as
a supplement to BioProcess InternationalTM Magazine’s September issue and
distributed to all conference attendees at registration.
5:20 Improving Access and Affordability
to Biopharmaceuticals in the
Emerging Markets through
Partnerships
The expansion of biotechnology in the
emerging markets comes at an inflection point for industry,
governments, and patients. With expanding life expectancy,
increasing per capita income, and significant unmet medical
need, the allure for industry is clear. This is tempered,
however, with concerns regarding intellectual property
protection, an uncertain regulatory landscape, and limited
biotechnology expertise. This presentation explores these
factors along with the need for effective partnerships to
improve access and affordability.
Matthew B. Walker, Vice President,
Operations, Pfizer Global Supply, Pfizer Inc.
Four awards will be granted for each of the three pillars of bioprocessing:
Upstream Processing, Downstream Processing, and Manufacturing:
• Technology of the Decade (supplier based)
• Technical Application of the Decade (end-user based)
• Collaboration of the Decade
• Thought Leader of the Decade
The awards dinner and ceremony will take place on Tuesday,
October 9th 7-9pm at the 2012 BioProcess InternationalTM Conference in Providence, Rhode Island. To attend, a separate
registration fee is required. Space is limited.
To submit your nomination and for all the award details,
visit www.bioprocessintl.com/awards
Early Registration and Group Discounts are Available (see page 27) 14

8:00
8:15
8:45
9:15
Thursday, October 11, 2012
7:00 Networking Coffee
7:30 Technology Workshop with Light Continental Breakfast Sponsored by:
Disposable Chromatography Has Finally Arrived! A Technincal Review of the Key Process Criteria of Chromatographic Performance, Flexibility and Economics
Stephen Tingley, Vice President, Sales and Marketing, Repligen BioProcessing
Cell Culture Recovery & Purification
Case Studies and Lessons Learned in
Cell Culture Process Development
Chairperson’s Opening Remarks
Chetan T. Goudar, Ph.D., P.E., Head, Cell Culture Development,
Global Biological Development, Bayer HealthCare
Optimizing the Business Process of
Cell Line Development
Intelligent business practices that support scientific processes are
essential in today’s competitive environment. This talk will discuss
preclinical enabling strategies and decision processes to create
competitive advantages with increased efficiency and reduced risk.
Steve Lang, Ph.D., MBA, Associate Scientific Director,
Biologics Research, Cell Line Development,
Janssen Research & Development, LLC
Using a Perfusion Cell Culture Process to
Achieve High Productivity for the Production
of a Monoclonal Antibody
CASE STUDY
UNPUBLISHED
DATA
A perfusion cell culture platform for the production of
monoclonal antibodies has been developed by integrating
continuous manufacturing concepts including continuous downstream
purification. This talk will focus on the development and challenges that
we have encountered specifically in the upstream cell culture process. The
use of different cell separation devices will be compared in a case study.
Marcella Yu, Ph.D., Process Engineer III, Commercial
Cell Culture Development, Genzyme, a Sanofi company
LEAN Process Development and Platform
Technology in Upstream Antibody Production
Principles of LEAN Development are applied to the Drug
Product Development system from the pre-NME phase
through Process Validation. Improved Development
timelines result from cross-functional cooperation, combining
high-level planning with much attention to detail and deployment
of Platform Technology in both Upstream Production and
Downstream Purification.
Ben A. Bulthuis, Ph.D., M.S., Director,
Pharmaceutical Development & Manufacturing Science,
Janssen Research & Development
CASE STUDY
UNPUBLISHED
DATA
Expanding the Tool Box - Disruptive
Technologies in Harvest and Recovery
Session Sponsored by:
Chairperson’s Opening Remarks
Joseph P. Martin Jr., Ph.D., Research Fellow, Senior Scientist,
Downstream Operations, Pfizer Inc.
Sequential Multi-Column Chromatography
(SMCC): Purification Bottleneck Solution
Improvements in upstream processes result in high titers
hindering downstream processing efficiency. SMCC is a
bottleneck solution that streamlines purification efficiency.
In this study, performed at Seattle Genetics, a high titer
monoclonal antibody process was converted from Protein A batch to a
sequential four-column operation and shown to offer significant benefits.
Ruby Leah Casareno, Ph.D., Principal Scientist,
BioProcess Development, Seattle Genetics, Inc.
CASE STUDY
UNPUBLISHED
DATA
A New Downstream Infrastructure for IgG Purification
We introduce a novel downstream processing infrastructure for
purification of IgG monoclonal antibodies. The process begins with a new
harvest clarification technology that removes and/or inactivates more
than 5 logs of virus, up to 4 logs of endotoxin, 98% of DNA, and reduces
aggregates to less than 0.2% while supporting 98% antibody recovery.
The process continues with a new method of IgG capture that works by
manipulating hydration water associated with biological entities and a
hydrophilic surface. Selectivity is size based, offering a rapid high capacity
alternative to size exclusion chromatography. Host protein is reduced
99%. Capacity per unit volume of chromatography media is about same
as traditional bioaffinity materials, but material cost is less than 1%.
The method is performed in a tangential flow format that avoids the
productivity limitations of column-based capture. We also introduce a
new polishing technique that achieves 2–8-fold better DNA, virus, and
host protein removal than anion exchange chromatography. Experimental
results will be shown with biosimilar Herceptin, compared head-to-head
with a three-step protein A > cation exchange > anion exchange process.
Pete Gagnon, Senior Research Technology Specialist, Bioprocessing
Technology Institute, Singapore
Evaluation of Single-Use Fluidized Bed
Centrifuge Technology for Cell Recovery Process
Single use technology is now commonly used for production of
biological products. However cell harvest is typically performed
using non-disposable technology such as disc –stack centrifuge.
This presentation will demonstrate the application of a novel
single use fluidized bed centrifuge (FBC) for cell harvesting step.
The data will be discussed on identification and optimization of
critical process parameters of FBC technology to meet the process
requirement of clarification efficiency, which was determined by
turbudity and particle count measurements.
Jason Condon, MSc, Scientist, Cell Technologies, Janssen R&D
9:45 Networking Refreshment Break in Poster and Exhibit Hall Sponsored by:
CASE STUDY
Vaccine and Complex Biologics
Development and Production
Chairperson’s Opening Remarks
Peter Latham, President, Latham BioPharm Group
Current Challenges in Vaccine Production
Successful production of vaccines requires understanding of the
complex operations involved. Process performance is impacted
by biological variability, difficult to characterize raw materials and
limitations of analytical tools. Mitigation of these risks includes
process monitoring and six sigma programs for early identification and
correction of potential defects. Awareness of capacity bottlenecks and
options for scheduling adjustments will enable lean operations.
Sue Behrens, Ph.D., Independent Consultant; former Senior
Director, Vaccines & Biologics, Merck Manufacturing Division
Development of a High Density Fermentation
Process for a Recombinant Influenza Vaccine
All influenza vaccines currently licensed in the US are made in
embryonated eggs. In order to achieve rapid commercial production
of influenza vaccines, the use of a cell-based platform becomes
unavoidable. Protein Sciences Corporation (PSC) uses the baculovirus
expression vector system to produce recombinant hemagglutinin
(rHA) for the influenza vaccine FluBlok®. This talk will focus on
approaches used by PSC to develop a simple, low-cost and scalable
process for vaccine manufacturing in a very short time frame.
Jamal Meghrous, Ph.D., Cell Culture Specialist, Production,
Protein Sciences Corporation
A Probabilistic Model for Risk Assessment of
Residual Host Cell DNA in Biologic Products
Biological products contain residual DNA from host cells. It is theoretically
possible that the residual DNA could transmit oncogenes and infectious
agents to product recipients, and induce oncogenic or infective events.
A probabilistic model to estimate the risks is proposed. The model takes
account of enzyme inactivation process. It allows for more accurate risk
assessment when compared to methods currently in use.
Harry Yang, Ph.D., Senior Director, Non-clinical Biostatistics,
MedImmune, LLC
10:30 Thought Leadership Forum: Update on Global Advances in the Development and Regulation of Biosimilars (See more details on p.21)
15 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI
CASE STUDY

10:30
11:00
11:30
Thursday, October 11, 2012
Cell Culture Recovery & Purification
Production Capacity Increase and Flexibility in
a Perfusion Mammalian Cell Culture System
Production capacity of a continuous mammalian cell
culture platform was increased through perfusion rate
reduction coupled to use of recombinant-protein-product
stabilizers, increased media strength and bioreactor vessel/ cell
retention device working-volume adjustments - which countered
the impact of the increased residence time in the bioreactor and in
the cell retention device by compensating for product stability and
cell culture performance.
Yuval Shimoni, Ph.D., Principal Engineer, Manufacturing
Sciences, Bayer HealthCare
Process Optimization and Scale-Up
Challenges in the Development of a
Large-Scale Phase III Manufacturing Process
CASE STUDY
UNPUBLISHED
DATA
CASE STUDY
UNPUBLISHED
DATA
Developing a Phase III/commercial cell culture process
presents many challenges including optimizing cell culture
conditions in order to maintain quality and maximizing process
performance. Development of a phase III/commercial process will be
described for a CHO monoclonal antibody product through process
optimization and scale-up. A new chemically defined medium (CDM)
formulation was implemented for this Phase III process at large scale
for the first time. The use of this CDM formulation resulted in highly
consistent cell culture performance at the small scale and pilot scale.
However, during scale-up for clinical manufacturing, additional
challenges were identified and potential process improvements were
investigated to mitigate risk for future campaigns.
Jason Goodrick, M.S., Senior Engineer, Late Stage Cell Culture,
Genentech, Inc.
A Comparative Analysis of Two Chemically-
Defined Feed Media Design Strategies for High
Titer CHO Fed Batch Cultures
UNPUBLISHED
DATA
This talk highlights the use of two approaches for the
development of chemically-defined feed media. One approach
utilized robotic liquid handling to generate hundreds of variants
for high-throughput screening. The second approach utilized a
novel media enrichment strategy. These approaches increased
antibody titers at g/L levels without adversely impacting quality. The
advantages and disadvantages of both approaches will be discussed.
Patrick Hossler, Ph.D., Senior Scientist II, Process Sciences,
Abbott Laboratories
Do We Still Need Centrifugation? Innovative
Single-Use Solution to Replace Centrifugation
with Dynamic Depth Filtration
UNPUBLISHED
DATA
Depth filtration is the method of choice for removal of cells and
cell debris from high density fed-batch processes using mammalian
cells. Depth filters are composed of inert cellulosis materials usually
combined with active diatomite earth (DE). At scales of 1K and above,
depth filtration has to be combined with precentrifugation resulting in
a more complex and costly unit step. An alternative approach to depth
filtration using Celpure pharma grade DE is being developed as a joint
collaboration between SSB, ChangeXplorer and sanofi. This approach
will use the properties of DE which are well established in food and
plasma fractionation industry to improve filterability with the benefits of
drastically reducing the surface area, process time and capital expenditures
required for harvest clarification. The final solution is intended to be a fully
integrated single-use system scaleable from ml to thousands of liters and
able to replace centrifugation from lab to commercial scale.
Laure Landric-Burtin, M.S., Head of Downstream Processing,
Sanofi
Novel Depth Filtration Media to Improve
Consistency and Enhance Impurity Removal
Natraj Ram, Ph.D., Associate Director,
Manufacturing Sciences, Abbott Bioresearch Center
Implementing New Technologies for Post
Approval Changes
Deirdre O’Sullivan, Senior Engineer, Genentech, Inc.
12:00 Concurrent Technology Workshops
Characterization of a Hybrid Purifier for Cell Debris,
DNA and HCP Removal
Majid Entezarian, PhD., Manager, Scientific Applications Support Services,
3M Purification Inc.
Protein PCR: A Fully-Automated ELISA Alternative for
Residual Protein Quantification Leveraging the
Advantages of qPCR
Christan Ryan, Senior Staff Specialist in Pharmaceutical Analytics, Life Technologies
UNPUBLISHED
DATA
Vaccine and Complex Biologics
Development and Production
Systematic Screening and Optimization of Host
Platforms to Address Vaccine Expression Challenges
Shyamsundar Subramanian, Ph.D., Expression Systems Lead,
Vaccine Research, Merck & Co., Inc.
Late Stage CMC Challenges for Oligonucleotide/
Adjuvant used in Vaccines
This session will focus on late stage CMC challenges associated
with vaccines containing oligonucleotide/adjuvants including
hands-on experience and the regulatory challenges this
convergence represents.
Tracy TreDenick, Head of Quality and Regulatory and Partner,
BioTechLogic
William Turner, Vice President, Regulatory Affairs and Corporate
Quality Systems, Dynavax Technologies
Transition of an Existing Bioprocess into a Single
Use Platform to Enable Global Deployment
Jeffrey C. Johnson, New Technology Lead, Sterile Technology and
Comercialization, Merck & Co., Inc.
The CHOZN® Platform: Enabling Therapeutic Protein
Manufacturers' Development
Kevin Kayser, Ph.D., Associate Director, Cell Sciences and Development, SAFC
Characterization of a High Throughput Micro Bioreactor:
Process Control, Consistency and Comparability in CHO
Clone Ranking and Process Optimization Studies
Barney Zoro, EngD., Product Manager, TAP Biosystems
12:30 Networking Luncheon and Last Chance for Exhibit and Poster Viewing in the Exhibit Hall
Early Registration and Group Discounts are Available (see page 27) 16

1:40
1:45
2:15
2:45
Thursday, October 11, 2012 (continued)
Cell Culture Recovery & Purification
Effect of the Cell Culture Environment
on Product Quality
Chairperson’s Remarks
Gary J. Welch, Director, Process Science,
Abbott Bioresearch Center
Engineering a Glycosylated Full-Length IgG
Antibody: Bypassing Glycosylation, Developing
Novel Effector Functions and Enhancing Potency
UNPUBLISHED
DATA
In IgG molecules, removal of the glycan at Asn297 abolishes
binding to FcγRs and effector functions mediated by
leukocytes. We have developed a robust screening platform
for engineering aglycosylated full length IgG with various FcγRs
selectivity. A set of Fc engineered versions of aglycosylated antibody
with unique or improved effector functions have been generated and
will be discussed.
Sang Taek Jung, Ph.D., Research Associate, Staff Scientist,
Department of Chemical Engineering,
The University of Texas at Austin
Optimizing Productivity and Product Quality
of a Commercial Cell Culture Process for
a High Demand mAb Product
CASE STUDY
UNPUBLISHED
DATA
This case study will highlight challenges and key
achievements in developing a high titer cell culture
process under short timelines. Initial platform process
bioreactor studies yielded unexpectedly low titers, but a two-fold
improvement was obtained through mimicking the uncontrolled
pH profile observed in shake flasks. Several product quality
challenges were also addressed, including mitigating sequence
variants and modulating charge variants.
Melissa Mun, M.S., Engineer II, Late Stage Cell Culture,
Genentech, Inc.
A Scale-Down Model Qualification Case Study
for QbD Cell Culture Process Characterization
Cell culture process characterization studies for a protein
production process were performed using a scale-down
model. A Quality by Design (QbD) approach was taken
in order to improve overall process understanding, with the final
outcome being both univariate and multivariate acceptable ranges
for each parameter tested. However, applicability of these study
results to the manufacturing scale depends on the validity of
the scale-down models that have been used. In this particularly
complex case study, both small and pilot scale models were
qualified. Evaluation of some product quality attributes required
further downstream processing through scale-down purification
models. As a result, qualification of the cell culture model
ultimately relies on qualification with the purification scale-down
model as well. The way the models were applied depends both
on the product quality attribute being evaluated and the unitoperation
being characterized. Our scale-down model qualification
approach will be presented and challenges related to applying
scale-down results to manufacturing scale will be discussed.
Angela Meier, B.Sc., Engineer I, Late Stage Cell Culture Process
Development, Genentech, Inc.
CASE STUDY
UNPUBLISHED
DATA
Streamlining Downstream Processing to
Improve Cost and Time to Clinic
Chairperson’s Remarks
Uwe Gottschalk, Ph.D., Vice President, Purification Technology,
Sartorius Stedim Biotech, Germany
Manufacturing High Concentration mAb
Formulations using Ultrafiltration / Diafiltration
Monoclonal antibody therapeutics have traditionally been
delivered using intravenous (IV) administration. Companies are
now increasingly developing high concentration formulations of
monoclonal antibody therapeutics to allow subcutaneous (SC)
administration. New UF/DF systems can be designed to minimize
hold-up volume and enhance mixing in the recycle tank, allowing for
formulation at high concentrations. Utilizing legacy UF/DF systems
for SC formulation can lead to many challenges. Challenges will be
discussed, and a case study will be presented on implementation
of high concentration formulation on a UF/DF commercial scale
system not originally designed for SC formulation.
Stephen Hohwald, Engineer, Purification Development,
Genentech, Inc.
Exploiting Online Refractometry for Improved
Ultrafiltration Development and Manufacturing
Engineering Operation Control
CASE STUDY
CASE STUDY
UNPUBLISHED
DATA
Accurate targeting of high protein concentration Drug
Product formulations has become a challenge within
biological manufacturing arenas via traditional absorbance methods
and process control techniques. The work presented here will
demonstrate the application of inline refractometry to provide
real-time concentration measurements for enhanced ultrafiltration
process monitoring and control. Data will be presented from
pilot and clinical manufacturing systems. In summary, inline
probes demonstrated >96% concentration accuracy up to 150g/L.
Additional applications for inline refractometry will be discussed for
Biologics processing.
Nickolas Brings, MBA, Process Engineer,
Global Engineering and Facilities, Biogen Idec
Robustness and Efficiency of Two Column
Purification Process
Timothy Iskra, M.S., Principal Scientist, Pfizer Inc.
UNPUBLISHED
DATA
Vaccine and Complex Biologics
Development and Production
Chairperson’s Remarks
Hari Pujar, Ph.D., Director, External Process Development,
Merck & Co., Inc.
QbD for Vaccines: From Regulatory Relief to
Design for Manufacturing
Due to the complexity of vaccines manufacturers are working
together with regulators to appropriately apply QbD approaches
to vaccine development and control. Many companies, however,
have realized the value of these enhanced methods in developing
a robust manufacturing process and in helping to ensure product
quality through a carefully established control strategy. This talk
will highlight QbD approaches which help assure an ample supply
of quality vaccines to the public.
Timothy Schofield, Managing Director, Arlenda USA
Implementing Vaccine QbD
Robert Repetto, M.S., MBA., Research Fellow, External Affairs,
Pfizer BioTherapeutics Pharmaceutical Sciences;
Chair, PDA Single-Use System Task Force
Presentation TBA
17 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

3:15
Thursday, October 11, 2012 (continued)
3:45 Networking Refreshment Break
4:15
4:30
5:00
5:30
Cell Culture Recovery & Purification
Effective Methodologies to Target Antibody Quality
Attributes in Cell Culture Process Development
Antibody structures such as specific Glycan profile and charge
variants are considered important quality attributes for their certain
biological activities. These quality attributes may be impacted by
cell culture bioprocess conditions. Many have explored methods to
keep the antibody quality attributes consistent and have successfully
implemented the methods in antibody process development. It
is considered more challenging to try to target a specific quality
attribute of an antibody in development within a desired range
with a flexible methodology that is not in conflict to the direction
of developing higher productivity. In this presentation, we intend to
demonstrate a few methodologies applied effectively in targeting
specific antibody quality attribute profile while maintaining or
advancing productivity.
Jerry Yang, Ph.D., Director, Process and Product Development,
Amgen Inc.
Plenary Session: Developing Truly Continuous Drug Substance Processes
Chairperson’s Remarks
Frank Riske, Ph.D., Senior Director, Purification Development, Genzyme, a Sanofi company
Strategies to Streamline the Two-Column
Monoclonal Antibody Purification Platform
In two-column mAb purification platforms, traditional Q
column or, increasingly, Q membrane adsorber is used as a
polishing step in a product flow-through mode. For mAbs
with a low pI (< 7.0) or solubility issues under low ionic strength
solution conditions, however, poor process performance is
expected. We have developed a robust mAb purification platform
which demonstrates high process yield and efficient clearance of
impurities (HCP, HMW, host DNA, leached protein A) for those
challenging antibodies.
Yun (Kenneth) Kang, Ph.D., Principal Scientist and Head of
Purification Team, Bioprocess Sciences, ImClone Systems,
a wholly-owned subsidiary of Eli Lilly and Company
How do We Move from Fed Batch to a Truly Continuous Process? Linking Upstream and Downstream – What are the Advantages?
Konstantin Konstantinov, Ph.D., Vice President, Commercial Cell Culture Development, Genzyme, a Sanofi company
Integrated Continuous and Semi-Continuous Downstream Processing: Strategies & Large Scale Implementation UNPUBLISHED
DATA
Jens H. Vogel, Ph.D., Director & Global CMC Development Team Leader, Global Biologics Development, Isolation & Purification, Bayer Healthcare
Biomanufacturing - Deconstructed UNPUBLISHED
DATA
The complexity associated with biomanufacturing has increased over the last 30 years with the advent of biotechnology. The implementation of new technologies, quality risk management,
improved process and product understanding allows the industry to re-think cost effective ways to supply new products and markets. Concepts discussed include; continuous processing with appropriate
controls, application of single use technologies to enable flexible and portable manufacturing, and facility ballroom design with appropriate area classification to support concurrent multi-product processing.
Kenneth Green, Ph.D., Director, Operational Excellence, Pfizer Inc.
6:00 Close of Thursday Sessions
UNPUBLISHED
DATA
Vaccine and Complex Biologics
Development and Production
Mass Spectrometry as a Tool for
Vaccine Development
Mass spectrometry is a versatile tool that can be leveraged
throughout vaccine development. It can be used during early
stage development to measure levels of key protein antigens in
complex vaccine candidates before availability of critical immunoreagents.
Additionally, mass spectrometry can be used for in-depth
characterization of vaccines which can include monitoring of
functional groups and identifying protein post-translational
modifications.
Van M. Hoang, Ph.D., Associate Director, Vaccine Analytical
Development, Merck
Early Registration and Group Discounts are Available (see page 27) 18
UNPUBLISHED
DATA

Friday, October 12, 2012
7:00 Networking Coffee
7:30 Technology Workshop with Light Continental Breakfast Sponsored by:
New Tools for High Throughput Analysis in Biopharmaceutical Development
This talk presents applications of the AssayMAP high throughput microchromatography platform for automated sample preparation prior to various protein/peptide analytical methods.
The system can purify protein products from complex samples for quantitation and downstream analysis. A major application is automated sample preparation for N-glycan profiling,
including enzymatic digestion, fluorescent labeling and cleanup. Peptide mapping will also be shown.
Scott P. Fulton, MSc., Head, AssayMAP Operations & Workflow Development, Agilent Technologies, Inc.
8:00
8:15
8:45
9:15
Cell Culture Process Development for Novel Molecules
and Next Generation Protein Therapeutics
Chairperson’s Opening Remarks
Kathie Fritchman, Manager, BioProcess Application - Advanced Bioprocessing, BD Biosciences
Expression, Purification and Characterization of an IL-1
CASE STUDY
Therapeutic Inhibitor
UNPUBLISHED
DATA
Gregory Zarbis-Papastoitsis, Ph.D., Senior Director, Protein Production and Analytical
Development, Eleven Biotherapeutics
Kathryn Golden, M.S., Scientist III, Protein Production and Analytical Development, Eleven Biotherapeutics
Process and Technology Development for the Production of
UNPUBLISHED
Non-Antibody Therapeutic Proteins in a Continuous Manner
DATA
The integration of bioprocessing steps into continuous operations is paving the future for streamlined
and flexible biopharmaceutical production. Despite such simplifications, the process, hardware, and
associated control strategies must be carefully optimized to achive overall robustness and product
quality goals. This presentation will cover these topics as applied to the development of a continuous
non-antibody protein producing process.
Timothy Johnson, Ph.D., Senior Manager, Process Development, Genzyme, a Sanofi company
Keynote Address
The Evolution of QbD Implementation in Cell Culture at
Genentech and Lessons Learned
Cell Culture Recovery & Purification
CASE STUDY
UNPUBLISHED
DATA
The expectations for cell culture process characterization have evolved over the
last decade, and integration of Quality by Design (QbD) principles is the latest example. Several
Genentech projects have applied various aspects of QbD in the last several years, and with each new
project, we’ve built upon lessons learned. The broadest QbD strategy consists of a Quality Target
Product Profile, risk assessments to determine Critical Quality Attributes (CQAs), risk assessments to
determine what process parameters to study, Design of Experiment studies to investigate parameter
effects on CQAs, a Critical Process Parameter identification tool, risk assessments related to Control
System definition, and lifecycle management. Development and use of the risk assessments and other
tools has been the most challenging aspect of applying QbD to cell culture process characterization.
At first glance, all the moving pieces that are part of QbD can appear quite complex, both to
people within the company and to Health Authorities. While it is complex, one main benefit is that
it has provided a structured approach to document rationale for how we execute and interpret our
characterization studies. As we’ve become more experienced with QbD, our study designs and tools
have evolved. This talk will review the evolution of tools and studies, and discuss lessons learned in
applying QbD.
Steven Meier, Ph.D., Principal Engineer, Senior Group Leader, Genentech, Inc.
9:45 Networking Refreshment Break
10:15 Thought Leadership Forum Co-Sponsored by:
Understanding Sources of Process Variability
Chairperson’s Opening Remarks
Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden
Optimization of Process Steps during Scale Up to Reduce
CASE STUDY
UNPUBLISHED
Unanticipated Sources of Process Variability
DATA
We had developed a three step Phase 1 mAb process using typical anion and cation
exchangers (Sepharose Fast Flow). Anticipated commercial demand stimulated the development
of a modified upstream process yielding a doubling in harvest titer. Fixed tankage limitations in the
intended commercial facility stimulated the use of high capacity ion exchangers and a modification
in the flow of the process streams which resulted in a doubling of the process throughput. The new
resins were used in both the normal titer and doubled titer processes during scale-up and yielded
equivalent product quality and process performance in both process versions.
Joseph P. Martin Jr., Ph.D., Research Fellow,
Senior Scientist, Downstream Operations, Pfizer Inc.
Identification of Chromatogram Variances and
CASE STUDY
UNPUBLISHED
Their Relation to Product Quality and Process Performance
DATA
Chromatogram monitoring and trending has become a routine and powerful
tool to ensure consistent performance of liquid chromatography columns and quality of the final
product. Trending of chromatograms against a Gold Standard was implemented for both clinical
and commercial manufacturing processes at HGS to ensure downstream purification processes
are performing as expected. Several case studies will be presented to demonstrate chromatogram
variances and their potential impacts on product quality and process performance. Process
monitoring and its follow up investigations proved to be extremely valuable for better process
understanding and continuous improvement of the downstream purification processes. Several
lessons learnt, in the execution of these studies, will be presented.
Yaling Wu, Ph.D., Senior Scientist, Human Genome Sciences, Inc.
Mitigation of Chromatography Adsorbent Lot Variability
CASE STUDY
UNPUBLISHED
Through Design Space and Process Control
DATA
Lot to lot variability in chromatography adsorbent properties can result in
unacceptable performance, in both product quality and process consistency. The column operating
conditions may need to be designed to be adsorbent lot specific to achieve acceptable and consistent
performance. In this presentation, we discuss how a design space strategy can be used to mitigate
such risks for an anion exchange chromatography step, by providing additional flexibility in applying
the appropriate column operating conditions for different chromatography adsorbent lots.
Ionela Iliescu, M.S., Scientist I, Technical Development, Biogen Idec
Structuring Process Knowledge to Achieve Robust Processes, Simplified Technology Transfer and Regulatory Compliance (See more details on p.21)
19 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

10:15
10:45
11:15
Friday, October 12, 2012 (continued)
Cell Culture Recovery & Purification
Early Process Development and Cell Line Engineering
Session Sponsored by:
Early Process Development Integrating Chemically Defined Supplements and Feeds
The choice of chemically defined media, supplements and feeds is a widespread decision these days.
But it is not easy to predict the success of a new process based on historical results. Four case studies
will show that choice of cell culture medium and supplement alone, or in combination, has an impact
on protein production, cell metabolism, and potentially quality, including evidence of potential
deamidation and N-linked glycosylation variants.
Elizabeth C. Dodson, Ph.D., Manager, Research & Development, Advanced Bioprocessing,
BD Biosciences
Targeting Gene Expression Hot Spots in CHO Using
UNPUBLISHED
Engineered Meganucleases
DATA
Precision BioSciences has developed a set of engineered meganucleases that target the insertion of
transgenes into well-characterized housekeeping gene clusters in the CHO genome. We show that cell
lines produced by targeting transgenes to these gene expression “hot spots” express at a high level
consistently over time without the need to pre-engineer a “landing pad” into the cell.
Derek Jantz, Ph.D., Vice President of Scientific Development, Precision BioSciences
Engineering Enhanced Cell Lines Using Zinc Finger Technology UNPUBLISHED
Nan Lin, Ph.D., Cell Engineering, Cell Sciences and Development,
DATA
Principal R&D Scientist, SAFC
11:45 Technology Workshop Opportunities Available
12:15 Lunch on Your Own
1:25
1:30
2:00
Eliminating Bottlenecks – Impact of New Tools on
Cell Culture Development
Chairperson’s Remarks
Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, Genzyme, a Sanofi company
A Holistic Approach to High-Throughput Process Development
Over the recent years there has been an increasing need for shortening development timelines for
initial process development. At the same time it is required to generate a substantial more profound
process understanding towards commercial processes. Boehringer Ingelheim has expanded its
technologies around flexible small scale model systems and the corresponding miniaturized analytical
methods spanning the entire process chain. The presentation aims to show how these successes will
be also critical to success for pipelines expanding towards classical IgG molecules.
Hitto Kaufman, Ph.D., Vice President, Process Science,
Boehringer Ingelheim GmbH & Co., KG, Germany
Developing Analytical Systems to Support
CASE STUDY
UNPUBLISHED
High Throughput Bioreactors in Cell Culture
DATA
Cell line and process development play a major role in producing therapeutic proteins
with high productivity and appropriate product quality attributes. To support this development,
analyses of large number of samples generated from thousands of clones and process optimization
are critical. Analyzing large number of samples has been a bottleneck in biotech industries because
conventional analytical assays are low-throughput. Here we present various high-throughput (HTP)
analytical platforms to facilitate rapid and parallel analyses of product quantity and quality using
96-well plate formats. These platforms include HTP protein quantitation followed by HTP protein
purification and product quality analyses. With these analytical capabilities, we can assess product
quality in the early stage of clone screening, as well as expedite the cell line and process development.
Shashi Prajapati, Ph.D., Senior Scientist, Cell Culture Development, Biogen Idec
Impact of Disposable Technologies and Flexible Platforms/
Manufacturing on Downstream Processing
Development and Start Up of a Fully Disposable Facility CASE STUDY
UNPUBLISHED
DATA
A Biogen Idec warehouse has been retrofitted for use as a disposable manufacturing
facility. The repurposed facility utilizes a combination of existing traditional
infrastructure to make cell culture media and chromatography solutions along with new disposable
technology equipment to produce and purify clinical products. The disposable technology includes a cell
culture suite with 1000 liter single-use bioreactors and two purification suites. This case study will cover
the facility design, development of purification disposable process and successful start-up of the facility.
Lynn Conley, Associate Director, Process Biochemistry, Biopharmaceutical Development, Biogen Idec
A Case Study on a Process and Economical/Analytical Approach
for Virus Filtation Step - Comparison of Stainless Steel and
Disposable Virus Filtration Skids
Peter Rogge, Director, Downstream Processing, Rentschler Biotechnologie GmbH, Germany
Keynote Address
Implementation of a QbD Approach for a Monoclonal Antibody
Biologic License Application: A Downstream Purification Case Study
CASE STUDY
UNPUBLISHED
DATA
CASE STUDY
UNPUBLISHED
DATA
A case study of a Quality-by-Design (QbD) approach to characterizing a Monoclonal
Antibody downstream process will be presented. Discussion will focus on Risk Ranking and Filtering
tools, scale-down models, criticality assessments, and unit operation/Design Space linking approaches.
Tony Cano, Ph.D., Senior Engineer, Purification Development, Genentech, Inc.
Developing Downstream Processes for Novel Molecules and
Next Generation Protein Therapeutics
Chairperson’s Remarks
David W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human Genome Sciences, Inc.
Application of a Novel Affinity Adsorbent for the Capture
CASE STUDY
UNPUBLISHED
and Purification of FVIII Compounds
DATA
Factor VIII (FVIII) therapies are used for the treatment of Hemophilia A, an inherited bleeding
disorder caused by mutation in the FVIII gene. The development of a chromatography step that
results in a product of high purity and yield is a major complexity. In this work, we describe the use
of the VIIISelect, a commercially available affinity adsorbent. Following laboratory-scale process
development, the VIIISelect was scaled up and used in the large scale manufacturing of a FVIII
compound.
Keith Selvitelli, Senior Associate Scientist, Process Biochemistry, Biogen Idec
Finding Solutions to the Challenges of Developing a Platform
Purification Approach for Domain Antibodies and Other
Non-mAb Molecules
UNPUBLISHED
DATA
The emergence of novel classes of antibody fragments creates new challenges for the development
of standard downstream platforms. An approach that combines high-throughput and small column
process development is presented in the perspective of early and late stage process development.
Particular emphasis is given to the development of capture steps that can accommodate a variety of
molecular scaffolds.
André C. Dumetz, Ph.D., Investigator, GlaxoSmithKline
Early Registration and Group Discounts are Available (see page 27) 20

2:30
Friday, October 12, 2012 (continued)
Cell Culture Recovery & Purification
3:00 Networking Refreshment Break
3:30
4:00
4:30
Development and Integration of a Fully Automated High-Throughput UNPUBLISHED
Platform for Cell Line Selection and Cell Culture Development
DATA
This presentation will identify the advantages of integrating, within a single system, fully automated
process workflows for both cell line and cell culture development. Both the development and
implementation of an in-house, customized automation platform and software tools for data analysis
will be highlighted. Data will be shared to illustrate key features of the platform and the impact on cell
line selection and characterization. Results will illustrate how this approach increased efficiency and
allowed for the processing of multiple cell line screening and cell culture development projects in parallel.
John Cesarek, Staff Automation Engineer, Five Prime Therapeutics
Disposables in Cell Culture
Disposable Implementation in Conjunction with High
UNPUBLISHED
Throughput and Automation Technologies
DATA
A strategy will be presented applying targeted automation tools to resolve resource constraints in
upstream development. This includes automated spin tubes for the elimination of manual shake
flask stages during clonal evaluations. Development of a 250mL single use prototype bioreactor for
both mammalian and microbial cultures designed to be implemented in an automated platform with
robotic sampling, feeding and independent control. Finally, disposable perfusion systems to intensify
cell culture densities to enable high protein production will be shown.
Rachel Bareither, M.S., Research Biomedical Engineer, Bioprocess Development, Merck & Co., Inc.
Take II – More Findings and Updates on Our Experiences with CASE STUDY
Disposable Bags for Cell Culture Media Storage
UNPUBLISHED
Dr. Masaru Shiratori’s presentation at the 2011 BPI Conference & Exhibition in Long DATA
Beach, CA investigated challenges associated with specific disposable bags and usage conditions that
resulted in reduced cell growth and product yield. In this presentation, we will provide updates on the
ongoing investigation and give an in-depth review of our current understanding of the root-cause of
the problem. Lessons learned and recommendations for selecting disposables for future applications
will be shared.
Joseph Wood, M.S., Engineer I, Process Development Engineering, Genentech, Inc.
Co-Development of a New 2-D Rocking-type Single-Use
UNPUBLISHED
Bioreactor to Streamline Cell Expansion Processes
DATA
Co-development by an equipment vendor and an operating company of a novel 2-D rocking
bioreactor is presented. The rocking mechanism enables high oxygen transfer rates and the single-use
bioreactor bag is designed to have a wide range of working volumes, eliminating labor-intensive multistage
cell expansion trains. The bag is also fitted with integrated single-use sensors to allow better
control of cell culture conditions.
Bert Frohlich, Ph.D., Director, Bioengineering, Process Development, Shire Human Genetic Therapies, Inc.
5:00 Close of BioProcess International TM Conference & Exhibition 2012
Novel Single-Use Method for Concentrating and Purifying
Therapeutic Cells and Incorporating Process Analytical Technology
in Downstream Processing
CASE STUDY
As cell therapy lot sizes increase to larger scales, it will be important to apply scalable bioprocessing
concepts and technologies to therapeutic cell production. We have developed and characterized a
scalable, closed system concentration and purification technology for therapeutic cell processing
based on Tangential Flow Filtration (TFF). Examples will be provided where disposable and noninvasive
sensor technologies are used to acquire real time data to make process decisions, enhance
process knowledge, monitoring process performance and product quality.
Jacob Pattasseril, Engineering Manager, Cell Processing Technologies, Lonza
Developing Downstream Processes for Next Generation and
Novel Molecules
Utilization of Fluidized Bed Centrifuge Technology for
UNPUBLISHED
Cell Therapy Bioprocess Development
DATA
A fluidized bed centrifuge (FBC) was used to process cell culture harvests by concentrating and
washing cells for cell therapy applications. In cell therapy bioprocess development, it is crucial to
take into consideration the capability to concentrate cells to an efficacious target dosage, dictated by
viable cell density, as well as reducing remnants of cell culture impurities such as serum to acceptable
levels. By optimizing FBC process parameters such as flowrates and centrifugal force, results showed
that the FBC is effective in separating cells from the supernatant to achieve the targeted cell density
dosage and at the same time efficient in the removal of undesirable impurities. Overall cell loss
during processing was minimal thus achieving a high cell yield from the FBC. Detailed results will be
discussed in the presentation.
Paul Ko, Ph.D., Research Scientist, Cell Technologies, Janssen Research & Development
Design Space Around a Non mAb Complex Protein Therapeutic CASE STUDY
One of the important quality by design (QbD) concepts is to establish a design space
around a drug product. This presentation discusses the development of a design space
UNPUBLISHED
DATA
around one of our non mAb complex protein therapeutics. The minimal concentration requirement
for the protein therapeutic is 20 g/L. Protein charge profiles were identified as a critical quality
attribute that will affect the protein solubility. An ion exchange (IEX) chromatography step in the
downstream process was identified as a critical step that will impact the protein solubility. A design of
experiment (DoE) study was performed to define a design space to control the protein solubility. First,
a risk assessment (FMEA) was performed to rank the process parameters in the IEX step. Second,
the high risk parameters were screened by a high throughput screening (HTS) platform using Atoll
Mini-columns. The significant parameters that might impact protein solubility, recovery, and impurity
clearance were identified. Third, the significant parameters were further studied by scale down column
runs to define a design space. Finally, a process control strategy was developed based on the DoE
study results to better control the process performance and product quality.
Yiming Yang, M.S., Senior Scientist, Purification Process Development,
Shire Human Genetic Therapies, Inc.
Development of an Integrated Protein
UNPUBLISHED
Reduction/PEGylation Platform
DATA
PEGylation has been shown to improve therapeutic protein half-life. A reduction and PEGylation
process is optimized for a complex therapeutic protein to minimize by-product. The PEGylation
efficiency is dependent of reductant and PEG concentrations as well as incubation time. The process
is successfully incorporated into a scalable integrated platform where the entire reduction/PEGylation
process is performed in a single unit operation.
Brian To, Ph.D., Senior Staff Development Scientist, Isolation and Purification, Bayer HealthCare
21 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

Tap into China’s Fast-Growing Biopharmaceutical Market
IBC’s 4th Annual
Tuesday, October 9, 2012
1:30 pm – 3:15 pm
Smart Solutions for Early Development and Manufacturing
of Biopharmaceuticals: How CMO’s Can Help Product
Companies be Successful
Co-Sponsored by:
Optimizing drug substance and drug product development & manufacturing is a key success factor in preclinical
development of biopharmaceuticals with a high impact on product quality and value. Both processes go hand in
hand and most biotech companies rely on external partner. This panel discussion focuses on critical issues such
as when to start, how to reduce the risk, how to keep costs down before POC and many other crucial questions.
This panel shall provide models and solutions for early stage product development leveraging a CMO’s core
competence. Leaders of international CMO’s bring in their view and answer specific questions from the audience.
Panelists:
Larry Thomas, Vice President, Global Sales & Marketing, DSM Biologics
David P. Wellis, Ph.D., Senior Vice Presidnet, Business Development, BioAtla LLC
Axel Schleyer, Ph.D., Vice President, Business Development & Key Account Management Americas,
Boehringer Ingelheim
Klause B. Schoepe, Vice President, Client Relations, Rentschler Biotechnologie GmbH
Wednesday, October 10, 2012
10:30 am – 12:00 pm
Reducing the Risk of a Contamination Event Due to
Raw Materials
Sponsored by:
Friday, October 12, 2012 (continued)
There are a number of strategies for reducing raw materials risk, including sourcing of animal-free or chemicallydefined
components. But, as the old saying goes, ‘the devil is in the details.’
For example, there is no standard definition for ‘animal free’ or ‘chemically defined’ media or supplements. As
a result, suppliers can have different interpretations, which can have implications for risk mitigation and raw
materials consistency in biopharmaceutical production.
This panel will address topics such as:
• What are the current definitions for AF and CD materials?
• Is there a need for standard definitions of AF and CD across the industry?
• What are the key criteria for mitigating the risk of viral or other biological contaminants?
• What are the best practices for sourcing raw materials in order to mitigate the risk of a
contamination event?
• What does the future hold for raw materials sourcing?
Moderator:
Barbara Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting, LLC
Panelists:
To be announced
Thought Leadership Forums
August 21-22, 2012
Grand Hyatt Hotel
Shanghai, China
Download the brochure today at: www.IBCLifeSciences.com/BPIChina
Thursday, October 11, 2012
10:30 am - 12:00 pm
Update on Global Advances in the Development and Regulation
of Biosimilars
The global regulatory framework for biosimilars continued to evolve over the past year with the development
and publication of a number of significant new regulatory guidance documents. Notable milestones include
the publication of the first three draft biosimilar guidance documents by the US FDA and additional
draft product-specific guidelines by the EMA. In addition, the EMA initiated the process to update the
overarching guidelines on similar biological medicinal products originally published in 2006. This Thought
Leadership Forum will explore recent developments in this area, including:
• The US FDA risk-based “totality-of-evidence” approach to demonstrating biosimilarity;
• Challenges associated with the US interchangeability concept;
• Originator perspectives on innovation and biosimilars;
• Strategies for conducting global biosimilar programs;
• Revision of the overarching EMA guidelines on similar biological medicinal products;
• Post-approval changes and comparability exercises with biosimilar products.
Co-Moderators:
Stephen C. Hosselet, Ph.D., Director, Global Analytical Sciences, Amgen Inc.
Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc.
Panelists:
Michael J. Grace, Ph.D., Executive Director, Analytical Development and Testing, Bristol-Myers Squibb
Cyrus Karkaria, Ph.D., President, Biotech Division, Lupin Ltd., India
Steven Kozlowski, M.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group
Thomas Stangler, Ph.D., Development Strategy and Technology Manager, Biopharmaceuticals, Sandoz, Austria
John Stubenrauch, MBA, Ph.D., Head of External Commercialization and Operations, Biologics, Merck & Co., Inc.
Friday, October 12, 2012
10:15 am – 11:45 am
Structuring Process Knowledge for the Opportunity to Achieve Robust
Processes, Simplified Technology Transfer and Regulatory Compliance
Co-Sponsored by:
Learn and contribute your insights about the regulatory expectations and the potential benefits to be gained from
managing process information in a structured way. The panel will explore with the audience how this would facilitate
communication, accessibility and usability of process information within development and the manufacturing supply
chain. A sampling of goals to be addressed includes:
• How to speed up the development of robust processes by linking process development to manufacturing and
providing a framework to share process information to all stakeholders
• Methods to greatly facilitate the transfer of processes to manufacturing assets
• Managing process knowledge in a way that facilitates process understanding and continuous improvement
Moderator:
Peter Latham, President, Latham BioPharm Group
Panelists:
Barak Barnoon, Associate Director, Process Engineering Biotech Technology and Engineering, Pfizer Inc.
Jerry Chapman, Senior Editor, International Pharmaceutical Quality Journal
David E. Fein, Ph.D., Senior Process Engineer, Viral Vaccine Technology and Engineering, Merck & Co., Inc.
Rebecca Sendak, PhD, Senior Scientific Director, Therapeutic Protein Development, Genzyme, a Sanofi company
Andrew Sinclair, Managing Director, BioPharm Services Ltd., United Kingdom
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Early Registration and Group Discounts are Available (see page 27) 22

Meet the People Behind the Products and Get the Answers You Need
3M Purification Inc. is a world leader in advanced depth filtration systems and
membrane-based separations, offering a range of high performance and high quality
products to meet a variety of processing challenges facing today's bioprocess industry.
From cell culture clarification, to soluble impurity removal, to final sterilizing filtration, 3M Purification’s
technologies deliver an economical, efficient and robust solution for your processing needs.
BD is a medical technology company that serves healthcare institutions, life
science researchers, clinical laboratories, industry and the general public. The
BD Biosciences—Advanced Bioprocessing business segment is focused on the
development of cell culture media and supplements that improve the production of biological medicines.
Diamond Sponsor
ReadyToRock Tour 2012
Plug & Play biomanufacturing with ReadyToProcess
Bringing our single-use platform to you. Visit the ReadyToRock Tour exhibit to experience a complete
platform of flexible, single-use products configured for vaccine or MAb production. Our team of experts will
demonstrate how the ReadyToProcess single-use technologies can be incorporated in your process.
• Speak with our product experts about our
single-use systems.
• Listen to seminars on vaccine and mAb processes
developed by our R&D utilizing single-use technologies.
• Participate in demonstrations on single-use equipment
for cell culture, chromatography, and filtration.
Platinum Sponsor
• Learn to make connections between sterile operations
and, between single-use to traditional systems.
• Review our regulatory, validation and quality
documentation with the ReadyToProcess platform.
Pall’s leading edge separation, purification, cell culture, analytical technologies and services play an essential role in the Life Sciences industry. Pall singleuse
and traditional filtration, chromatography, fluid handling, sampling, monitoring and quality assurance products and engineered systems, together with
technical services in validation, assays and process optimization are applicable to all phases and scales of therapeutic, vaccine, and diagnostic product research,
development and manufacturing.
EMD Millipore is the Life Science division of Merck KGaA of Germany and offers products used
by pharmaceutical and biotechnology companies to develop and manufacture biopharmaceutical
drugs safely and efficiently. We provide fully integrated solutions to biopharmaceutical customers
and an attractive range of development and regulatory services to biopharmaceutical manufacturers.
Novasep develops, markets and operates
innovative technologies to produce active
molecules for the life sciences industry.
Our global solution for biopharmaceutical manufacturing includes:
• Bioprocess development: upstream and downstream processing;
formulation; fill and finish, • Contract biomanufacturing services
• Chromatography and tangential flow filtration equipment, systems
and consumables.
Gold Sponsors
Silver Sponsors
Utilizing innovative technologies and
competencies, SAFC is focused on
developing tailored solutions that resolve
biopharmaceutical development and manufacturing challenges in
order to accelerate speed to market. Our rich portfolio includes
critical raw materials, biological testing services, and specialized
contract manufacturing such as viral vaccines and antibody drug
conjugates. Learn more at www.safcglobal.com.
Session Sponsors
Technology Workshop & Presentation Sponsors
Panel Discussion & Thought Leadership Forum Sponsors
Bio-Rad Laboratories is a leading provider of innovative tools to the life
science and clinical diagnostics markets, where the company’s products
are used for scientific discovery, drug development, and biopharmaceutical
production. Bio-Rad’s Life Science Group has long served the bioprocessing industry by supplying
advanced purification and process technologies. Bio-Rad provides a full line of scalable — from pilot to
production — process chromatography media and hardware solutions.
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology
company dedicated to moving science forward to improve life in meaningful
ways for everyone. Our premier brands are the most cited, most trusted in the
life sciences industry: Invitrogen, Applied Biosystems®, Gibco®, Molecular
Probes®, Novex®, TaqMan®, Ambion®, and Ion Torrent.
Thermo Scientific Cell Culture and
BioProcessing products deliver proven solutions
at every scale. Our products and services are
specifically designed for performance with innovative, efficient and
highlyeffective upstream or downstream applications. From a single
source, you can optimize production, improve process efficiency and
fast track product development and market introduction.
www.thermoscientific.com/hyclone
Badge & Lanyard Sponsor Refreshment Break Sponsor Formulation Strategies Session Sponsor
23 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

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2012 Exhibitor List (as of June 19, 2012):
3M
Advanced Instruments
AdvantaPure / NewAge Industries
Agilent Technologies
Applikon Biotechnology
Aragen Bioscience
Arkema Inc
Asahi Kasei Bioprocess
ASI
ATMI
ATR, Inc
Avid Bioservices
BAC
BD Biosciences - Advanced
Bioprocessing
Bio-Rad Laboratories
BioGenes GmbH
Biopharm Services
BioPro International
Bioproduction Group
BioReliance
BioTechLogic
Boehringer Ingelheim
Broadley-James Corporation
Catalent Pharma Solutions
CellGenix
Charles River
The World’s Largest Bioprocess Industry Destination: Hosting over 150 Companies
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Chemglass Life Sciences
CMC Biologics
Colder Products Co
Cook Pharmica
Corning Incorporated
Cygnus Technologies, Inc
Cytovance Biologics
DASGIP BioTools
DSM Biologics
em-tec Flow Technology LP
EMD Millipore
FeF Chemicals A/S
Finesse Solutions, Inc
Fluid Imaging
Forte Bio
Freeslate
FrieslandCampina DOMO
Fujifilm Diosynth Biotechnologies
Gallus Biopharmaceuticals
GEA Tuchenhagen
GEA Westfalia Separator
Gyros, Inc
Hamilton Company
Hospira
Informetric Systems
Irvine Scientific
JSR Micro
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=SOLD =POSTERS
Kaiser Optical Sytems
Kaneka Americas Holding
KBI Biopharma
Kemwell Biopharma
Lancaster Laboratories
Laureate Biopharma
LEWA, Inc
Life Technologies
M+W Group
m2p Labs
Meissner
Metabolon, Inc.
Molecular Devices
MSP Corporation
Natrix Separations
New Brunswick Scientific/
Eppendorf
NNE Pharmaplan
Novasep
Ocean Optics Inc.
optek-Danulat
P.S.G.
Pall Life Sciences
Parker Hannifin domnick
hunter
PBS Biotech
PendoTECH
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Pneumatic Scale Angelus
PreSens
Qosina
Refine Technology
Rentschler
Repligen BioProcessing
Roche Custom Biotech
Saint-Gobain Perfromance Plastics
Sandoz
Sartorius Stedim Biotech
Scilog
Senova Systems
SGS Life Sciences
Soluble Therapeutics
Spectrum Labs
TAP Biosystems
Tarpon Systems
About the Exhibition:
In the largest exhibition devoted
exclusively to biopharmaceutical
manufacturing, learn about the latest
technologies and services developed
to overcome challenges and streamline
processes. Network and consult with
the experts from product and service
provider companies.
Exhibition Highlights:
• Meet over 150 industry leading
product and service companies
• NEW! Visit GE Healthcare’s cutting
edge ReadytoRock mobile exhibit
• Network with other industry players
via the speed networking session
• Consult with industry experts and win
prizes with the BPI Passport
• Meet new companies in the exhibit
hall’s Emerging Marketplace section
• Gain valuable face time with
1,500+ attendees
• Novel poster presentations now
within the exhibit areas for increased
interaction
Exhibit Hall Hours:
Tuesday, October 9
3:15 pm to 7:00 pm
Wednesday, October 10
9:45 am to 7:15 pm
Thursday, October 11
9:45 am to 1:40 pm
Terumo BCT
Therapure
Thermo Fisher Scientific
Thomas A Little
Tosoh Bioscience
Value Plastics
Vante
Wuxi Apptec
Xcellerex
Limited Space Available
To learn more about exhibiting at this year’s
BioProcess International conference, please contact:
Jennifer Thebodo, A-L
(508) 614-1672 • jthebodo@ibcusa.com
Kristen Schott, M-Z
(508) 614-1239 • kschott@ibcusa.com
Early Registration and Group Discounts are Available (see page 27) 24

For 2012, Formulation Strategies focuses on
the challenges of emerging drug products and
the analytical methods employed by formulators
to achieve the depth of product understanding
required in today’s regulatory environment.
Tuesday, October 9, 2012
7:45 Registration and Networking Coffee
8:30 Chairperson’s Opening Remarks
Mary E.M. Cromwell, Ph.D., Director, Late Stage
Pharmaceutical Development, Genentech, Inc.
Formulation Strategies for Biosimilars and
Next-Generation Biologics
Keynote Presentation
8:45 The Next Generation of
Biotherapeutic Dosage Forms .
Kevin R. King, Ph.D., Senior Director,
Formulation & Process Development,
Pharmaceutical R&D, BioTherapeutics
Pharmaceutical Sciences, Pfizer Inc.
9:30 Formulation Development for a Bispecific
Antibody
Rajesh Krishnamurthy, Ph.D., Director, Zyngenia
10:00 Networking Refreshment Break
10:45 Drug Product Development of Biosimilars:
Strategies and Approaches
Krishnan Sampath, Ph.D., Associate Director, Formulation
and Drug Product Process Development, Global Biologics
R&D, Hospira
11:25 Process and Product Development
for Biosimilars
Valentyn Antochshuk, Ph.D., Group Leader, Formulation Design
and Process Compatibility, Merck Bioprocess Development
12:10 Lunch on Your Own
1:40 Chairperson’s Opening Remarks
Valentyn Antochshuk, Ph.D., Group Leader,
Formulation Design and Process Compatibility,
Merck Bioprocess Development
Panel Discussion
Sponsored by:
1:45 Ten Key Questions for Subvisible Particle
Characterization, Monitoring and Control
Panelists:
Maria Toler, MS, Senior Principal Scientist,
Pfizer Global Biologics
Mary Cromwell, Ph.D., Director, Late Stage Pharmaceutical
Development, Genentech
Rob Simler, Ph.D., Staff Scientist, BioFormulations
Development, Genzyme, a Sanofi company
Valentyn Antochshuk, Ph.D., Group Leader, Formulation Design
and Process Compatibility, Merck Bioprocess Development
Melissa D. Perkins, Ph.D., Senior Director, Drug Product
Sciences, Human Genome Sciences, Inc
Co-Located Event: IBC’s 12th Annual
Formulation Strategies for Protein Therapeutics
CASE STUDY
By attending, you will learn:
• Approaches to formulation development for biosimilars and second generation biologics
• How to resolve the remaining challenges of subvisible particle characterization, monitoring and control
• How Quality by Design approaches are now maturing into useful tools for drug product development
• The most predictive analytical methods used for protein characterization and formulation development
• Strategies for using rational selection and design in early development to improve the stability and
pharmacokinetics of your drug products
2:45 Technology Workshop
Accelerating Formulation
Development using the HSC TM Technology
Joseph N. Garner, Ph.D., CEO, Soluble Therapeutics, Inc.
3:15 Grand Opening of Poster and Exhibit Hall
with Refreshments
Sponsored by:
Rational Selection and Design for Improved
Pharmacokinetics
3:45 Difficult Dual Variable Domain
Immunoglobulins: Lessons Learned and
Strategies for Faster Formulation Development
Vineet Kumar, Ph.D., Senior Research Scientist,
Pharmaceutics, Abbott
4:15 Rational Selection and Design of a PEGylated
Protein to Improve Pharmacokinetics
Anna (Sung-Hae) Park, Ph.D., Senior Scientist, Transitional
Research, Genzyme, a Sanofi company
4:45 Evaluation of Protein Degradation In Vivo to
Support Formulation Development
Zhuchun Wu, Ph.D., Principal Scientist, Analytical Sciences
Department, Human Genome Sciences, Inc.
5:15 Networking Cocktail Reception; Opening of
BioProcess InternationalTM Exhibit and Poster Hall
Wednesday, October 10, 2012
7:30 Networking Coffee
7:75 Chairperson’s Opening Remarks
Bernardo Perez-Ramirez, Ph.D., Senior Scientific Director,
Genzyme, a Sanofi company
Quality by Design for Drug
Product Development
Keynote Presentation
8:00 Experiences in a QbD-Based FDA
Regulatory Filing: Drug Product
Considerations .
Mary E.M. Cromwell, Ph.D., Director, Late Stage
Pharmaceutical Development, Genentech, Inc.
8:45 A QbD Approach to Design the “Formulation
Robustness” for a Highly Concentrated Protein
Solution in a Pre-filled Syringe
Karin Schoenhammer, Ph.D., Group Leader Late-Stage
Pharmaceutical and Process Development,
F. Hoffmann-La Roche Ltd., Switzerland
9:15 Application of DOE with Mixture Design to
Overcome Viscosity and Stability Issues in High
Concentration mAb Formulation Development
Holly Z. Huang, MS, Scientist, Amgen
9:45 Networking Refreshment Break in BioProcess
International TM Exhibit and Poster Hall
CASE STUDY
CASE STUDY
CASE STUDY
CASE STUDY
CASE STUDY
Product Characterization for
Formulation Development
25 For full abstracts and to register, visit www.IBCLifeSciences.com/Formulation
10:30 Evaluating the Long Term Oxidation
Potential of Methionine in Biologics
Vikram Sadineni, Ph.D., Senior Research Investigator,
Bristol-Myers Squibb
11:00 Biophysical Analysis to Understand and Mitigate
Challenges in Downstream Process Developmen
Haripada Maity, Ph.D., Principal Scientist, Formulation
Development, ImClone Systems, A Wholly-Owned Subsidiary
of Eli Lilly & Co.
11:30 Characterization of Antibody Charge Variants
Isolated by Gram-Scale Ion Exchange
Displacement Chromatography
Zephania Kwong Glover, Senior Research Associate, Late Stage
Pharmaceutical Development, Genentech, Inc.
12:10 Technology Workshops presented by
GE Healthcare, Kerry, Life Technologies, or
Sartorius Stedim Biotech. (See page 13 for details)
12:30 Networking Luncheon in BioProcess
InternationalTM Exhibit and Poster Hall
2:10 Chairperson’s Opening Remarks
Murali Bilikallahalli, Ph.D., Senior Scientist and Group Leader,
MedImmune, Inc.
2:15 Oxidation Detection in Formulation and Drug
Product Process Development
Caroline Loew, Ph.D., Postdoctoral Fellow, Late-Stage
Pharmaceutical and Processing Development,
Hoffmann-La Roche, Switzerland
Predictive Methods in Formulation Development
2:45 Methods to Identify Aggregation Prone Precursors
Tim Kelly, Ph.D., Vice President, Biopharmaceutical
Development, KBI Biopharma, Inc.
3:15 Mind the Gap: Light Scattering Techniques for
Biotherapeutics in High and Low Concentration
Michael S. Marlow, Ph.D., Staff Scientist, Protein Biochemistry,
Regeneron Pharmaceuticals, Inc.
3:45 Networking Refreshment Break in BioProcess
InternationalTM Exhibit and Poster Hall
4:30 Detecting the Aggregation Propensity of Protein
by Bis-ANS Binding Kinetics and Thermodynamics
Murali Bilikallahalli, Ph.D., Senior Scientist and Group Leader,
Vaccines Formulation and Development, MedImmune, Inc.
5:00 How Useful is Rapid Thermostability Screening in
Protein Formulation Design?
Mark Brader, Principal Scientist, Protein Pharmaceutical
Development, Biogen Idec
5:30 Thermal Stability and Native-State Solubility
Studies for Selecting De-Risked Drug Lead
Candidates in Discovery
Michael Doyle, Ph.D., Senior Principal Scientist, Protein Science
and Structure, Bristol-Myers Squibb
6:00 End of Formulation Conference; Networking
Cocktail Reception in BioProcess International
Exhibit and Poster Hall
CASE STUDY
CASE STUDY
CASE STUDY

Delivery Strategies blends practical
solutions related to the development
of high dose drug products and drug/
device combinations with forward looking
information on novel delivery approaches for
biotherapeutics.
Thursday, October 11, 2012
7:45 Registration and Networking Coffee
8:00 Chairperson’s Opening Remarks
Paul Burke, Ph.D., Principal, Burke Bioventures LLC
Keynote Presentation
8:15 The Next Generation of Biologics
and the Role of Drug Delivery and
Device Technologies
William J. Lambert, Ph.D., Fellow, Drug Delivery
and Device Development, MedImmune, Inc.
Delivery Strategies for High Viscosity and
High Concentration Drug Products
9:00 Large-Dose Subcutaneous Injection of
Monoclonal Antibodies.
Robin Hwang, Ph.D., Consultant, ICP Consulting Corp.
9:30 Novel Yet Practical Solutions to UF/DF
and Processing Challenges at High Protein
Concentrations and Excipient Based
Formulation Strategies for High
Concentration Protein Products
Jeff Abel, Scientist, Amgen
10:00 Networking Refreshment Break in BioProcess
International TM Exhibit and Poster Hall
10:30 The Role of Protein Charge in Formulation Stability
Tom Laue, Ph.D., Professor, University of New Hampshire
11:00 Protein Crystallization as a Strategy for
Reducing Viscosity of High Concentration
Protein Formulations
Tod Lauerman, Ph.D., Corporate Development Scientific
Consultant, Althea Technologies
11:30 Exhibit and Poster Viewing in BioProcess International
Exhibit Hall
12:00 Networking Luncheon in BioProcess
International TM Exhibit and Poster Hall;
Last Chance for Exhibit and Poster Viewing
Group Discounts Provide Significant Savings
Companies can benefit from significant savings on standard
registration fees when registering 3 or more people from the
same company for the event at the same time. For group
discount information, please call 646-895-7445.
Co-Located Event: IBC’s 5th Annual
Delivery Strategies for Biologics
By attending, you will learn:
CASE STUDY
CASE STUDY
• Delivery strategies for the challenges of high viscosity and high concentration drug products
• How to effectively co-develop drug product formulations and related delivery devices
• Methods for achieving local and targeted delivery of biologics
• Next generation approaches to overcoming the barriers to oral and pulmonary delivery of macromolecules
1:25 Chairperson’s Opening Remarks
Tim Kelly, Ph.D., Vice President, Biopharmaceutical
Development, KBI Biopharma, Inc.
Co-Development Strategies for
Biologic-Device Product Combinations
1:30 Compatibility of Manufacturing Process
Materials and Dosing Device with Therapeutic
Protein and Peptide Formulations
Soumendu Bhattacharya, Ph.D., Principal Scientist,
BioProcess Development, Merck & Co., Inc.
2:00 Growth Factor Retention on a Collagen
Matrix for Local Delivery
Chandra Webb, Senior Principal Scientist, Pfizer, Inc.
2:30 Importance of Evaluating Clinical In-Use
Conditions during Early Phases of Formulation
Development of Antibody Products
Camellia Zamiri, Ph.D., Senior Scientist, NBE Formulation
Sciences, Abbott Biotherapeutics Corp.
3:00 Networking Refreshment Break
3:30 Delivering Therapeutic Biologics: Drug-Device
Synergies for Early Stage Screening and
Successful Product Development
Anand Subramony, Ph.D., Principal Fellow & Head, Novel
Delivery Technologies & Therapeutics (NDT), Technical Research &
Development, Novartis Institutes for BioMedical Research, Inc.
4:00 Patch Pumps for Large Volume,
Subcutaneous Delivery
Gerhard Mayer, Ph.D., Vice President, Sensile Medical AG
4:30 Technology Workshop Presentation Opportunity
For information on sponsoring a Technology Workshop, please
contact Jennifer Thebodo: JThebodo@ibcusa.com or 508-614-1672.
5:00 End of Sessions
CASE STUDY
CASE STUDY
CASE STUDY
Friday, October 12, 2012
8:00 Networking Coffee
8:25 Chairperson’s Opening Remarks
Kenneth S. Graham, Ph.D., Director, Formulation
Development, Regeneron Pharmaceuticals Inc.
Localized and Targeted Delivery of Biologics
8:30 Microencapsulation of Biomacromolecules in
PLGA without Organic Solvents
Steven P. Schwendeman, Ph.D., Professor, Department of
Pharmaceutical Sciences, University of Michigan
9:00 Development of a Liquid Biotheraputic
Formulation for Intravitreal Injection
Kenneth S. Graham, Ph.D., Director, Formulation
Development, Regeneron Pharmaceuticals Inc.
9:30 CNS Delivery of Lysosomal Enzymes
Perry Calias, Ph.D., Head of Analytical and
Pharmaceutical Development, Shire
10:00 Networking Refreshment Break
10:30 Nanoparticles and Ligand-Conjugates for Tumor-
Targeted Delivery of RNA-Based Gene Therapy
Christopher J. Cheng, Ph.D., Postdoctoral Fellow,
Department of Biomedical Engineering, Yale University
11:00 Strategies to Deliver Biologics to the Brain
Reinhard Gabathuler, Ph.D., Vice President, Research and
Development, biOasis Technologies Inc.
11:30 Delivery Matrices for Use of Biologics in Cell
Therapy and Tissue Engineering
David Kaplan, Ph.D., Professor and Chair,
Department of Biomedical Engineering, Tufts University
12:00 Lunch on Your Own
1:25 Chairperson’s Opening Remarks
Next Generation Routes of Administration
for Biologics
1:30 On Bioadhesion, Nanoparticles, and the Future
of Oral Delivery of Biologics
Edith Mathiowitz, Ph.D., Professor of Medical Science &
Engineering, Brown University
2:00 Simple Oral Delivery of Poorly
Bioavailable Molecules
Jonathan Behr, Ph.D., Senior Director, Technology and
Business Development, Entrega
2:30 Delivery of Biologics by Oral Inhalation:
It’s Not Just for Pulmonary Disease Anymore
Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical
Research and Development, MannKind Corporation
3:00 End of Delivery Conference
For full abstracts and to register, visit www.IBCLifeSciences.com/Delivery 26
CASE STUDY
CASE STUDY
CASE STUDY
CASE STUDY

Two-Day Training Courses: Combine in-depth training with a conference registration & save!
Introduction to Biopharmaceutical
and Vaccine Manufacturing
This course introduces the manufacturing process and common unit operations used in
the manufacture of biopharmaceuticals. Starting with an industry overview that provides
insight into what drives process development and manufacturing, the course then moves
through expression systems, protein characterization, fermentation/cell culture, recovery,
purification, formulation, fill and finish. The course will follow with facility design,
construction and start up, and key parameters for scaling up with industry examples. The
course concludes with the role of quality and the regulatory environment under which
biologicals are produced, including validation. This course is designed to introduce you
to the language of manufacturing, provide a perspective on the operations that make up
a manufacturing process, and help you understand how a process works to produce safe
and effective products.
Instructor:
Sue Behrens, Ph.D., Independent Consultant; former Senior Director, Vaccines &
Biologics, Merck Manufacturing Division
Analytical Method Development and Validation
for Therapeutic Proteins
This course is a panoramic review of analytical method development and validation for
therapeutic proteins, including antibodies and enzymes. It is intended for scientists working
on therapeutic proteins in AD, QC, PD, or related functional areas. It will start with basic
knowledge of working on therapeutic proteins: manufacturing of proteins drugs, basic
regulatory affairs and basic protein chemistry. It will then discuss the fundamentals and
practical aspects of commonly used analytical methods for proteins, including methods
for structure elucidation, biophysical characterization, potency measurement, purity and
impurity analyses. The course will conclude with the strategy and common practice in
method validation and method transfer, including regulatory compliance at different stage
of product development, application of DOE and QbD. The course puts an emphasis on
practical applications, real-world examples, and useful tips.
Instructor:
Jichao Kang, Ph.D., Director, Analytical and Formulation Development,
Laureate Biopharmaceutical Services, Inc.
Conference Venue
Rhode Island Convention Center
One Sabin Street, Providence, RI 02093
www.riconvention.com
Conference Hotel Special Room Rate:
Westin Providence $199 per night + tax
One West Exchange Street,
Providence, RI 02093
www.starwoodmeeting.com/Book/BPI
Please call the hotel at 1-888-627-8449 (reference BPI 2012)
before Friday, September 7, 2012 or visit the website:
www.starwoodmeeting.com/Book/BPI to be included in IBC's
dedicated room block for this conference. Please identify yourself
as part of IBC’s BPI/Formulation event to receive the reduced room
rate of $199 (single/double) per night plus taxes.
Hotel Reservation Policies: A non-refundable deposit equal to the
first and last night’s stay is required to hold each guest’s reservation.
All deposits shall be charged at the time the reservation is made and
are non-refundable. Cancellations to a reservation will be refundable
up until Friday, September 7, 2012 (cut-off date). After Friday,
September 7, 2012 the first and last night deposit will NOT be
refunded. Your credit card is subject to being charged if cancellation
or changes to a reservation are received after the cut-off date.
Tuesday, October 9, 2012 - Wednesday, October 10, 2012 • 9:00 am - 5:00 pm
Additional Registration Information
For onsite registrations, please add $100.
Program content and speakers subject to change. Conference
badges are non-transferable and lost badges will not be replaced
without payment of the full conference registration fee. Please note
that payment is required in advance of the conference. Please make
check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC Life
Sciences. Confirmation of your booking will be sent. MasterCard,
Visa and American Express are accepted.
Registration Substitutions/Cancellations: If you need to make any
changes or have any questions, please feel free to contact IBC’s
customer service team via email at reg@ibcusa.com. Cancellations
must be in writing and must be received by IBC prior to 10
business days before the start of the event. Upon receipt of a timely
Cell Culture & Fermentation Bioprocessing
This course provides a comprehensive discussion of the scientific principles of microbial
fermentation and mammalian cell culture bioprocessing as pertinent to the development of
pilot and large scale manufacturing of biopharmaceutical products. The course begins with a
discussion of fundamental concepts in molecular biology, protein expression systems, host cell
engineering, selection of high producing clones, and cell culture and fermentation technology.
The next segment focuses on how to develop manufacturing processes, including scale up/
scale down and process characterization and optimization. The final segment includes a
discussion of recent trends in bioprocessing, with a focus on PAT implementation, application
of concepts from ICH Q8-Q11, and the use of disposables in biomanufacturing. The course
makes use of interactive group discussions, literature-based case studies, and extensive
technical references to engage the participants in active dialogue with the goal of returning
home with new knowledge that can be immediately put to practice in their situations.
Instructor: Antonio R. Moreira, Ph.D., Professor, Chemical and Biochemical Engineering, Vice
Provost, University of Maryland, Baltimore County
Stability and Specifications for Biological
and Biotech Products
Stability programs are used to establish the shelf life of new or improved biological
products, and to assure quality throughout their expiry period. Approaches for setting shelf
life or release specifications, and for assessing stability of manufactured material should
be carefully established to minimize the risks to the consumer and manufacturer alike. In
addition, understanding the distinct roles of specifications and manufacturing control limits
is critical to the implementation of a risk based quality system. Consumer and manufacturer
risks are managed through strategic design and statistical analysis of the studies that
support control of marketed product. This workshop will delineate the several uses of
development and commercial stability studies, and explore the critical inter-relationships
among these and other sources of development and manufacturing information.
Instructor:
Timothy Schofield, MA, Managing Director, Head of Nonclinical Statistical Services,
Arlenda, Inc.
For details about the course agendas and instructors, visit www.IBCLifeSciences.com/Courses
cancellation notice, IBC will issue a
credit voucher for the full amount
of your payment, which may
be applied towards registration
fees at any future IBC event held
within 6 months after issuance
(the “Expiration Date”). All credit
vouchers shall automatically expire
on the Expiration Date and shall
thereupon become void. In lieu
of issuance of a credit voucher,
at your request, IBC will issue
a refund less a $595 processing fee per registration. Registrants
are advised that no credit vouchers or refunds will be issued for
cancellations received 10 business days or less prior to start of
the event, including cancellations due to weather or other causes
beyond the registrant’s control. IBC therefore recommends that
registrants allow for unexpected delays in making travel plans.
Substitutions are welcome at any time. If for any reason IBC
decides to cancel this conference, IBC accepts no responsibility
for covering airfare, hotel or other costs incurred by registrants,
including attendees, sponsors, speakers and guests.
SPECIAL NEEDS: If you have a disability or special dietary needs,
please let us know in order that we may address your special
needs for your attendance at this show.
Please send your special needs via email to custserv@ibcusa.com.
27 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI

We expanded the coverage you valued and
added so much more this year:
• Full-day track on development and production of
Antibody Drug Conjugates
• Expanded programming for quality managers
in Lifecycle track and Pre-Conference Symposia
• Co-located conference on Delivery Strategies
for Biologics
• Plenary Session on Developing Truly Continuous
Drug Substance Processes
• Coverage of drug product topics including
fill/finish and cleaning
• Expanded roster of Pre-Conference Symposia
so you can customize and add value to your
conference experience
"This conference is a great place to meet the technical experts
in the industry. I enjoyed exchanging research ideas with global
companies and sparking new collaboration."
THE Industry Meeting Place to Exchange Real-World Solutions
to Improve Speed, Cost and Quality
Conference: October 8-12, 2012
Exhibition: October 9-11, 2012
Rhode Island Convention Center, Providence, RI
Hear 3 Critical Viewpoints on Genentech’s Recent BLA Submission Using a Quality by Design Approach
PROJECT LEADER'S PERSPECTIVE UPSTREAM PERSPECTIVE DOWNSTREAM PERSPECTIVE
Andrew Kosky, Ph.D.
Associate Director
GENENTECH, INC.
– Kelvin Lau, Senior Process Engineer, Abbott
Steven Meier, Ph.D.
Principal Engineer,
Senior Group Leader
GENENTECH, INC.
Conference: October 8-12, 2012 • Exhibition: October 9-11, 2012
Rhode Island Convention Center, Providence, RI
Tony Cano, Ph.D.
Senior Engineer,
Purification Development
GENENTECH, INC.
Enjoy your experience
and surroundings of
New England
in October
Only a one-hour drive from
Boston, Providence combines the
accessibility and friendliness of a
small town with the culture and sophistication of a big city. The RICC is within walking
distance to many hotels, shops, art galleries, nightclubs, museums and more.
Among foodies, Providence is known as a red-hot destination and was recently
featured in Food & Wine. BPI conference attendees will find a large choice of excellent
restaurants for their business dinners within a short walk or drive from the Rhode Island
Convention Center. Rhode Island is a world-class destination offering some of the best
natural beauty, culinary offerings, history and cultural attractions.
Register Early and Save • www.IBCLifeSciences.com/BPI