Program Information - IBC Life Sciences

Program Information 

Conference: September 20-24, 2010 

Exhibition: September 21-23, 2010 

Rhode Island Convention Center 

Providence, RI 

Co-located with IBC’s 10th Annual Formulation Strategies for Protein Therapeutics 

Exhibit Hall Only Attendees have access to Keynote Presentations, Poster Presentations, 

Exhibit Hall Presentation & Panel Discussion and Mid-Day Technology Workshops 

Table of Contents 

Program Guide Co-Sponsors: 

Keynote Presentations....................................3 

Agenda Overview.........................................4-5 

General Information......................................19 

Sponsors...............................................................6 

Founding 

Publication: 

Organized by: 

Conference Agendas 

Monday, September 20..................................7 

Tuesday, September 21............................8-11 

Wednesday, September 22................... 11-13 

Thursday, September 23.......................14 -16 

Friday, September 24.............................. 17-18 

Bioprocess Training Academy Courses.....7 

Exhibition Hours and Information 

Poster Presentations...............................20-21 

Exhibitor List.....................................................22 

Exhibit Hall Floor Plan...................................23 

Session Room Floor Plan............ Back Cover

Tuesday, September 21, 2010 

8:05 am 

Optimizing Manufacturing Network 

Performance and Planning for the Future 

Biologics manufacturing network performance can be measured across many 

dimensions including cost, compliance, cycle time etc. It has been useful 

to consider both plant and network parameters to optimize current state 

performance. These parameters in addition to considerations of likely business, technology 

and socioeconomic changes help shape our thoughts for future biologics manufacturing. 

Alison Moore, Ph.D., Vice President, Corporate Manufacturing, Amgen 

Keynote and Plenary Presentations 

4:00 pm (available to all attendees) 

Regulatory Modernization - FDA's Desired 

State for Product Quality 

The Pharmaceutical Initiative of 2002 introduced the concept 

of improving the regulation of product quality throughout the 

pharmaceutical community. As a result, CDER initiated "quality by 

design" as a tool to assist industry in meeting higher product quality standards. Many 

innovator and generic firms have moved forward in implementing quality by design. 

This presentation will focus on the opportunities and challenges of implementing 

quality by design for biotech products. 

Helen N. Winkle, Director, Office of Pharmaceutical Science, CDER, US FDA 


The Role of Biosimilars in Driving Innovation 

in the Biopharmaceutical Industry 

Over the past few years, biosimilars have emerged as an important new 

sector of the biopharmaceutical industry. The competitive nature of this 

new sector is encouraging innovation among leading biosimilar companies 

to bring differentiated and lower cost biologic products to patients. The introduction of 

biosimilar products is also likely to spur innovation from originator companies facing 

a more competitive marketplace. This presentation will explore the growing role of the 

biosimilars sector in driving innovation across the biopharmaceutical industry. 

Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc. 

Wednesday, September 22, 2010 

8:30 am 

Global Vaccine Production Challenges: 

Emerging Immunotherapeutics, 

Manufacturing Flexibility and Reducing COGS 

Manufacturers have to face the challenges of being able to answer the 

many challenges of a growing and changing global vaccines business. The 

amplitude of the challenges ranges from a need to develop innovative and/or sophisticated 

approaches to properly address the complexity of immune system and the patient 

interaction, to strong economical pressures to make products affordable for broader 

population. To best serve patient interest, staying economically efficient, manufacturers 

need to re-invent themselves to be agile in a highly changing and regulated environment. 

René Labatut, Ph.D., Vice President, Global Manufacturing Technology, 

Sanofi Pasteur, France 

2:00 pm 

Flexible Manufacturing for a Diverse Biologics Portfolio 

The manufacture of biologics has changed dramatically over the last 10 

years. Multi-product production has become possible, and the continued 

development of single-use systems has enabled dramatic reduction in 

capital costs and reduced cycle times. This presentation will focus on 

the conceptual analysis of production of a broad portfolio of low-volume biologics 

for biodefense, and the challenge and opportunities associated with such a design 

exercise. Previous examples will also be presented, and the future challenges for 

diverse product facility and portfolio designs. 

Phillip Gomez, Ph.D., Director, PRTM Management Consultants 

2:30 pm 

Patient-Driven Delivery Devices: Is your Company 

Playing to Win 

This presentation will outline the keys to winning in delivery devices 

starting in discovery through process optimization to formulation 

development, container closure selection, and device design. The 

presentation will outline how to truly understand customer needs, and why winning 

in delivery devices is really about the integration of process optimization, the 

formulation, the container, and the device technology. 

James J. Collins, Jr., P.E., M.B.A., Vice President, Drug Delivery and Device R&D, 

Eli Lilly and Company 

3:00 pm 

Prevnar 13: The Story Behind the Vaccine 

Prevnar 13 was approved this year by Europe and the United States and is indicated 

for active immunization for the prevention of invasive disease caused by 13 strains of 

Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 

13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar – approved 

in the United States in 2000 - plus an additional six serotypes (1, 3, 5, 6A, 7F, and 19A). 

Hear about challenges faced during manufacturing/network design and operation. 

Willard Waterfield, Ph.D., Senior Director, Manufacturing Sciences & Technology, 

Andover and Pearl River, Pfizer GMS 

Chairperson: Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec 


Sustainable Commercial Cell Culture Operations 

Developing a cell culture process which delivers a product with defined and 

acceptable critical quality attributes is but the first, and in many respects 

the easiest, element in the product lifecycle. Maintaining performance, 

ensuring the currency of the technical foundation and improving 

productivity and efficiency become the key challenges in having a sustainable operation. 

Knowledge is perishable; establishing routine can maintain performance but inhibit 

improvement; and everything ages. Hear about the systems that can be put in place to 

deal with these concepts across People, Process and Infrastructure. 

W. Blair Okita, Ph.D., Senior Vice President, Manufacturing Sciences and Technical 

Operations, Genzyme Corporation 


Finding a Home for Process and Product Development 

In order to compete in today’s cost-conscious world, the biotechnology 

industry needs to reinvent itself. Recognition of Manufacturing Technology 

and Product Development as a critical strategic element in this reinvention 

process and putting in place organizational design which enables their 

contributions are key to ultimate success. Process and product development are 

effectively carried out within the biotechnology industry under a number of different 

organizational designs (OD). The presentation will address, through example and 

guiding principles, where OD can enable game-changing outcomes. 

S. Robert Adamson, Ph.D., Advance Biotech Consultants; former Senior Vice 

President Product and Process Development, Wyeth Biopharma 

Thursday, September 23, 2010 

8:15 am 

Challenges and Efficiencies Gained by Integrating 

Upstream and Downstream Drug Substance PD 

In the thirty-five years since the Asilomar conference on rDNA, the 

biopharmaceutical industry has undergone significant expansions both 

in terms of scale and the frequent need to support multiple sites. Cost 

pressures have resulted in tighter budgets and timelines for development, tech transfer, 

and commercialization. Yet most PD organizations look pretty much the same as they 

did decades ago. We will present some novel approaches to organizing and integrating 

PD activities that we feel will be required to maintain competitiveness in the years ahead. 

Gene Schaefer, Ph.D., Senior Director, API-Large Molecule Development, Johnson & Johnson 

8:45 am 

Optimizing Interfaces and Hand-offs between Upstream 

and Downstream Processing 

Biopharmaceuticals are inherently complex, with product quality and 

business relevant parameters affected by the various unit operations 

and their respective linkage. Strategies to optimize the overall efficiency 

of bioprocess development and manufacturing need to address in particular 

the technical and organizational interfaces between upstream and downstream 

processing. An integrated approach will be discussed. 

Jens H. Vogel, Ph.D., Global CMC Development Team Leader & Head, Isolation & 

Purification Department, Global Biological Development, Bayer HealthCare 

9:15 am 

Linking Upstream and Downstream 

Jonathan Coffman, Ph.D., Principal Engineer III, Pfizer Biotherapeutics 

Friday, September 24, 2010 

10:15 am 

An Industrial View of Biopharmaceutical 

Comparability and Characterization 

Process and product changes (including manufacturing site, containerclosure, 

and analytical changes) are an inevitable part of biopharmaceutical 

development, and have been made for every product currently on the 

market. Comparability studies are typically performed to assess whether the change(s) 

is likely to affect product safety and efficacy. Most of these have positive outcomes, but 

sometimes the results require additional nonclinical or clinical studies. Strategies for 

management of comparability study risks will be reviewed. 

Anthony S. Lubiniecki, Sc.D., Senior Fellow, CMC Strategy, Large Molecule Portfolio 

Management, Janssen Pharmaceutical Companies of Johnson & Johnson 

BioProcess International Conference & Exhibition 3

Agenda Overview (Includes Room Assignments) 

Monday, September 20, 2010 

1:00 pm - 5:00 pm 

Symposium #1: Prevention of Microbial and Viral Contamination of 

Mammalian Cell Culture Processes (Room 554) 

Symposium #2: How Much Data is Enough 

The Statistical Approach to Process Validation (Ballroom C) 

Symposium #3: Technology Transfer for Biopharmaceuticals 

(Ballroom E) 

Tuesday, September 21, 2010 Exhibit Hall Hours: 5:30 pm – 7:00 pm 

Managing Manufacturing 

Morning 

Networks (Ballroom B/C) 

Leveraging our Assets - How do We 

Reconcile the Installed Base with Current 

Technologies and Demand 

Leveraging our Assets - How do We 

Reconcile the Installed Base with Current 

Technologies and Demand (session continues) 

Product Lifecycle Management 

(Ballroom D/E) 

Process Design: Establishing Design Space 

and Robust Process Parameters 

9:45 am Networking Refreshment Break 

Process Design: Establishing Design Space 

and Robust Process Parameters 

(session continues) 

Sponsored Session by Bio-Rad 

(Room 551) 

Strategic Discussion Forum 

(Rotunda) 

Formulation Strategies for 

Protein Therapeutics (Room 555A/556) 

Advancements and Case Studies of 

Hydroxyapatite for Biomanufacturing Pre-Conference Workshop: 

The Formulator of the Future: Using High 

Throughput Technologies, Informatics 

and Rational Design to Accelerate and 

Advancements and Case Studies of 

Hydroxyapatite for Biomanufacturing 


10:15 am 

Managing Partners and Contractors 

– Practical Solutions to the Issues that Arise 

11:45 am Technology Workshops Sponsored by: Sheffield Bio-Science (Room 553), Mirus Bio (Room 550) and Novasep, Inc. (Room 552) 

12:15 pm Luncheon Presentation Sponsored by Millipore Corporation (Ballroom A) 

Afternoon 

Smart Flexibility in Facilities Implementation and Execution 

Networking Refreshment Break 

Opening Keynote Presentations: I. Regulatory Modernization - FDA's Desired State for Product Quality 

II. The Role of Biosimilars in Driving Innovation in the Biopharmaceutical Industry 

(Ballroom A) 

5:30 pm Opening Night Reception Sponsored by: Pall Life Sciences (Exhibit and Poster Hall) 

1:45 pm 

Manufacturing: What will Take Us to the 

Next Level of Efficiency and Economics 

Sponsored by Pall Life Sciences 

Optimize Formulation Development 

Keynote Presentations: 

Holistic QbD; Particles, Particles Everywhere 

Development of Formulation and Drug 

Product Design Space 

Comparability and Characterization Exercises 

during Formulation Development 


Exercises during Formulation 

Development (session continues) 

Wednesday, September 22, 2010 Exhibit Hall Hours: 9:45 am – 7:00 pm 

Managing 

Manufacturing 


Product Lifecycle 

Management 


Raw Materials/ 

Supply Chain 

(Room 551) 

Strategic 

Discussion Forum 

(Rotunda) 

Recovery & 

Purification 

(Room 552) 

Rapid Vaccine 

Development and 

Production (Room 555B) 

7:15 am Technology Workshop with Continental Breakfast Sponsored by: SAFC Biosciences (Rotunda) Keynote Presentation: Global 

Vaccine Production Challenges: 

Emerging Immunotherapeutics, 

Manufacturing Flexibility and 

Morning 

The Future of Manufacturing 

Networks and Facilities 




Continuous Process 

Improvement 

Continuous Process 

Improvement 


Point Counterpoint Session: 

Integrating Raw Materials 

and Suppliers into 

a Pharmaceutical 

Quality System 

Advances in Process 

Monitoring and Control in 

Downstream Processing 

9:45 am Networking Refreshment Break Sponsored by: Luminex (Exhibit and Poster Hall) 


Integrating Raw Materials 

and Suppliers into a 

Pharmaceutical Quality 

System (session continues) 

10:30 am 

Continuous Disposable 

Multi-Column 

Chromatography 

Sponsored by Tarpon Biosystems 

Cell Culture & 

Upstream Processing 

(Room 552) 

Integrating In-Line Process 

Monitoring and Control 

Technologies 

Reducing COGS 

Lessons Learned from the 2009 

Flu Season to Guide Rapid Vaccine 

Development and Manufacturing 

Scale Up 

Process Development 

for Novel Vaccines and 

Immunotherapeutics 

Formulation Strategies 

for Protein Therapeutics 

(Room 555A/556) 

Keynote Presentation: Modeling 

Protein Degradation Processes 

and the Development of 

Rational Approaches to 

Stabilization 

Keynote Presentation: NIST 

Perspective on Standards and 

GMP Processes for Subvisible 

Particles in Protein Therapeutics 

Implementing Analytical 

Methods and Control Steps for 

Subvisible Particles

12:00 pm 

Technology Workshops Sponsored by: 

Diosynth Biotechnology, now a part of MERCK BioManufacturing Network (Room 552), GE Healthcare (Room 551), 

Natrix Separations Inc. (Room 550), and New Brunswick Scientific (Room 553) 

12:30 pm Networking Luncheon in with Dedicated Poster Viewing (Exhibit and Poster Hall) 

Afternoon 

Plenary Session – Critical Industry Issues 

(Ballroom A) 

Networking Refreshment Break Sponsored by: Luminex (Exhibit and Poster Hall) 

Keynote Presentations: I. Sustainable Commercial Cell Culture Operations 

II. Finding a Home for Process and Product Development 

(Ballroom A) 

Defending Biosimilar 

Competition: Bioprocess IP 

Protections for Next Generation 

Vaccines and Immunotherapeutics 

Process Development and 

Analytical Characterization for 

Vaccine Production 

Rapid Vaccine Development 

and Production 

Technology Workshop 

Sponsored by 

Avacta Analytical Ltd. 

Evaluation and Control of 

Biopharmaceutical Stability 




5:30 pm Networking Reception in Exhibit and Poster Hall Sponsored by: BD Biosciences 

Thursday, September 23, 2010 Exhibit Hall Hours: 9:45 am – 4:00 pm 

Recovery & Purification 

(Ballroom B/C) 

Cell Culture & Upstream 

Processing (Ballroom D/E) 

Emerging Analytical 

Requirements (Room 551) 

7:15 am Technology Workshop with Continental Breakfast Sponsored by: BD Biosciences (Rotunda) 

Strategic Discussion Forum 

(Rotunda) 


Protein Therapeutics (Room 555A/556) 

Morning 

Plenary Session - Integration of Upstream and Downstream Processing 


Breakthroughs to De-Bottleneck 


Accelerating & Optimizing Cell Line & 

Process Development 

Emerging Analytical Requirements and 

Their Impact on Process Development 

and Manufacturing 

Networking Refreshment Break (Exhibit and Poster Hall) 

Emerging Analytical Requirements and 

Their Impact on Process Development and 

Manufacturing (session continues) 

Smart Flexibility: What Creates the Right 

Degree of Flexibility and Cost Reduction 

in Different Phases of Manufacturing 

Formulation Strategies for Vaccines 

Formulation Impacts of Device and 

Packaging Systems 

12:00 pm Technology Workshops Sponsored by: 3M Purification Inc. (Room 550), Irvine Scientific (Room 553), Applied Biosystems, a part of Life Technologies (Room 552), and Invitrogen, a part of Life Technologies (Room 551) 

12:30 pm Networking Luncheon in Exhibit and Poster Hall with Dedicated Poster Viewing 

1:00 pm Featured Presentation in Exhibit and Poster Hall: The Enduring Need for Operational Excellence: Lessons Learned from the Oil Field to Biotech and How Great Companies Can Still Fall Short (BallroomB/C) 

Afternoon 

Implementing the Latest Tools and 

Techniques to Optimize the Harvest Step 

Overcoming Challenges of Production, 

Purification and Characterization of Next 

Generation Antibody-Like Molecules & 

Protein Therapeutics 

Friday, September 24, 2010 

Morning 

Host Cell Engineering to Improve the 

Yield and Quality of Biotherapeutics 


Strategies for Biosimilars Products 

Networking Refreshment Break in Exhibit and Poster Hall (Last chance to consult with suppliers and view posters) 

Implementation of Novel Media 

Development and Feed Strategies 

Site Tour to Amgen’s BioNext Facility 

Pre-registration required. Please check in at registration by 2:00 pm Wednesday. 

Recovery & Purification (Ballroom B/C) Cell Culture & Upstream Processing (Ballroom D/E) 

Evaluation and Implementation of Next Generation Purification Technologies What Comes Next after Titer Increase 

Process Characterization for Developing Design Space 


Formulation Development for Next 

Generation Biologics 

3:00 pm Conference Ends 

Featured Presentation: An Industrial View of Biopharmaceutical Comparability and Characterization 

Approaches to Improve Product Quality and Achieve Process Optimization 

12:15 pm Technology Workshops Sponsored by: Novozymes Biopharma (Room 551), Thermo Scientific NanoDrop Products (Room 552), Rentschler Biotechnologie GmbH (Room 553) 

12:45 pm Lunch on your own 

Afternoon 

Utilizing Continuous Processing to Decrease Operation Time and Improve Facility Utilization Advantages of Using Mixed Mode Technologies 


Applications of Automated, High-Throughput Technologies in Downstream Processing Overcoming Challenges of Producing Specific Proteins

Platinum Sponsors: 

Aisle Sign Sponsor: 

Registration Area Sponsor: 

Gold Sponsors: 

Program Guide Co-Sponsors: 

Internet Café Sponsor: 

Technology Workshop Sponsors: 

Silver Sponsors: 

Session Sponsor: 

Opening Night Networking Reception Sponsor: 

Second Night Networking Reception Sponsor: 

Networking Refreshment Breaks Sponsor 

Roundtable Strategic Discussion Group Sponsor: 

Literature Sponsor: 

Strategic Discussion Group Sponsors: 

Founding Publication 

Luncheon Presentation Sponsor: 

Media Partners 

Tote Bag Sponsors: 

Association Sponsor 

Featured Web Partner 

Badge & Lanyard Sponsor: 

6 www.IBCLifeSciences.com/BPI

Symposium #1: 

Prevention of Microbial and Viral 

Contamination of Mammalian 

Cell Culture Processes 

Lessons Learned and Case Studies 

(Room 554) 

1:00 Chairperson’s Remarks 

Robert D. Kiss, Ph.D., P.E., Director, Late Stage 

Cell Culture - Pharma Technical Development, 

Genentech, Inc. 

1:15 How to Prevent Microbial Contaminations 

of Bioreactors, and Successful Strategies 

for Addressing Them if/when They Occur 

Andrew Brewer, Senior Engineer, Biologics 

Manufacturing Science and Technology, 


1:45 CSI GMP Production; Lessons from 

the Contamination Scene 

Katie Stewart, M.S., Technical Training Supervisor, 

Technical Training, Human Genome Sciences Inc. 

2:15 CASE STUDY Microbial Contamination 

in a CHO Based Production Culture 

– A Case Study 

Jim McColgan, Associate Director, Pilot Lab and 

Production Operations, Pfizer Global Manufacturing 

2:45 Networking Refreshment Break 

3:15 Successful Elimination of Parvovirus 

(MVM) Infections of Industrial Scale 

Cell Cultures – Two Case Studies 

Tim Hughes, Director, Processes & GMP Facilities, 

CSL Ltd., Australia 

3:45 Inactivation of Viruses and Mycoplasma 

by Several Barrier Methods 

Houman Dehghani, Ph.D. Principal Scientist, 

Biosafety Development Group, Amgen Inc. 

4:15 Audience Interactive Panel Discussion 

5:00 Close of Symposium 

Monday, September 20, 2010 • Pre-Conference Symposia 

12:00 Registration (Exhibit Hall Foyer) 

Symposium #2: 

How Much Data is Enough 

The Statistical Approach 

to Process Validation 

(Ballroom C) 

1:00 Chairpersons’ Remarks 

Ali M. Afnan, Ph.D., Principal, Step Change 

Pharma, Inc.; Former Senior Staff Fellow, OPS, 

CDER, US FDA 

1:05 Statistical Assurance of Process 

Knowledge and Control: The Means to 

a Validated Process 

Ali M. Afnan, Ph.D., Principal, Step Change 

Pharma, Inc.; Former Senior Staff Fellow, OPS, 

CDER, US FDA 

1:50 Elements of a Quality by Design 

Approach for Biopharmaceutical Drug 

Substance Bioprocesses 

Nathan McKnight, Ph.D., Senior Engineer, 

Late Stage Cell Culture, Genentech, Inc. 


3:00 New, Unpublished Data 

CASE STUDY Process Understanding: 

How do We Demonstrate that We 

Know What We Know 

Carl A. Anderson, Ph.D., Associate Professor of 

Pharmaceutical Sciences, Duquesne University 

3:45 Strategies for Multi-Variate Studies of 

Critical Process Parameters 

Ronald D. Snee, Ph.D., Founder and President, 

Snee Associates 



Symposium #3: 

Technology Transfer for 

Biopharmaceuticals 

(Ballroom E) 


Jean Bender, Ph.D., Principal Engineer, 


1:15 Technology Transfer from 

Development to Manufacturing 

John Knighton, MBA, Director, Pharmaceutical 

Development & Manufacturing Sciences, Johnson & 

Johnson Pharmaceutical Research & Development 

1:45 Technology Transfer and Scale-up of 

an Antibody Process 

Magnus Glad, Ph.D., Senior Project Manager, 

Biopharmacy & Protein Technology, 

BioInvent International, Sweden 

2:15 Technology Transfers: Internal versus 

External, Domestic versus International 

Younok Dumortier Shin, Ph.D., Technical Lead, 

Manufacturing Technology, Bristol-Myers Squibb 


3:15 Applying Principles of Operational 

Excellence in Managing Technology 

Transfer Projects 

Greg Zarick, M.S., PMP, Associate Director of 

Project Management, Lonza Biologics, Inc. 

Michael J. Gorman, M.S., Certified Lean Six 

Sigma Black Belt and Project Manager, Operational 

Excellence, Lonza Biologics, Inc. 

3:45 Integration of Quality Risk 

Management into Technology Transfer 

Lori Richter, Quality Risk Management Associate, 

Global Quality Risk Management, Genentech, Inc. 



Two Day Training Courses • Tuesday, September 21, 2010 - Wednesday, September 22, 2010 

Introduction to 

Biopharmaceutical Manufacturing 

(Room 554A) 

Scott M. Wheelwright, Ph.D., President and CEO, 

Strategic Manufacturing Worldwide, Inc. 

Bioprocess Training Academy 

Protein Characterization for 

Biotechnology Product Development 

(Room 558A) 

Christine P. Chan, Ph.D., Senior Manager, Technology Development, 

Genzyme Corporation 

Cell Culture and Fermentation Bioprocessing 

(Room 554B) 

Regulatory Compliance in CMC Development 

(Room 558B) 

Antonio R. Moreira, Ph.D., Professor, Chemical and Biochemical Engineering, 

Vice Provost, University of Maryland, Baltimore County 

Bruce K. Burnett, Ph.D., RAC (US, EU), Director, Regulatory Affairs, 

Duke University 

Sneak Preview: Be the first to visit the newest Xcellerex FlexFactory 

Tuesday, September 21st at 12noon 

Please join Xcellerex and IBC for a tour of our newly completed FlexFactory® facility 

in Marlborough, Massachusetts. This biomanufacturing facility will open for GMP 

production in October, less than 6 months from completion of final design. The 

facility, which encompasses upstream and downstream operations, demonstrates 

the unprecedented speed at which new capacity can be achieved with FlexFactory 

technology. Coach transportation will be provided, at 12:00 noon on Tuesday, 

September 21. Please register for the Site Tour at the BPI Registration Area. 



7:00 Registration and Coffee 

Managing Manufacturing Networks 




Leveraging our Assets – How Do We 

Reconcile the Installed Base with 

Current Technologies and Demand 


Shishir Gadam, Ph.D., Director, Manufacturing Science and Technology, 


Keynote Presentation 

8:05 Optimizing Manufacturing Network 

Performance and Planning for the Future 

Alison Moore, Ph.D., Vice President, Corporate Manufacturing, 

Amgen 


CASE STUDY Manufacturing Aspects of a New Facility: 

Lessons Learned 

Jeff Johnson, Engineering Director, BioVaccine Process Engineering, Global 

Engineering Services, Merck & Co., Inc. 

9:15 Building the First Patient Specific Product Manufacturing 

Plants: Design and Construction of Dendreon Corporation’s 

Innovative Manufacturing Facilities 

Ken Hammer, Vice President, Facilities and Engineering, Dendreon Corporation 



CASE STUDY Enabling High Throughput Production in an 

Existing Commercial Plant 

Carol D. Basey, Senior Manufacturing Technical Specialist, Genentech, Inc. 


CASE STUDY The Dinosaurs Reborn: Retrofitting 

Existing Facilities to Speed Tech Transfer and Support 

the Platform Process 

Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, 

University of California, Berkeley 

11:15 How Process Simulation is used in Biogen Idec to Optimize 

Manufacturing Processes 

Ian Gosling, Ph.D., Principal, ChemSim LLC 

Room 553 

Key Considerations when 

Screening Supplements 

for Medium Optimization 

The contribution of protein hydrolysates to the 

performance of a biopharmaceutical production system 

is largely medium dependent. The improper application 

of hydrolysates during medium optimization may result 

in decreased system performance and/or increased 

system variability. This medium dependence will be 

discussed, along with key elements of a suggested 

hydrolysate screening protocol that will help ensure 

effective evaluation of a supplementation scheme’s 

overall contribution to system performance. 

J.F. Babcock, Ph.D., Cell Culture Applications Manager, 

Sheffield Bio-Science 

8 www.IBCLifeSciences.com/BPI 

11:45 Concurrent Technology Workshops 

Room 550 

Maximizing Protein 

Expression in Suspension 

CHO Cell Transient Transfection 

Transient transfection allows researchers to bridge the 

development bottleneck and shorten the time to usable 

protein. CHO suspension cells are used for stable protein 

expression, despite being refractory to commonly used 

transfection methods (e.g. linear PEI). Mirus Bio has 

developed a more effective alternative, the TransIT®-PRO 

transfection reagent. Maximum transient expression 

is achieved through optimization of cell density, DNA 

concentration, quantity of transfection reagent, and 

media formulation. 

Laura Juckem, Ph.D., R&D Senior Scientist, Mirus Bio 

12:15 Luncheon Presentation (Ballroom A) 

Process Design: Establishing Design 

Space and Robust Process Parameters 


Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc. 

8:15 CASE STUDY Developing an Appropriate Design Space Strategy 

to Mitigate Variability in Downstream Processing Operations 

Justin McCue, Ph.D., Principal Engineer, Downstream Process Development, 

Biogen Idec 

8:45 Multivariate Data Analyses and Real-time Multivariate 

Process Monitoring of Upstream Operations in 

Biopharmaceutical Manufacturing 

Cenk Undey, Ph.D., Senior Principal Engineer, Amgen, Inc. 

9:15 CASE STUDY Creating a QbD Chromatography Design Space 

Using Mechanistic Modeling Techniques 

Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting Inc. 



CASE STUDY Use of DOE to Determine Process Parameters 

for a Robust Design Space in the Formulation of a 

Biopharmaceutical Product 

Martin Kane, Associate Director Process Statistics, Department of Biostatistics, 

Human Genome Sciences, Inc. 

10:45 What do you Need to Do to Fully Leverage Flexibility Inherent 

in QbD 

Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; 

former Senior Staff Fellow, OPS, CDER, US FDA 


Leveraging Flexibility in QbD 

Moderator: 

Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc. 

Panelists: 

Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; 

former Senior Staff Fellow, OPS, CDER, US FDA 

Martin Kane, Associate Director Process Statistics, Department of Biostatistics, 


Justin McCue, Ph.D., Principal Engineer, Downstream Process Development, 

Biogen Idec 

Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc. 

Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting Inc. 

Room 552 

Efficient Packing of 

Biochromatography 

Media with Novasep Prochrom® Columns 

Novasep's new high performance low to medium 

pressure Prochrom® columns are made especially for 

biochromatography. The combination of a moving piston 

and valves with an automated packing unit makes their 

design special and allows various modes of efficient, 

effortless and fast "in place" packing. More particularly, 

"flow packing" and "dynamic axial compression packing" 

will be presented for a polymer-based media. Efficiency 

measurements and scale-up strategies will also be 

illustrated for these two packing modes. 

Jin Seok Hur, Ph.D., R&D Manager, Novasep, Inc. 

Jason Spacek, M.S., Biopharmaceuticals Business 

Manager, Novasep, Inc. 

A Novel Approach to Integrate the Purification Process for Monoclonal Antibodies that Increases Processing Productivity 

As the demands and challenges associated with the purification of therapeutic proteins increase, new tools are needed. In this talk, the development of three 

chromatography media to enable improved process flexibility in terms of plant fit and buffer requirements will be described. Efforts to develop a flexible three 

step monoclonal antibody purification involving minimal buffer changes/dilution between process steps will be discussed. Optimization of a process using 

Protein A affinity capture directly eluted onto a cation exchange column followed by elution and direct loading of an anion exchange membrane adsorber will be 

used to describe the process flexibility benefits of these new purification tools. 

Richard Pearce, Program Director - Purification Solutions, Millipore Corporation

Strategy 

Discussion Forum 

(Rotunda) 

10:15 Managing Partners and 

Contractors – Practical Solutions 

to the Issues that Arise 

Moderator: 

Susan Dexter, 

Senior Principal Consultant, 

Latham BioPharm Group 

Panelists: 

Pierre Beaurang, CMC Director, 

Five Prime 

Anne Collins, Ph.D., Hospira Inc., 

Australia 

Cyrus Karkaria, Ph.D., 

Vice President, Bioprocess Technology, 

Celldex Therapeutics 

Mark O'Mahony, Vice President, Process 

Development, Manufacturing and QC, 

Tolerx, Inc. 

Mark O’Neill, Director, CMO Business 

Development, Amgen Inc. 

Jenifer L. Wheat, Vice President, Business 

Development, CMC Biologics, Inc. 

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8:00 am-12:00 pm 

Topics & Presenters: 


Advancements and 

Case Studies of Hydroxyapatite 

for Biomanufacturing 

(Room 551) 

Dissociation of Antibody: DNA Complexes 

by Hydroxyapatite 

Pete Gagnon, Chief Scientific Officer, 

Validated Biosystems 

Packing Ceramic Fluoroapatite at Multiple 

Process Scales 

Jaclyn Shaffer, R&D Associate II, MedImmune 

A New, Robust Method for Protein Elution 

from Ceramic Hydroxyapatite 

Mark A. Snyder, Ph.D., Process R&D Applications 

Manager, Bio-Rad Laboratories 

Ceramic Hydroxyapatite Usage in 

Process Manufacturing 

Norbert Schuelke, Ph.D., Associate Director, 

Millennium Pharmaceuticals, Inc. 

Best Practices for Packing Ceramic 

Hydroxyapatite at Process Scale 

Kim Brisack, M.S., Staff Scientist, 

Bio-Rad Laboratories 

Key industry leaders to present additional 

case studies 

Roundtable Discussion 

• Downstream process of monoclonal antibodies 

• Scale-up and optimization of hydroxyapatite, handling 

and qualification testing 

• Chemical robustness of ceramic hydroxyapatite 

• Application of hydroxyapatite in vaccine production 

Formulation Strategies for Protein 

Therapeutics (Room 555A/556) 

Pre-Conference Workshop: 

The Formulator of the Future: Using High Throughput 

Technologies, Informatics and Rational Design to 

Accelerate and Optimize Formulation Development 

7:45 Registration and Networking Coffee 


David Volkin, Ph.D., Distinguished Professor, Pharmaceutical 

Chemistry, University of Kansas 

8:30 Application of a High Throughput Screening Procedure 

with PEG-induced Precipitation to Compare Relative 

Protein Solubility during Formulation Development 

with IgG1 Monoclonal Antibodies 

Todd Gibson, Ph.D., Senior Research Scientist, 

Johnson & Johnson Pharmaceutical R&D, Inc. 

9:00 Critical Analysis of Multiple Complex Datasets 

in Solving Challenges during Formulation 

Development and Protein Characterization 

Haripada Maity, Ph.D., Senior Scientific Manager, Formulation 

Development, ImClone Systems, A Wholly-Owned Subsidiary 

of Eli Lilly & Co. 

9:30 CASE STUDY Characterization of Stability 

Characteristics of Drug Candidates in Discovery Research 

Sharon Gao, Ph.D., Principal Scientist, Analytical Biochemistry, 

Biogen Idec, Inc. 


10:30 CASE STUDY Incorporation of Fluorescence-Based 

Screening Technique to High-Throughput, 

Gated Workflow for Biologic Formulation Screening 

Pooja Arora, Ph.D., Research Investigator II, Bristol-Myers Squibb 

11:00 Finding the Perfect Lead: Strategies to Select Proteins 

with Optimal Properties for Further Development 

Hubert Kettenberger, Ph.D., Senior Scientist, Protein Analytics, 

Roche Diagnostics GmbH, Germany 

11:30 Panel Discussion with Workshop Speakers: Use and 

Limitations of HTS in Formulation Development 

12:00 Workshop Ends; Lunch on Your Own 

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Tuesday, September 21, 2010 (continued) 





Smart Flexibility in Facilities 


Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, 

GE Healthcare Life Sciences, Sweden 


CASE STUDY Design and Operation of a Disposable 

Based Facility 

Robert J. Steininger II, Senior Vice President, Manufacturing, 

Acceleron Pharma 

2:30 Design of a Protein A pH Gradient Elution Offers New 

Flexibility in mAb Processing 

Asha Radhamohan, Engineer I, Bioprocess Development, Genentech, Inc. 

3:00 CASE STUDY Commissioning BioMarin’s Highly Disposable, 

Multi-Product Commercial Facility 

Chris M. Brodeur, Senior Operations Manager, Commercial Expansion Head, 

BioMarin Pharmaceutical Inc. 

This session will be followed by a break-out discussion on the same topic on 

Thursday morning. 


4:00 Regulatory Modernization - FDA's Desired State 

for Product Quality 

Helen N. Winkle, Director, Office of Pharmaceutical Science, 

CDER, US FDA 

Implementation and Execution 


Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc. 


CASE STUDY Update on the Implementation of QbD at 

Genentech and Participation in the FDA QbD Pilot Program 

Vassia Tegoulia, Ph.D., Scientist, Pharma Technical Regulatory, Genentech, Inc. 

2:30 Role of PAT in Operational Excellence 

F. Ceylan Erzen, Senior Engineer, Industrial Engineering, Amgen Inc. 


CASE STUDY Development of Robust Process Parameters for 

the Production of a Therapeutic Glycoprotein Derived from 

Glyco-engineered Pichia Pastoris 

Thomas Potgieter, Ph.D., Senior Investigator, Merck & Co 

Co-authors: M. van Maanen; J. Pollard; R. Chmielowski; T. Linden, Ph.D. 


Keynote Presentations (Ballroom A) 

Chairperson: Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc. 

4:45 The Role of Biosimilars in Driving Innovation 

in the Biopharmaceutical Industry 

Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics 

R&D, Hospira, Inc. 

5:30 Opening Night Reception in the Exhibit and Poster Hall Sponsored by 



7:15 Technology Workshop (Light Continental Breakfast will be served.) (Rotunda) 

Biological Assays for Characterization of Raw Materials Used in Mammalian Cell Culture Media Formulations 

SAFC Biosciences raw materials characterization initiative was established to evaluate variability in raw materials used to formulate cell culture media and 

thereby improve media consistency and performance in cell culture manufacturing processes. Cell-based biological assays were developed to investigate the effects of raw materials 

on cell growth, production and product quality. Biological assays were designed to include appropriate indicator cell lines, assay media and conditions to detect lot-to-lot variability 

among raw material suppliers. 

Andrew Christie, Principal Scientist, Cell Sciences & Development, SAFC Biosciences 






Alison Moore, Ph.D., Vice President, Corporate 

Manufacturing, Amgen Inc. 

8:15 CMC-Related Regulatory Considerations 

for Development of Antibody-Drug 

Conjugates: An FDA Perspective 

Jun Park, Ph.D., Regulatory Quality Reviewer, 

Division of Monoclonal Antibodies, Office of 

Biotechnology Products, CDER, US FDA 

8:45 Leveraging Innovation to Achieve 

Successful Strategies for the 

Biotech Business 

Günter Jagschies, Ph.D., Senior Director, Strategic 

Customer Relations, GE Healthcare Life Sciences, 

Sweden 




Continuous Process Improvement 

8:00 Co-Chairpersons’ Remarks 

Maninder Hora, Ph.D., Vice President, 

Product Operations, Facet Biotech 

Ellen L. McCormick, Director, BioSciences Group, 

Pfizer Inc 


CASE STUDY A Continuously Evolving 

mAb Process 

Debbie O’Connor, Scientist, Late Stage 

Purification, Process R&D, Genentech, Inc. 


CASE STUDY Continued Understanding 

of Biopharmaceutical Production 

Processes Post-Validation 

Ciaran Brady, Ph.D., Associate Director, 

Biopharmaceutical Development, 

Human Genome Sciences Inc. 

Raw Materials/Supply Chain 

(Room 551) 


Integrating Raw Materials and 

Suppliers into a Pharmaceutical 

Quality System 

8:00 Co-Chairpersons’ Remarks: 

Duncan Low, Ph.D., Scientific Executive Director, 

Process Development, Amgen, Inc. 

Wolfgang Noe, Ph.D., Vice President, Bioprocess 

Development, Biogen Idec 

8:05 Risk Assessment and Management for 

Raw Materials 

Duncan Low, Ph.D., Scientific Executive Director, 


8:30 Supply Chain Risk Management 

Methodologies 

Joydeep Ganguly, Associate Director, 

Manufacturing Sciences, Biogen Idec

Strategy Discussion Forums 

(Rotunda) 

1:45 Manufacturing: What will Take us 

to the Next Level of Efficiency 

and Economics 

Sponsored by 

Moderator: 

Peter Latham, President, Latham BioPharm Group 

Panelists: 

Shishir Gadam, Ph.D., Director, Manufacturing 

Science and Technology, Genentech, Inc. 

Dave Lescinski, Vice President, Chromatography, 

Pall Life Sciences 

Alison Moore, Ph.D., Vice President, Corporate 

Manufacturing, Amgen Inc. 

Thomas C. Ransohoff, 

Vice President and Senior Consultant, 

BioProcess Technology Consultants, Inc. 

Dr. Jens H. Vogel, Global CMC Development 

Team Leader and Head, Isolation and Purification, 

Bayer Healthcare 

Willard Waterfield, Ph.D., Senior Director, 

Manufacturing Sciences & Technology, 

Andover and Pearl River, Pfizer GMS 

Tuesday, September 21, 2010 (continued) 

Formulation Strategies for Protein Therapeutics (Room 555A/556) 


Haripada Maity, Ph.D., Senior Scientific Manager, Formulation Development, 

ImClone Systems, A Wholly-Owned Subsidiary of Eli Lilly & Co. 

Development of Formulation and Drug Product Design Space 


1:15 Holistic QbD: The Integration of Formulation, Process Development 

and Process Validation 

Sherry Martin Moe, Ph.D., Director, Late Stage Pharmaceutical and Processing Development, 


2:00 CASE STUDY Lyophilization Process Validation based on Quality by Design 

Bingquan (Stuart) Wang, Ph.D., Senior Scientist, Pharmaceutics, Genzyme Corporation 


2:30 Particles, Particles Everywhere: Causes, Consequences and Control of 

Aggregates and Subvisible Particles in Therapeutic Protein Formulations 

John F. Carpenter, Ph.D., Professor, Department of Pharmaceutical Sciences, University of Colorado 


Comparability and Characterization Exercises during Formulation Development 

3:45 CASE STUDY Comparability Assessments with Protein Therapeutic and Vaccine Dosage 

Forms: Challenges and Opportunities 

David Volkin, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of Kansas 

4:15 Characterization of Site Specific Degradation Pathways of Antibody-Maytansinoid 

Conjugates (AMC) 

Alex Lazar, Ph.D., Mass Spectrometry Group Leader, Analytical and Pharmaceutical Sciences Department, 

ImmunoGen, Inc. 

4:45 CASE STUDY Evaluating the Impact of a Container Closure Change on the Stability 

of a Protein Therapeutic 

Angela W. Blake-Haskins, Ph.D., Senior Scientist II, Drug Product Sciences Department, Human Genome Sciences, Inc. 

5:15 Session Ends 

5:30 Opening Night Reception in the Exhibit and Poster Hall Sponsored by 


(Room 552) 


Gary J. Welch, Director, Process Science, 

Abbott Bioresearch Center 

Advances in Process Monitoring 

and Control in Downstream 

Processing 

8:15 Evaluation of Raman Spectroscopy 

for Purification Operations 

Natraj Ram, Ph.D., Senior Group Leader, 

Purification, Technical Operations, 


8:45 On-line HPLC as a PAT for 

Controlling Product Collection 

from Process Scale 

Chromatography Columns 

Rick E. Cooley, Market Development Manager, 

Process Analytics, Dionex Corporation 

9:15 Using Multivariate Batch 

Process Monitoring and Soft 

Sensors for Advanced Process 

Control in Commercial Scale 

Purification Operations 

Thomas Mistretta, M.S., Senior Engineer, Process 



in Exhibit and Poster Hall 

Sponsored by 




and Production (Room 555B) 


Ulrich Valley, Head, Technology Development, 

Novartis Vaccines & Diagnostics, Inc., Germany 


8:30 Global Vaccine Production 

Challenges: Emerging 

Immunotherapeutics, 

Manufacturing Flexibility 

and Reducing COGS 

Pierre Fournier, Ph.D., Associate Vice President, 

Manufacturing Technology International, 

Sanofi Pasteur, France 

Lessons Learned from the 

2009 Flu Season to Guide 

Rapid Vaccine Development and 

Manufacturing Scale Up 

9:15 CASE STUDY Cell Culture Based 

Pandemic Flu Production 

Ulrich Valley, Head, Technology Development, 

Novartis Vaccines & Diagnostics, Inc., Germany 



Sponsored by 

Formulation Strategies for Protein 

Therapeutics (Room 555A/556) 


Angela W. Blake-Haskins, Ph.D., Senior Scientist II, 

Drug Product Sciences Department, Human Genome 

Sciences, Inc. 


8:15 Modeling Protein Degradation 

Processes and the Development 

of Rational Approaches 

to Stabilization 

Bernhardt Trout, Ph.D., Professor, Chemical 

Engineering, Massachusetts Institute of Technology 

Implementing Analytical 

Methodsand Control Steps for 

Subvisible Particles 


9:00 NIST Perspective on Standards 

and GMP Processes for Subvisible 

Particles in Protein Therapeutics 

Dean Ripple, Ph.D., Group Leader, Process Measurements 

Division, Process Sensing Group, National Institute of 

Standards and Technology 



Sponsored by 

10:30 Does SE-HPLC Tell the Whole Story 

Use of Orthogonal Methods to Detect 

Aggregates and Subvisible Particles 

Brian K. Meyer, Ph.D., Research Fellow, 

Merck Research Laboratories 


Managing Manufacturing 



CASE STUDY Development 

and Implementation 

of a Next-Generation 

Manufacturing Process for a 

New rFVIII Product 

Dr. Jens H. Vogel, Global CMC 

Development Team Leader and 

Head, Isolation and Purification, 

Bayer Healthcare 



Sponsored by 

10:30 Subcutaneous Protein 

Delivery: Challenges, 

Opportunities, and Key 

Lessons from a Drug 

Delivery Platform 

Michael J. LaBarre, Ph.D., Vice 

President, Product Development, 

Halozyme Therapeutics, Inc. 


CASE STUDY Biodefense: 

Human Genome Sciences’ 


Manufacture of an Antibody 

for Treatment of Anthrax 

Delivered to the Strategic 

National Stockpile 

Craig Malzahn, Director, Supply 

Chain / Manufacturing Operations, 


11:30 Upgrading Current 

Facilities for Future 

High Titer Processes 

Rich Meinel, Associate Director 

Global Process Engineering 

Technology, Biogen Idec 

Product Lifecycle 

Management (Ballroom D/E) 

9:15 Humira Downstream 

Process: Challenges in 

Continuous Improvement 

and Technical Transfer 

Helen Yang, Technical Operations, 




Sponsored by 


CASE STUDY Utilization 

of QbD Principles for the 

Management of 

Post-Approval Changes 

Marc Better, Ph.D., Executive Director, 

Process Development, Amgen Inc. 


CASE STUDY Advanced 

Process Control and 

Real-Time Chromatography 

Monitoring 

Robert Genduso, Scientist II, 

Biogen Idec 


Design of a Contamination 

Barrier for Serum-Containing 

Cell Culture Media of a 

Licensed Product 

R. Michael Boychyn, Ph.D., Principal 

Engineer, Amgen Colorado Process 


Room 552 

Achieving Reproducible Manufacturing 

Outcomes through the Use of 

Scale-down Models 

The use of accurate scale down modeling ensures that lab data represent the 

manufacturing case when transferring bioprocesses between sites. Diosynth has used a 

lab scale fermentation model to accurately reflect manufacturing operations, leading to 

successful scaling of five microbial processes over the last two years. Discussion will center 

upon how and when to use scale-down models to achieve reliable manufacturing results. 

Raghu Shivappa, Ph.D., Fermentation Team Leader, Upstream Process Development, 

Diosynth Biotechnology, now a part of MERCK BioManufacturing Network 

Stewart McNaull, Ph.D., Section Leader, Upstream Process Development, 


Room 551 

Fully Disposable, Multiple mAb Processing 

for Clinical Trials 

A step-by-step review of a typical mAb platform process from 

inoculation to final filtration will provide solutions for single- or 

campaign-use technology as well as technical and economical criteria 

to decide what the best alternative would be: a classic equipment setup or the 

disposable option. 

Jonathan Royce, Category Leader Bioprocess, GE Healthcare Life Sciences 

Luncheon Roundtable 

Discussion Topics: 

Wednesday, September 22, 2010 (continued) 

Raw Materials/Supply 

Chain (Room 551) 

8:55 Global Adventitious Agent 

Regulations of Raw Materials 

Used in Biopharmaceutical 

Manufacturing 

Barbara Potts, Ph.D., 

Senior Consultant, 

Biologics Consulting Group, Inc. 

Co-author: T.W. Tanaka 


CASE STUDY Supplier 

Perspective on Risk 

Assessment and Management 

of Critical Raw Materials 

for the Manufacture of 

Biological Therapeutics 

David Kolwyck, Technical Manager, 

SAFC, a division of Sigma Aldrich 



Sponsored by 

10:30 Implementing a Raw Materials/ 

Supplier Management Risk 

Mitigation Strategy with 

Limited Resources 

Paula Shadle, Ph.D., 

Principal Consultant, 

Shadle Consulting Services 

10:55 New Applications of Analytical 

Methodologies for Raw 

Material Characterization 

Maureen Lanan, Ph.D., Principal 

Scientist, Analytical Development, 

Biogen Idec 

11:20 Audience Interactive 

Panel Discussion with 

All Session Presenters 

Strategy 

Discussion Forums 

(Rotunda) 

Sponsored by 

12:30 Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing and Roundtable Discussions 

Poster presenters are requested to stand by their posters for discussion. 



1. Is process development dead for antibodies 

2. Can we be more flexible and efficient with our facilities 

3. What are the future drivers for upstream process development 

4. What does the future hold for automation in bioprocessing 

10:30 Continuous 

Disposable Multi-Column 

Chromatography: 

Emerging Technology 

to Enable More Efficient 


Station 1: 

Economic Modeling 

of Multi-Column 

Chromatography 

Applications 

Facilitator: 

Peter Latham, President, 

Latham BioPharm Group 

Station 2: 

QA Discussion of Areas 

Relating to Multi-Columns 

Operations 

Facilitator: 

Art Rankis, Quality and 

Regulatory Consultant 

Station 3: 

Modeling your Clinical 

Manufacturing Process 

Facilitator: 

Marc Bisschops, Scientific 

Director, Tarpon Biosystems 

Station 4: 

Adoption of New 

Technologies into 

Organizations 

Facilitator: 

Scott Fulton, Founder & CEO, 

BioSystem Development, LLC 

Room 550 

Relieving Bottlenecks in Downstream Purification: 

Further Advances in Membrane Chromatography 

Part 1: Dr. Carl Lawton will present his recent work on scaling up 

purification of E. coli expressed proteins using single step capture 

and clarification. 

Carl W. Lawton, Ph.D. Associate Professor, Biological Engineering Program Coordinator, 

Director, Massachusetts BioManufacturing Center (MBMC) 

Part 2: Novel Chemistries for High-Capacity / High-Throughput Single-Use Membrane 

Chromatography 

C. Howie Honeyman, Ph.D., Vice President, Research and Product Development, Natrix 

Separations Inc. 

Room 553 

CelliGen BLU: How New Brunswick has 

Combined the Performance of Stirred Tank 

Technology with the Benefits of Single-Use 

The CelliGen BLU is New Brunswick’s newest offering in the benchtop bioreactor and fermentor 

family of products. Positioned as a novel system offering 5.0L or 14.0L stirred tank single-use 

vessels; this system mimics traditional autoclavable technology while providing all the benefits of 

disposable technology. The CelliGen BLU will meet the demands of the single-use system users 

not satisfied with the current bench scale single-use bioreactors available on the market. 

Richard Mirro, Product Manager, New Brunswick Scientific 

5. Are we replacing one set of problems for another with chemically-defined media 

6. What are the best strategies for resolving downstream bottlenecks 

7. Is there a realistic scenario to launch generic monoclonal antibody drugs


Processing (Room 552) 

Chairperson: Susan Casnocha, Ph.D., Research 

Fellow, Bioprocess R&D, Culture Process Development, 

BioTherapeutics Pharmaceutical Sciences, Pfizer Inc 

Integrating In-Line Process 

Monitoring and Control Technologies 

in Upstream Processing 

10:30 Fully Automated Mammalian Cell 

Culture via Multi-Functional Off-Line 

Analyzer and Online Sampling System 

Gayle Derfus, Engineer II, Oceanside Pharma 

Technical Development, Genentech, Inc. 

11:00 Achieving Process Robustness 

through Process Analytical 

Technology (PAT) Implementation 

Li Malmberg, Ph.D., Director, Technical Operations, 

Biologics Manufacturing, Abbott Laboratories 

11:30 Understanding the Latest Automated 

Online Analytics as a QbD Tool in 

Fermentation Processes 

Stefan Steigmiller, Ph.D., Senior Project Manager, 

PAT, Bayer Technology Services GmbH, Germany 


12:30 Networking Lunch in Exhibit and Poster 

Hall with Dedicated Poster Viewing 

Poster presenters are requested to stand by their 

posters for discussion. 

Plenary Session 

Critical Industry Issues 

1:45 Chairperson's Remarks 

Howard L. Levine, Ph.D., President, 

BioProcess Technology Consultants, Inc. 

2:00 Flexible Manufacturing for 

a Diverse Biologics Portfolio 

Phillip Gomez, Ph.D., Director, 

PRTM Management Consultants 

2:30 Patient-Driven Delivery 

Devices: Is your Company 

Playing to Win 

James J. Collins, Jr., P.E., M.B.A., 

Vice President, Drug Delivery and 

Device R&D, Eli Lilly and Company 

3:00 Prevnar 13: The Story Behind 

the Vaccine 

Willard Waterfield, Ph.D., Senior Director, 

Manufacturing Sciences & Technology, Andover 

and Pearl River, Pfizer GMS 



Sponsored by 

Plenary Keynote Presentations 

(Ballroom A) 

Chairperson: Wolfgang Noe, Ph.D., Vice President, 

Bioprocess Development, Biogen Idec 

4:00 Sustainable Commercial 

Cell Culture Operations 

W. Blair Okita, Ph.D., 

Senior Vice President, Manufacturing 

Sciences and Technical Operations, 

Genzyme Corporation 

4:45 Finding a Home for Process 

and Product Development 

S. Robert Adamson, Ph.D., Advance 

Biotech Consultants; former Senior 

Vice President Product and Process 

Development, Wyeth Biopharma 

Wednesday, September 22, 2010 (continued) 


and Production (Room 555B) 

Process Development for Novel 

Vaccines and Immunotherapeutics 

10:30 CASE STUDY Process Development and 

Clinical Manufacturing for Autologous 

Dendritic Cell Immunotherapies 

Tamara Monesmith, Director of Manufacturing 

and Process Development, Argos Therapeutics 

11:00 CASE STUDY Rapid Production of a 

Novel VLP Vaccine 

Richard M. Schwartz, Ph.D., Chief, Vaccine 

Production Program Lab, Vaccine Research Center, 

National Institutes of Health 

11:30 CASE STUDY Rapid Analytical, Process 

and Regulatory Strategies for Seasonal 

and Pandemic Flu Vaccines 

Robert Boulanger, Ph.D., Manager, Production, 

Protein Sciences Corporation 

Special Presentation 

12:00 Defending Biosimilar Competition: 

Bioprocess IP Protections for 

Next Generation Vaccines and 

Immunotherapeutics 

George A. Xixis, Partner, 

Nutter McClennen & Fish LLP 





Process Development and Analytical 

Characterization for Vaccine Production 


Vincent Turula, Ph.D., MBA, Associate Research 

Fellow, BioTherapeutics and Vaccines Outsourcing, 

Pfizer, Inc. 

2:00 CASE STUDY Analytical 

Characterization for Conjugate 

and Protein Vaccines 

Vincent Turula, Ph.D., MBA, Associate Research 

Fellow, BioTherapeutics and Vaccines Outsourcing, 

Pfizer, Inc. 

2:30 CASE STUDY Particle and Endotoxin 

Control in Form/Fill Tubing Manifolds 

for Vaccines 

Michael Moussourakis, Technical Manager, 

Pall Life Sciences 

3:00 CASE STUDY Scale-up of an Intensified 

Process for rAd35 Adenovirus Production 

using the PER.C6® Cell Substrate 

Ciska Dalm, Ph.D., Senior Scientist, Upstream 

Process Development, Crucell, The Netherlands 



Sponsored by 

Rapid Vaccine Development & Production 

4:00 CASE STUDY Production and 

Downstream Processing of Norovirus 

Virus-Like Particles 

Ross Taylor, Ph.D., Director, Process Development, 

LigoCyte Pharmaceuticals, Inc. 

4:30 From Bench to Bag: Deployment and 

Implementation of Novel Solutions for 


Andrew Clutterbuck, Purification Development 

Team Leader, Eden Biodesign Ltd., United Kingdom 

5:00 Vaccines Track Ends 

5:30 Networking Cocktail Reception in Exhibit and Poster Hall Sponsored by 



(Room 555A/556) 

11:00 Analysis of Subvisible Particles by 

Flow Microscopy 

Rajesh Krishnamurthy, Ph.D., Director, Analytical 

and Pharmaceutical Sciences, ImmunoGen, Inc. 

11:30 CASE STUDY Investigation of 

Therapeutic Protein Particle 

Formation during Filling Operations 

Shona C. Patel, Ph.D., Senior Development 

Engineer, Merck Research Laboratories 

12:00 Technology Workshop 

Tm and Beyond! Combining 

Equilibrium and Kinetic Stability 

Data to Add a New Dimension to High 

Throughput Formulation Development 

The equilibrium thermal transition temperature, Tm, 

of a protein is a widely used metric of protein physical 

‘stability’ in the screening of candidate proteins and 

formulations. This value may rapidly be obtained from 

many samples whilst consuming very little protein 

sample using recently available instrumentation. 

However, the ‘equilibrium’ Tm represents only 

part of the physical stability story, and the kinetic 

(time dependant) behaviour of both unfolding and 

aggregation may provide additional valuable insights to 

guide candidate selection and formulation development. 

This is discussed and example data is presented. 

Simon Webster, Ph.D., Chief Scientific Officer, 

Avacta Analytical Ltd., United Kingdom 






Andrea Ji, Ph.D., Scientist, Genentech, Inc. 



2:00 CASE STUDY Mitigation of Oxidation 

in Therapeutic Proteins 

Andrea Ji, Ph.D., Scientist, Genentech, Inc. 

2:30 CASE STUDY Formulation Development 

of Therapeutic Antibodies using Highthroughput 

Fluorescence and Static 

Light Scattering Techniques: Role of 

Conformational and Colloidal Stability 

Sathish Hasige, Ph.D., Senior Scientist, Formulation 

Sciences, Process Biochemistry, MedImmune, Inc. 

3:00 CASE STUDY The Impact of Prefilled 

Syringe Leachables on Protein Stability 

Xiaofeng Lu, Ph.D., Senior Scientist, Facet Biotech 



Sponsored by 

4:00 Low Volume, High-Throughput Thermal 

Analysis of Proteins by Fluorescence Dye 

Binding using a RT-PCR Instrument 

Thomas Palm, Ph.D., Senior Research Investigator, 

Pharmaceutics, Bristol-Myers Squibb Company 

4:30 CASE STUDY The Importance of 

Understanding the Physical State 

of Excipients in a Freeze-Dried 

Formulation: Implications for Overall 

Product Quality 

Juan Davagnino, Ph.D., Director, Biopharmaceutical 

Development, KBI Biopharma, Inc. 

5:00 CASE STUDY Effects of Surface 

Tension and Excipient Binding on 

the Conformational Stabilization of a 

Monoclonal Antibody 

Suzanne J. Hudak, Associate Scientist, 

MedImmune, Inc. 

5:30 Networking Cocktail Reception 


Sponsored by 



7:00 Coffee 

7:15 Technology Workshop (Light Continental Breakfast Will Be Served) (Rotunda) 

Are Your ANIMAL FREE Raw Materials Really Animal Free 

This workshop discusses the approach BD Biosciences-Advanced Bioprocessing is taking to address this question. 

Michael J. Titus, Ph.D., Director, Quality Management & Regulatory Compliance, BD Biosciences -Advanced Processing 


Cell Culture & 

Upstream Processing 

Emerging Analytical 

Requirements (Room 551) 

Plenary Session – Integration of Upstream and Downstream Processing 

(Room Ballroom B/C) 

8:00 Chairperson’s Opening Remarks 

Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corporation 

8:15 Challenges and Efficiencies Gained by Integrating Upstream and 

Downstream Drug Substance PD 

Gene Schaefer, Ph.D., Senior Director, API-Large Molecule Development, Johnson & Johnson 

8:45 Optimizing Interfaces and Hand-offs between Upstream 

and Downstream Processing 

Jens H. Vogel, Ph.D., Global CMC Development Team Leader & Head, 

Isolation & Purification Department, Global Biological Development, Bayer HealthCare 

9:15 Linking Upstream and Downstream 

Jonathan Coffman, Ph.D., Principal Engineer III, Pfizer Biotherapeutics 

9:45 Networking Refreshment Break in Exhibit and Poster Hall 



Breakthroughs to De-Bottleneck 


Chairperson: Jens H. Vogel, Ph.D., Global CMC Development 

Team Leader & Head, Isolation & Purification Department, 

Global Biological Development, Bayer HealthCare 

10:30 Evaluation of Single Pass TFF to 

Debottleneck Downstream Processing 

of Monoclonal Antibodies 

Jemelle Dizon-Maspat, Senior Research Associate, 


11:00 Downstream Breakthroughs in 

Downstream Processing of High Titer 

and Cell Density Harvests 

Blanca Lain, Senior Scientist, Downstream Process 

Development, Percivia, LLC 

11:30 Process Design and Facility Fit 

Optimization Models for Higher Titer 

Purification of Monoclonal Antibodies 

Nuno Fontes, Ph.D., Senior Engineer, Group 

Leader, Genentech, Inc. 


Processing (Ballroom D/E) 

Accelerating & Optimizing 

Cell Culture & Process Development 

Chairperson: Charles Sardonini, Ph.D., Associate Director, 

Process Engineering/Development, Genzyme Corporation 

10:30 CASE STUDY Rapid Generation of 

High-Producing Clonal Cell Lines for 

Recombinant Monoclonal Antibody 

Manufacture 

Jolanda Gerritsen, Technical Expert, Cell Line 

Development, Genmab, The Netherlands 

11:00 Scale Down Approaches to Facilitate 

CHO Clone Development for High- 

Level mAb Expression 

Gareth Lewis, Ph.D., Scientist II, 

MedImmune, United Kingdom 

11:30 Boosting Yield, Speeding Up Process 

Development and Improving Quality by 

Process Intensification in Mammalian 

Cell Culture 

Rolf Douwenga, Vice President, Global R&D, 

DSM Biologics, The Netherlands 

Emerging Analytical Requirements 

and their Impact on Process 



Ciaran Brady, Ph.D., Associate Director, 

Biopharmaceutical Development, 

Human Genome Sciences Inc. 

8:15 FDA Expectations Regarding 

Bioburden Control in Biotech Processes 

Patricia F. Hughes, Ph.D., 

Biotech Manufacturing Team, Office of Compliance, 

CDER, U.S. Food and Drug Administration 


CASE STUDY Methods for Analysis of 

Subvisible Particles and the Utility in 

Biopharmaceutical Process Evaluations 

Tristan Marshall, Research Associate III, 

Human Genome Sciences 

9:15 Acidic Variants of Antibodies: 

Characteristics and PK Properties 

Paul Motchnik, Ph.D., Associate Director, Protein 

Analytical Chemistry, Genentech, Inc. 

9:45 Networking Refreshment Break in Exhibit 

and Poster Hall 

10:30 Analytical Strategies for Monitoring 

Impurities Encountered in 

Bioprocessing 

Jon S. Kauffman, Ph.D., Director, Method 

Development & Validation and Biopharmaceutical 

Services, Lancaster Laboratories 

11:00 The Potency Assay -- Still Relevant 

after All These Years 

Sally Seaver, Ph.D., President, Seaver Associates, LLC 


with All Session Presenters 

Site Tour to Amgen’s BioNext Facility 

Please arrive for the site tour at 3:45pm at the Sabin Street entrance on the Lobby level. Bus will depart promptly 

at 4:00pm. You will return to the Rhode Island Convention Center at 6:30pm. 

Pre-registration is required. 

Thursday, September 23 • 4:00 pm – 6:30 pm 

Amgen’s manufacturing plant in West Greenwich, RI, is a four-story, 364,000-square-foot building that contains 

state-of-the-art manufacturing, production, warehousing, utilities, and office space areas. Built in 2004 

to provide manufacturing capacity for Enbrel®, the plant operates 24 hours a day, seven days a week. The 

plant provides a controlled environment for the manufacture of bulk drug substance. Tour participants will 

walk through the plant and view through windows some of the production suites, including upstream and 

downstream manufacturing areas, and will hear from Amgen staff about processes in these areas. 

Closed-toed shoes must be worn; no high heels are allowed. 

Check in at attendee registration desk by Wednesday at 2:00 pm if you are pre-registered or would like to attend. 



7:00 Coffee 

Strategy 

Discussion Forums 

(Rotunda) 

Sponsored by 

10:30 

Smart Flexibility: 

What Creates the Right 

Degree of Flexibility 

and Cost Reduction 

in Different Phases of 

Manufacturing 

Moderator: 

Günter Jagschies, Ph.D., 

Senior Director, 

Strategic Customer Relations, 

GE Healthcare Life Sciences, 

Sweden 

Panelists: 

Carol D. Basey, 

Senior Manufacturing Technical 

Specialist, Genentech, Inc. 

Chris M. Brodeur, 

Senior Manager, Operations, 

Commercial Expansion Head, 


Rick Johnston, 

Co-Director, Center for 

Biopharmaceutical Operations, 

University of California, Berkeley 

Duncan Low, Ph.D., 

Scientific Executive Director, 


Robert J. Steininger II, 

Senior Vice President, 

Manufacturing, 

Acceleron Pharma 

12:00 

Technology Workshops 

(See next page) 

12:30 

Networking Luncheon in 

Exhibit and Poster Hall 

1:45 


Manufacturing Strategies 

for Biosimilars Products 

Moderator: 

Thomas J. Vanden Boom, Ph.D., 

Vice President, Global Biologics R&D, 

Hospira, Inc. 

Panelists: 

Parrish M. Galliher, 

Founder and Chief Technology Officer, 

Xcellerex, Inc. 

John Kim, Director, Analytical 

Development, Celltrion, Inc., Korea 

Friedrich Nachtmann, Ph.D., 

Head, Biotech Cooperations, 

Sandoz Biopharmaceuticals, Austria 

Curran Simpson, 

Senior Vice President, Operations, 


Formulation Strategies for Protein Therapeutics (Room 555A/556) 


Pooja Arora, Ph.D., Research Investigator II, Bristol-Myers Squibb 

Formulation Strategies for Vaccines 

8:30 CASE STUDY Impact of Recombinant Albumin on the Stability of a Malarial Antigen Vaccine 

Phuong Tran, Ph.D., Senior Scientist, Research and Development, Novozymes, Australia 

9:00 CASE STUDY Examining and Correlating the Long Term and Accelerated Stability of a 

Pneumococcal Antigen Vaccine 

Manvi Hasija, Ph.D., Sanofi-Pasteur, Canada 

9:30 CASE STUDY Formulation and Process Considerations for Stabilization of Live Attenuated Typhoid Vaccine 

Satoshi Ohtake, Ph.D., Senior Scientist and Senior Manager, Aridis Pharmaceuticals 

10:00 Networking Refreshment Break in Meeting Room 

Formulation Impacts of Device and Packaging Systems 

10:30 Characterization, Modelization and Control of Primary Packaging Surfaces to Minimize Non-Native 

Aggregation of Therapeutic Proteins 

Thomas Ballet, R&D Engineer, Advanced Technology, Becton Dickinson Medical Pharmaceutical Systems 

11:00 CASE STUDY Product Quality and Formulation Considerations in the Development of a Delivery 

System and Product Packaging 

Joe Fire, Senior Device and Packaging Engineer, Human Genome Sciences, Inc. 

11:30 CASE STUDY The Influence of Formulation on Delivery System Design, and Vice-Versa 

Douglas Nesta, Ph.D., Director, Biopharmaceutical Technologies, Biopharm R&D Unit, GlaxoSmithKline 

12:00 Networking Luncheon, Last Chance for Exhibit and Poster Viewing 


Shan Jiang, Ph.D., Director, Formulations, Seattle Genetics, Inc. 

Formulation Development for Next Generation Biologics 

1:30 CASE STUDY Formulation Development for Antibody-Drug Conjugate (ADC) Brentuximab 

Vedotin (SGN-35) 

Shan Jiang, Ph.D., Director, Formulations, Seattle Genetics, Inc. 

2:00 CASE STUDY Development and Implementation of a Thermal Melting Assay for High-Throughput 

Screening of Liquid Adenoviral Formulations 

Janik Adriaansen, Ph.D., Scientist, Crucell, The Netherlands 

2:30 CASE STUDY Formulation Development for Subcutaneous Delivery of Plasma Derived Proteins 

Sylvain Huille, Ph.D., Head of Department, Biopharmaceutical Development, LFB Biotechnologies, France 

3:00 Conference Ends 

Audience Interactive Panel Discussion: Point/Counterpoint (Exhibit and Poster Hall) 

2:30 BPSA Quality Agreement Templates for Single-Use Products used under Drug cGMP 

Presenters: 

BPSA Representative: David Radspinner, Ph.D., Global Director of Marketing and Product Management, Thermo Fisher Scientific 

Industry End-User Representative: Wolfgang Noe, Ph.D., Vice President, Strategic Development & Technical Alliances, Biogen Idec 

March 14 - 18, 2011 

Hyatt Regency Bellevue 

Bellevue, WA 

Register Early & 

Save $400 

n Antibody Development & Production 

n Process & Product Validation 

n Technology Transfer for Biopharmaceuticals 

n Outsourcing Manufacturing of Biopharmaceuticals 

n Recombinant Protein & Complex Biologic Development & Production 

n Analytical Technologies for Biotherapeutic Development 

Save Up to $400 if you register online by November 19, 2010 with Priority Code BDPWG 

www.IBCLifeSciences.com/bdpweek 

Discounts are off standard rates, valid for new registrations only & cannot be combined with any other offer. 


Thursday, September 23, 2010 (continued) 


Room 550 

Hybrid Purification – The Next Generation 

of Cell Clarification 

Centrifuge Replacement Via Single-Use Depth Filtration in 

Cell Culture Clarification 

This workshop will explore the use of single-use depth filtration technology and its 

implementation in cell clarification, primarily as a tool to replace conventional centrifuges. 

Encapsulated Zeta Plus disposable depth filters represent the latest product innovation from 

3M Purification Inc. and its features and benefits will be highlighted during this session. 

Thomas P. O’Brien, Ph.D., Senior Scientific Applications Support Specialist, 

3M Purification Inc. 

Room 553 

Cell Culture Media Platform for the Rapid 

Production of Gram Quantities of Recombinant 

Antibodies from CHO Cells Transformed with 

the Selexis Vectors 

Results from a collaborative program between Irvine Scientific, CA., 

USA and Selexis, S.A., Geneva, Switzerland will be presented. 

Tom Fletcher, Director, Cell Culture R&D, Irvine Scientific 

Pierre-Alain Girod, Ph.D., Chief Scientific Officer, R&D, Selexis SA, Switzerland 

Room 551 

Multi-Fold Titer Improvement through 

Integrated Medium and Feed Design 

High cell densities and product yields require culture media 

and feeds formulated so that no one nutritional component becomes limiting. 

Integration of the basal medium and feed design ensures nutrient availability. IgG 

titers of 2.6 g/L were reached using an integrated design strategy compared with 

starting titers of 0.5 g/L. This represents a 10-fold improvement over batch culture. 

Potential challenges and solutions will be discussed. 

Shawn Barrett, Senior Manager, R&D, Invitrogen, part of Life Technologies 

Room 552 

POROS® XS: A High Capacity, 

High Resolution CEX Resin 

The features and performance of POROS® XS chromatography 

resin will be highlighted. The benefits of a high capacity, high resolution, salt tolerant 

CEX resin as they relate to improving downstream purification process performance 

and productivity will be proposed. Applications data and process productivity 

modeling will be used to demonstrate the benefits of utilizing POROS XS. 

Christine Gebski, M.S., Director, POROS Applications and R&D, 

Applied Biosystems, part of Life Technologies 

12:30 Networking Luncheon in Exhibit and Poster Hall 

1:00 Featured Presentation in Exhibit and Poster Hall 

The Enduring Need for Operational Excellence: Lessons Learned from the Oil Field to Biotech and How Great Companies can Still Fall Short 

BP’s oil disaster in the Gulf shows how decisions and events can impact global organizations. Genzyme was hit with a virus that was undetectable by the industry’s standard viral 

tests and led to a global shortage in supply of critical medicines. During this presentation, Mark Bamforth will reflect on the importance of relentlessly pursuing operational 

excellence and how events can still impact an organization. 

Mark R. Bamforth, President & CEO, Gallus Biopharmaceuticals; Former Senior Vice President, Corporate Operations and Pharmaceuticals, Genzyme Corporation 

Recovery & Purification (Ballroom B/C) 


Uwe Gottschalk, Ph.D., Vice President, Purification Technology, 

Sartorius Stedim Biotech, Germany 

Implementing the Latest Tools and 

Techniques to Optimize the Harvest Step 

2:00 Optimization of the Harvest Step 

Roy Hegedus, Ph.D., Senior Scientist, Purification, Process Sciences, 


2:30 Enabling Precipitation as an Operation to Manage Critical 

Contaminants in Bioprocessing 

Daniel G. Bracewell, Ph.D., M.S., Department of Biochemical Engineering, 

University College London, United Kingdom 

3:00 Exploring Expanded Bed Adsorption for Capture of 

Antibodies from CHO Cultures 

Richard S. Wright, Principal Research Scientist, Pfizer Biotherapeutics 

3:30 Networking Refreshment Break, 

Last Chance for Exhibit and Poster Viewing 

Overcoming Challenges of Production, Purification 

and Characterization of Next Generation 

Antibody-Like Molecules & Protein Therapeutics 

4:00 CASE STUDY Investigation into the Concentration Limit of a 

PEGylated Protein 

Sarah Holtschlag, M.S., Senior Scientist, Downstream Process Development, 


4:30 Assembly and Purification of Knob and Hole Bispecific Antibodies 

Josefine Persson, Ph.D., Scientist, Early Stage Purification, Genentech, Inc. 

5:00 Applications for Biopharmaceuticals in Regenerative Medicine 

Peter W. Wojciechowski, Ph.D., Director, Product and Process Development, 

Advanced Technologies and Regenerative Medicine, LLC (ATRM) 

5:30 Immunodrugs TM – Development of a New Class of 

Therapeutic Vaccines 

Frank Hennecke, Ph.D., Executive Vice President, Product Development, 

Cytos Biotechnology, Switzerland 

6:00 Close of Day 

Cell Culture & Upstream Processing (Ballroom D/E) 


Kevin J. Kayser, Ph.D., Associate Director, Cell Sciences and Development, SAFC 

Host Cell Engineering to Improve the Yield 

and Quality of Biotherapeutics 

2:00 Proven Approaches to Determine Manufacturability of 

Candidate Molecules 

Czeslaw Radziejewski, Ph.D., Senior Group Leader, Protein Analytics, 


2:30 Profiling Highly Conserved MicroRNA Expression in 

Chinese Hamster Ovary Cells and Its Applications in 

Cell Engineering 

Nan Lin, Principal R&D Scientist, Cell Sciences and Development, Sigma-Aldrich 

3:00 Use of RNAi to Transform Biotherapeutics 

David Kocisko, Ph.D., Principal Scientist, Alnylam Biotherapeutics 

3:30 Networking Refreshment Break, 

Last Chance for Exhibit and Poster Viewing 

Implementation of Novel Media 

Development and Feed Strategies 

4:00 CASE STUDY Learning from High-Performance Chemically- 

Defined Media Formulations for CHO Platform Processes 

Masaru Shiratori, Ph.D., Engineer II, Late Stage Cell Culture, Genentech, Inc. 

4:30 How Media Optimization Impacts Quality 

Zhaohui Geng, M.D., M.S., Principal Scientist, Cell Process Development, 

Pfizer Biotherapeutics 

5:00 From Hydrolysates to Unique Molecules: Identification of 

Bioactive Components 

Elizabeth Dodson, Ph.D., R&D Manager, BioAnalytical Chemistry Bionutrients 

R&D, BD Biosciences - Advanced Bioprocessing 

5:30 Chemically-Defined Cell Culture Platform Development for 

Therapeutic Antibody Production. 

John Fann, Ph.D., Senior Group Leader, Cell Culture, Process Sciences, 


6:00 Close of Day 


Friday, September 24, 2010 

7:30 Coffee 

Recovery & Purification (BallroomB/C) 


Günter Jagschies, Ph.D., Senior Director, Strategic Cusatomr Relations, 

GE Healthcare Life Sciences, Sweden 

Evaluation and Implementation of 

Next Generation Purification Technologies 

8:15 CASE STUDY Strategies to Address Clarification of High 

Concentration Refold Pools for E. coli Based Therapeutics 

Xuankuo Xu, Ph.D., Scientist, Process Science Downstream, Bristol-Myers Squibb 

8:45 Downstream Process Continuous Improvement – 

Meeting High Titer mAb Production Demands 

Diane D. Dong, Ph.D., Senior Scientist II, Technical Operations, 


9:15 Bioengineered Protein A Polymer Beads for High-Affinity 

Antibody Purification 

Bernd H. A. Rehm, Ph.D., Chief Scientific Officer, PolyBatics Ltd., New Zealand 


Process Characterization for Developing Design Space 

10:15 Challenges of Technology Transfer Exacerbated by a Small 

Scale Model Artifact 

Marcus P. Luscher, Scientist, Purification Process Development, Amgen Inc. 

10:45 CASE STUDY Accelerated Methionine Oxidation Due to Viral 

Filtration A Case Study of the Limitations of Small Scale Models 

Tom Strickland, Ph.D., Principal Scientist, Purification Process Development, 

Amgen Inc. 

11:15 CASE STUDY Downstream Process Characterization for a 

Highly Glycosylated Fc-Fusion Protein 

Canping Jiang, Ph.D., Senior Scientist, Manufacturing Sciences and Technology, 

Bristol-Myers Squibb 

11:45 CASE STUDY Developing and Characterizing a 

High Concentration Ultra-Filtration Process 

Kelby Lau, Engineer II, Process Development – Late Stage Purification, 




Denny Kraichely, Ph.D., Associate Director, CMC Team Lead, 

Portfolio Management & Technical Integration, 

Johnson & Johnson Pharmaceutical R&D, Inc. 

What Comes Next After Titer Increase 

8:15 The Next Challenge(s) in Bioprocess Development 

Martin S. Sinacore, Ph.D., Site Head, Cell Culture Development, Biogen Idec 

8:45 Investigating Mammalian Cell Physiology using ‘Omics’ Tools 

Karthik P. Jayapal, Ph.D., Process Development Scientist, Cell Culture 

Development, Bayer HealthCare 

9:15 Taking a Leap Off the Platform: Reducing Timelines to Meet 

New Challenges 

Jim Mercer, Principal Engineer I, Culture Process Development, Pfizer Biotherapeutics 


Featured Presentation 

10:15 An Industrial View of Biopharmaceutical 


Anthony S. Lubiniecki, Sc.D., Senior Fellow, CMC Strategy, 

Large Molecule Portfolio Management, Janssen Pharmaceutical 

Companies of Johnson & Johnson 

Approaches to Improve Product Quality and 

Achieve Process Optimization 

10:45 CASE STUDY A Research Strategy to Enhance mAb Product 

Quality and Productivity in CHO Cell Culture Process 

Min Zhang, Ph.D., Senior Research Scientist, BioProcess R&D, Eli Lilly and Company 

11:15 CASE STUDY Maintaining Product Quality and Process 

Optimization from Early to Late Stage Process Development 

Jason Goodrick, M.S., Senior Engineer, Late Stage Cell Culture, Genentech, Inc. 

11:45 CASE STUDY QbD Approach to Cell Culture Process 

Characterization: A Case Study for a Monoclonal Antibody 

Production Process 

Szu-Han Wang, Engineer I, Late Stage Cell Culture, Pharma Technical 

Development, Genentech, Inc. 

Room 551 

Improving 

Biomanufacturing 

Efficiency through Recombinant 

Solution 

The current requirement for the biomanufacturing 

industry is to shorten the time taken to deliver 

new drugs to the market and reduce overall costs 

while maintaining regulatory compliance and 

product quality. During this workshop, Novozymes 

will discuss how the introduction of innovative 

technologies and products, such as recombinant 

protein solutions, and ongoing collaborative dialogue 

with the manufacturer is helping to drive efficiency 

improvements across the product lifecycle. 

Dr. Anthony Simula, General Manager, 

Novozymes Biopharma, Australia 

12:15 Technology Workshops 

Room 552 

Simple, Innovative 

Technology Reduces 

Testing Complexity and Streamlines 

Bioprocessing Operations 

This case study details how a leading protein 

processing facility, Diosynth Biotechnology, 

implemented microvolume UV-Vis testing at critical 

points in the workflow to greatly reduce processing 

time and increase efficiency. NanoDrop microvolume 

UV-Vis spectrophotometers are simple tools which 

can be easily implemented throughout a processing 

organization including R&D, manufacturing and 

quality control with great impact on the entire 

workflow and on debottlenecking steps. 

Philippe Desjardins, Scientific Marketing Manager, 

Thermo Scientific NanoDrop Products 

12:30 Lunch on Your Own 

Room 553 

Full Plastics - 

A Comprehensive Study on Using Single-Use 

Strategies for Generic Mab Manufacturing 

Using Total Disposable Technology 

The consistent and integrated use of disposable technologies 

enables a fast and reproducible GMP manufacturing and 

allows a substantial cost cutting for clinical supply. A 

comparative study on commercially available single-use 

technologies will be presented providing an in-depth cost 

comparison with conventional non-disposable facilities. Data 

from different stirred single-use bioreactor systems regarding 

operability and process kinetics at 250-L scale will be supplied 

as well as cell separation capacities assigned for using as 

disposable state-of-the-art filtration units. The integration of 

disposable downstream technologies will be discussed. 

Dethardt Müller, Ph.D., Rentschler Biotechnologie GmbH, 

Germany 

Gregor Dudziak, Ph.D., Vice President, Cell Culture, 

Rentschler Biotechnologie GmbH, Germany 

Enhance Your Conference 

Experience with 

twitter.com/ibcbioprocess 

• Follow @ibcbioprocess on Twitter for special offers and news from the event. 

• Monitor the #bpiconf topic to connect with others at the event. 

• End your Tweets from the event with #bpiconf to join the conversation. 


Recovery & Purification (Ballroom B/C) 


Natraj Ram, Ph.D., Senior Group Leader, Purification, Technical Operations, 


Utilizing Continuous Processing to Decrease 

Operation Time and Improve Facility Utilization 

2:00 Continuous Protein A Chromatography for the Purification 

of Monoclonal Antibodies Using an Automated Column 

Switching Approach 

Stephen Lyle, M.S., Principal Research Advisor, Bioprocess Development, 

Pfizer Inc 

2:30 CASE STUDY Straight Through Processing (STP) in 

Monoclonal Antibody Purification 

Bin Lin, Ph.D., Principal Research Scientist, Strategic Technology Development, 

API Large Molecules, Johnson & Johnson Pharmaceutical R&D 


Applications of Automated, High-Throughput 

Technologies in Downstream Processing 

3:30 Miniaturization of Chromatography Processes for Use in 

High Throughput Screening 

Maricel G. Rodriguez, Senior Research Associate, Early Stage Purification, 


4:00 Multi-Modal Ion Exchange Resins – An Explorative Study 

Hans J. Johansson, Staff Scientist, R&D, GE Healthcare Bio-Sciences, Sweden 

4:30 High Throughput Screening of Mixed Mode 

Chromatography Media to Develop a Two-Column Process 

for Monoclonal Antibody Purification 

Chen Wang, Ph.D., Senior Scientist II, Process Sciences, Purification, 


5:00 Close of BioProcess International TM Conference 2010 

Admission 

For security precautions, photo identification and an industry-related business 

card will be required of ALL attendees at check-in. Admission is limited to 

persons actively engaged in biopharmaceutical process development and 

manufacturing, IBC has taken every effort to prohibit admissions to persons not 

engaged in this area. 

Children under 18 are not permitted in the exhibit hall under any circumstances. 

Badges and badge holders must be worn at all times while attending the event. 

Conference badges are non-transferable and lost badges will not be replaced 

without payment of the full conference registration fee. No exceptions. 

Registration Hours 

Attendee Registration: Monday, September 20 

Tuesday, September 21 

Wednesday, September 22 

Thursday, September 23 

Friday, September 24 

Exhibitor Registration: Monday, September 20 




Friday, September 24, 2010 (continued) 

12:00 pm – 5:00 pm 

7:00 am – 7:00 pm 

7:00 am – 7:00 pm 

7:00 am – 5:30 pm 

7:30 am – 2:00 pm 

4:00 pm – 5:30 pm 

7:00 am – 7:00 pm 

7:00 am – 7:00 pm 

Thursday, September 23 7:00 am – 4:00 pm 

Speaker Check-In & Preparation Area 

Speaker registration is located at the main registration area located in the 

Exhibit Hall Foyer. It will be open and operational during attendee registration 

hours listed above. There will also be a Speaker Ready Room located in Show 

Suite C. This room will have a laptop, internet access and a printer for your 

convenience and will also provide a quiet area to prepare for your presentation. 

Speaker Preparation Area Hours: 

Monday, September 20 12:00 pm – 5:30 pm 



Thursday, September 23 

Friday, September 24 

7:00 am – 5:30 pm 

7:00 am – 5:45 pm 

7:00 am – 5:30 pm 

7:00 am – 4:00 pm 



Chetan T. Goudar, Ph.D., P.E., Head, Cell Culture Development, Global 

Biological Development, Bayer HealthCare 

Advantages of Using Mixed Mode Technologies 

1:30 Advances, Capabilities, and Limitations of Perfusion 

Technologies/Processes 

Timothy Johnson, Senior Manager, Process Development, BioEngineering, 

Genzyme Corp. 

2:00 Approaches to Rapid Development and Evaluation of Fed- 

Batch and Perfusion Processes 

Kesav Reddy, Associate Development Scientist, Upstream Process Development, 

CMC Icos Biologics Inc. 

2:30 CASE STUDY Running Inoculum Cultures in Perfusion Mode 

to Enable Higher Seeding Densities of Production Cultures 

Robel Tezare, Senior Research Associate, Pharma Technical Development, 



Overcoming Challenges of Producing Specific Proteins 

3:30 CASE STUDY Protein Engineering of an Alternative Scaffold 

for Improved Development & Production 

Subinay Ganguly, Ph.D., Associate Director, CMC Team Lead, REDSRIPT 

Ventures, Johnson & Johnson 

4:00 Key Considerations for the Production of Therapeutic 

Enzymes for ERT Using Perfusion Cell Culture 

Guru R. Thuduppathy, Ph.D., Scientist II, Manufacturing Sciences, 


4:30 CASE STUDY Challenges in Applying Platform Approach to a 

Cell Line Producing Non-mAb 

Yao-Ming Huang, Ph.D., Senior Engineer III, Cell Culture Development, 

Biogen Idec 

5:00 Close of BioProcess International TM Conference 2010 

General Information 

IBC Bioprocess Training Academy Courses 

#1. Introduction to Biopharmaceutical Manufacturing 

#2. Regulatory Compliance in CMC Development 

#3. Protein Characterization for Biotechnology Product Development 

#4. Cell Culture and Fermentation Processing 

Registration begins at 8:15 am on Tuesday, September 21 outside of Room 554/558. 

Courses run 9:00 am to 5:00 pm, Tuesday and Wednesday. Continental breakfast will be 

served inside the room at 8:15 am. 

Conference Evaluation 

To provide you with a leading conference and exhibition that addresses the issues that 

are important to you, we need to hear from you! Conference and exhibition attendees 

will be asked to complete evaluation forms that provide feedback to help us improve 

this event. Your feedback will help us enhance the learning and networking experiences 

at future events. Evaluation forms can be dropped in the appropriate collection bins 

throughout the Ballroom Level of the Rhode Island Convention Center. Thank you 

in advance for your cooperation. One completed evaluation form will be selected at 

random every day and that person will win a $75 gift card, to be delivered after the 

conference. 

Program Changes 

IBC does everything in its power to ensure there are no changes to the published 

program but sometimes circumstances that are beyond our control (i.e. speaker 

cancellations, speaker changes, etc.) do arise. In the event this does occur, every effort 

is made to find a suitable replacement. Please Note: The listings and contents of this 

book are proprietary and cannot be reproduced in part or in whole without permission. 

Every effort has been made to ensure the accuracy of this Guide. However, IBC USA 

Conferences, Inc. cannot be held responsible for errors or omissions. Product names 

may be trademarks or registered trademarks of their companies. 

Assistance and Special Needs 

The organizers of BioProcess International Conference and Exhibition 2010 fully 

support the Americans with Disabilities Act. If you require assistance of any kind, please 

inquire at Attendee Registration. 

Lost and Found 

Items found (such as books, apparel, bags etc…) can be dropped off at Attendee 

Registration. Items not claimed by the conclusion of the conference will be turned over 

to building security. 

Language 

The official conference language is English. Simultaneous translation is not available.

Poster Presentations Featured in the Exhibit Hall (Open to all attendees) 

Dedicated Poster Viewing: Wednesday, September 22, 12:30 pm – 2:00 pm 

Cell Culture & Upstream Processing 

An Improved Method for Animal Free Single Cell Cloning of Recombinant CHO Cell Line Janmeet Anant Millipore Corporation 

Application of An Automated Sampling System for Cell Culture Process Development Michael Biksacky Flownamics 

Development of Analytical Methods for Identifying Bioactive Components in Protein Hydrolysates Jim Blasberg Sigma-Aldrich 

Evaluation of Mammalian Transgenic Clones Through the Use of a Small-Scale System That Predicts Bioreactor Performance Steven Brennan Pfizer Inc 

Manipulation of Antibody Glycoforms in a High-Yield GS-CHO Process to Meet Comparability Requirements Michael Gramer Genmab, Inc. 

The EB66® Cell Line: An Anatine-Derived Embryonic Stem Cell for the Production of ADCC Enhanced Monoclonal Antibodies Louis Cantolupo Vivalis SA 

Evaluation and Implementation of a 24-Well Deep Well Plate System for a High-Throughput Cell Line Selection Platform Melisa Carpio Takeda San Francisco 

Insulin Independent Media Provides a Tool for Process Improvement Tara Chamberlain Pfizer 

Molecular PINCERs as Biosensors For For Quick Analysis Of Biologics Yie-Hwa Chang Saint Louis University 

Medical School 

A Novel Dynamic Gas Control Technique to Increase Yield and Eliminate Foaming in Cell Culture Bioreactors Alan Cheng Praxair Inc. 

Increased Process Understanding Through Characterization of Host-cell Protein Patterns Philip Culture GE Healthcare 

A Case Study Describing the Characterization of a 3L Single-Use Bioreactor as a Replacement for Glass Stirred-Tank Reactors Michael Cunningham Millipore Corporation 

Quantitation of Recombinant Human Factor IX in Bioreactor Harvest Samples Using Bio-Layer Interferometry Daniel Eustace Pfizer Inc 

Identifying the Mechanisms of and Developing Tools to Prevent Product Sequence Variants Lauren Feeney Genentech, Inc 

The Challenges of Maintaining Product Comparability While Improving Cell Line Productivity Linda Francullo Pfizer Inc 

Continuous Improvement of a Legacy Cell Culture Process through Statistical Analysis Melani Gantes Genentech Inc 

Adaptation of CHO Cells to a Growth Factor Supplement Improved Growth Rate and Productivity Sally Grosvenor Novozymes Ltd 

Evaluation of Recombinant Human Transferrin as an Animal-Free Alternative to Serum-Derived Transferrin Erika Hanley-Onken Millipore Corporation 

Development of Single-Use Pneumatic Bioreactor System Yas Hashimura PBS Biotech 

Homogeneous Antibody Binding Assay: Comparing Imaging Systems and Optimizing Acquisition Parameters for 

Jayne Hesley 

Molecular Devices 

High-Throughput Screening 

HYPERStack—Space Saving Scale Up Solution for Bioprocessing Vitaly Klimovich Corning Life Sciences 

Accelerating Development and Ensuring Product Quality of Biosimilars Using a Micro Bioreactor Platform Rachel Legmann Seahorse Bioscience 

The Humalex® Human Antibody Discovery Platform: An Optimized Approach Using Epstein-Barr Virus Immortalization Frederic Legros Vivalis SA 

Secreted host cell proteins used to characterize expression of IgG in CHO DG44 cells Ming Lei Life Technologies 

Accelerated Development of High Producing Cell Lines using UCOE® (Ubiquitous Chromatin Opening Elements) Technology Kara Levine Millipore 

Can Lactate Actually Be Beneficial to Cho Cell Culture Processes Jincai Li Genentech Inc 

Using Intact Protein Accurate Mass Data to Assess Clonal Difference in High-Mannose Oligosaccharide Content in 

Nan Lin 

SAFC/Sigma-Aldrich 

Recombinant Humanized IgG Producing Chinese Hamster Ovary Cell Lines 

A New Advanced Microscale Bioreactor Technology For Cell line and Process Development. Richard Lugg Medimmune 

Cell Culture Design Space Modeling Using a Scale-Down Approach Le Ly Biogen IDEC 

Reducing the Cost of a Mycoplasma Contamination Event Through Early Detection Wayne Miller EMD Millipore 

Investigation of Tag-lite Applications for Screening Biotherapeutics on Cell Surface Protein Targets Nicolas Pierre Cisbio US 

Increasing Antibody Yield and Modulating Quality Using Improved and Efficient Cloning and Production Platforms Graziella Piras Life Technologies 

Sub-Visible Particle Analysis in High Concentration Protein Formulations using Micro-Flow Imaging Deepark Sharma Brightwell Technologies Inc. 

Application of Fluid Bed Granulation Technology to Produce a Novel Dry Format Nutrient Supplement for CHO Cells James Smith Life Technologies 

Case Study: Utilization of Aa Capability Analysis to Support the Implementation of In-line Optical Density Technology in 

Order to Improve Bioreactor Seeding Capability 

Ziran Sun 

Genentech, Inc 

Development of Corning® HYPERStack® Multi-layer Cell Culture Vessels Allison Tanner Corning Life Sciences 

CAP-T Cell Expression System – a Novel Rapid and Versatile Human Cell Expression System for Fast and High Yield Transient Hartmut Tintrup Cevec Pharmaceuticals 

Protein Expression 

Integrating Next Generation Genomics Technologies can Significantly Improve Biopharmaceutical Process Optimization Len van Zyl ArrayXpress Inc. 

Highly Efficient Chemically-defined Fed-batch Process for Antibody Production Developed Using the SimCell® Technology Yuan Wen Life Technologies Corporation 

High Titer / High Throughput Cell Culture Process Developmen Carrie Weymer Medimmune 

Global Biochemical Profiling for Applications in Cell Culture, Cell Line Engineering and Bioprocessing Matt Zaske Metabolon, Inc 

40 Liter Reactor Microcarrier Satellite Cultures Using a Shake Flask Model Tom Hayes Genzyme 


Single Calibrant Approach to Cleaning Validation Using Dual Gradient Pump and Charged Aerosol Detection Christopher Crafts ESA - A Dionex Company 

Closing the Gap between R&D and Manufacturing Fatime Ly Siemens 


Case Study for Solving Formulation Issues of a Challenging Monoclonal Antibody Nicolas Fouque NovImmune SA 

Process Optimization, Quality and Efficiency Gains in Bioprocess Organizations Eliot Randle IDBS 

SWAP: A High Throughput Automated Microfluidic Alternative to Western Blotting Laurel Provencher CaliperLS 

Application of Animal-free Recombinant Bioactive Protein Supplements to Improve the Performance of Cell-based Viral 


Collette Sheahan 

Novozymes 


Poster Presentations Featured in the Exhibit Hall (continued) 

In recognition of the significant educational impact and value poster presentations 

provide our attendees, the publishers at BioProcess International TM magazine have 

created the 2010 BPI Conference Best Poster Awards, to be launched at this year's 

BioProcess International Conference & Exhibition. 

Posters will be reviewed and judged by BioProcess International TM magazine's 

Editor-in-Chief and magazine Scientific Advisory Board with two winning posters 

announced at the conference, one from academia/industry and one from a supplier. 


Early Downstream Process Optimization for Definition of Viral Safety is Critical in Platform Process Development for 

Monoclonal Antibodies 

Best Poster Award 

Jeffrey Bettencourt 

XOMA (US) LLC 

3-step Chromatography Process With No Intermediate Tanks Dayne Callum Millipore 

AbSolute TM by Novasep : High Performance Protein A Media Ludovic Chauchat Novasep 

Peptidomemetic Mixed-mode Ligand For Igg Purification 

Designing Alternative Monoclonal Antibody Purification Platforms without Protein A Affinity by Using Mixed-Mode 

Chromatography Sorbents 

Soren Flygenring 

Christensen 

Yamuna Dasarathy 

FeF Chemicals A/S 

Pall Corporation 

Rapid Recombinant Protein Purification Development using ÄKTA Avant Systems Tuomo Frigard GE Healthcare 

New Process Development Tool for Depth Filter Selection and Optimization Merrilee Galloway Millipore Corporation 

Feasibility Study of Continuous Chromatography on Monoclonal Antibody Capture Processes Siu-Man Kelvin Lau Abbott Bioreserch Center 

Use of Process Analytical Technology (PAT) to Dilute Buffer from Concentrate with Linear pH Gradient for Downstream Bioprocessing Michael Li 

Asahi Kasei Bioprocess 

Nuvia S: A High Capacity Cation Exchanger for Process Purification of Monoclonal Antibodies Jai-Li Liao Bio-Rad Laboratories 

Application of the Proximity Ligation Assay to Quantitate Protein A in Biopharmaceutical Samples Sueh-Ning Liew Life Technologies (ABI 

The Effect of Conductivity on Dynamic Binding Capacity on Cation Exchange Resins Mira Linhart Abbott Laboratories 

kSep®: A novel Bioprocessing Technology to Concentrate and Wash cells Sunil Mehta KBI BioPharma Inc 

Optimization of Intermediate Wash Conditions Using High Throughput Techniques 

Kristina Nilsson-Valimaa GE Healthcare 

Single-use Redundant Filtration Assembly – Design and Testing Ranjeet Patil Millipore Corporation 

Tangential Flow Filtration: New Application for Therapeutic Cell Processing Jacob Pattasseril Lonza 

Platform Quantitation of Residual Protein A across Antibody Isotypes and in Diverse Buffers with High Accuracy and Sensitivity Melissa Payer Repligen 

Identification and Implementation of an Aggregate Removal Step in a Large-scale Manufacturing Process 

Saravanamoorthy Medimmune 

Rajendran 

Differential Scanning Calorimetry — a Valuable Tool for the Development of Biotherapeutic Antibody Manufacturing Processes Eric Reese GE Healthcare 

Impact of Acidification of Mammalian Cell Culture Harvest on Process Robustness and Performance Linda Rich Abbot Laboratories 

Performance of the BioScale ViBE Host Cell Protein Assay Katherine Sheldon BioScale Inc 

New Membrane Adsorber for Polishing at High Salt Concentration Kevin Shomglin Genentech, Inc 

Towards Sustainable Economic Bioprocessing: How Advanced Modelling Provides Insight Andrew Sinclair Biopharm Services 

Experience with Diverse Cell Concentration, Retention, and Wash Applications for Use in Stem Cell Processing and 

Cell Therapy Processing 

Robert Speziale 

Invetech, Inc. 

Automated Parallel Chromatographic Separations in Process Development Lynn Sutherland ATOLL GmbH 

Effective Protein Secretion Platform Using Corynebacterium Glutamicium Yasuhiro Takenaka Ajinomoto USA 

Optimization of Protein Purification Using Small-Scale Separation Columns Lisa Thurston PhyNexus 

Principles and Practice of Ion-Exchange and Size-Exclusion Chromatography for Protein Characterization Bill Warren Waters Corporation 

Development of Hydrophilic Polymer-based Ion Exchange Media for Analysis and Purification of Various Biological Molecules Jeff Wilson YMC America 

Understanding and Reducing Your Mycoplasma Risk through Prevention, Clearance and Detection Christine Wright Millipore Corporation 

Optimization of Downstream Production for Live Attenuated Influenza Vaccine to Improve Manufacturing Efficiency and Hong Zhang 

MedImmune Inc 

Final Bulk Quality 

Continuous Protein Purification Using Simulated Moving Bed: Taking the Chromatography Platform to the Next Level Alla Zilberman Semba Biosciences 

Formulation Strategies for Protein Therapeutics 

Formulation Screening of Transiently Expressed Antibodies against Types B and E Botulinum Neurotoxins to Support Susan Babuka XOMA, LLC 

Pre-Clinical Candidate Selection 

Phase Behaviour of an IgG1 Monoclonal Antibody Rachel Castell MedImmune Ltd 

External Fluorescent Probes as Stability Indicating Markers in Formulation Screening Arun Ignatius Cook Pharmica 

Novel Formulations of Protein Biologics with Considerably Reduced Rate of Aggregation Jan Jezek Arecor Limited 

Impact of Recombinant Albumin on the Stability of Malarial Antigen Vaccine Phuong Tran Novozymes Ltd. 

Formulation Development using a Targeted Forced Degradation Approach Richard Zajicek Lonza 

The two winning posters will be published in 

Sponsored by 

BioProcess International TM magazine's November 

2010 Poster Hall Supplement. The 2010 Poster 

Hall Supplement is a compilation of process 

technologies and expertise, categorized 

by technology. It will be published in tabloid format as a supplement to BioProcess 

International TM magazine's November issue, then housed as an interactive online experience 

for a full year on BPI magazine’s website, www.bioprocessintl.com 


Exhibitor List 

Exhibit Hall & 

Poster Viewing Hours 


5:30 pm - 7:00 pm 


9:45 am - 7:00 pm 


9:45 am - 4:00 pm 

3M Purification Inc. . . . . . . . . . . . . . . . . . . . . . . . . .508 

Advanced Instruments Inc.. . . . . . . . . . . . . . . . . .221 

Advanced Scientifics Inc.. . . . . . . . . . . . . . . . . . . .321 

Advantapure/Newage Industries. . . . . . . . . . . .307 

Ajinomoto . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .817 

Althea Technologies , Inc. . . . . . . . . . . . . . . . . . . .406 

Amgen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124 

Applied Biosystems, 

part of Life Technologies . . . . . . . . . . . . . . . . . . . .201 

Applikon Biotechnology Inc. . . . . . . . . . . . . . . . .513 

Aragen Bioscience Inc. . . . . . . . . . . . . . . . . . . . . . .707 

Arkema Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .825 

Asahi Kasei Bioprocess. . . . . . . . . . . . . . . . . . . . . .801 

ATMI Life Sciences . . . . . . . . . . . . . . . . . . . . . . . . . .607 

ATR, Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .424 

Avacta Analytical . . . . . . . . . . . . . . . . . . . . . . . . . . .907 

Avid Bioservices Inc. . . . . . . . . . . . . . . . . . . . . . . . .709 

BAC B.V., The Affinity Experts. . . . . . . . . . . . . . . .225 

BaroFold Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .905 

Baxter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .705 

Bayer Technology Services . . . . . . . . . . . . . . . . . .619 

BD Biosciences . . . . . . . . . . . . . . . . . . . . . . . . . . . . .401 

BioDtech, Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .921 

Bioengineering Inc. . . . . . . . . . . . . . . . . . . . . . . . . .420 

BioPharm Software Solutions . . . . . . . . . . . . . . .324 

BioProcess International 

Magazine . . . . . . . . . . . . . . . . . . . . Registration Area 

Bioproduction Group . . . . . . . . . . . . . . . . . . . . . . .805 

Bio-Rad Laboratories . . . . . . . . . . . . . . . . . . . . . . .213 

BioReliance Corp . . . . . . . . . . . . . . . . . . . . . . . . . . .627 

Bioresearch Online . . . . . . . . . . . . . . . . . . . . . . . . .103 

BioScale, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .916 

BioSystem Development, LLC . . . . . . . . . . . . . . .326 

BioTechLogic Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . .626 

Boehringer Ingelheim . . . . . . . . . . . . . . . . . . . . . .207 

Brightwell Technologies Inc. . . . . . . . . . . . . . . . .727 

Broadley-James Corporation . . . . . . . . . . . . . . . .525 

Caliper Life Sciences . . . . . . . . . . . . . . . . . . . . . . . .219 

Catalent Pharma Solutions. . . . . . . . . . . . . . . . . .517 

Celeros Inc.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .313 

CEVEC Pharmaceuticals GmbH . . . . . . . . . . . . . .902 

Charles River . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .526 

Charter Medical Ltd. . . . . . . . . . . . . . . . . . . . . . . . .720 

Chisso. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125 

Cisbio US, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .327 

CMC Biologics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .315 

Colder Products . . . . . . . . . . . . . . . . . . . . . . . . . . . .520 

Cook Pharmica LLC . . . . . . . . . . . . . . . . . . . . . . . . .624 

Corning Incorporated. . . . . . . . . . . . . . . . . . . . . . .724 

Crucell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .408 

Cygnus Technologies . . . . . . . . . . . . . . . . . . . . . . .418 

Cytovance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .421 

DASGIP BioTools LLC. . . . . . . . . . . . . . . . . . . . . . . .913 

DCI Biolafitte . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .206 

Dionex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .625 

Diosynth Biotechnology, now a part 

of MERCK BioManufacturing Network . . . . . . .519 

DSM Biologics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .400 

Eden Biodesign. . . . . . . . . . . . . . . . . . . . . . . . . . . . .912 

EMD Chemicals. . . . . . . . . . . . . . . . . . . . . . . . . . . . .319 

Enzo Life Sciences . . . . . . . . . . . . . . . . . . . . . . . . . .900 

Finesse Solutions LLC . . . . . . . . . . . . . . . . . . . . . . .708 

Flownamics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .317 

Fluid Imaging Technologies Inc . . . . . . . . . . . . .224 

FOGALE nanotech Inc. . . . . . . . . . . . . . . . . . . . . . .120 

Forte Bio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .425 

Friesland Campina Domo . . . . . . . . . . . . . . . . . . .427 

Gallus Biopharmaceuticals . . . . . . . . . . . . . . . . . .114 

GE Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .616 

GEA Westfalia Separator . . . . . . . . . . . . . . . . . . . .109 

Genetix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .924 

Goodwin Biotechnology, Inc.. . . . . . . . . . . . . . . .926 

Gyros US Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .701 

Hamilton Company. . . . . . . . . . . . . . . . . . . . . . . . .908 

Health Protection Agency. . . . . . . . . . . . . . . . . . .419 

IDBS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .804 

Integrity Bio, Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . .915 

Invitrogen, part of Life Technologies . . . . . . . .201 

Irvine Scientific . . . . . . . . . . . . . . . . . . . . . . . . . . . . .407 

KBI Biopharma, Inc. . . . . . . . . . . . . . . . . . . . . . . . . .719 

Lancaster Laboratories. . . . . . . . . . . . . . . . . . . . . .614 

Latham BioPharm Group. . . . . . . . . . . . . . . . . . . .818 

LAUDA- Brinkmann LP . . . . . . . . . . . . . . . . . . . . . .325 

Laureate Pharma . . . . . . . . . . . . . . . . . . . . . . . . . . .812 

LEWA Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .824 

Life Technologies, Inc . . . . . . . . . . . . . . . . . . . . . . .201 

List Biological Laboratories . . . . . . . . . . . . . . . . .826 

Lonza . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .414 

Metabolon, Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . .920 

MetanomicsHealth . . . . . . . . . . . . . . . . . . . . . . . . .127 

Microbiotest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126 

Millipore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .813 

Mirus Bio LLC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .227 

ENTER TO WIN 

Stop by Life Technologies’ booth #201, and enter our 

“Fastest Way From Molecule To Market” contest. In addition 

to receiving a free gift for registering, you will be entered 

for a chance to win one of twenty $50 gift cards from the 

world’s largest online e-tailer. 

Molecular Devices . . . . . . . . . . . . . . . . . . . . . . . . . .808 

M-Scan, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .226 

MSP Corporation . . . . . . . . . . . . . . . . . . . . . . . . . . .819 

Natrix Separations . . . . . . . . . . . . . . . . . . . . . . . . . .713 

New Brunswick Scientific . . . . . . . . . . . . . . . . . . .412 

Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . .606 

NOVASEP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .821 

Novozymes Biopharma . . . . . . . . . . . . . . . . . . . . .507 

Ocean Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108 

Optek . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .800 

Pall Life Sciences . . . . . . . . . . . . . . . . . . . . . . . . . . .413 

PBS Biotech . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .925 

PendoTECH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102 

Pfenex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .204 

Polestar Technology . . . . . . . . . . . . . . . . . . . . . . . .116 

Praxair Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .524 

PreSens Precision Sensing . . . . . . . . . . . . . . . . . .703 

Prometic Biosciences Ltd. . . . . . . . . . . . . . . . . . . .621 

PSA CARRCentritech . . . . . . . . . . . . . . . . . . . . . . . .725 

QOSINA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .909 

Quattroflow Pumps/ 

Triangle Process Equipment. . . . . . . . . . . . . . . . .320 

RecipharmCobra Biologics . . . . . . . . . . . . . . . . . .301 

Refine Technology . . . . . . . . . . . . . . . . . . . . . . . . . .802 

Rentschler Biotechnologie . . . . . . . . . . . . . . . . . .308 

Repligen Corporation. . . . . . . . . . . . . . . . . . . . . . .816 

SAFC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .601 

Saint-Gobain Performance Plastics . . . . . . . . . .101 

Sandoz. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .820 

Sartorius Stedim North America Inc.. . . . . . . . .501 

SciLog, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .827 

Selexis SA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106 

Sheffield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .608 

Smartflow Technologies . . . . . . . . . . . . . . . . . . . .303 

Spectrum Laboratories Inc. . . . . . . . . . . . . . . . . .208 

STEMCELL Technologies Inc . . . . . . . . . . . . . . . .903 

TECAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .806 

Techniserve, INC. . . . . . . . . . . . . . . . . . . . . . . . . . . .200 

The Automation Partnership . . . . . . . . . . . . . . . .807 

Therapure Biopharma . . . . . . . . . . . . . . . . . . . . . .717 

Thermo Scientific. . . . . . . . . . . . . . . . . . . . . . . . . . .613 

Tosoh Biosciences . . . . . . . . . . . . . . . . . . . . . . . . . .901 

Value Plastics Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . .904 

Vante (formerly SEBRA) . . . . . . . . . . . . . . . . . . . . .112 

Vivalis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118 

WuXi AppTec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .612 

Xcellerex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113 


Exhibit Hall Floor Plan – Level 3 

Posters 

100 

102 

104 

106 

108 

112 

114 

116 

118 

120 

124 

126 

Presentation Stage 

101 

200 

103 

202 

105 

204 

107 

206 

109 

208 

113 

125 

224 

127 

226 

201 

207 

219 221 225 227 

213 

308 320 324 326 

301 

303 

307 

313 

315 

317 

319 

321 

325 

327 

Resource Ctr. 

Entrance 

400 

401 

501 

406 408 

407 

508 

507 

606 608 

412 414 418 420 

413 

419 421 

520 

513 517 519 

612 614 616 

424 

425 427 

524 526 

525 

624 626 

601 

607 

619 621 625 627 

613 

708 720 724 

701 

703 

705 

707 

709 

713 

717 

719 

725 

727 

800 

802 

804 

806 

808 

812 

816 

818 

820 

824 

826 

801 

805 

807 

813 

817 

819 

821 

825 

827 

900 

902 

904 

908 

912 

916 

920 

924 

926 

901 

903 

905 

907 

909 

913 

915 

917 

919 

921 

925 

IBC Sales Office 

Posters 


Session Room Floor Plan – Level 5 

Bioprocess Training 

Academy Courses 

557 

558A 558B 

556 

Formulations Sessions 

554A 554B 

555A 

555B 

Conference Sessions 

C 

B 


Exhibit Hall/ 

Registration 

Level 3 

Escalators 

BioProcess 

International 

Magazine 

Ballrooms 

A 

Plenary/Keynote Sessions 

E 

D 


Strategic 

Discussion 

Groups 

Breakfast 

Technology 

Workshops (W-Th) 

Rotunda 

553 552 



550 

551 


Mark your 

calendar for 

next year 

BioProcess International 

Conference & Exhibition 

Conference: October 31 - November 4, 2011 

Exhibition: November 1-3, 2011 

Long Beach Convention Center, Long Beach, CA 



November 1-3, 2011 

Long Beach Convention Center, Long Beach, CA

Program Information - IBC Life Sciences

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