Register Early and Save up to $300 (See page ... - IBC Life Sciences

Companies that Continue 

to Attend Year after Year 

Abbott Bioresearch Center 

Abbott Laboratories 

Acceleron Pharmaceuticals Inc 

Acorda Therapeutics 

Alexion Pharmaceuticals Inc 

Alnylam Biotherapeutics 

Altus Pharmaceuticals 

Amgen Inc 

Astellas Pharma Inc 

AstraZeneca 

Avecia 

Baxter Biosciences 

Bayer Healthcare 

Biogen Idec 

Biolex Therapeutics Inc 

BioMarin Pharmaceutical 

Boehringer Ingelheim 

Bristol Myers Squibb 

Celltrion Inc 

Centocor 

Chugai Pharmaceutical Company 

Ltd 

CMC ICOS Biologics Inc 

Cubist Pharmaceuticals Inc 

Dendreon Corporation 

Diosynth Biotechnology 

DSM Biologics 

Elan Pharma 

Eli Lilly and Company 

EMD Serono 

Enobia Pharma 

F. Hoffmann La Roche 

Genentech, Inc. 

Genzyme Corporation 

GlaxoSmithKline 

Human Genome Sciences Inc 

ImClone Systems 

ImmunoGen 

Johnson & Johnson 

Kirin Pharma Company Ltd 

Lonza 

Maxygen Inc 

Medarex 

MedImmune 

Merck & Co. 

Merck Serono 

Millennium Pharmaceuticals 

Novartis 

Novo Nordisk A S 

PDL BioPharma 

Percivia 

Pfizer Inc 

Progenics Pharmaceuticals 

Roche Inc 

Sandoz Biopharmaceuticals 

Sanofi Aventis 

Sanofi Pasteur 

Schering-Plough Corporation 

Seattle Genetics Inc 

Shanghai Hengrui Pharmaceuticals 

Shire Human Genetic Therapies 

Talecris Biotherapeutics 

Tracon Pharmaceuticals 

Trubion Pharmaceuticals 

Unither Pharmaceuticals Inc 

Wyeth 

Xoma LLC 

Plus, many more! 

Register Early and Save up to $300 (See page 15 for details) 

Conference: September 20-24, 2010 

Exhibition: September 21-23, 2010 

Rhode Island Convention Center 

Providence, RI 

Accelerating and Optimizing Biopharmaceutical Process and Product Development 

Keynote Presentations 

Regulatory Modernization – 

FDA’s Desired State for Product Quality 

Helen N. Winkle 

Director, Office of Pharmaceutical Science, CDER, US FDA 

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. 

Sustainable Commercial Cell Culture Operations 

W. Blair Okita, Ph.D. 

Senior Vice President, Manufacturing Sciences and Technical 

Operations, Genzyme Corporation 

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 

Platinum Sponsors: 

Founding 

Publication: 

“A key forum for all aspects 

of biopharmaceutical process 

development and CMC!” 

– Dr. Jens H. Vogel, Global CMC Development Team Leader 

and Head, Isolation and Purification, Bayer Healthcare 

“The networking opportunities, 

caliber of presentations and the 

vendor exhibits were simply 

outstanding! I will be back!!” 

– Timothy Atolagbe, Senior Development Scientist, 

United Therapeutics Corp 

“BPI is an excellent forum 

for networking with others 

within the industry!” 

– Jayanth Sridhar, Associate Director, 

BioMarin Pharmaceutical 

Gold Sponsors: 

www.IBCLifeSciences.com/BPI





Top Eleven Reasons Why BPI Should Be Your #1 Conference Choice this Year 

1 

Advance 

2 

Maximize 

3 

Learn 

4 

Plan 

5 

Hear 

6 

Learn 

7 

Hear 

8 

Tour 

9 

Streamline 

10 

your knowledge quickly and comprehensively with BPI’s broad coverage and detailed case studies. 

your present and future facilities by hearing case studies and experiences with biodefense, subcutaneous 

high concentration dosing, high titre projects and many other cutting-edge case programs and strategies 

to use design space strategies to leverage flexibility, mitigate variability, and continuously improve your process 

how to integrate raw materials and suppliers into your quality system by applying science- and risk-based 

approaches to fulfill your responsibility to both shareholders and patients 

what comes next after titer increase as companies demonstrate approaches to accelerate 

process development and control costs while improving quality in upstream processing 

to optimize the interface and hand-offs between upstream and downstream processing 

behind-the-scenes thinking about today’s bioprocessing realities and tomorrow’s possibilities during small group 

break-out discussions – to ensure the direction of your career and your company’s projects 

Amgen’s State-of-the-Art BioNext Facility and gain first-hand knowledge of an industry leader’s operations 

your projects by developing alliances with providers you meet in the largest exhibit hall exclusively devoted 

to biopharmaceutical manufacturing 

Connect with peers facing similar development and product challenges as you are, so that you can develop new 

collaborations and relationships to continue the dialogue after the event 

11 

Gain recognition from your peers as you showcase your accomplishments and share experiences by presenting a poster 

Featured Presentations 

Optimizing Manufacturing Network Performance 

and Planning for the Future 

Alison Moore, Ph.D. 

Vice President, Corporate Manufacturing, Amgen 

Flexible Manufacturing for a Diverse Biologics Portfolio 

Phillip Gomez, Ph.D. 

Director, PRTM Management Consultants 

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 

Optimizing Interfaces & 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 

“A must-attend annual conference 

for biopharmaceutical industry!” 

– Jinyou Zhang, Ph.D., Associate VP, Process Development 

& Manufacturing, Immunomedics, Inc. 

An Industrial View of Biopharmaceutical Comparability and 

Characterization 

Anthony S. Lubiniecki, Sc.D. 

Senior Fellow, CMC Strategy, Large Molecule Portfolio Management, Janssen 

Pharmaceutical Companies of Johnson & Johnson 

Linking Upstream and Downstream 

Jonathan Coffman, Ph.D. 

Principal Engineer III, Pfizer Biotherapeutics 

Challenges and Efficiencies Gained by Integrating Upstream and 

Downstream Drug Substance PD 

Gene Schaefer, Ph.D. 

Senior Director, API-Large Molecule Development, Johnson & Johnson 

Prevnar 13: The Story Behind the Vaccine 

Willard Waterfield, Ph.D. 

Senior Director, Manufacturing Sciences & Technology, 

Andover and Pearl River, Pfizer GMS 

“The premier annual bioprocessing event for the 

development of biologics. The BPI conference is one 

meeting that everyone looks forward to attending.” 

– Denny Kraichely, Ph.D., CMC Team Leader, 

Portfolio Management & Technical Integration, 

Janssen Pharmaceutical Companies of Johnson & Johnson 

www.IBCLifeSciences.com/BPI





THE Meeting Place for the Bioprocessing Industry 

“BPI offers a highly effective forum to 

share and showcase cutting-edge advances in 

process development and manufacturing” 

– Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical Development, 

Human Genome Sciences, Inc. 

This is the one conference you need to attend this year if your goals are to: 

• Streamline your processes by adopting new technologies or improving current 

manufacturing operations 

• Implement QbD 

• Manufacture patient-friendly biopharmaceuticals in a cost-effective manner 

• Expedite your candidates through the CMC approval process 

• Manage process changes in your post-approval products 

New value-added programming gives you more for your conference budget: 

4 comprehensive tracks to update your knowledge 

in all areas of bioprocessing at one outstanding forum: 

• Point Counterpoint Session: Integrating Raw Materials and Suppliers into a Pharmaceutical 

Quality System 

• Emerging Analytical Requirements and their Impact on Process Development 

and Manufacturing 

• Rapid Vaccine Development and Production 

• 4 comprehensive Two-Day Training Courses 

• Site Tour to Amgen's BioNext Facility 

Managing Manufacturing Networks 

• Maximize your present and future facilities from experience with biodefense, subcutaneous high 

dosing, high titer projects and many other cutting-edge case studies and strategies 

Product Lifecycle Management 

• Learn to use design space strategy to leverage flexibility, mitigate variability, and continuously 

improve your process 

Cell Culture & Upstream Processing 

• Hear what comes next after titer increase as companies demonstrate approaches to accelerate 

process development and control costs while improving quality in upstream processing 

Recovery & Purification 

• Evaluate and explore the latest breakthroughs to de-bottleneck downstream capabilities with 

next generation purification technologies 

Plus, Access Co-Located Conference at No Extra Charge 

• Formulation Strategies for Protein Therapeutics 

(Agenda on Page 14) 

Intimate break-out discussions to guide your career and your company 

in the right direction: 

Strategic Discussion Forums 

• Managing Partners and Contractors – Practical Solutions to the Issues that Arise 

• Manufacturing: What will Take us to the Next Level of Efficiency and Economics 

• Smart Flexibility: What Creates the Right Degree of Flexibility and Cost Reduction in Different 

Phases of Manufacturing 

• Development and Manufacturing Strategies for Biosimilars Products 

Roundtable Discussion Groups 

• Continuous Disposable Multi-Column Chromatography: Emerging Technology to Enable 

More Efficient Downstream Processing 

Station 1: Economic Modeling of Multi-Column Chromatography Applications 

Station 2: QA Discussion of Areas Relating to Multi-columns Operations 

Station 3: Modeling your Clinical Manufacturing Process 

Station 4: Adoption of New Technologies into Organizations 

Gain Recognition from Your Peers and Present a Poster 

Best Poster Award Sponsored by 

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. 

Dedicated Poster Viewing 

Wednesday, September 22 • 12:30 pm - 2:00 pm 

Poster & Exhibit Viewing Hours 

Tuesday, September 21 • 5:30 pm – 7:00 pm 

Wednesday, September 22 • 9:45 am – 7:15 pm 

Thursday, September 23 • 9:45 am – 3:45 pm 

The two winning posters will be published in 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.bioprocesintl.com 

The deadline to submit an abstract for inclusion in the conference documentation is August 20, 2010 

(Abstract and full payment of conference and poster fees must be received by this date.) After that date 

posters are on a space available basis. To submit your poster and for additional details on the poster 

sizes and regulations, please visit www.IBCLifeSciences.com/BPI/poster.xml 

3 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

Monday, September 20, 2010 

1:00 pm - 5:00 pm 

Symposium #1: Prevention of Microbial and Viral Contamination of 

Mammalian Cell Culture Processes - Lessons Learned and Case Studies 

Tuesday, September 21, 2010 

Morning 

Managing Manufacturing 

Networks 

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 

Process Design: Establishing Design 

Space and Robust Process Parameters 



(session continues) 

Agenda Overview 

Symposium #2: How Much Data is Enough 

The Statistical Approach to Process Validation 

Networking Refreshment Break 

Sponsored Session by Bio-Rad Strategic Discussion Forum 

Advancements and Case Studies of 

Hydroxyapatite for Biomanufacturing 




11:45 am Technology Workshops Sponsored by: Sheffield Bio-Science, Mirus Bio and Novasep 

12:15 pm Luncheon Presentation by Millipore 

Afternoon 

Smart Flexibility in Facilities 

Implementation and Execution 


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 

Symposium #3: Technology Transfer for Biopharmaceuticals 

Managing Partners and 

Contractors – Practical Solutions 

to the Issues that Arise 

Manufacturing: What will Take us to the 

Next Level of Efficiency and Economics 

Sponsored by Pall Life Sciences 

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

Wednesday, September 22, 2010 

Managing 

Manufacturing 

Networks 

Product Lifecycle 

Management 

Raw Materials/ 

Supply Chain 

Strategic Discussion 

Forum 

Recovery & 

Purification 

Rapid Vaccine 

Development and 

Production 

7:15 am Technology Workshop with Continental Breakfast Sponsored by: SAFC Biosciences Keynote Presentation: 

Global Vaccine Production 

Challenges: Emerging 

Morning 

The Future of 

Manufacturing Networks 

and Facilities 

The Future of 

Manufacturing Networks 



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 

Networking Refreshment Break Sponsored by Luminex in Exhibit and Poster Hall 


Integrating Raw Materials 

and Suppliers into a 

Pharmaceutical Quality 

System (session continues) 

Continuous Disposable 

Multi-Column 

Chromatography: Emerging 

Technology to Enable 

More Efficient Downstream 

Processing - Sponsored by 

Tarpon Biosystems 

Cell Culture & 

Upstream Processing 

Integrating In-Line Process 

Monitoring and Control 

Technologies in Upstream 

Processing 

12:00 pm Technology Workshops Sponsored by: Diosynth Biotechnology, GE Healthcare, Natrix Separations Inc., and New Brunswick Scientific 

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

Afternoon 

Plenary Session – Critical Industry Issues 

Networking Refreshment Break Sponsored by Luminex in Exhibit and Poster Hall 

Keynote Presentations: I. Sustainable Commercial Cell Culture Operations 

II. Finding a Home for Process and Product Development 

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

Thursday, September 23, 2010 


Cell Culture & Upstream 

Processing 

Emerging Analytical 

Requirements 

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

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 in Exhibit and Poster Hall 

Emerging Analytical Requirements and 

their Impact on Process Development 

and Manufacturing (session continues) 

Immunotherapeutics, 

Manufacturing Flexibility and 

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 

Defending Biosimilar 

Competition: Bioprocess 

IP Protections for Next 

Generation Vaccines and 

Immunotherapeutics 

Process Development and 

Analytical Characterization 

for Vaccine Production 

Process Development and 

Analytical Characterization 

for Vaccine Production 


Strategic Discussion Forum 

Smart Flexibility: What Creates the Right 

Degree of Flexibility and Cost Reduction 

in Different Phases of Manufacturing 

12:00 pm Technology Workshops Sponsored by: 3M Purification Inc., Irvine Scientific, Applied Biosystems, a part of Life Technologies, and Invitrogen, a part of Life Technologies 

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

Formulation Strategies for 

Protein Therapeutics 

Pre-Conference Workshop: 

The Formulator of the Future: Using 

High Throughput Technologies, 

Informatics and Rational Design to 

Accelerate and 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 

Comparability and Characterization 

Exercises during Formulation 

Development (session continues) 

Technology Workshop 

Formulation 

Strategies for Protein 

Therapeutics 

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 

Technology Workshop 

Evaluation and Control of 

Biopharmaceutical Stability 




Formulation Strategies for 

Protein Therapeutics 

Formulation Strategies for Vaccines 

Formulation Impacts of Device and 

Packaging Systems 

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 

Implementing the Latest Tools and 

Techniques to Optimize the Harvest Step 

Host Cell Engineering to Improve the 

Yield and Quality of Biotherapeutics 

Development and Manufacturing 

Strategies for Biosimilars Products 

Formulation Development for Next 

Generation Biologics 

Afternoon 

Overcoming Challenges of Production, 

Purification and Characterization 

of Next Generation Antibody-Like 

Molecules & Protein Therapeutics 

Friday, September 24, 2010 

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 

(space is limited) 

3:00 pm Conference Ends 



Evaluation and Implementation of Next Generation Purification Technologies 

What Comes Next after Titer Increase 

Morning 


Process Characterization for Developing Design Space 

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, Thermo Scientific NanoDrop Products, Rentschler Biotechnologie GmbH 

12:45 pm Lunch on your own 

Afternoon 

Utilizing Continuous Processing to Decrease Operation Time and Improve Facility Utilization 

Applications of Automated, High-Throughput Technologies in Downstream Processing 


Advantages of Using Mixed Mode Technologies 

Overcoming Challenges of Producing Specific Proteins 

Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event 4

Monday, September 20, 2010 • Pre-Conference Symposia 

12:00 Registration 

Symposium #1: Prevention of Microbial and Viral 

Contamination of Mammalian Cell Culture Processes 

- Lessons Learned and Case Studies 

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, Genentech, Inc. 

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 


Symposium #2: 

How Much Data is Enough The Statistical Approach 

to Process Validation 

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 


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, 



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 



Tuesday, September 21, 2010 • Main Conference 

7:00 Registration and Coffee 


Symposium #3: 

Technology Transfer for Biopharmaceuticals 


Jean Bender, Ph.D., Principal Engineer, Genentech, Inc. 

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. 





Leveraging our Assets – How Do We 

Reconcile the Installed Base with 

Current Technologies and Demand 


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

Technology, Genentech, Inc. 

Keynote Presentation 

8:05 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 


CASE STUDY Manufacturing Aspects of a New 

Facility: Lessons Learned 

Shakedown, qualification, and start-up of new biotech 

manufacturing facilities is a challenging undertaking. Balancing 

cost, schedule and resources is always a challenge. This talk will 

review the lessons learned from the design, commissioning, 

qualification, shakedown, and validation of numerous large scale 

biotech manufacturing facilities, including process equipment and 

automation 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 

Abstract not available at press date. Please visit 

www.IBCLifeSciences.com/BPI for program updates. 

Ken Hammer, Vice President, Facilities and Engineering, 

Dendreon Corporation 



CASE STUDY Enabling High Throughput Production 

in an Existing Commercial Plant 

Lowering cost of goods is achievable by producing product at higher 

run rates in an existing facility. This case study presentation focuses 

on evaluation of historical performance to identify and implement 

equipment and operational modifications to enable manufacture 

of product at high run rates. The presentation will report on actual 

performance after modifications were implemented. Implications for 

design of future processes will also be discussed. 

Carol D. Basey, Senior Manufacturing Technical Specialist, 





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 

Lot to lot variability in chromatography adsorbent properties can 

result in unacceptable performance. The column operating conditions 

may need to be designed to be adsorbent lot specific to achieve 

acceptable performance. In this presentation, we discuss how a 

design space strategy can be used to mitigate such risks, by providing 

additional flexibility in applying the appropriate column operating 

conditions. Several case studies will be presented. 

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 

Biopharmaceutical processes generate large amount of data in 

commercial operations that require advanced modeling and 

monitoring. Multivariate technology allows quickly identifying 

patterns in the process data to help facilitate process learning 

and troubleshooting. Examples from large-scale manufacturing 

applications in cell culture process monitoring approaches by using 

real-time process supervision will be demonstrated. 

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

9:15 CASE STUDY Creating a QbD Chromatography 

Design Space Using Mechanistic Modeling Techniques 

The FDA has called QbD “a good scientific approach” which involves 

“using good science” which “will result in cost benefits for the 

industry”. This case study applies mechanistic modeling to identify 

critical parameters and define an ICH/FDA Q8 compliant QbD 

design space. Simulations were used to improve the separation, 

reduce operating costs and troubleshoot separation anomalies. 

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 

Design of experiments (DOE) tools in product and process 

development can be confusing and frustrating, resulting in 

missed opportunities for increased knowledge about the product 

or process under consideration. This presentation will outline 

general DOE concepts for factorial and fractional factorial 

DOE’s and describe a DOE used to optimize the formulation of a 

biopharmaceutical product. 

Martin Kane, Associate Director Process Statistics, Department of 

Biostatistics, Human Genome Sciences, Inc. 

“This conference is invaluable for the quality of ideas 

exchanged by the participants.” 

– David Kolwyck, Technical Manager, SAFC, a division of Sigma Aldrich 

Sponsored by: 

8:00 am-12:00 pm 

We are pleased to bring you a half-day technology workshop featuring 

many of the world's leading authorities to discuss new advancements 

and applications in separation science using hydroxyapatite and related 

materials. In this session, we will discuss modern techniques for separation 

and analysis of immunoglobulins, enzymes, and related biomolecules from 

micropreparative to industrial scale. Speakers will present case studies 

and the latest developments using hydroxyapatite in the manufacturing of 

biopharmaceuticals. A roundtable discussion will conclude this workshop 

highlighting key biomanufacturing topics and challenges today. 

Topics & Presenters: 

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 

Methodology for Extension of Ceramic Hydroxyapatite 

Column Lifetime 

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 

Visit www.IBCLifeSciences.com/BPI 

for complete session details 


Tuesday, September 21, 2010 (continued) • Main Conference 



CASE STUDY The Dinosaurs Reborn: Retrofitting 

Existing Facilities to Speed Tech Transfer and Support 

the Platform Process 

We discuss the current bifurcation of biomanufacturing capacity into small 

volume manufacturing plants, (dominated by single use technologies) and 

large volume plants (that are still stainless steel). Such a bifurcation is likely 

to continue, with large facilities becoming increasingly important drivers of 

revenue - provided they can be transformed into more agile manufacturing 

plants. We suggest technologies that support this effort focusing around 

changeovers, tech transfer and platform process design. 

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 

Biogen Idec is continually investigating the impact of new technologies on 

their operations. This includes using process simulation to determine process 

fits of new products into existing facilities. Here we present several case studies 

including the impact of employing high titer processes. We investigate the 

potential bottlenecks, determine equipment changes/upgrades that are required, 

and the effect this has on the overall costs of goods, and required investment. 

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


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

Inherent in QbD 

The overarching initiative of the FDA remains the “Drug Product Quality.” 

It embraces many initiatives, one of which is Quality by Design (QbD). QbD 

is not a new concept. It has recently however, been formally introduced to 

our industry, in particular in terms of regulatory processes. Unless and until 

the regulatory, science, engineering and control issues are addressed then the 

desired regulatory flexibility will not be realized. This presentation will address 

possible means of gaining flexibility within the QbD framework. 


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: 


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. 

Strategy Discussion 

Forums 

10:15 Managing Partners and Contractors 

– Practical Solutions to the Issues that Arise 

As manufacturing partnerships and capacity “sharing” 

become more prevalent, companies are faced with the 

challenges and issues associated with managing these 

relationships. This session will present and discuss some 

of the pitfalls faced and will look at some of the solutions 

that have been tried (successful or otherwise). Topics such 

as intellectual property, timeline management and project 

scope creep will be discussed in addition to specific 

challenges raised from the panel or floor. If you are 

contracting or partnering to access or leverage capacity, 

this session will provide insight on specific challenges to 

expect and strategies for their management/resolution. 

Moderator: Susan Dexter, Senior Principal Consultant, 

BioPharm Services US 

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. 

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 

11:45 Concurrent Technology Workshops 

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 

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. 

Michael LaBreck, Sales Manager - Biopharma, Novasep, Inc. 

A Novel to 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 


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 

For a small, emerging biotechnology company, the timely delivery of preclinical 

and clinical material is extremely important to the early success of the company. 

The flexibility, cost, and ease of operation of a multiproduct facility based on 

disposable technology and delivered media and buffers provides an alternative 

to traditional stainless steel based designs or the use of contract manufacturing 

organizations. 

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 

pH gradient elutions on protein A enhanced the removal of process and product 

related impurities as compared to traditional step elution. The substantial purity 

improvement enables use of more streamlined membrane chromatography 

operations in place of downstream columns. Preparative and pilot-scale results 

for multiple mAbs suggest the technique is scalable and robust and may hold 

promise as a platform approach. 

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

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

Multi-Product Commercial Facility 

Starting up a flexible and disposable facility requires utilization of proven 

technologies while exploring and implementing novel applications. This 

presentation will review the complexities involved in BioMarin’s execution 

of commissioning and qualification of their newly expanded Commercial 

Operations facility located in Novato, California. 

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. 



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 

Genentech is piloting implementation of QbD with a monoclonal antibody that is 

in Phase III development. As part of that effort, Genentech was successful at getting 

the late stage product into the FDA QbD Pilot Program. This presentation will 

include an update on the strategy and approach being taken to implement QbD, and 

the lessons learned from the Pilot Program to date. 

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

2:30 Role of PAT in Operational Excellence 

Operational excellence involves continuously improving a business, i.e., 

process and performance, enhancing quality, and minimizing waste. 

Process Analytical Technologies (PAT) may create a synergistic effect in 

the operational excellence strategies employed in the bio/pharmaceutical 

companies. PAT’s role in the journey towards operational excellence in 

biopharma manufacturing environment will be discussed. 

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 

In this case study, a robust manufacturing process was transferred to a CMO. In 

order to meet aggressive development time lines, design of experiments and ultrascale 

down models were used to identify the design space for each unit operation. 

The presentation will also discuss some relationships of process parameters to 

identified critical product quality attributes. 

Thomas Linden, Ph.D., Associate Director, Bioprocess R&D, Merck & Co., Inc. 

Co-authors: M. van Maanen; J. Pollard; R. Chmielowski; T. Potgieter 


1:45 Manufacturing: What will Take us 

to the Next Level of Efficiency 

and Economics 

Sponsored by 


Forums 

Biomanufacturing has matured over the last ten 

years with the implementation of more industrial 

practices and new, more flexible and efficient 

processes and technologies. Nevertheless, with 

the pending reforms in healthcare and the advent 

of biosimilars, price pressures are likely to drive 

a new level of cost efficiency in manufacturing. 

This panel will look at some of the bottlenecks 

and possible solutions for getting this next level. 

Issues discussed will include new technologies, 

the potential use of old/low cost technologies, 

regulatory and analytic hurdles and the 

implementation of industrial practices. 


Peter Latham, President, BioPharm Services US 

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, 


4:00 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 


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

4:45 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. 

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


Wednesday, September 22, 2010 • Main Conference 


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

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 



Raw Materials/Supply Chain 

The Future of Manufacturing Networks 



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 

Antibody-drug conjugates (ADCs) are designed to deliver a cytotoxic 

drug through a targeting moieties (e.g., tumor cells) utilizing the 

specificity of a monoclonal antibody. Although such ADCs are simple in 

principle, significant chemistry, manufacturing, and control (CMC)- 

related challenges arise during development and regulatory review. 

CMC-related issues unique to this class of molecules will be discussed. 

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 

Based on a discussion of various elements of strategic uncertainty today, 

this talk will look at technology, financial, and strategic business aspects that 

in combination could form sources for success tomorrow. We will challenge 

the mainstream discussion of manufacturing issues and will provide a view 

on innovation that goes beyond what R&D alone can deliver. 

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

Relations, GE Healthcare Life Sciences, Sweden 


CASE STUDY Development and Implementation of 

a Next-Generation Manufacturing Process for a New 

rFVIII Product 

Building on the experience with Bayer’s recombinant Kogenate® 

product line, the strategy of the BAY 81-8973 CMC development team 

was to utilize targeted innovation to develop, scale-up and implement 

a new, simplified and more efficient upstream and downstream 

manufacturing process. The resulting new technologies now also form 

the manufacturing platform for other complex biologics. 

Dr. Jens H. Vogel, Global CMC Development Team Leader and Head, 

Isolation and Purification, Bayer Healthcare 

9:45 Networking Refreshment Break in Exhibit and Poster Hall 

Sponsored by 

10:30 Subcutaneous Protein Delivery: Challenges, 

Opportunities, and Key Lessons from a Drug 

Delivery Platform 

Biotech companies are often spending much effort concentrating 

mAbs to ≥ 100 mg/mL to accommodate subcutaneous dosing at 

high doses. Halozyme’s Enhanze Technology permits SC dosing 

of much greater than 1 mL/injection, which enables bypassing high 

concentration formulation challenges with the potential to allow rapid 

conversion of intravenous drugs to subcutaneous administration, 

which may benefit patients’ convenience and compliance. 

Michael J. LaBarre, Ph.D., Vice President, Product Development, 

Halozyme Therapeutics, Inc. 


CASE STUDY Biodefense: Human Genome Sciences’ 

Development and Manufacture of an Antibody for 

Treatment of Anthrax Delivered to the Strategic 

National Stockpile 

The anthrax attacks of 2001 reaped fear and panic in our nation. In 

response President Bush proclaimed "we will rally the great promise 

of American science and innovation to confront the greatest danger 

of our time." Eight years later Human Genome Sciences delivered 

the first doses of raxibacumab to the U.S. government. The antibody 

program and its unique twists and turns are chronicled. 

Craig Malzahn, Director, Supply Chain / Manufacturing Operations, 


11:30 Upgrading Current Facilities for Future High 

Titer Processes 

Success in biopharmaceutical manufacturing is increasingly 

challenged by new production requirements, aggressive timelines and 

economic drivers. New product platform strategies and technologies, 

as well as process simulation tools have been incorporated to meet 

future manufacturing demands. The new upgrades will develop facility 

flexibility by increasing asset utilization, assist in long term capital 

planning of projects and coordinate cross site facility consistency. 

Rich Meinel, Associate Director Global Process Engineering 

Technology, Biogen Idec 

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 

Over the life cycle of a mAb, drivers such as supply demands, 

increased process knowledge, new technologies, regulatory standards 

and additions to manufacturing network all contribute in the decision 

to make process changes. This case study follows the strategy and 

challenges of a currently approved mAb purification process as it 

evolves from its original to its current and potential future state. 

Debbie O’Connor, Scientist, Late Stage Purification, Process R&D, 



CASE STUDY Continued Understanding of 

Biopharmaceutical Production Processes Post-Validation 

Understanding of biopharmaceutical production process is a 

continuous task performed over the lifecycle of the product. Effective 

analysis of manufacturing data allows identification of trends 

and their potential root cause, as well as potential improvement 

opportunities within the design space. Procedures and case studies for 

effective process monitoring and identification and implementation of 

process and technology improvements will be presented. 

Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical 

Development, Human Genome Sciences Inc. 

9:15 Humira Downstream Process: Challenges in 

Continuous Improvement and Technical Transfer 

Humira (adalimumab) was successfully launched in 2002. Currently, it is 

manufactured at 6,000-L to 12,000-L scales in different facilities. In the past 

years, continuous efforts have been made to enhance process robustness, 

to ensure the consistency of product quality and process performance 

at different facilities, as well as to satisfy and harmonize divergent global 

regulatory demands. QbD approaches have been applied to the process 

optimization with implementing better process control strategies. 

Helen Yang, Technical Operations, Abbott Bioresearch Center 


Sponsored by 


CASE STUDY Utilization of QbD Principles for the 

Management of Post-Approval Changes 

Management of post-approval process changes for biotechnology 

products is well suited to the application of QbD principles and 

risk-based approaches. Here the application of QbD principles for 

the management of post-approval changes is applied to support drug 

substance changes intended to improve process efficiency, reduce raw 

material risks and support scale-up and process transfer. 

Marc Better, Ph.D., Executive Director, Process Development, Amgen Inc. 


CASE STUDY Advanced Process Control and Real- 

Time Chromatography Monitoring 

Liquid chromatography plays an important role in the purification 

of pharmaceutical products derived from biotechnology processes. 

Process-scale separations often involve multiple column operations, 

each consisting of multiple phases so column packing, qualification and 

process monitoring are important areas of concern. This presentation 

discusses Biogen Idec’s strategy for chromatography analysis and 

monitoring. This approach leverages the power of multivariate analysis, 

advanced analytical algorithms, and process knowledge to achieve the 

enhance process understanding and improved process performance. 

Robert Genduso, Scientist II, Biogen Idec 


Design of a Contamination Barrier for Serum- 

Containing Cell Culture Media of a Licensed Product 

Despite their infrequency, microbial, viral and mycoplasma 

contaminations of biomanufacturing facilities have had significant 

financial, production and regulatory impacts to companies. 

Robustness of the contamination barrier depends on the degree 

of inactivation/clearance conferred by treatment technologies and 

the risk of raw materials. HTST, UVC, viral filtration and gamma 

irradiation, as well as raw material decomposition strategies, were 

evaluated to overcome impact to process/product. 

R. Michael Boychyn, Ph.D., Principal Engineer, Amgen Colorado 

Process Development, Amgen Inc. 



Integrating Raw Materials and Suppliers 

into a Pharmaceutical Quality System 

8:00 Co-Chairpersons’ Remarks: 



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

Biogen Idec 

8:05 Risk Assessment and Management for Raw Materials 

A holistic risk assessment approach is described, including 

supplier capabilities, quality systems, and material safety data. 

In addition, an assessment of material properties on the process, 

which links parameters to critical quality attributes, is required. The 

information required is significant but the outputs can result in a 

clearer prioritization of the data required, more rational setting of 

specifications, avoidance of redundant testing and a better foundation 

for continuous improvement. 



8:30 Supply Chain Risk Management Methodologies 

Using case studies, this talk will demonstrate the usefulness of 

applying an analytical driven sourcing methodology to mitigate risks 

within a company's supply chain. In addition, this talk will address 

Biogen Idec's approach to ensure objectives of assurance of product 

supply, product quality and financial compliance within the supply 

chain through a instituting a decentralized GMP sourcing model. 

Issues like organizational approaches, governance structures, sourcing 

tools and risk management techniques will be discussed. 

Joydeep Ganguly, Associate Director, Manufacturing Sciences, Biogen Idec 

8:55 Global Adventitious Agent Regulations of Raw 

Materials Used in Biopharmaceutical Manufacturing 

Abstract unavailable at press date. Please visit 


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 

The pharmaceutical market is requiring greater characterization and 

transparency of the supply chain for critical raw materials used in 

manufacturing due to the continuing need to minimize variability 

and increased regulatory oversight. This presentation will focus 

on techniques for characterization and a case study on how these 

techniques improved our understanding of the solubility of these 

components to enhance the consistency of the manufacturing process. 

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 

• What do you do after you assess the risks 

• What can you use to compensate for identified risks-- short term 

and long term 

• Tactics for small firms 

• Leveraging information 

Paula Shadle, Ph.D., Principal Consultant, Shadle Consulting Services 

10:55 New Applications of Analytical Methodologies for 

Raw Material Characterization 

Abstract not available at press date. Please visit 


Maureen Lanan, Ph.D., Principal Scientist, Analytical Development, 

Biogen Idec 

11:20 Audience Interactive Panel Discussion with 

All Session Presenters 

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 

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

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. 

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 

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

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

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 



Wednesday, September 22, 2010 • Main Conference 


Rapid Vaccine Development and Production 


Forums 


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 

Raman spectroscopy is one of the powerful quantitative techniques that is amenable 

to analysis of biological process solutions. It is capable of providing accurate 

quantitation of multiple components in a solution with minimal sample preparation, 

and often able to be used as an in-line or at-line monitoring tool. Evaluation of this 

technique for preparation and release of buffers, control of excipient levels during 

formulation and other downstream operations will be presented. 

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 

Large scale chromatography is a widely used unit operation in peptide and protein 

manufacturing. Variability in the elution of these process columns makes it difficult to know 

precisely where to start and stop collecting the product pool. On-line HPLC based analyzers 

are a PAT that provides product purity information enabling automated control of product 

pool collection with increased yield, decreased product variability, and decreased cycle time. 

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 

Multivariate Biopharmaceutical Batch Process Modeling and Monitoring is evolving 

as a key Process Analytical Technology (PAT) to enable real-time design space 

monitoring to support Quality-by-Design paradigm. The use of this technology 

for bioprocess supervision, troubleshooting, process understanding, and control at 

commercial-scale manufacturing will be summarized. Incorporating this technology 

with the use of soft-sensors will also be discussed, with industrial examples. 

Thomas Mistretta, M.S., Senior Engineer, Process Development, Amgen Inc. 


Sponsored by 


Chairperson: Susan Casnocha, Ph.D., Research Fellow, Bioprocess R&D, 

Culture Process Development, BioTherapeutics Pharmaceutical Sciences, Pfizer 

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 

Mammalian cell culture based bioprocesses require considerable labor-intensive 

operator support, including maintenance and monitoring of culture conditions as 

well as data compilation. This work demonstrates the integration of a multi-functional 

analyzer and online sampler into existing commercial control and in-house data 

management system for fully automated bioreactor control, monitoring, feeding, and 

standardized data management in a bioprocess development environment. 

Gayle Derfus, Engineer II, Oceanside Pharma Technical Development, Genentech, Inc. 

11:00 Achieving Process Robustness through Process Analytical 

Technology (PAT) Implementation 

Examples of PAT applications in Biologics Manufacturing at Abbott Bioresearch 

Center (ABC) will be presented. Evaluation of various biosensors in cell culture 

process demonstrates applications in monitoring cell growth and cell metabolism. 

Biosensor was successfully implemented in Production Reactors at ABC and shown 

to be more consistent compared to offline measurements. In addition, on-line sensor 

enables tighter process control and reduces variability, achieving process robustness. 

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 

Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI 

for program updates. 

Stefan Steigmiller, Ph.D., Senior Project Manager, PAT, Bayer Technology 

Services GmbH, Germany 



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 

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 lowvolume 

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 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 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, 



Sponsored by 


Ulrich Valley, Head, Technology Development, 

Novartis Vaccines & Diagnostics, Inc., Germany 


8:30 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. 

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 

Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for updates. 

Ulrich Valley, Head, Technology Development, Novartis Vaccines & Diagnostics, Inc., 

Germany 


Sponsored by 

Process Development for Novel Vaccines 

and Immunotherapeutics 

10:30 CASE STUDY Process Development and Clinical Manufacturing 

for Autologous Dendritic Cell Immunotherapies 

One of the challenges to developing robust autologous RNA and dendritic cell processing 

methods is the variability in the biological starting materials. Despite this variability, 

Argos Therapeutics has been able to develop robust processes for manufacturing 

autologous dendritic cell immunotherapies for both oncology and infectious diseases. 

These processing methods have been successfully employed for Phase 2 clinical trials in 

renal cell carcinoma and human immunodeficiency virus indications. 

Tamara Monesmith, Director of Manufacturing and Process Development, 

Argos Therapeutics 

11:00 CASE STUDY Rapid Production of a Novel VLP Vaccine 

The Vaccine Research Center (VRC) develops vaccines against a wide range of viral diseases. 

Chikungunya is a mosquito-borne viral disease that is growing in severity due to a recent 

expansion in its host species. Rapid development of a Phase I clinical process for a VLPbased 

vaccine has been initiated at the VRC. Optimization of an early phase manufacturing 

process based on transient transfection along with purification strategies will be presented. 

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 

Responding to the genetic drift in seasonal and pandemic influenza viruses requires 

process modifications by vaccine manufactures to produce an efficacious vaccine. The 

changes that are made to analytical techniques and process steps must occur within a 

short timeline (as little as 8 weeks) and satisfy the regulatory requirements of a licensed 

vaccine. This presentation will provide an outline to how these requirements have evolved 

for recombinant hemagglutinin-based vaccine candidates (FluBlok® and PanBlok®). 

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 

Recent legislation has brought the prospect of biosimilars much closer to reality. 

One of the keys to forestalling "generic" competition for biologics lays in the ability 

to develop a comprehensive IP portfolio that targets not only the biologic and its 

administration but its method of manufacture as well. We will walk through a 

hypothetical and examine the issues involved in putting together such an IP strategy 

and give examples of some useful techniques in light of recent case developments. 

George A. Xixis, Partner, Nutter McClennen & Fish LLP 



Process Development and Analytical 

Characterization for Vaccine Production 


Rasappa Arumugham, Ph.D., Senior Director, BioTherapeutics Pharmaceutical 

Sciences, Pfizer Inc. 

2:15 CASE STUDY Analytical Characterization for Conjugate and 

Protein Vaccines 

Rasappa Arumugham, Ph.D., Senior Director, BioTherapeutics Pharmaceutical 

Sciences, Pfizer Inc. 

2:45 CASE STUDY Particle and Endotoxin Control in Form/Fill 

Tubing Manifolds for Vaccines 

Single-use tubing manifolds used in sterile formulation and filling of vaccines 

may be a potential source of particles and endotoxins. A method was qualified for 

determining particulate matter and endotoxin content in radiation-sterilized singleuse 

tubing manifold systems, to set appropriate limits and monitor levels over multiple 

manufacturing lots, and to establish a master surrogate system enabling representative 

product auditing. Test method development and qualification is described, along with 

data collected over time from multiple system designs and lots. 

Michael Moussourakis, Technical Manager, Pall Life Sciences 

3:15 CASE STUDY Scale-up of an Intensified Process for rAd35 

Adenovirus Production using the PER.C6® Cell Substrate 

Given the uncertainties attendant to the CAPEX commitment required to develop a 

facility for a 10,000-liter bioreactor process and the unprecedented need to develop 

a viral vaccine manufacturing process at 10,000L scale under BSL 2 conditions, our 

approach is to focus on intensification of the rAd35 manufacturing process. This 

presentation will highlight our progress in upstream development. We will show a 

10-fold intensification at bench scale and in 50L single-use bioreactors. 

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

Crucell, The Netherlands 


Sponsored by 

Sponsored by 

10:30 Continuous Disposable 

Multi-Column Chromatography: 

Emerging Technology 

Tto Enable More Efficient 


BioSMB is an emerging technology 

that refines traditional multicolumn 

chromatography techniques 

via disposable components into a 

viable option for biopharmaceutical 

purification. Continuous processes 

are shown to reduce chromatographic 

media, reduce buffer and WFI 

consumption while increasing flexibility 

and manufacturing efficiencies. 

Advance registration is required 

for this special roundtable. Please 

indicate when you register that you 

wish to attend this session. 

This interactive session will be divided 

into four round table sessions focused 

on educating attendees on topics 

relating to BioSMB: 

Station 1: 

Economic Modeling of Multi- 

Column Chromatography 

Applications 

Facilitator: Peter Latham, President, 

BioPharm Services US 

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: TBD 

“BPI offers a 

highly effective 

forum to share 

and showcase 

cutting-edge 

advances in process 

development and 

manufacturing.” 

– Ciaran Brady, Ph.D., 

Associate Director, 

Biopharmaceutical Development, 


“A must attend 

conference 

every year!” 

– Rochelle Shapland, Process 

Development Associate, 

Alexion Pharmaceuticals Inc. 


Wednesday, September 22, 2010 (continued) • Main Conference 


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

4:00 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, 


4:45 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 

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

Rapid Vaccine Development and Production 

4:30 CASE STUDY Production and Downstream Processing of Norovirus Virus-Like Particles 

Norovirus infection is the most common cause of acute gastroenteritis in the U.S., estimated to afflict 23 million 

people per year. To generate a bivalent vaccine that confers broad protection against this disease state, the 

baculovirus expression system has been used for production of two distinct norovirus virus-like particles (VLPs). 

Downstream processing using orthogonal chromatography methods results in highly purified norovirus VLPs. 

cGMP manufacturing to support Phase I clinical trials has recently been completed. 

Ross Taylor, Ph.D., Director, Process Development, LigoCyte Pharmaceuticals, Inc. 

5:00 From Bench to Bag: Deployment and Implementation of Novel Solutions for 

Vaccine Production 

Classical purification processes for Ad5 adenoviral viral vectors, such as density gradient centrifugation, 

are laborious, time consuming and scale limiting. A recent upsurge in interest in rapid, flexible and scalable 

vaccine production has demanded a radical rethink. From small-scale process development through to cGMP 

manufacture using disposable and novel technologies for both the production and purification; this presentation 

is a case study in the development and implementation of a manufacturing process provides specific solutions to 

the manufacture of adenoviral vectors and offers a general approach for other vaccine platforms. 

Andrew Clutterbuck, Purification Development Team Leader, Eden Biodesign Ltd., United Kingdom 

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


Thursday, September 23, 2010 • Main Conference 

7:00 Coffee 


Processing 

Plenary Session – Integration of Upstream and Downstream Processing 

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 

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 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 Linking Upstream and Downstream 


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



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 

Single Pass Tangential Flow Filtration (SPTFF) is a novel 

technology that can significantly improve downstream 

processing capacity and yields. In this presentation, we will 

compare SPTFF with conventional TFF and show proofof-concept 

data on reducing pool volumes with multiple 

monoclonal antibody molecules. An implementation 

strategy to debottleneck downstream capability in 

commercial manufacturing will also be discussed. 

Jemelle Dizon-Maspat, Senior Research Associate, 


11:00 Downstream Breakthroughs in 

Downstream Processing of High Titer and 

Cell Density Harvests 

Use of the PER.C6® cell line resulted in 27 g/L of 

antibody in XD®, and 10 g/L in Fed-Batch. These high 

titers and accompanying high cell densities create 

challenges for downstream processing. Here we present 

high capacity and single use technologies developed 

to answer some of these challenges. These techniques 

enable speed, flexibility, and smaller facilities. The final 

product quality is equal or better to traditional processes. 

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 

Genentech has developed two generations of facility fit 

models covering a commercial manufacturing network 

with 6 production sites. We present an overview of the 

models which, based on equipment and operational 

constraints, identify site-specific bottlenecks, recoverable 

titer ranges and optimal processing parameters. We 

further show how their use has enabled the design of a 

very high productivity (Kg/batch) process concept. 

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


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

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 


Processing 

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 

Timelines, throughput and quality are of the utmost 

importance in generating monoclonal antibody 

producing CHO cell lines. We improved both factors 

by implementing the ClonePixFL for clonal picking 

and the 24 µm reactor system to mimic the conditions 

in a bioreactor. Optimal use of these systems led to 

increased quality and throughput and decreased 

timelines within our cell line development process. 

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 

With increasingly diverse portfolios of biotherapeutics, 

more efficient methods for creating and screening high 

expressing stable cell clones are starting to be used. The 

ability to screen multiple clones expressing multiple 

recombinant protein and mAb candidates for each 

therapeutic project is becoming a requirement in order 

to identify the appropriate clone / mAb combination for 

effective drug development. Increasingly, shaking microwell 

and microbioreactor scale down models are being used 

to facilitate such clone selections leading to increased 

predictability of Bioprocessing. Strategies, Issues and case 

studies will be described to illustrate this approach. 

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 

The challenges for protein manufacturing are time to 

market, cost of goods, and reduction of the financial 

risks. Process intensification can achieve these goals. 

Using DSM Biologics XD® process culture strategy 

viable cell densities over 150 million cells/mL, ten-fold 

to fed-batch, are achieved with CHO and other cell 

lines, yielding up to 27 g/L of product with right quality. 

Gerben Zijlstra, Ph.D., Senior Scientist, R&D, 

DSM Biologics, The Netherlands 

Emerging Analytical 

Requirements 

Emerging Analytical Requirements 

and their Impact on Process 

Development and Manufacturing 


Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical 

Development, Human Genome Sciences Inc. 

8:15 FDA Expectations Regarding Bioburden 

Control in Biotech Processes 

Microorganisms can affect product quality attributes and 

lead to process and product failures. A well designed process 

can be derived from the systematic use of scientific and riskbased 

approaches, prior knowledge and the implementation 

of a pharmaceutical quality system. Elements of a well 

designed biotech process and appropriate control strategies 

for microbial control will be discussed. 

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 

Monitoring of residual impurities encountered in 

bioprocessing can be quite challenging. Due to the range 

of potential impurities (antibiotics, surfactants/antifoams, 

etc.), many different analytical approaches may need to 

be employed. This presentation will explore some of the 

approaches taken to monitor low level impurities. 

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 

The potency assay is the one product release/stability test 

that assesses the “bioactivity” of a specific lot at a specific 

time for biological/biotech therapeutics and therefore is 

required for these products. This talk will discuss how 

the role of potency assays has changed over time. It will 

also focus on common issues and timing (1) for choosing 

a potency assay from several candidate bioassays, (2) 

for developing, validating and maintaining this assay 

and (3) for trying to use this assay to assess neutralizing 

antibodies in patients or animals. 

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


with All Session Presenters 

Site Tour to Amgen’s BioNext Facility 

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

Space is limited to first 50 conference registrants 

Amgen’s manufacturing plant in West Greenwich, RI, is a fourstory, 

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. 

Space is limited and available to the first 50 conference registrants on 

a first come first served basis. A wait list will be creted after it has been 

sold out. Pre-registration is required. Please be sure to indicate when 

you regisater that you wish to attend. Flat, Closed-toed shoes must 

be worn; no high heels are allowed. 

9 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com 


Forums 

Sponsored by 

10:30 Smart Flexibility: 

What Creates the Right 

Degree of Flexibility and Cost 

Reduction in Different Phases 

of Manufacturing 

What could be done technically may 

not make sense for the business while 

what the business may desire may 

not be technically feasible. Between 

manufacturing for early clinical trials 

and regular manufacturing post approval 

there are 2 or 3 distinctly different 

scenarios that each have their own needs 

and preferred setups. Dependent on 

whether a facility already exists or not, 

whether it is time or costs that drive 

selection of the most suitable path to 

production, and whether or not capital 

is a scarce resource, the priorities will 

differ significantly, and the best solutions 

for flexibility and cost optimization will 

be widely divergent. The discussion 

group will collect experiences and 

insights from panelists and the audience 

to provide the various facets of "truth" 

on this topic. 


Günter Jagschies, Ph.D., Senior 

Director, Strategic Customer Relations, 

GE Healthcare Life Sciences, Sweden 

Panelists: 

Rick Johnston, Co-Director, Center 

for Biopharmaceutical Operations, 

University of California, Berkeley 

Carol D. Basey, Senior Manufacturing 

Technical Specialist, Genentech, Inc. 

Duncan Low, Ph.D., Scientific 

Executive Director, Process 


Robert J. Steininger II, Senior 

Vice President, Manufacturing, 

Acceleron Pharma 

Chris M. Brodeur, Senior Manager, 

Operations, Commercial Expansion 

Head, BioMarin Pharmaceutical Inc.

Thursday, September 23, 2010 • Main Conference 


Hybrid Purification – The Next Generation of Cell Clarification 

Cell clarification in the biopharmaceutical industry has long been dominated by adsorptive 

depth filtration. Traditional cellulose-based depth filters feature natural materials that 

are prone to variation in performance and extractable profile. This workshop will present 

an overview of a fully synthetic “hybrid purifier” that is being designed to increase flexibility in cell clarification, 

minimize performance variation and improve overall process efficiency both upstream and downstream. 

Thomas P. O’Brien, Ph.D., Senior Applications Specialist, 3M Purification Inc 

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 

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 

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 



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 

Cell culture harvest often involves centrifugation and filtration operations. The 

requirements for the filters depend on the size and amount of particles which remain 

suspended in the broth after centrifugation. Particle-size analysis of benchtop 

centrifuge clarification runs gives information which can be used for specification of 

the filters and for optimization without needing to gather data at the production scale. 

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


2:30 Enabling Precipitation as an Operation to Manage Critical 

Contaminants in Bioprocessing 

Precipitation is a versatile technique for contaminant removal and product capture 

but not commonly used in the production of biologics. Reasons cited for this 

surround difficulty in finding the desired yield and purity. This dogma is removed 

if we adopt techniques to accelerate this search process, enabling evaluation of the 

large design spaces that result from combinations of precipitation agents. 

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 

A New Protein A based expanded bed adsorption chromatography media 

was examined as a method of capture for monoclonal antibodies from CHO 

cell cultures. Purification performance of this resin was examined relative to 

conventional protein A chromatography. Capacity, cleaning alternatives, and 

stability of the resin in cleaning and storage solutions are examined. 

Richard S. Wright, Principal Research Scientist, Pfizer Biotherapeutics 


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 

This study illustrates concentration limitations for a mono PEGylated protein. The 

desired PEGylated protein concentration was 60mg/ml but only 24 mg/ml was achieved 

by UF/DF. We demonstrated that the protein could be concentrated to >60mg/ml while 

linear PEG could be concentrated to 25 or 35 mg/ml in formulation buffer or WPU, 

respectively, demonstrating that PEG was the limiting concentration factor. 

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


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

Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI 

for updates. 

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

5:00 Applications for Biopharmaceuticals in Regenerative Medicine 

Many biopharmaceuticals and biological products are designed to block disease 

pathways or replace missing factors but there is a growing interest in their 

application to regenerative medicine wherein biological systems are restored to 

their healthy state. This presentation will discuss some of the manufacturing and 

analytical challenges that are specific to products for 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 

Cytos Biotechnology is developing a new class of vaccines (Immunodrugs TM ) 

targeting several indications including major chronic diseases. By highly repetitive 

presentation of disease-related proteins on the surface of virus like particles (VLPs), 

Immunodrugs TM elicit a potent immune response against said disease-related 

proteins with the potential to offer therapeutic benefits. The concept, production 

and application of Immunodrugs TM will be presented. 

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

Cytos Biotechnology, Switzerland 

6:00 Close of Day 

Interested in sending a team 

Take advantage of discounted group rates for 3 or more. 

For more information, contact 646-895-7445 



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 

An early determination of the manufacturability of biological molecules is crucial 

for the successful development of biotherapeutics. This assessment begins with an 

evaluation of the drug-like properties of candidate molecules and continues with 

the development of cell line and downstream processing. This presentation will 

explore analytical approaches for the selection of the most suitable immunoglobulin 

molecules for development as biotherapeutics. 

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 

We used microRNA array and quantitative RT-PCR to profile highly conserved 

microRNA expression in CHO cells. miR-221, miR-222, miR-125b, miR-19a and let- 

7b were differentially expressed in IgG producing lines. We also investigated miR-24 

expression in CHO cell lines with different DHFR genotypes. The results represent 

initial effort towards understanding miRNA expression in CHO cells and towards 

using miRNAs in cell engineering. 

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

3:00 Use of RNAi to Transform Biotherapeutics 

RNAi technology can be utilized in bioprocessing to reduce levels of proteins 

in cellular pathways that impact biotherapeutic quality, activity, and specific 

productivity. 1 nM siRNA added directly to 40L of CHO cells reduced levels of a 

selected protein >80%. This approach is amenable to existing cell lines, and the 

expression of multiple proteins can be reduced simultaneously. 

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


Implementation of Novel Media Development 

and Feed Strategies 

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

Defined Media Formulations for CHO Platform Processes 

Chemically-defined media without hydrolysates were developed and compared for 

a platform fed-batch process and enhanced fed-batch processes. The development 

and implementation approach will be described. Key features will be presented 

including media component effects on performance and product quality. In addition, 

manufacturability aspects on implementing the platform process media will be described. 

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

4:30 How Media Optimization Impacts Quality 

Maintaining quality comparability while maximizing productivity creates constant 

challenges for bioprocess development. The effect of culture media on cell 

performance and product quality was investigated for antibodies with established 

quality profiles. Media composition impacted cell growth, productivity and posttranslational 

modifications. The results provide guidance for further correlation 

between media and product 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 

Supplementation of cell culture media with hydrolysates has replaced serum to 

increase cell viability and productivity of recombinant bio-therapeutics. Although 

hydrolysates are a better option than animal-derived serum, they are still a 

biologically-based raw material with potential to add variability and risk to an 

already complex bioprocess. Deconstruction of hydrolysates using chromatography, 

peptide sequencing, and other biochemical techniques has allowed our team to utilize 

high resolution analysis techniques, such as LC-MS and GC-MS to identify unique 

components. DoE of these identified molecules has resulted in the formulation of 

a chemically-defined animal-free component supplement that provides the cell 

productivity properties of a hydrolysate in mammalian cell culture. 

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 

We have developed a protein-free chemically-defined fed-batch process which could 

support cell growth at high cell density across several Abbott cell lines. The antibody 

titer produced from this CD process is comparable to the existing hydrolysate-based cell 

culture platform. To further optimize the process, we have applied genetic and metabolic 

analyses to identify key nutrients and possible limitations on cell growth and productivity. 

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


6:00 Close of Day 


Forums 

1:45 Development and 

Manufacturing Strategies 

for Biosimilars Products 

Topics for discussion: 

• Status of US regulatory framework 

• Role of contract manufacturing 

organizations in biosimilars 

• Lessons learned from Europe 

• Managing regulatory and market 

uncertainties in the Biosimilars sector 


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. 

Stanley S. S. Hong, Ph.D., Senior 

Vice President, Head of Research & 

Development, Celltrion, Inc., Korea 

Friedrich Nachtmann, Ph.D., 

Head, Biotech Cooperations, 

Sandoz Biopharmaceuticals, Austria 

Curran Simpson, Senior 

Vice President, Operations, 


Play an active role in 

this conference by 

showcasing your results 

in a poster display. 

Did you know that 85% of our 

conference attendees stated that 

reviewing posters is one of the most 

important features of our events Get 

your research in front of your peers and 

make your mark in this industry – gain 

the visibility you need to find exciting 

new opportunities in your company or 

your career. 

Justify Your Trip – presenting a poster 

at a scientific conference helps justify 

the time and cost for you to attend 

the conference. Not only are you 

attending the conference to learn new 

techniques and strategies, but you 

are also gaining for yourself and your 

company well-deserved recognition for 

innovative research findings, successful 

business models, unique service 

propositions, or creative business 

strategies. 

Share – this is your opportunity to 

offer your experience, expertise and 

insights to fellow colleagues and 

potential partners. 

Gain Recognition – all posters will be 

displayed for attendees, exhibitors, and 

presenters to see during exhibit hall 

hours and networking functions. 

The deadline to submit an abstract 

for inclusion in the BioProcess 

International Magazine September 

Issue Pre-Show Event Guide Insert is 

August 4th, 2010. (Abstract and full 

payment of conference and poster fees 

must be received by this date.) The size 

of the poster board is 4'x8'. Please note: 

Poster presentations may not be used 

as exhibit displays or for marketing 

purposes. All posters are subject to 

approval by conference organizers. 

The deadline to submit an abstract 

for inclusion in the conference 

documentation is August 20, 

2010 (Abstract and full payment of 

conference and poster fees must 

be received by this date.) After that 

date posters are on a space available 

basis. To submit your poster and for 

additional details on the poster sizes 

and regulations, please visit 

www.IBCLifeSciences.com/BPI 


Friday, September 24, 2010 • Main Conference 

7:30 Coffee 




Pete Gagnon, MS., Chief Scientific Officer, Validated Biosystems 

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 Evaluation and Implementation of New Alternatives to Standard Anion 

Exchange Resins and Membranes 

Standard industry monoclonal antibody purification processes generally include an anion exchange unit 

operation. Historically this has utilized a chromatography resin, but new flavors of antibody molecules 

in conjunction with the drive towards lower cost-of-goods and streamlined processes have led to 

development of alternative media forms such as membranes in flat sheet or hollow fiber configurations. 

This presentation will focus on evaluation of new anion exchange technologies that could improve 

robustness and flexibility of purification processes, presenting a comparison in terms of yield and 

specificity as well as robustness in a platform process. 

Judy Glynn, M.S., Senior Principal Scientist, BioTherapeutics R&D, Pfizer Inc 

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

Bacterial cells were engineered to cost-effectively produce polyester beads displaying the IgG binding ZZ 

domain of protein A at high density. The ZZ domain is part of a fusion protein which remains naturally 

cross-linked to the polyester core of the beads. The performance of these beads in antibody purification 

and their proposed use as disposable purification media will be discussed. 

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 

An accelerated stability study of protein solutions subjected to small-scale viral filtration found 

that viral filtered samples exhibited a higher rate of methionine oxidation compared with unfiltered 

controls. A series of troubleshooting studies were performed to determine if the source of the 

accelerant of methionine oxidation is the small-scale viral filter or the bench-scale viral filtration 

pressure apparatus. 

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 

Glycosylation represents one of the most common yet complex post-translational modifications for 

protein biopharmaceuticals. Here we describe a case study on downstream process characterization for a 

highly glycosylated Fc-fusion protein. Results of this study were employed to establish a hydrophobicity 

specification for the HIC resin, harvest criterion for the production bioreactor and CPP acceptance 

criteria for the downstream chromatography steps. 

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 

As more products utilize high concentration formulations, the development of UFDF processes become more 

complicated and challenging. Process complexities combined with meeting product quality requirements, 

maintaining project timelines, and tailoring the process to fit into multiple manufacturing facilities create 

additional hurdles. This talk will discuss process development strategies used to develop, characterize, and 

scale up a high concentration UFDF process to full scale production. In addition, this presentation will include 

some of processing data collected at small, pilot, and manufacturing scale along with how they compared. 

Kelby Lau, Engineer II, Process Development – Late Stage Purification, Genentech, Inc. 


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 

Current strategies for bioprocess development rely on monitoring a limited set of process variables as 

proxies for cell physiology. Quite often, this information is insufficient and there remains a significant 

disconnect between these parameters and process outcomes. This presentation will provide a perspective 

on the use of ‘omics’ tools to query intracellular mRNA, protein and metabolite concentrations which 

are more likely reflective of the cell’s physiology. These tools can potentially be applied to define the 

molecular signature of a ‘good’ cell culture process. 

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 

The ubiquitous Platform for early-stage protein production has proven itself over the years to be very 

effective. However, the "one size fits all" nature lacks flexibility, and therefore is not always the right tool 

for the job. We have developed methods for making small to moderate amounts of protein; a scale more 

suited to supporting a variety of research needs, but with a flexibility, speed, and throughput that far 

exceeds our current platform, but remains compatible with it. 

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


Featured Presentation 

10:15 An Industrial View of Biopharmaceutical Comparability 

and Characterization 

Process and product changes (including manufacturing site, container-closure, 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 

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 

An effective strategy was developed to support a mAb production in CHO cells. We observed a significant 

polymer increase with an IgG4 expressed from a CHO cell line by comparing to its NS0 counterpart. 

Evidence suggested that the aggregation is originated from cell culture oxidation. A new cell culture 

process was developed from a DOE study as well as antioxidant study. The oxidation and polymer growth 

were reduced significantly. The concept of QbD was also introduced to in the study. 

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 

Maintaining product quality and optimization of monoclonal antibody production through all phases of clinical 

development creates many challenges. A case study will be presented on the efforts to maintain product quality 

and optimization of the cell culture process from early to late stage development. The effects of cell culture 

process conditions and media composition on protein production and product quality will be presented. 

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 

This case study presents a Quality by Design (QbD) approach used to characterize a Genentech CHO 

mammalian cell culture unit operation. The final outcomes of the QbD approach are both univariate and 

multivariate acceptable ranges for each parameter tested and a design space which ensures acceptable 

process performance and product quality. 

Szu-Han Wang, Engineer I, Late Stage Cell Culture, Pharma Technical Development, Genentech, Inc. 

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. 

Sally Grosvenor, Ph.D., Senior Scientist and Scientifict 

Communications Manager, Applied R&D, 

Novozymes Biopharma 

Founding Publication 

12:15 Technology Workshops 

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 

12:45 Lunch on Your Own 

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 

Featured Web Partner 

BioProcess International provides the biotechnology industry with monthly, 

peer-reviewed information necessary to successfully drive products through 

the biopharmaceutical, biovaccine and biodiagnostic development and 

manufacture process. BPI’s circulation consists of 30,017 mid-to-upper 

managers working in all phases of the biotherapeutic development and 

manufacturing process in the United States, Europe and Canada. 

Media Partners 

Association Sponsor 

For more information please visit www.bioprocessintl.com 


Friday, September 24, 2010 (continued) • Main Conference 




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

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 

We present an automated control strategy for continuous chromatography that permits monitoring of 

system performance by continuously comparing signals measured throughout the system. This strategy 

enables the automation of column switching and was tested using both high and low titer harvests. The 

system has proven to be quite robust and has provided yields and quality that are comparable with batch 

mode chromatography. 

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

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

Purification 

Straight Through Processing (STP) in downstream purification (DSP) is an evolutionary platform to 

enable on-demand supply of process buffer prepared in-line, and to automate three purification steps, a 

DSP1 Chromatography step, a DSP2 Chromatography step, and a Virus Removal Filtration (VF) step into 

a continuous streamlined single unit of operation. This would shorten the overall operation time, improve 

facility utilization and throughput, and eliminate certain intermediate hold and in-processing testing 

requirements for monoclonal antibody manufacturing. 

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 

We have developed purification methods using a 96-well filter plate format to achieve similar yield and 

product quality to purification using preparative columns. Two chromatography modes were evaluated: 

protein A affinity and ion exchange chromatography. The development of these robotic methods & their 

comparison to preparative scale chromatography will be discussed along with the potential applications 

of these robotic tools. 

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

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

Since the development of combinatorial chemistry and ligand libraries significant efforts have been spent 

screening for affinity mimetics, targeting commercially interesting biomolecules - with limited success. 

Using HTPD technologies and DoE we have studied ligand density effects on capacity, yield, and removal 

of critical contaminants. Two different multi-modal ligands, N-benzyl-N-methyl ethanolamine and N- 

benzoyl-homocysteine, has shown promising results. 

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 

Multimodal chromatography media have attracted great deal of attention due to their unique selectivity 

for monoclonal antibody (mAb) purification. The performances of these resins are highly dependent 

upon processing conditions when used in polishing step. In this work, we applied a high-throughput 

screening (HTS) approach to quickly evaluate multiple mixed-mode resins in a wide range of operating 

conditions for flow-through polishing of a mAb molecule. A central composite DOE was run in 96-well 

plate for these resins, and the key performance parameters were measured and compared with column 

run data. The best mixed mode resin was selected and further used to develop a two-column purification 

process, which gives comparable product yield and quality as a standard three-column process. 

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

5:00 Close of BioProcess International TM Conference 2010 


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 

The use of perfusion in cell culture processes continues to increase throughout the industry. As the 

benefits and complexities of continuous processing are clear, this presentation aims to discuss the current 

state and advancements of upstream perfusion technologies and processes as well as considerations 

necessary to achieve robust manufacturing. Examples will be given where warranted. 

Timothy Johnson, Senior Manager, Process Development, BioEngineering, Genzyme Corp. 

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

Perfusion Processes 

The different approaches for rapid development and evaluation of fed-batch and perfusion processes 

are discussed. Fed-batch variables were evaluated in multiple iterative sets of bench-scale bioreactors. In 

parallel with the exact same cell line, sequential steady states in a limited series of perfusion bioreactors 

were used to evaluate perfusion specific variables. Crosstalk between the two approaches gives further 

opportunity for improved productivity and product quality. The differences in development approach 

and the advantages / disadvantages of the process development approach for each mode of operation are 

discussed. 

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 

Perfusion cultures have the advantage of reaching very high cell densities in short time. Inoculum train 

culture operated in perfusion mode provides the option of inoculating batch and fed-batch production 

cultures at higher seeding densities which, in turn, have the potential to achieve increased titer in same 

time or the same titer in shorter run duration or a combination of both. 

Robel Tezare, Senior Research Associate, Pharma Technical Development, Genentech, Inc. 


Overcoming Challenges of Producing Specific Proteins 

3:30 CASE STUDY Protein Engineering of an Alternative Scaffold for Improved 

Development & Production 

Alternative scaffolds are small stable proteins often expressed in bacteria. We have eveloped a scaffold 

that can be expressed at high levels in a soluble form without periplasmic expression or secretion. To fully 

exploit this property, it is necessary to optimize the expression and purification process. These steps will 

be discussed, together with modifications required to ensure a homogeneous product. 

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 

Production of enzymes for enzyme replacement therapies using perfusion cell culture will be discussed 

with special attention to the optimization of process parameters for operational consistency. A discussion 

of the differences between perfusion and fed-batch cell culture aspects will be provided with experience 

from the 6 years of commercial manufacturing of Naglazyme. The talk will conclude with a summary of 

differences between the manufacturing of therapeutic enzymes and antibodies. 

Guru R. Thuduppathy, Ph.D., Scientist II, Manufacturing Sciences, BioMarin Pharmaceutical Inc. 

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

Producing Non-mAb 

The use of platform process formats to reduce resource requirements for early-stage clinical product 

development is a common practice. In this case study, challenges of applying one platform process to a 

cell line producing a smaller protein therapeutic were identified. Potential yield improvement through 

process parameter vs. feed optimization and their impacts on critical product quality will be discussed. 

Yao-ming Huang, Ph.D., Senior Engineer III, Cell Culture Development, Biogen Idec 

5:00 Close of BioProcess International TM Conference 2010 

IBC Life Sciences 

Bioprocess Training Academy 

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

Introduction to Biopharmaceutical 

Manufacturing 

Protein Characterization for 

Biotechnology Product Development 

Cell Culture and 

Fermentation Bioprocessing 

Regulatory Compliance in 

CMC Development 

This course introduces the fundamental 

processes and operations in the manufacture of 

biopharmaceuticals. Beginning with expression 

systems and moving through fermentation, 

cell culture, recovery, purification, formulation 

and filling, we will discuss the process steps 

involved in producing biological products. You 

will also be introduced to the basic concepts 

of process design and analytical methods for 

characterization of biological products. The 

course will conclude with a description of the 

role of quality and the regulatory environment 

under which biologicals are produced, including 

validation. 

Though the manufacture of biopharmaceuticals 

is complicated and difficult, this course will 

provide a perspective on the many operations 

that make up a manufacturing process and help 

you understand how they work together to 

produce safe and effective products. 

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

Strategic Manufacturing Worldwide, Inc. 

This course covers the fundamentals of 

protein structural analysis using modern 

analytical technologies. We will review the 

post-translational modifications commonly 

observed on recombinant proteins produced 

from manufacturing cell lines and discuss the 

potential impact of the structural heterogeneities 

on biological activity and process control 

strategies. In addition, biophysical methods used 

for characterization of higher order structure 

and aggregates as well as functional assays will be 

discussed. We will review application examples on 

characterization of recombinant proteins including 

monoclonal antibodies and evaluate the use of key 

orthogonal techniques. The objective is to provide 

participants with key technical information along 

with perspectives to enable them to apply the 

technologies to their own projects and evolve their 

own analytical strategy to support the various 

stages of product development. 

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

Development, Genzyme Corporation 

This course provides a comprehensive discussion 

of the principles and procedures involved 

in developing cell culture and fermentation 

processes for pilot and large scale manufacturing 

of biopharmaceutical products. The course 

begins with the fundamental concepts of 

molecular biology, protein expression systems, 

host cell engineering, and selection of high 

producing clones. It moves on to discussing cell 

culture and fermentation technology and how 

to develop the corresponding manufacturing 

processes. The course finishes by addressing 

current trends, including PAT implementation 

and the application of ICH Q8, Q9 and Q10 

concepts. Disposable manufacturing is addressed 

as well. The course uses interactive group 

discussions, case studies and technical references 

to provide participants with new knowledge that 

can be immediately put to practice in their bioproduction 

systems. 

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

Biochemical Engineering, Vice Provost, University of 

Maryland, Baltimore County 

This course will follow the drug/biologic 

development pathway and the concomitant 

CMC requirements by regulatory agencies. 

As drug development moves from concept to 

commercialization, the breadth and depth of 

CMC information required in submissions 

increases in parallel. It is important for 

manufacturers to understand the level of 

CMC compliance expected, so that regulatory 

submissions contain stage-appropriate 

information. The course will examine the broad 

range of DS (Drug Substance) and DP (Drug 

Product) CMC elements, and in particular, which 

elements are required, and in what detail, at each 

stage of development. FDA Guidelines and Points 

to Consider will be surveyed. 

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

Regulatory Affairs, Duke University 

For details about the course agendas and instructors, visit www.IBCLifeSciences.com/Courses 


Meet the People Behind the Products and Get the Answers You Need 

Platinum Sponsors: 

BD Biosciences-Advanced Bioprocessing (BDB-AB) products are currently being used as critical components in the 

production of some of the most widely used drugs and vaccines on the global market today. BDB-AB is playing a 

major role in biopharmaceutical drug production, enabling customers to have a tremendous impact on the future of 

human healthcare. Our novel portfolio of hydrolysates, cell culture media, supplements and services is the optimal 

choice for your mammalian cell culture and bacterial fermentation bioprocessing needs. 

Xcellerex is transforming biomanufacturing with its breakthrough bioprocess technology: FlexFactory 

biomanufacturing platform speeds deployment of new capacity by more than 50%; industry-leading XDR line of 

single-use bioreactors (50L to 2000L), and XDM single-use mixers. Xcellerex technology is also the centerpiece of our 

world-class GMP contract manufacturing operations (CMO). 

Gold Sponsors: 

 

Session Sponsor: 

Opening Night Networking Reception Sponsor: 

Life Technologies is responding to the quest to improve the human condition by setting technology, product and 

safety standards for the worldwide production of biotherapeutics and vaccines. Products and services offered under 

Applied Biosystems include industry leading downstream chromatography purification resins and rapid molecular 

methods for contaminant and impurity analyses. http://info.appliedbiosystems.com/poros. www.microseq.com 

Bio-Rad Laboratories is a leading provider of innovative tools to the life science and clinical diagnostics 

markets, where the company’s products are used for scientific discovery, drug development, and 

biopharmaceutical production. Bio-Rad’s Life Science Group has long served the bioprocessing industry by 

supplying advanced purification and process technologies. Bio-Rad provides a full line of scalable — from 

pilot to production — process chromatography media and hardware solutions. 

Diosynth Biotechnology, a full service contract manufacturer, has a proven track record in clinical and commercial 

cGMP manufacturing for more than 80 complex recombinant proteins, vaccines and monoclonal antibodies. 

We help our customers succeed by offering technical excellence, reliable execution, collaborative project 

management, and demonstrated regulatory expertise. Diosynth is a subsidiary of Merck. 

GE Healthcare provides the integrated expertise in bioprocessing that helps developers and manufacturers of 

biopharmaceuticals to achieve operational efficiency. Our portfolio offers technologies and products for efficient 

upstream and downstream processing including the plug & play platform of disposable and single-use products, 

innovative tools for process development as well as chromatography and filtration systems, services and education. 

Life Technologies is responding to the quest to improve the human condition by setting technology, product 

and safety standards for the worldwide production of biotherapeutics and vaccines. Products and services 

offered under Invitrogen include industry leader GIBCO® media and feeds and PD-Direct® Bioprocess Services for 

cell culture development. www.invitrogen.com/bioproduction 

The biotherapeutics and vaccine production solutions from Life Technologies are offered under trusted industryleading 

brands: GIBCO® and Applied Biosystems . Products and services help solve everyday problems from 

improving cell line titers, optimizing media formulations, and scaling cell culture production, to performing 

same-day critical impurity analyses and reducing purification run times. www.lifetech.com 

Pall’s leading edge filtration, separation, purification technologies and services play an essential role in the Life 

Sciences industry. In Biopharmaceuticals, Pall filtration, chromatography, sampling, monitoring and quality assurance 

products, together with technical services in validation, assays and process optimization are applicable to laboratory, 

pilot-scale development, aseptic processing, biologicals, bioprocessing, fermentation and downstream processing. 

SAFC Biosciences develops, manufactures and markets cell culture reagents and services targeted for commercial 

firms involved in developing and producing biopharmaceuticals using mammalian and insect cell culture 

methods. We are a leading provider of critical raw materials and services for upstream and downstream processes 

in the biopharmaceutical industry. 

Sartorius Stedim Biotech, the leading supplier of equipment and services for the biopharmaceutical industry, 

offers Bioreactors, Fermenters, Crossflow, Integrity Test equipment, Housings, Life Science Laboratory Devices, 

Single-Use Fluid Handing and Mixing Technology. Consumables include crossflow cassettes, membrane 

adsorbers, depth filters, sterilizing & prefilter cartridges, capsules, mycoplasma and viral filtration. Comprehensive 

Validation and Training service support our products. 

Second Night Networking Reception Sponsor: 

Reach the Largest Group of 

Qualified Decision-Makers and 

Influencers at the Best Marketing 

Forum in the Bioprocessing Industry 

The BPI Conference and Exhibition is one of the most 

highly regarded forums in this industry. With over 

1500 participants and more than 150 exhibitors, BPI is 

the largest event devoted specifically to bioprocessing 

scientific information, products and services. Where 

else can you meet face-to-face with key decisionmakers 

within biopharmaceutical development and 

production responsible for making bottom-line driven 

technology & services decisions all under one roof 

BPI continues to grow in sheer numbers and in the 

respect and praise it receives from the industry – don’t 

miss out, contact us today to participate. 

Customize Your Marketing Program to 

Meet Your Company’s Goals 

With competition for the market’s attention stronger 

than ever, we understand that your company needs 

to extend its reach beyond your booth in order to 

build relationships and connect with attendees. BPI’s 

sponsorships offer a variety of ways for you to raise 

your company’s awareness in this valued market both 

pre-show and on-site. 

Maximize Your Outreach though 

Sponsorship Opportunities, Including: 

Content-Specific Sponsorships 

• Pre & Post Event Web Seminar – NEW! 

• Session/Track – Connect Your Company Name 

with High Quality Scientific Content 

• Luncheon Presentation 

• Technology Workshop – Only a few remaining! 

• Post Event Presentation Website 

• Site Tours 

• Speaker Presentation Download Kiosk 

Roundtable Strategic Discussion Group Sponsor: 

Luncheon Presentation Sponsor: 

Badge & Lanyard Sponsor: 

Program Guide Co-Sponsor: 

Technology Workshop Sponsors: 

Strategic Discussion Group Sponsors: 

Tote Bag Sponsors: 

Registration Area Sponsor: 

Internet Café Sponsor: 

Brand-Awareness Sponsorships 

• Breakfast or Luncheon 

• Padfolios 

• Event Publications: Print & Electronic 

• Direct Mail 

• Special Events/Outings: Evening Dinners, etc. 

• Networking Breaks 

• On-Site Banners & Signage 

• Water Bottles 

• Espresso Café 

Have a Different Idea 

All sponsorships are custom and our team will work 

with you on developing what is needed for your 

overall marketing and lead generation strategy. 

Sponsorships are Selling Fast! 

To learn more about sponsoring or exhibiting at 

this year’s BioProcess International conference, 

please contact: 

Kristen Schott, Sales Executive 

(508) 614-1239 

kschott@ibcusa.com 

Jennifer McElligott, Sales Executive 

(508) 614-1672 

jmcelligott@ibcusa.com 


The Most Extensive Biopharmaceutical Marketplace – Over 150 Vendors! 

About the Exhibition: 

The exhibition hall will provide you with many opportunities that you find most important when embarking 

on the venture through the hall. In addition to all of the products and services that will be featured, we have 

developed a fun and exciting environment that will allow you to explore, communicate, network and challenge 

your approaches. 

Exhibition Highlights: 

• An array of new products and services just released to the market 

• 90+ Scientific and Technical Posters with Dedicated Author Time 

• Tuesday “Opening Night” Cocktail Reception sponsored by 

• Wednesday Night Cocktail Reception sponsored by 

• Delegate Roundtable Luncheons 

• Poster Contest sponsored by 

• Face-to-Face Valuable Discussions with Over 1,500+ Attendees 

Who You Will Meet at BPI 2010 

Exhibit Hall Hours 

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

Wednesday,September 22, 2010 9:45 am – 7:15 pm 

Thursday, September 23, 2010 9:45 am – 3:45 pm 

During the exhibit hall special events you will meet with Chief Scientific Officers, Vice Presidents, 

Directors, Managers and Plant Managers, Heads of Departments, Group/Team/Project Leaders, 

Senior Scientists, Engineers, Development and Technical/Application Specialists, Research 

Associates, Consultants and Analysts working in the following areas: 

• Process Development 

• Process Engineering 

• Cell Line Development and Engineering 

• Upstream Processing 

• Cell and Molecular Sciences 

• Protein Sciences 

• Media Development 

• Technical Operations 

• Bioprocess R&D 

• Drug Substance Development 

• Analytical Development 

• Regulatory Compliance/Affairs 

• Quality Assurance/Control 

• Purification 

• Supply Chain 

• Manufacturing 

• Strategic Planning 

• Business Development 

Exhibitor List (as of July 30, 2010) 

3M Purification Inc 

Advanced Instruments Inc. 

Advanced Scientifics Inc. 

AdvantaPure / NewAge Industries 

Ajinomoto 

Althea Technologies , Inc 

Applied Biosystems 

Applikon Biotechnology Inc. 

Aragen Bioscience Inc. 

Arkema, Inc. 

Asahi Kasei Bioprocess 

ATMI Life Sciences 

ATR, Inc 

Avid Bioservices Inc. 

BAC B.V., The Affinity Experts 

BaroFold, Inc 

Baxter 

Bayer Technology Services 

BD Biosciences – Advanced 

Bioprocessing 

Bioengineering Inc. 

BioPharm Software Solutions 

BioProcess International TM Magazine 

Bioproduction Group 

Bio-Rad Laboratories 

BioReliance Corp 

BioScale, Inc 

BioSystem Development, LLC 

BioTechLogic Inc 

Boehringer Ingelheim GmbH 

BPSA 

Brightwell Technologies, Inc. 

Broadley-James Corporation 

Caliper Life Sciences 

Catalent Pharma Solutions 

Celeros Separations 

CEVEC Pharmaceuticals GmbH 

Charles River 

Charter Medical Ltd. 

Chisso 

Cisbio US, Inc 

CMC Biologics 

Cobra Biomanufacturing 

Colder Products Company 

Cook Pharmica LLC 

Corning Life Sciences 

Crucell 

Cygnus Technologies, Inc 

Cytovance Biologics, LLC 

DASGIP BioTools LLC 

DCI-Biolafitte 

Dionex 


DSM Biologics 

Eden Biodesign 

EMD Chemicals 

Finesse Solutions LLC 

Flownamics 

Fluid Imaging Technologies, Inc 

FOGALE nanotech, Inc 

Forte Bio 

Friesland Campina Domo 

GE Healthcare 

GEA Westfalia Separator 

Genetix 

Goodwin Biotechnology, Inc 

Gore Pharmbio Products 

Gyros US Inc. 

Hamilton Company 

Health Protection Agency 

IDBS 

Invitrogen 

Irvine Scientific 

KBI Biopharma, Inc. 

Lancaster Laboratories 

Latham BioPharm Group 

LAUDA-Brinkmann LP 

Laureate Pharma 

LEWA 

Life Technologies 

Lonza 

Metanomics Health 

Millipore 

Mirus Bio 

Molecular Devices 

Natrix Separations 

New Brunswick Scientific 

Nova Biomedical 

NOVASEP 

Novozymes Biopharma 

Optek 

Pall Life Sciences 

PBS Biotech 

PendoTECH 

Pfenex 

PSA Carr Centritech 

Praxair Inc. 

PreSens Precision Sensing 

Prometic Biosciences Ltd. 

QOSINA 

Refine Technologies 

Rentschler Biotechnologie 

SAFC Biosciences 

Sandoz 

Sartorius Stedim North America Inc. 

SciLog, Inc. 

SEBRA 

Sheffield 

Smartflow Technologies 

Spectrum Laboratories Inc. 

The Automation Partnership 

Therapure Biopharma 

Thermo Scientific 

Tosoh Bioscience 

Transonic Systems Inc. 

Quattrflow Pumps/Triangle Process 

Equipment 

Value Plastics Inc. 

WuXi AppTec 

Xcellerex, Inc. 

Limited space still available 

To learn more about exhibiting at this year’s 

BioProcess International conference, 

please contact: 

Kristen Schott, Sales Executive 

(508) 614-1239 

kschott@ibcusa.com 

Jennifer McElligott, Sales Executive 

(508) 614-1672 

jmcelligott@ibcusa.com 


Co-Located Conference 

Paid delegates for BioProcess International TM Conference & Exhibition may attend the sessions of this conference at no additional charge. 

IBC’s 10 th Annual 

Formulation Strategies for Protein Therapeutics 

A Case Study Forum on Improving the Pace and Quality of Formulation Development 

September 21-23, 2010 • Rhode Island Convention Center • Providence, RI 

For further information, and to access the speaker presentation abstracts, please visit: 

www.IBCLifeSciences.com/Formulation 

Tuesday, September 21, 2010 

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 

Main Conference 


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, 



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 

Wednesday, September 22, 2010 

7:45 Networking Coffee 


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 Methods and 

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 SEC-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 

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 

For further information on sponsoring a Technology Workshop, 

please contact Jennifer McElligott at jmcelligott@ibcusa.com or 

508-614-1672 for additional information. 

12:30 Networking Luncheon in BioProcess International 

Exhibit and Poster Hall 


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



2:15 CASE STUDY Mitigation of Oxidation in 

Therapeutic Proteins 

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

2:45 CASE STUDY Formulation Development of 

Therapeutic Antibodies using High-throughput 

Fluorescence and Static Light Scattering Techniques: 

Role of Conformational and Colloidal Stability 

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

Process Biochemistry, MedImmune, Inc. 

3:15 CASE STUDY The Impact of Prefilled Syringe 

Leachables on Protein Stability 

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


Sponsored by 

4:30 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 

5:00 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. 

5:30 CASE STUDY Effects of Surface Tension and 

Excipient Binding on the Conformational 

Stabilization of a Monoclonal Antibody 

Suzanne J. Hudak, Associate Scientist, MedImmune, Inc. 

6:00 Networking Cocktail Reception in Exhibit and Poster Hall 

Sponsored by 

Thursday, September 23, 2010 


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, 


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 

Pieter Rijken, Ph.D., Senior 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 

“This IBC conference 

is a unique opportunity to 

get an overview of the 

latest developments in 

protein formulation with the 

technical experts from the 

biotech industry” 

– Sylvan Huille, Department Head, Formulation 

Development, LFB France 


1 q Please register me for BioProcess International Conference and Exhibition 

NAME 

JOB TITLE 

E-MAIL q Yes, I would like to receive occasional e-mail messages and offers from other organizations. 

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2 Select a Package 

Main Conference Fees On or before On or before On or before Standard Rate 

Industry June 25, 2010 July 23, 2010 August 20, 2010 After August 20, 2010 

4-Day Conference Pass Plus Symposium (Mon.-Fri.) – BEST VALUE l n o $2,499 o $2,599 o $2,699 o $2,799 

3-Day Conference Pass Plus Symposium (Mon.-Thurs.) l n o $2,199 o $2,299 o $2,399 o $2,499 

4-Day Main Conference Pass (Tues.-Fri.) n o $1,999 o $2,099 o $2,199 o $2,299 

3-Day Main Conference Pass (Tues.-Thurs. OR Wed.-Fri.) n o $1,699 o $1,799 o $1,899 o $1,999 

Training Course (Tues.-Wed.) + 2-Day Main Conference (Thurs.-Fri.) u o $2,599 o $2,699 o $2,699 o $2,799 

Training Course (Tues.-Wed.) u o $1,599 o $1,699 o $1,699 o $1,799 

Government/Academic* - 40% discount 

4-Day Conference Pass Plus Symposium (Mon.-Fri.) – BEST VALUE l n o $1,499 o $1,559 o $1,619 o $1,679 

3-Day Conference Pass Plus Symposium (Mon.-Thurs.) l n o $1,319 o $1,379 o $1,439 o $1,499 

4-Day Main Conference Pass (Tues.-Fri.) n o $1,199 o $1,259 o $1,319 o $1,379 

3-Day Main Conference Pass (Tues.-Thurs. OR Wed.-Fri.) n o $1,019 o $1,079 o $1,139 o $1,199 

Training Course (Tues.-Wed.) + 2-Day Main Conference (Thurs.-Fri.) u o $1,559 o $1,619 o $1,619 o $1,679 

Training Course (Tues.-Wed.) u o $959 o $1,019 o $1,019 o $1,079 

* Academic rate is extended to full-time employees of government, universities & university-affiliated hospitals only. 

For on-site registrations, please add $100. See policies regarding Substitutions, Cancellations and Special Needs. 

On or before On or before Register After 

August 27, 2010 August 28-Sept. 15, 2010 Sept. 15, 2010 (onsite) 

Exhibit Hall & Keynote Pass Only o $25 o $50 o $100 

Add-on: 

3 

4 

5 

6 

7 

Reserve 

a Posterboard (space is limited) 

o Vendor/Supplier* $300 o Pharma/Biotech $100 o Academic/Government FREE 

* Vendor rate is for exhibiting/sponsoring companies and/or other posters that upon review are of commercial/product focus. 

Poster abstract must be submitted online at www.IBCLifeSciences.com/BPI by August 20, 2010 for inclusion in the BioProcess 

International Pre-Show and On-site Event Guide. 

l Please indicate which Pre-Conference Symposium you plan to attend: 

o #1: Prevention of Microbial and Viral Contamination of Mammalian Cell Culture Processes - Lessons Learned and Case Studies 

o #2: How Much Data is Enough The Statistical Approach to Process Validation 

o #3: Technology Transfer for Biopharmaceuticals 

n Please indicate which sessions/tracks you plan to attend (select all that apply): 

o Managing Manufacturing Networks 

o Recovery & Purification 

o Vaccine Development & Production 

o Raw Materials/Supply Chain 

u Please indicate which training course you plan to attend: 

o #1. Introduction to Biopharmaceutical Manufacturing 

o #2. Regulatory Compliance in CMC Development 

o Process Development throughout the Product Lifecycle 

o Cell Culture & Upstream Processing 

o Emerging Analytical Requirements 

o #3. Protein Characterization for Biotechnology Product Development 

o #4. Cell Culture and Fermentation Processing 

Please Indicate if you would like to attend: 

o Sponsored Session by Bio-Rad (Tuesday, Sept. 21; 8:00 am – 12:00pm) 

o Sponsored Roundtable Strategic Discussion Group by Tarpon (Wednesday, Sept. 22; 10:30 am) 

o Site Tour to Amgen (Thursday, Sept. 23; 4:00 pm – 6:30 pm, space for site tour is limited and available on a first come, first serve basis) 

8 

Payment Information (Required 30 days in advance of the conference. If registering within 30 days, payment is due immediately) 

r Mastercard r Visa r American Express r Check r Wire Transfer Total: $_____________ 

Please make check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC USA Conferences and attach to the registration form. Confirmation of your booking will 

be sent. Wire Transfer: Please tell your bank to include the conference code, invoice number, person attending, name and date of the conference in the transfer 

instructions. Wire transfers and EFT payments: please contact accounts receivable at Account-liaison@informausa.com for banking details. 

Card # Exp. Date CVV Code 

Name (as appears on card) 

Signature 

Unable to Attend Purchase the Conference Materials. Conference materials including a selection of speaker presentations will be available 

for purchase following the event. 

o I cannot attend and would like to purchase the conference materials. Enclosed is my payment for $399 (fee does not include shipping and 

handling, when applicable). 

Additional Registration Information 

For onsite registrations, please add $100. Unauthorized solicitation is strictly prohibited at this event and failure to comply could result in revocation 

of your access privileges. This is a trade only event. For your safety and security, a photo identification and industry related business card are 

required at the conference check-in to complete your registration. 

Program content and speakers subject to change. Children under 18 are not permitted in the exhibit hall under any circumstances. Conference 

badges are non-transferable and lost badges will not be replaced without payment of the full conference registration fee. 

Please note that payment is required in advance of the conference. Please make check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC Life 

Sciences and attach to the registration form. Confirmation of your booking will be sent. Should you elect to pay by MasterCard, Visa or American 

Express, please send your credit card number, expiration date, name as it appears on card and signature along with the registration form. 

Registration Substitutions/Cancellations: 

If you need to make any changes or have any questions, please feel free to contact us via email at reg@ibcusa.com. Cancellations must be in writing 

and must be received by IBC prior to 10 business days before the start of the event. Upon receipt of a timely cancellation notice, IBC will issue a 

credit voucher for the full amount of your payment, which may be applied towards registration fees at any future IBC event held within 6 months 

after issuance (the “Expiration Date”). All credit vouchers shall automatically expire on the Expiration Date and shall thereupon become void. In lieu 

of issuance of a credit voucher, at your request, IBC will issue a refund less a $595 processing fee per registration. Registrants are advised that no 

credit vouchers or refunds will be issued for cancellations received 10 business days or less prior to start of the event, including cancellations due to 

weather or other causes beyond the Registrant’s control. IBC therefore recommends that registrants allow for unexpected delays in making travel 

plans. Substitutions are welcome at any time. If for any reason IBC decides to cancel this conference, IBC accepts no responsibility for 

covering airfare, hotel or other costs incurred by registrants, including delegates, sponsors, speakers and guests. 

SPECIAL NEEDS: If you have a disability or special dietary needs, please contact IBC via email at custserv@ibcusa.com. 

5 Easy Ways to Register! 

(800) 390-4078 

International Callers: US +1 941 554-3500 

(941) 365-0104 

reg@ibcusa.com 

www.IBCLifeSciences.com/BPI 

IBC USA Conferences, 

P.O. Box 414525, Boston, MA 02241-4525 

Priority Code: B10171PDFWDL 

Group Discounts for Significant Savings! 

Delegates can enjoy significant savings on standard 

registration fees when registering for the BioProcess 

International Conference and Exhibition by sending teams 

to the event. IBC Life Sciences offers competitive discounted 

rates for companies sending groups of 3 or more. For more 

information, contact 646-895-7445. 

Venue & Accommodations 

Conference Venue 

Rhode Island Convention Center, 1 Sabin St., Providence, RI 02903 

Ph: 401-458-6000 • www.riconvention.com 

Conference Hotel 

Westin Providence, 1 West Exchange St, 

Providence, RI 02903 

Ph: (401) 598-8000 

Please call the hotel directly before August 20, 2010 to be 

Special 

Conference Rate 

$188 plus taxes 

included in IBC's dedicated room block for this conference. Please 

identify yourself as part of IBC’s BPI/Formulation event to receive 

the reduced room rate of $188 plus taxes. Be sure to make your 

reservations as soon as possible as rooms tend to fill up very quickly 

and all reservations are subject to availability. 

Hotel Reservation Policies: 

1. A first and last night non-refundable deposit is required at the 

time of reservation. 

2. Cancellations and changes to a reservation will be accepted 

without further financial responsibility up until August 20, 

2010. Your credit card is subject to being charged for your 

full reservation if cancellation or changes to a reservation are 

received after August 20, 2010. 

If you find that the Westin Providence is sold out on one or more 

nights please call the Hilton Providence directly at 401.831.3900 

or the main Hilton reservation line at 1.800.HILTONS and reference 

the BPI conference. The Hilton will honor our discounted rate of 

$188 + tax per night until the cut-off date of August 21st. After 

that date the rooms and rate will be based on availability. 

Only a one-hour drive from Boston, Providence combines the 

accessibility and friendliness of a small town with the culture and 

sophistication of a big city. The RICC is within walking distance to 

many hotels, shops, art galleries, nightclubs, museums and more. 

Among foodies, Providence is known as a red-hot destination and 

was recently featured in Food & Wine. BPI conference attendees 

will find a large choice of excellent restaurants for their business 

dinners within a short walk or drive from the Rhode Island 

Convention Center. 

Rhode Island just became the first U.S. state to receive the 

“International Star Diamond Award” – the tourism industry’s 

Academy Award -- presented by The American Academy of 

Hospitality Sciences (AAHS). The Award represents the highest and 

most prestigious form of achievement in the industry, recognized 

and sought after by tourism and hospitality professionals worldwide. 

The honor is typically awarded to five-star resorts and hotels, spas, 

restaurants, airlines and cruise lines. Rhode Island will be only the 

tenth destination and the first U.S. state to receive the Award. 

Rhode Island is a world-class destination offering some of the best 

natural beauty, culinary offerings, history and cultural attractions. 

Travelers may fly to the easily accessible TF Green Airport, just 

ten minutes away in Warwick, RI, or into Boston’s Logan Airport. 

Travel from Boston Logan Airport to the Westin 

Providence: 

Travel by Rail. The Providence Amtrak station is located 

downtown, about a 5 minute walk from the RICC and the Westin 

Providence. Providence is located on Amtrak's Northeast Corridor 

with service from Boston-Providence-New Haven-New York- 

Philadelphia-Baltimore and Washington D.C. The high speed Acela 

Express train service transports passengers from New York City to 

Providence in about two and a half hours. 

Travel by Automobile. Located at the intersection of I-95 and 

I-195, Providence is 50 miles south of Boston (about a one hour car 

ride) and 185 miles northeast of New York City (about three hours 

by car). 

Travel by Bus. From Logan International Airport, take the Peter 

Pan Bus, 800-343-9999, to Providence ($22 one way or $40 round 

trip). Buses run almost hourly (on the half-hour) and circulate 

throughout the terminal area of Logan. The bus will drop you off at 

Kennedy Plaza in downtown Providence, less than a 5 minute walk 

from the Westin Providence.

Register Early and Save up to $300 (See page ... - IBC Life Sciences

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