Cell Culture & Upstream Processing - IBC Life Sciences

THE Meeting Place for the 

Bioprocessing Industry 

OVER 1500 ATTENDEES 

110 Presentations featuring 40 Case Studies 

New FDA and Industry Plenary Session 

Site Tours to Irvine Scientific 

September 23-26, 2008 

Disneyland® Hotel • Anaheim, California 

Four comprehensive conference tracks 

1 

Production & Economics of 

Biopharmaceuticals 

3 

Cell Culture & 

Upstream Processing 

Sponsored by 

• Strategic Planning for Biopharmaceuticals: Challenges 

for a Maturing Industry 

• Approaches to Reduce Timelines and Manage 

Instability in Cell Line Development 

• Production Planning for Cost-Efficient Manufacture 

when Demand is Uncertain 

• Achieving 10+ Grams Per Liter and the Challenges 

on Process Development 

• Improving Competitiveness and Quality of 


• Exploring Different Development Paths to Higher 

Productivity and Improved Quality 

2 

Scaling Up from Bench 

through Commercialization 

4 

Recovery & Purification 

• Knowledge Management Strategies to Leverage and 

Exploit Process Data to Accelerate Process Development 

• Regulatory Updates including Tools for Implementation 

of Quality by Design 

• Advances in Process Models to Enable Improved 

Scale-Up and Technology Transfer 

• Alternative Approaches to Overcome Challenges of 

Large Scale Protein Production 

• Implementation of a 2-Step Purification Processes 

for Monoclonal Antibodies 

• Platform Development Approaches for Non-Platform 

Projects: Processes for Non-Antibody Drugs 

PLUS! Access to IBC's 8th Formulation Strategies for Protein Therapeutics 

Executive Sponsor 

Corporate Sponsors 

Founding Publication 

Maximize Your Savings by Registering Early 

www.IBCLifeSciences.com/BPI/US 

Organized by

THE Meeting Place for the 

Bioprocessing Industry 



www.IBCLifeSciences.com/BPI/US 

Keynote Presentations 

Biosimilars – Follow-on Biologics 

Subsequent Entry Biologics – Biogenerics? 

Robert L. Garnick, Ph.D. 

Senior Vice President 

Regulatory, Quality and Compliance 

Genentech, Inc. 

Paths to Flexible Regulatory Notification of 

Large Molecule Life-Cycle Changes 

John K. Towns, Ph.D. 

Director 

Global CMC Regulatory Affairs 

Eli Lilly and Co. 

The Challenges and Successes of Creating 

a Biologics Organization within Pfizer 

Rick Rutter, Ph.D. 

Vice President 

Pharmaceutical Sciences Biologics 

Pfizer Inc 

Manufacturing Support – Lessons 

Learned and Trends for the Future 

Konstantin Konstantinov, Ph.D. 

Vice President 

Technology Development 

Genzyme Corp. 

Using Knowledge Management for Technical 

Collaboration across Generations 

Jeanne Holm, Ph.D. 

Chief Knowledge Architect 

NASA Jet Propulsion Laboratory 

How to Motivate Staff to Implement Lean 

Manufacturing to Raise the Bottom Line 

Rob Bryant, MBA 

Vice President, Quality, Lean/Six Sigma 

Program Lead Master Blackbelt 

Computer Sciences Corporation 

Featured Presentations 

What's Inside 

FDA Manufacturing 

Initiatives in 

Biotechnology Products 

Steven Kozlowski, Ph.D. 

Director, Office of 


OPS, CDER, US FDA 

Post-Registration Process 

Changes: Considerations 

for Comparability 

Robert A. Baffi, Ph.D. 

Senior Vice President 

Technical Operations 

BioMarin Pharmaceutical Inc. 

Special Exhibit Hall Keynote Presentation 

Biomanufacturing 2008: 

Where We’ve Been, Where 

We’re Going, and Why 

Randy Maddux, Ph.D., 

Vice President, Manufacturing 

Operations, Human Genome 

Sciences, Inc. 

The Treacherous Path to Success 

in the Biotech Industry 

Prof. Charles L. Cooney 

Robert T. Haslam (1911) Professor, Department of 

Chemical Engineering, and Faculty Director, 

Deshpande Center of Technological Innovation, MIT 

Conference-at-a-Glance. . . . . . . . . . . . . . 3 

Track Descriptions . . . . . . . . . . . . . . . . . . . 4 

Pre-Conference Workshops . . . . . . . . . . 5 

Main Conference Sessions . . . . . . . . 6-17 

Site Tour Information . . . . . . . . . . . . . . . 14 

Formulation Conference Highlights . 18 

Training Courses . . . . . . . . . . . . . . . . . . . . 19 

Sponsorship Information. . . . . . . . . . . . 20 

Exhibit Information . . . . . . . . . . . . . 20-21 

Poster Guidelines . . . . . . . . . . . . . . . . . . . 22 

Venue Information. . . . . . . . . . . . . . . . . . 22 

Registration Form. . . . . . . . . . . . . . . . . . . 23 

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



Building on the success of the past four years, an all-new program has been 

developed for 2008 by expert end-users together with the IBC research team. 

This year the agenda focuses unwaveringly on methods to reduce time to market 

and cost of goods, to dramatically accelerate development of robust processes, 

to achieve higher than ever yields from cell culture, and to break through the 

downstream bottleneck. 

This in-depth program allows you to choose from over 110 presentations 

from industry leaders as well as emerging, small- to medium-sized companies. 

Customize your own BPI experience to meet your needs as well as gain a 

comprehensive look at today’s industry. 

Comprehensive Coverage of the Business, Scientific, Technical and 

Operational Changes which are Driving the Industry 

2 High-Level 

Strategy Tracks 

The Production & Economics and Scaling Up from Bench 

through Commercialization tracks have new focus this year 

on developing and exploiting platforms for maximum efficiency 

and modernization, utilizing knowledge and information 

management as well as supply chain and life cycle management. 

2Cutting-Edge 

Technology Tracks 

The Cell Culture & Upstream Processing and Recovery & 

Purification tracks will highlight cutting-edge technologies 

and best practices on how they are applied to accelerate speed 

to market, increase process efficiency and productivity while 

controlling quality and cost. 

MORE In-Depth 

Coverage 

• Increased focus on reducing cost of goods and timelines for speed to market and competitiveness 

• Over 110 scientific podium presentations, over 50 posters, 40 cutting-edge case studies, 

and small group networking discussion and problem-solving sessions 

• Expanded opportunities to hone your skills with pre-conference workshops on: 

Technology Transfer • Single Use Processes • Process Characterization & Control for Biologics 

• Plus! Site Tour to Irvine Scientific 

NEW Program 

Features 

• Exhibit hall presentations including visionary keynote plus innovative technology launches and demonstrations 

• High-level strategy discussion forum on strategies for the adoption of new technologies plus industry-supplier panel on 

downstream technology needs 

• Pre-Event Online Partnering System, a community to schedule meetings in advance of the conference 

• Interactive workshop and discussion on cell line stability and heterogeneity 

A plenary session featuring FDA and high-level industry speakers who tackle the need to modernize and make changes 

in a highly regulated environment. By attending you hear the most influential thought leaders address the all-important 

PLUS...challenges of post-registration changes and implementing Quality by Design – Don’t miss it! 

Expanded 

Exhibit Hall & 

Networking 

More than 120 suppliers will offer products and services and over 50 posters will be displayed in the large exhibit hall which 

will feature a stage area for product demonstrations and keynote presentations. You will be able to enjoy an intensive and 

lively learning experience through the high quality scientific presentations, poster displays, high-level strategy forum, peer-topeer 

problem solving groups, roundtable discussions, and networking lunches and receptions. This event is truly THE place 

to gain the latest industry updates, make new contacts and initiate collaborations in biopharmaceutical production. 


Monday, September 22, 2008 

1:00 pm - 5:30 pm Workshop A: Technology Transfer 

Tuesday, September 23, 2008 



8:00 am - 11:45 am 

8:15 am - 8:45 am 

Strategic Planning for Biopharmaceuticals: 

Challenges for a Maturing Industry 

Keynote Presentation 



Rob Bryant, MBA, Computer Sciences Corporation 

Conference-At-A-Glance 

Workshop B: Single Use Bioprocess Systems: 

Intensive Update 

Scaling Up from Bench through 

Commercialization 

Strategic Scale Up Decisions to Accelerate 

Process Development 

11:45 am - 12:15 pm Technology Workshops sponsored by: Applied Biosystems, New Brunswick Scientific and Thermo Scientific 

12:15 pm - 1:45 pm Networking Luncheon and Technology Workshop Sponsored by Invitrogen 

1:45 pm - 3:30 pm 

4:00 pm - 5:30 pm 

Production Planning for 

Cost-Efficient Manufacture 

Special Strategy Discussion Forum: 

Adopting New Technology: 

The Cost of Change 

Regulatory Updates: Tools for QbD 

(Quality by Design) Implementation 


The Challenges and Successes of Creating a Biologics Organization within Pfizer 

Rick Rutter, Ph.D., Vice President, Pharmaceutical Sciences, Biologics, Pfizer Inc 

Using Knowledge Management for Technical Collaboration across Generations 

Jeanne Holm, Chief Knowledge Architect, NASA Jet Propulsion laboratory 

5:30 pm - 7:00 pm Exhibit Hall Opens with Cocktail Reception sponsored by SAFC Biosciences 

Wednesday, September 24, 2008 



7:15 am - 7:45 am Technology Workshop Sponsored by Applied Biosystems 

8:00 am - 12:00 pm 

Improving Competitiveness and 

Quality of Biopharmaceuticals 

Interactive Workshop and 

Discussion on Cell Line Stability 

and Heterogeneity 



Use of Scale Down Models throughout 

Product Lifecycle: Early to Late 

to Post Registration 

12:00 pm - 12:30 pm Technology Workshops Sponsored by BIA Separations, ForteBio, GE Healthcare, and Thermo Scientific 

12:30 pm - 2:00 pm Networking Luncheon in Exhibit/Poster Hall with Dedicated Poster Viewing 

2:00 pm - 3:45 pm 

4:15 pm - 5:45 pm 


FDA Manufacturing Initiatives in Biotechnology Products 

Steven Kozlowski, Ph.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA 

BioManufacturing 2008: Where Are We Now? 

Anthony Mire-Sluis, Ph.D., Executive Director, Global Product Quality and External Affairs, Amgen Inc. 

Post-Registration Process Changes: Considerations for Comparability 

Robert A. Baffi, Ph.D., Senior Vice President, Technical Operations, BioMarin Pharmaceutical Inc. 


Paths to Flexible Regulatory Notification of Large Molecule Life-Cycle Changes 

John K. Towns, Ph.D., Director, Global CMC Regulatory Affairs, Eli Lilly and Co. 

Biosimilars - Follow-on Biologics - Subsequent Entry Biologics – Biogenerics? 

Robert L. Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc. 

5:45 pm - 7:15 pm Networking Cocktail Reception in Exhibit/Poster Hall 

6:30 pm - 7:00 pm 

Workshop C: Process Characterization and Monitoring During 

Development & Commercialization of Biopharmaceuticals 

Exhibit Hall Opens 5:30 pm - 7:00 pm 

Co-Located Formulation Strategies 

for Protein Therapeutics 

8:20 am – 12:00 pm 

Pre-Conference Workshop: 

Developing Formulations for Prefilled 

Syringe-Based Products – From Early Development 

to Commercialization 

1:30 pm - 2:15 pm 

Keynote Presentation 

Scientific Issues in Lifecycle Management: Optimizing 

Drug Products Based on Market Demands 

Anthony B. Barry, Ph.D., Principal Research Scientist, 

Drug Product Development, Wyeth BioPharma 

2:15 pm – 3:45 pm 

Measuring and Predicting Protein Aggregation 

4:15 pm – 5:45 pm 

Improving the Stability of Protein Therapeutics 

Exhibit Hall Hours: 9:45 am - 7:15 pm 

Co-Located Formulation Strategies 

for Protein Therapeutics 

Applying Quality by Design to Formulation 

and Process Development 

Advancing Formulation Development for 

High Concentration Protein Products 

2:10 pm – 3:15 pm 

Advancing Formulation Development for High 

Concentration Protein Products (continued) 

3:15 pm - 4:15 pm 

Special Presentation: The Role of Formulation 

Development in Biologics Patent Protection 

Timothy J. Shea, Jr., Director, Sterne, Kessler, 

Goldstein & Fox P.L.L.C. 

4:15 pm - 5:45 pm 

Small Group Scientific Exchange Discussions 

Exhibit Hall Keynote Presentation: The Treacherous Path to Success in the Biotech Industry – Prof. Charles L. Cooney, Robert T. Haslam (1911) Professor, Department of Chemical 

Engineering, and Faculty Director, Deshpande Center of Technological Innovation, Massachusetts Institute of Technology 

Thursday, September 25, 2008 







Recovery & 

Purification 

Exhibit Hall Hours: 9:45 am - 4:00 pm 

Co-Located Formulation 

Strategies for Protein 

Therapeutics 

7:15 am - 7:45 am Technology Workshop to be announced 8:15 am – 9:00 am 

Extended Long-Term Formulation 

Development Case Study 

8:00 am - 12:00 pm 

Discussion and Workshop Sessions: 

• Lean Six Sigma in a Biotech Setting: 

Constraint or Enabler? 

• Standards for Disposables: 

What would End-Users Like to See? 

Advances in Cell Line Development 

& Clone Selection 

Overcoming Challenges of Large 

Scale Protein Production – Present 

and Future 

12:00 pm - 12:30 pm Technology Workshops Sponsored by Novasep Process, Nysa Membrane Technologies, Novozymes and Sartorius Stedim North America Inc. 

12:30 pm - 1:45 pm Networking Luncheon in Exhibit/Poster Hall 

1:45 pm - 6:00 pm 

Discussion and Workshop Sessions: 

• Biosimilars: Where Are We Now? 

• Use of Scale-Down Models in 

Non-Conformance Resolution 

Proven Strategies for Process 

Development and Optimization 

Friday, September 26, 2008 

Cell Culture & Upstream Processing 

Approaches for Successful Process 

Development and Optimization 


9:00 am – 10:00 am 

Predictive Methods for Formulation 

Development 

10:30 am – 12:00 pm 

Formulation Development for 

Lyophilized Products 

2:00 pm – 3:00 pm 

Formulation Development for 

Lyophilized Products (continued) 

3:00 pm – 5:00 pm 

Formulation Development for Novel Proteins 

7:15 am - 7:45 pm Technology Workshop Sponsored by BD Biosciences – Advanced Bioprocessing 

8:00 am - 11:45 am Media Development and Feed Strategies Product Quality and Regulatory Considerations 

8:05 am - 8:45 am 

Keynote Presentation: Manufacturing Support – Lessons Learned and Trends for the Future 

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

Overcoming the Direct Impact of High Titer Processes on Downstream Processing 

Interactive Panel Discussion: Challenges and Opportunities in Using BioSMB or other 

Multi-Column Approaches for Downstream Processing – Sponsored by Tarpon Biosystems Inc. 

11:45 am - 12:15 pm Technology Workshops Sponsored by SAFC Biosciences, Millipore and Percivia LLC 

12:15 pm - 1:30 pm Networking Luncheon and Technology Workshop Sponsored by Pall Life Sciences 

1:30 pm - 3:15 pm 

Impact of Upstream Advances on Downstream Processing and Product Quality – 

Act Locally but Think Globally 

Protein A and Beyond 

3:15 pm - 5:00 pm Overcoming Manufacturing Issues Improving Downstream Economies and Efficiencies Using Disposables in Chromatography 

Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event 3

"IBC’s BioProcess International Conferences are terrific. They are the benchmark for meetings of this type. The programs always include 

great speakers on current topics. I always either deepen my knowledge or learn something new when I attend the BPI conference.” 

– Maik W. Jornitz, Group Vice President, Marketing & Product Management, Filtration/Fermentation Technologies, Sartorius Stedim North America Inc. 

1 Production & Economics of Biopharmaceuticals 3 Cell Culture & Upstream Processing 

Understand the potential impact of biosimilars through provocative 

presentations from Biocon, India and Boehringer Ingelheim, Germany. Learn 

how to achieve significant cost savings by implementing lean manufacturing in 

the keynote presentation from the high tech industry plus case study. Evaluate 

strategies for outsourcing and the economics of orphan drugs. Gain insight into 

pre-competitive research in logistics and manufacturing including long-range 

demand planning, plus hear strategies for production planning when demand 

is uncertain. Improve the competitiveness and quality of your product via 

reports on financial advantages of quality by design, analyses of disposables, 

and supply chain management. 

Advisory Board 

Joanne T. Beck, Ph.D., Plant Manager, Abbott Bioresearch Center 

Wolfgang Berthold, Ph.D., Chief Technical Officer, Biogen Idec 

William P. Botha, Director of Manufacturing, Baxter Healthcare Corporation 

Andrew Cockshott, Ph.D., Manager, Manufacturing Science and Technology, 

Eli Lilly and Co. 

Jon T. Conary, Ph.D., Senior Director, Manufacturing, 

Human Genome Sciences, Inc. 

Howard L. Levine, Ph.D., President, BioProcess Technology Consultants, Inc. 

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

Amgen Inc. 

Rhona M. O’Leary, Ph.D., Director, BioProcess Development, Genentech, Inc. 

Learn how to accelerate your cell line development programs by applying 

technologies to help reduce development timelines and workflows while 

managing instability. Hear case studies on multi-faceted approaches to 

developing fast and efficient processes that control quality and improve 

manufacturability. Discover how to apply quality by design to balance 

product quality and robustness during cell line or process changes and use 

best practices to avoid pitfalls during the application of quality by design. 

Investigate tools and techniques to optimize your media design, development 

and feed strategies. Hear proven strategies to help you overcome the impact 

of upstream advances in process development. 


Timothy S. Charlebois, Ph.D., Senior Director, Drug Substance Development, 

Wyeth BioPharma 

Geoffrey Francis, Ph.D., Chief Scientist, Applied R&D, Novozyme BioPharma 

AV Ltd., Australia 

Laurel Donahue-Hjelle, Ph.D., Director of Cell Line Development, 

Invitrogen Corporation 

Kevin J. Kayser, Ph.D., R&D Manager, Cell Line Engineering, SAFC Biosciences 

Dennis M. Kraichely, Ph.D., Principal Research Scientist, Expression 

Technologies, Centocor, Inc. 

Suzanne Kuo, Ph.D., Senior Engineer, Late Stage Cell Culture Process 

Development, Genentech, Inc. 

John Mott, Ph.D., Director, Bioprocess R&D, Cell Line Development, 

Pfizer Global Biologics 

Charles Sardonini, Ph.D., Associate Director, Process Engineering/ 

Development, Genzyme Corporation 

Thomas Seewoester, Ph.D., Director, Process Development, Amgen Inc. 

Gary Welch, Director, Process Development, Abbott Bioresearch Center 

2 

Scaling Up from Bench through Commercialization 

4 


Accelerate your process development with platforms by leveraging 

informational sciences to compound and use process characterization 

data. The first session focuses on this concept with strategy from NASA’s 

Jet Propulsion Laboratory, plus industry case studies and an audience 

interactive panel discussion to ask your questions to the experts. 

Understand the latest tools for implementing quality by design. Hone your 

scale-down skills in the session on use of scale down models throughout 

the product lifecycle, with six detailed case studies. 


Jeffrey C. Baker, Ph.D., Senior Research Advisor, Manufacturing Sciences and 

Technology, Eli Lilly and Co. 

Roger A. Hart, Ph.D., Scientific Director, Process Development, Amgen Inc. 

Maninder Hora, Ph.D., Vice President, Process Development, 

PDL BioPharma, Inc. 

Günter Jagschies, Ph.D., Director R&D, Customer Applications, Protein 

Separation, GE Healthcare Bio-Sciences, Sweden 

Ellen L. McCormick, Director, BioProcess R&D, Pfizer Global Biologics, Pfizer Inc 

R. Andrew Ramelmeier, Ph.D., Vice President, Manufacturing and Process 

Development, BioMarin Pharmaceutical, Inc. 

Thomas C. Ransohoff, Vice President and Senior Consultant, 

BioProcess Technology Consultants, Inc. 

David H. Reifsnyder, Ph.D., Principal Scientist, Process Development-Late Stage 

Purification, Genentech, Inc. 

Abhinav Shukla, Ph.D., Associate Director, Manufacturing Sciences, 

Bristol-Myers Squibb Company 

Hear how to develop new chromatographic and non-chromatographic 

methods to overcome the challenges of large scale protein production. 

Apply platform approaches for non-platform projects to efficiently 

develop purification processes for non-antibody drugs. Learn about the 

successful development of a 2-step purification process for monoclonal 

antibodies. Evaluate the economical and regulatory impact of sequential 

multi-column chromatography in downstream processing. Gain insights 

towards overcoming platform facility fit issues for high titer processes and 

reconfiguring a commercial biologics facility to a launch facility for new 

products. Benefit from case studies on the successful development and 

implementation of single-use processes in downstream processing. 


Edward Cole, Ph.D., Senior Vice President, Protein Development, 

Genzyme Corporation 

Chris Dowd, Ph.D., Senior Engineer, Late Stage Purification, Genentech, Inc. 

Adam Goldstein, M.S., Senior Manager, Oceanside Clinical Operations, 


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

Sartorius Stedim Biotech, Germany 

Brian R. Hubbard, Ph.D., Scientific Executive Director, Process and Analytical 

Sciences, Amgen Inc. 

David W. Kahn, Ph.D., Director, Late-Stage Purification Development, 


Charles Schmelzer, Ph.D., Senior Scientist, Late Stage Purification, 


Peter W. Wojciechowski, Director, Process and Analytical CMC, 

Johnson & Johnson Regenerative Therapeutics 

Paul Wu, Ph.D., Manager of Protein Isolation, Bayer Healthcare 


Monday, September 22, 2008 • Pre-Conference Workshops 

Workshop A 

Technology Transfer for 


1:00 Chairperson’s Opening Remarks 

Eric Ford, Manufacturing Technical Specialist, 

Late Stage Process Development, Genentech, Inc. 

1:10 Effective Data Management for 

Technology Transfer 

James Myers, Ph.D., Process Engineer, Engineering 

Science, Avecia Biologics Ltd., United Kingdom 

1:50 Achieve Full Integration of the 

Technology Transfer Process across 

Process Development through to Filing 

Patrick J. Watters, Principal Project Manager, 

Biotech Technology and Engineering, Wyeth Biotech 

2:30 Refreshment Break 

3:00 Challenges of International 

Transfers 

Siddarth J. Advant, Ph.D., Principal, 

Tunnell Consulting 

3:40 Challenges Faced During Optimization 

and Transfer of Legacy Processes 

Eric Ford, Manufacturing Technical Specialist, Late 

Stage Process Development, Genentech, Inc. 

4:20 Audience Interactive 

Panel Discussion 

5:00 Close of Workshop 

Workshop B 

Single Use Bioprocess 

Systems: Intensive Update 


Jerold Martin, Senior Vice President, Scientific Affairs, 

Pall Life Sciences; Director and Chair, Technology 

Committee, Bio-Process Systems Alliance 

1:10 Regulatory Requirements for 

Manufacturing and Validation of 

Single-Use Systems 

Andrew Sette, Director of Quality and Regulatory 

Affairs, Sartorius-Stedim Biotech, France 

1:50 Evaluation of Bioreactors and 

Single-Use Bioprocessing Supplies 

Leigh N. Pierce, President, PacificGMP 

2:30 Advances in Disposable-Format 

Downstream Processing Technologies 

Thomas C. Ransohoff, Vice President and Senior 

Consultant, BioProcess Technology Consultants, Inc. 


3:40 Analyzing the Carbon Footprint Left 

by a Company’s Use of Disposables 

Lindsay Leveen, Associate Director Strategic Planning 

and Lytics CMC Team Lead, Genentech, Inc. 

4:20 Working with Vendors – Setting 

up GMP Supplier Relationships 

under GMP 

Hélène Pora, Ph.D., Senior Director, Single-Use 

Systems, Pall Life Sciences, France 

5:00 Audience Interactive Panel 

Discussion 


Workshop C 

Process Characterization 

and Monitoring 

During Development & 

Commercialization of 



Siddharth J. Advant, Ph.D., Principal, 


1:10 Use of Statistical Tools during 

Process Characterization 

Jason Kamm, Managing Consultant, 


1:50 Development of Scale Down Models 

to support Process Validation for 

Cell Culture Processes 

Helena Yusuf-Makagiansar, Ph.D., 

Associate Director, Biopharmaceutical 

Development, Biogen Idec 


3:00 Industrial Experiences with 

the Continuum of Process 

Characterization, Validation & 

Process Monitoring During/Postcommercialization 

Neslihan DelaCruz, Principal Engineer, 

Amgen Inc. 

3:40 Quality by Design: A Biologics Case 

Study in Formulation & Process 

Development 

Carol F. Kirchhoff, Senior Principal Scientist, 

Pfizer Inc 

4:20 Interactive Panel Discussion 


From Climbing to the Top of the 

Earth to Launching into Orbit… 

…BioProcess International 2008 brings you inspiration 

for the future of a streamlined industry with keynote 

presentations by visionaries who have climbed the 

highest mountains, surmounted physical challenges to 

achieve world endurance records, and supported the 

launch of NASA shuttles and spacecraft… 

…But remains fully grounded in nuts and bolts case 

studies from biopharmaceutical 

industry speakers that will help 

you bring back new tips that 

can improve your processes 

tomorrow, while you plan for 

the coming decade’s changes. 

(See pages 6, 8 & 10 for complete 

abstracts) 


Tuesday, September 23, 2008 • Main Conference 

1 Production & Economics of Biopharmaceuticals 2 Scaling Up from Bench through Commercialization 

7:00 Registration and Coffee 

Strategic Planning for Biopharmaceuticals: 

Challenges for a Maturing Industry 

8:00 Chairperson’s Remarks 

Joanne T. Beck, Ph.D., Plant Manager, Abbott Bioresearch Center 

8:15 Keynote Presentation 



Experience from over 1,000 process improvements has demonstrated 

the elements necessary for success of a lean program: passionate 

executive sponsor, endorsed project charter, engaged team, and a 

phased approach with realistic goals. Gain strategic tips for incorporating value 

stream mapping, design of experiments (DOE), mistake-proofing, failure modes 

and effects analysis (FMEA), Root Cause/Risk Analysis, statistical process control 

(SPC), process mapping, process management performance metrics, trend analysis, 

process re-engineering, analysis of variation (ANOVA), benchmarking and more. 

Rob Bryant, MBA, Vice President, Quality, Lean/Six Sigma Program Lead Master 

Blackbelt, Computer Sciences Corporation 

8:45 Case Studies in Using Lean Six Sigma to Drive 

Optimization and Significant Financial Benefit 

Lean Six Sigma can be creatively applied to significant business opportunities 

to yield better and faster business outcomes. This presentation will review case 

study examples of the use of Lean Six Sigma to drive optimization and significant 

financial benefits for some common manufacturing business initiatives. 

Beth Whitacre, Quality Control Team Leader, Certified Six Sigma Black Belt, 

Eli Lilly and Company 

9:15 Process Economics and Life-Cycle Management 

Challenges to the Development and Manufacturing 

of Orphan Drugs: A Review of our Naglazyme Experience 

The process economics and life-cycle management of ultra-orphan biologics will 

differ greatly from larger market drug products. Patient accrual numbers and drug 

demand for clinical, launch and lifetime supply will shape strategies for process 

development, clinical production and qualification stages leading to launch. In this 

talk we will discuss these and other challenges unique to small market products. 

Jonathan Blackie, Director, Manufacturing, BioMarin Pharmaceutical Inc. 

9:45 Networking Refreshment Break 

10:15 Concentration and Dispersion in a Global Industry: 

The Geography of Biomanufacturing 

Based on data collected since 2000, this presentation will examine trends in the 

location of biomanufacturing capacity, specifically for mammalian cell culture 

production. Many factors influence companies’ location decisions: firm size and stage 

of development, product and technology maturity, and public policy. This research will 

posit some hypotheses as to what is driving the location dynamics of this industry. 

Elisabeth Reynolds, Industrial Performance Center, 

Massachusetts Institute of Technology 

10:45 Streamlining Technology Transfer of Biomolecules 

to CMO's 

Jose M. Hanquier, Principal Research Scientist, Large Molecule Outsourcing 

MS&T Leader, Eli Lilly and Company 

11:15 Managing a Biologics Supply Chain Using A Fully- 

Outsourced Manufacturing Model 

Millennium has managed the supply of several different biologics at all stages of 

clinical development using a fully outsourced manufacturing model including 

drug substance, drug product and release assays. Experiences related to process 

transfer and documentation, facility fit, demand planning and validation activities 

for launch will be presented. The importance of maintaining a fully functional 

internal process development group and pilot plant will be emphasized. 

Michael W. Glacken, Ph.D., Director of Biologics Process Development, 

Millennium Pharmaceuticals, Inc. 

7:00 Registration and Coffee 

Strategic Scale Up Decisions to 

Accelerate Process Development 



8:15 Knowledge Management at the Jet Propulsion Laboratory: 

Reuse for Innovation, Process Improvement, and Risk Reduction 

Knowledge Management (KM) Systems offer the potential to increase innovation, 

improve processes, and reduce risk. Realizing this potential, however, requires 

careful attention to people, processes, and products. This presentation synthesizes 

results from KM research and practice at JPL in our quest to explore our solar system 

and beyond, and offers suggestions for application to biopharmaceutical production. 

Lynne Cooper, Ph.D., Knowledge Strategist, Office of Opportunity Development, 

Jet Propulsion Laboratory, California Institute of Technology 

8:45 Knowledge Management Supporting QbD 

Regulatory Submissions 

Quality by Design (QbD) is an initiative aimed at streamlining process 

development efforts required to license a new product and Regulatory 

submissions required during a product’s lifecycle without sacrificing safety and 

efficacy. A key element of QbD is leveraging pre-existing data from similar 

molecules to facilitate establishing a design space. This presentation will provide 

an overview of the knowledge management approach Genentech will be taking as 

part of its implementation of QbD. 

Ron Taticek, Ph.D., Associate Director, CMC Regulatory Affairs, Genentech, Inc. 

9:15 Data Management Systems Facilitating 

Successful Root Cause Analysis in Cell Culture 

Production Processes 

Scale-up of cell culture production processes and their consistent performance in 

manufacturing present challenges due to their high level of complexity and the 

large number of process parameters involved. Large data management systems 

can capture and present the process data, but for their analysis and meaningful 

interpretation, the input from process experts is needed. A process was put in 

place to link the data management and data interpretation function to successfully 

identify root causes for process scale-up and consistency issues. 

Bernhard M. Schilling, Ph.D., Group Leader, Manufacturing Sciences, 



10:15 Design for Manufacturability in the Development 

of a Seamless Monoclonal Antibody Process 

Removal of intermediate steps between unit operations of biological purification 

processes lowers cost, simplifies operations and facilitates technical transfer. The 

development of a seamless process for purification of a monoclonal antibody and 

the tools used to improve the manufacturability and technical transfer will be 

discussed. Communication between Development and Manufacturing regarding 

criticality of timelines, data and problem solving will be presented. 

Pedro J. Alfonso, Ph.D., Associate Director, Centocor R&D, Inc. 

10:45 Developing Production Platforms for a Portfolio 

Approach: A Case Study in the US and Ireland 

To maximize the value of a robust and varied portfolio, processes must be 

inherently robust to facilitate technology transfer. Recent examples of the 

integration of multiple groups with a common goal illustrate the challenges 

and accomplishments of deliberately limiting options while maximizing the 

probability of success. 

E. Morrey Atkinson, Ph.D., Director, Bioprocess Research and Development, 


11:15 Audience Interactive Panel Discussion 

Platform Development: Leveraging Informational 

Sciences to Compound and Use Process Performance 

Characterization Data 

Moderator: 


Panelists will include all morning session presenters. 


Tuesday, September 23, 2008 • Main Conference (continued) 

11:45 Concurrent Technology Workshops 

POROS® Chromatography Media: 

Transforming Your Downstream Process 

The features and benefits of POROS® chromatography 

media as they relate to improving downstream 

purification will be discussed. Learn how POROS 

media are differentiated and the benefits to downstream 

purification. Process modeling will be used to highlight 

potential productivity gains. 

Christine Gebski, Process Applications Manager, 

Applied Biosystems 

Optimizing Cell Culture Data Management 

and Process Control through OPC Technology 

Rapidly becoming an industry standard, OPC enables realtime 

data exchange between multiple vendors’ devices and 

the control systems that support them. We’ll show how NBS’ 

new software can integrate your fermentor to metabolite 

analyzers, turbidity probes, scales, or third party software. 

The possibilities are endless and the advantages are clear 

– optimizing process control and improving quality control in 

support of PAT initiatives, with less time, effort and cost. 

Richard Mirro, Product Manager, 

New Brunswick Scientific 

12:15 Luncheon Presentation 

Economic Modeling of Single-Use Systems 

The potential economic benefits of single-use systems over 

traditional stainless steel systems are of increasing interest 

to the bioprocessing industry. This presentation examines 

modeling systems for specific applications including 

liquid storage, mixing, bioreactor processing and entire 

manufacturing flows. The return on investment models 

shown address key areas of operational, strategic and 

economic benefits. The models also provide customer-specific 

guidance concerning both direct and indirect benefits. 

Eric Isberg, Manager, Single-Use Process Systems, 

Thermo Fisher Scientific 

High Throughput Process Development: Promises, Myths, and Truths 

The ultimate goal of the process development team is to stay off the critical path to drug approval. To increase the effectiveness of the development 

process, many companies are turning to the use of high throughput (HT) technologies within their development platforms. In this workshop we 

will describe our experience with the implementation of three such HT technologies. We have learned that there are at least four keys to successful 

automation implementation, some of which could be anticipated and some of which are less obvious. Our experience will be shared. 

Peggy Lio, Process Science Fellow, Invitrogen Corporation 


Production Planning for 

Cost-Efficient Manufacture 


Rhona M. O’Leary, Ph.D., Director, 

BioProcess Development, Genentech, Inc. 

2:00 Research in Biopharmaceutical Operations: 

Advancing the State of the Art 

Biopharmaceutical research has traditionally focused on drug discovery, but with a 

maturing industry facing cost pressures there is increased need for pre-competitive 

research into wider issues around manufacturing and logistics, an approach that 

has greatly benefited other high-technology industries. We review several projects 

underway at the UC Berkeley Center for Biopharmaceutical Operations, focusing 

on explorations of risk and its impact across the supply chain. 

Philip Kaminsky, Ph.D., Associate Professor, Department of Industrial Engineering 

and Operations Research, University of California, Berkeley 

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

University of California, Berkeley 

2:30 Managing Production in Light of Uncertain Demand Forecasts 

During the first few years of commercial production in a new market, there can 

be significant uncertainty in demand forecasts. The relationship between demand 

and capacity for biologics can be very linear, so to accommodate some variability, 

elasticity can be added in the form of plant utilization choices and inventory 

control which can help to moderate the impact of demand swings. These 

approaches will be presented. 

Alison Moore, Ph.D., Vice President and Site Head, Amgen Inc. 

3:00 Production Planning in Light of Uncertainty 

ZymoGenetics launched a hospital-based product with entirely 

outsourced manufacturing. Robust quality and supply agreements 

with flexible forecasting mechanisms were critical. Close management of release 

cycle times and the impact on inventory levels and response time to changes in 

forecasts will be discussed. Finally, a case study of an expedited launch involving 

detailed planning and coordination between various contract manufacturers and 

internal resources will be presented. 

Joe McKinstry, Associate Director, Production Planning & Inventory Control, 

ZymoGenetics, Inc. 

Regulatory Updates: Tools for QbD 

(Quality by Design) Implementation 


Jeffrey C. Baker, Ph.D., Senior Research Advisor, Manufacturing Sciences and 

Technology, Eli Lilly and Co. 

2:00 Approaches to Defining Design Space for Bioprocesses 

Defining the design space for a bioprocess is an essential component of the 

Quality by Design approach to product development. Pfizer has implemented a 

comprehensive "Right First Time" approach to the development and commercial 

manufacture of biological products. This approach includes a structured 

methodology for risk assessment and experimental prioritization that facilitates 

the establishment of functional relationships between process parameters and 

quality attributes. This presentation will focus on implementation of this approach 

for a biologic product candidate, and demonstrate possible approaches to defining 

design space for bioprocesses. 

Natarajan Ramasubramanyan, Ph.D., Senior Principal Scientist, Pfizer Inc 

2:30 PCA/PLS Similarity Factors for 

Batch-to-Batch Comparisons 

This talk addresses pairwise comparison of fermentation and cell culture 

batches. In early development, there may only be a few batches available, from 

which performance guidelines must be set for manufacturing. Similarity factors 

from PCA/PLS models can be used for comparison of batches. This technique 

compares process models to look for differences in input-output relationships. 

The talk will discuss the similarity factor approach and include examples using 

pilot data. 

Jeremy Conner, Ph.D., Senior Engineer, Amgen Inc. 

3:00 Application of Multivariate Analysis (for Large Scale Data) and 

DOE (at Small Scale) to Understand Key Process Inputs for a 

Cell Culture Process 

Multivariate analysis (MVA) of large scale data was used to study the relationships 

between various offline, online, and raw material parameters. The resulting effects and 

interactions were further studied via small scale studies using univariate experimentation 

as well as by DOE. The raw material DOE study confirmed that interactions do exist 

between various raw materials and demonstrated the value of performing comprehensive 

DOE studies as part of qualification of a raw material for the process. 

Sanjeev Ahuja, Ph.D., Senior Scientist, Cell Culture Process Development, 

MedImmune 

Concurrent with 

1:45 - 3:30 Special Strategy Discussion Forum: Adopting New Technology: The Cost of Change See next page for details 


Tuesday, September 23, 2008 • Main Conference (continued) 

Special Strategy Discussion Forum: Adopting New Technology: The Cost of Change 

1:45 Moderator’s Introduction 

Peter Latham, President, BioPharm Services US 

2:00 Part One: 

Why Adopt New Technology? Exploring the Drivers and 

Successful Strategies for the Adoption of New Technologies 

In an industry where high margins make it difficult to risk product supply, the 

decision to implement new technology can be a difficult one to make. Despite 

this, there have been a variety of new biomanufacturing approaches ranging from 

novel expression systems to membrane chromatography and disposables which 

have made their way into commercial processes. So how does this happen; what 

are the drivers and decision processes that lead to the implementation of new 

technologies? This interactive panel session endeavors to answer these questions 

through feedback from people who have taken the risk to improve their processes. 

Additionally, we will look at some of the roadblocks to successful implementation 

and explore how they can be overcome. Whether you are a process development or 

manufacturing professional considering the use of a novel approach, or a vendor 

introducing a new technology, this session will provide invaluable insight on how 

to make the process run more smoothly. 

Panelists: 

Thomas C. Ransohoff, Vice President and Senior Consultant, BioProcess Technology 

Consultants, Inc. 

R. Andrew Ramelmeier, Ph.D., Vice President, Manufacturing and Process 

Development, BioMarin Pharmaceutical Inc. 

Bradley Wolk, Distinguished Engineer and Director of Process Development 

Engineering, Genentech, Inc. 



2:45 Part Two: 

Industry-Supplier Forum on Needs for New Technology 

Development for Downstream Processing 

With titers reaching record levels in the up-stream, the bottleneck and cost drivers 

for new bioprocesses are now shifting to purification. But are the current purification 

approaches good enough? This panel will start by discussing the potential need for 

advancement in purification processes and what the drivers are for that need. Against 

this backdrop, we will then discuss some of the new technologies and approaches 

and take a critical look at if and how they address these drivers. Discussions will also 

include feedback on how mature some of these technologies really are including the 

level of their current implementation. This panel will provide uncensored insight for 

people developing/optimizing purification processes as well as companies developing 

new purification technologies. 

Panelists: 

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

Biotech, Germany 

Brian R. Hubbard, Ph.D., Scientific Executive Director, Process and Product 

Development, Amgen Inc. 

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

GE Healthcare Life Sciences, Sweden 


Amgen Inc. 

Thomas C. Ransohoff, Vice President and Senior Consultant, 



Bristol-Myers Squibb 

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

Bio-Rad Laboratories 

Participation is limited to the first 40 attendees for each part of the discussion, on a first come, first served basis. 

4:00 The Challenges and Successes of Creating a 

Biologics Organization within Pfizer 

The presentation will examine the trials and challenges 

of establishing a Biologics Pharmaceutical Sciences and 

Manufacturing organization in a company that has a historical 

small molecule mind set. Hear details of the current status 

of biologics at Pfizer. Understand the major challenges with biologics 

formulations, process technology and manufacturing and how Pfizer is 

trying to leverage its extensive small molecule manufacturing experience to 

creatively resolve these issues. 

Rick Rutter, Ph.D., Vice President, Pharmaceutical Sciences, Biologics, 

Pfizer Inc 

4:45 Using Knowledge Management for Technical 

Collaboration across Generations 

The focus of NASA's knowledge management architecture is looking 

at how to facilitate access to and reuse of the knowledge gathered over 

the many NASA missions to support future missions and to help drive 

innovation. NASA's Knowledge Management Team looks to understand 

trends, technologies, and new learning that will help to better deliver systems, process 

improvements, and solutions of knowledge transfer to the people exploring space. 

Perspectives on knowledge management to modernize bioprocesses across generations 

will be offered. 

Jeanne Holm, Ph.D., Chief Knowledge Architect, 

NASA Jet Propulsion Laboratory 

5:30 Exhibit and Poster Hall Opens 

with Cocktail Reception sponsored by 

Network with your peers, learn about new products and services from over 

100 exhibiting companies, and see cutting-edge data in a large group of posters. 

Interactive Workshop and Discussion on Cell Line Stability and Heterogeneity 

Wednesday, September 24, 2008 • 9:00 am – 11:00 am 

Workshop Leaders: 



Robin A. Heller-Harrison, Ph.D., Associate Director, Cell & Molecular Sciences, 


Genotypic and phenotypic variability are central features in the use of mammalian cells 

for the development and production of biopharmaceuticals. Cell culture practitioners in 

the field continue to be challenged to attain ever-higher yields, while maintaining a level of 

consistency of process and product compatible with a drug manufacturing environment. 

The availability of tools to study the dynamics of cell populations has led to improved 

insight into the behavior and characteristics of cells, which in turn may afford opportunities 

to realize better control during production and to recognize and leverage heterogeneity 

for improved cell lines. This workshop will utilize an interactive, discussional format to 

exchange experiences and explore mechanisms and directions in cell line stability and 

heterogeneity. Several brief invited presentations by leading investigators are planned to 

serve as departure points for discussion, and participants will be encouraged to contribute 

instructive examples and perspective of their own. 

Questions to be discussed include: 

• What mechanisms underlie the trade-off between growth and productivity? 

• What molecular and cellular characteristics would be embodied in the ideal cell? To 

what extent (and how) can relevant-scale cell populations achieve these characteristics 

in production? 

• What opportunities does heterogeneity present for identifying potentially rare cells 

with truly extraordinary capabilities? How to overcome the biological and practical 

constraints of leveraging such capabilities into production? 

• What are the predominant mechanisms that drive instability? 

• What improvements in host-vector systems will enable more predictable cell line 

development while delivering outstanding outcomes? 

• What approaches for managing instability hold the most promise? 

• Do changes in cell populations negatively affect product quality and process consistency? 

Participation will be limited to the first 60 attendees, on a first come, first served basis. 


Wednesday, September 24, 2008 • Main Conference 

Improving Competitiveness and Quality of 

Biopharmaceutical Manufacturing 




8:15 Financial Advantages of Quality by Design (QbD): 

Making the Business Case for Process Improvements in 

Biopharmaceutical Manufacturing 

Regulations and philosophies in the pharmaceutical/biopharmaceutical industry 

have evolved to enable modern methods of process development, optimization 

and control. This study provides evidence of the financial advantages to be 

realized with QbD/PAT/Lean methods. Enhanced product quality can be 

achieved with concurrent improvements in process and supply chain velocity. 

James K. Drennen, III, Ph.D., Associate Dean for Graduate Programs and 

Research, Director, Center for Pharmaceutical Technology, Mylan School of 

Pharmacy, Duquesne University 

8:45 Disposables: Process Economics – Selection, 

Supply Chain and Purchasing Strategies 

CASE 

STUDY 

A new facility project implemented disposables for a broad spectrum of process 

applications. Key considerations included establishing a disposables use 

philosophy to meet the needs of the engineering project, strategy decisions to 

manage disposable vendors, and an integrated supply chain approach including 

product standardization. Other key considerations included lifecycle and risk 

management analysis along with development of a disposables validation strategy. 

Miriam Monge, Vice President, Biopharm Services Ltd, United Kingdom 

9:15 Disposables vs. Stainless Steel: Human Genome Sciences’ 

Cost Analysis of a Clinical Production Facility 

This presentation will focus on a cost analysis of a traditional hard-piped versus 

disposable clinical production facility at a 500L production scale. The scope of the 

analysis will include conceptual design through equipment validation and provide 

a discussion of predictive facility annual operating costs. 

Jason Slinchak, Manufacturing Engineer, Human Genome Sciences, Inc. 

9:45 Networking Refreshment Break in Exhibit and Poster Hall 

10:30 Managing an Agile and Cost-Effective Supply 

Chain with Evolving Biologics Processes 

CASE 

STUDY 

Does your supply chain continuously implement timely process improvements 

without extensive and costly supply segregation? Learn how Bristol-Myers Squibb 

took advantage of its first internally-discovered large molecule to create an agile 

biologics supply chain with cost-effective processes. 

Christele Hadjadj, Biologics Supply Chain Director, Bristol-Myers Squibb Company 

11:00 “Profitability vs. Affordability” of Biosimilars 

The talk will cover the current Biosimilars scenario, delving upon the debate around 

balancing the aspects of "profit for sponsors" vs. "affordable medicine for patients;" 

and discuss innovative approaches to enhance the cost effectiveness of biosimilars. 

Srinivasan Raman, General Manager, Operations, Biologicals Manufacturing, 

Biocon Limited, India 

11:30 How Similar Is a Biosimilar? 

Tissue plasminogen activator (t-PA) is a well characterized product. The biosimilar 

recently approved in India shows significantly high similarity in the carbohydrate 

moiety. However, the impurity profile and aggregates are significantly higher. The 

thrombolytic activity in various arrays is significantly below the innovative t-PA. 

From a protein analytical perspective and the consequences for the patient benefit 

the biosimilar cannot be considered to be similar. 

Barbara Esch, Ph.D., Director, Industrial Customer Business, Corporate Division 

Biopharmaceuticals, Boehringer Ingelheim GmbH, Germany 

7:00 Coffee 

7:15 Technology Workshop 

Rapid Molecular Methods for Pharmaceutical Quality Control and Process Development 

With recent regulatory recommendations and acceptance of Genotypic-based methods, these highly accurate and rapid technologies are being 

adopted for routine monitoring of biopharmaceutical products from process development through final product release. This workshop will provide 

an overview on rapid assays for broad species detection of Mycoplasma and monitoring of Residual DNA using a Real-Time PCR approach along 

with comparative DNA sequencing for accurate microbial identification using the MicroSeq® Microbial Identification system. 

James Bruce, Senior Product Manager, Applied Biosystems 


Use of Scale Down Models throughout Product Lifecycle: 

Early to Late to Post Registration: Case Studies 


David H. Reifsnyder, Ph.D., Principal Scientist, Process Development-Late Stage 

Purification, Genentech, Inc. 

8:15 Use of Computational Fluid Dynamics (CFD) to 

Identify and Resolve Cell Culture Issues Observed 

at Production Scale during Technology Transfer 

CASE 

STUDY 

We present a numerical case study on the environment to which cells are exposed 

in mechanically agitated and sparged bioreactors. The most relevant parameters 

are compared for two modeled production scale bioreactors with different designs 

and process conditions. Such information helps us to understand the culture 

process performance issues encountered during technology transfer, and to 

identify an optimal operating parameter design space. 

Zhiwu Fang, Ph.D., Principal IS Informatics Analyst, Amgen Inc. 

8:45 Application of CFD Modeling for Process 

Optimization in a New Large Scale Mammalian Facility 

CASE 

STUDY 

During start-up of HGS’s 20,000 L scale facility, cell growth and titer were lower than 

previously observed at pilot scales. This presentation will show how computational fluid 

dynamic modeling was utilized to determine the cause of and solution to the scaling issue. 

Stefanie Brady, Bioprocess Engineer, Human Genome Sciences, Inc. 

9:15 Use of a Scale-Down Model to Troubleshoot Cell 

Damage in Large Bioreactors 

CASE 

STUDY 

We have developed a scale-down model to investigate the effect of high gas 

sparger velocity on cholesterol-independent NS0 cells. The model correlates well 

with our observations of low cell viability and low antibody titer in some 600 L 

fed-batch cell cultures. This model has been used to develop design criteria for gas 

spargers in large bioreactors (e.g. 10k L) for high cell density antibody production. 

Ying Zhu, Ph.D., Scientist II, Upstream Processing, PDL BioPharma 


10:30 Scale-Up of a Mammalian Cell Culture Process: 

Internal and External Technology Transfers 

CASE 

STUDY 

Scale-down models enable robust process characterization studies and aid in process 

trouble-shooting and resolution of issues prior to commercial manufacturing. This 

presentation addresses some of the limitations of scale down models in terms of 

achieving all end points for product quality and process performance. Examples for 

both upstream and downstream unit operations are provided to illustrate key concepts. 

Sushil Abraham, Principal Engineer, Process Development, Amgen Inc. 

11:00 Using Scale Down Models at Various Stages during 

Commercialization of Biopharmaceuticals 

CASE 

STUDY 

Scale down models are not just a good idea, but they are essential during product 

transfers and during the entire commercial life cycle. This case study will present 

interesting examples and learning from both upstream and downstream processes 

where scale down models were used, sometimes successfully and sometimes not so 

successfully, to enable rapid product transfer, troubleshooting during commercial 

production and to drive continuous improvement of commercial processes. 

Aimee Lehman, Manufacturing Technical Specialist, Genentech, Inc. 

11:30 Development of a High Throughput Manufacturing 

Process for an Ovine Polyclonal Fab Fragment 

CASE 

STUDY 

In the original conception small scale process studies’ multi-factorial design 

considerations were purely related to the actual experiment. Their meaning now is to 

expand the design space, product characterization forced degradation studies as well 

as comparability elements to support perhaps several manufacturing sites and multiple 

sourced raw materials. This presentation will cover these aspects in relation to a large 

scale (> 120 Kg IgG per purification batch) ovine Fab fragment process and the process 

development linkage with the establishment of a commercial supply chain. 

Richard Francis, Director, Process Science, Protherics plc, United Kingdom 


Wednesday, September 24, 2008 • Main Conference (continued) 


Human Monoclonal Antibody Production Using a Disposable, 

Stirred-Tank Bioreactor and Novel Process Analytics 

This presentation looks at application-specific modeling systems for individual applications 

using the following as examples: storage and shipping systems, mixing systems, and bioreactor 

systems. The modeling systems are intended to address key areas of concern, to assess the 

direct and indirect benefits, and to give simple but customer-specific guidance. Process 

modeling systems which cover the whole manufacturing flow are also discussed. 

Cory Card, Senior Technical Services Manager, Thermo Scientific 

Modern Equipment for the 

CASE 

Management of Today’s High Titers and 

STUDY 

Perceived Downstream Processing Bottlenecks 

Productivity improvements from high expression levels and efficient 

capture of biomolecules need to be fully harvested. Next step is to 

upgrade equipment and product flow for optimized productivity during early product 

development. This presentation describes how to manage bottlenecks in existing and 

future facilities with focus on solutions that enable savings in time, resources and floor 

space to increase flexibility, robustness, scalability and quality. 

Roger Nordberg, Product Manager/Marketing, GE Healthcare, Sweden 

Sara Corin, Product Manager/Marketing, GE Healthcare, Sweden 



Amgen Inc. 


2:15 FDA Manufacturing Initiatives in 


Quality by Design (QbD), Pharmaceutical cGMPs for the 21st 

Century, and Process Analytical Technology are initiatives being 

applied to small molecule pharmaceutical development and there 

is significant interest in using QbD for biotechnology products. 

Although the principles are applicable, there may be some unique considerations 

for these products. The FDA critical path initiative may also provide 

opportunities for enhancing the development of biotechnology products. 

Steven Kozlowski, Ph.D., Director, Office of Biotechnology Products, OPS, 

CDER, US FDA 

2:45 Biomanufacturing 2008: Where We’ve Been, 

Where We’re Going, and Why 

Randy Maddux, Ph.D., Vice President, Manufacturing 

Operations, Human Genome Sciences, Inc. 

3:15 Post-Registration Process Changes: 

Considerations for Comparability 

Post-approval changes to manufacturing processes may be driven 

by the need to scale up to meet market demand, to enhance 

the overall robustness and reproducibility of the process or to 

stay abreast of evolving technology or regulatory requirements. 

Comparability protocol design strategy is an integral component of a 

successful post-registration process change. Strategies that may be employed 

for different types of process changes will be discussed. 

Robert A. Baffi, Ph.D., Senior Vice President, Technical Operations, 

BioMarin Pharmaceutical Inc. 


Plenary Session 

Bringing Downstream Productivity into Phase with Cell Culture 

Production with Monolithic Chromatography Supports 

Monolithic anion exchangers have recently demonstrated 50 times more effective DNA 

removal than traditional ion exchangers and twice the capacity of membranes. They have also 

demonstrated monoclonal antibody binding capacities greater than 40 mg/mL in high resolution 

bind-elute applications at linear flow rates greater than 3,000 cm/hr. This presentation will clarify 

the distinction between diffusive and convective chromatography supports and demonstrate the 

ability of convective supports to relieve the current bottleneck in downstream processing. 

Pete Gagnon, Chief Consultant, Validated Biosystems Inc. 

Qualification of the Octet System for Rapid IgG Titer Determination 

to Streamline Clone Selection and Cell Line Optimization 

Accurate titer determination remains a challenge, for cell line development, with less than desirable 

precision, accuracy, and throughput. A new technology was evaluated that provides a > 10x decrease 

in hands-on time and turnaround time vs. both HPLC and ELISA while providing accuracy and 

precision comparable to that of Protein A HPLC without the HPLC waste or maintenance. 

Keith A. Davis, Ph.D., Scientist, WPGRD, Global Biologics, Pfizer Inc 

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


4:15 Paths to Flexible Regulatory Notification 

of Large Molecule Life-Cycle Changes 

The seeds allowing for more flexible reporting options are sown 

early in the large molecule development process with an eye on 

reaping the benefits throughout the product lifecycle. This talk will 

focus on the unique aspects of large molecules in the generation 

and demonstration of this enhanced knowledge in the initial registration to best 

facilitate innovation and process improvements post-registration. 

John K. Towns, Ph.D., Director, Global CMC Regulatory Affairs, Eli Lilly and Co. 

5:00 Biosimilars – Follow-on Biologics – 

Subsequent Entry Biologics – Biogenerics? 

This presentation will discuss the current regulatory issues 

surrounding Biosimilars, Follow-on Biologics and Biogenerics. 

Specific concerns will be addressed with respect to how significant 

molecular differences will be identified and adjudicated as part of 

this process. The utility of bioassays and human clinical trials as compared to 

current analytical capabilities will be discussed and opportunities for regulators, 

the academic community as well as the generic and ethical pharmaceutical 

industry to work together to resolve these issues will be explored. 

Robert L. Garnick, Ph.D., Senior Vice President, Regulatory, Quality and 

Compliance, Genentech, Inc. 

5:45 Networking Cocktail Reception 

in Exhibit and Poster Hall 

Exhibit Hall Keynote 

6:30 The Treacherous Path to Success 

in the Biotech Industry 

After three decades of phenomenal scientific discovery in 

biotechnology, substantial uncertainty remains in the path 

of translating science into commercial success. Lessons from 

summiting the 7,000m Nepalese peak of Ama Dablam help in 

defining the goals and managing the risk of innovation in commercializing 

biological products. Setting the right goals and correct metrics is essential to 

mapping an efficient route to navigate the technical and regulatory uncertainty 

in manufacturing tomorrow’s products today. 

Prof. Charles L. Cooney, Robert T. Haslam (1911) Professor, Department 

of Chemical Engineering, and Faculty Director, Deshpande Center of 

Technological Innovation, Massachusetts Institute of Technology 


Thursday, September 25, 2008 • Main Conference 

7:00 Coffee 


Technology Workshop still available. Please contact Kristen Schott at (508) 614-1239 or kschott@ibcusa.com for more information. 

1 

2 





Choose from these Small Group 

Discussion Sessions and Workshops 

Sessions #1 and #2 will take place concurrently from 

8:00 am to 12:00 pm with a break at 9:45 am. 

Participation will be limited to 35 participants 

on a first come, first served basis. 

Workshop Discussion Session #1 

Lean Six Sigma in a Biotech 

Setting: Constraint or Enabler? 

Six Sigma is a well known program for compressing process 

variability and eliminating non-value adding work that has 

been applied in many business settings. Six Sigma has been 

applied with mixed success in the biotech industry. It has been 

suggested that Six Sigma is inappropriate for the biotech setting 

because it is a constraint upon creativity, hinders continuous 

improvement, and adds an administrative burden that slows 

speed to market endeavors. It has also been observed that, in 

a period where QBD and platform technologies are becoming 

more important to biotech, Six Sigma can provide a structure 

and shared vocabulary between business units and companies 

that aids innovation and speed to market. This workshop will 

explore both perspectives through facilitated discussion and 

examples of Six Sigma practices in the biotech industry. 

Note: This same discussion will be run two times in a row, first from 8:00 

am to 9:45, then again from 10:30 am to noon. Participation in each 

section will be limited to 35 participants on a first come, first served basis. 

Facilitators: 

Jeffrey C. Baker, Ph.D., Senior Research Advisor and Six 

Sigma Black Belt, Eli Lilly and Company 

Paul W. Allen, Vice President, Managing Partner, 

Life Sciences, Clarkston Consulting 

Discussion Session #2 

Standards for Disposables: 

What would End-Users Like to See? 

Disposable technology has made significant gains in popularity 

in recent years, based improvements in technology and on 

drivers such as convenience, flexibility, and capital deferral. 

However, there are user concerns over sourcing, disposal, and 

the proliferation of differing solutions to the same problems. 

Industry groups such as ISPE, PDA and BPSA have formed 

groups to address these concerns. In this workshop we will 

attempt to have a balanced discussion on the pros and cons 

of disposable technology and discuss where standards are 

required and what kind users would like to see. 

Moderator: 

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

Development, Amgen Inc. 

Panelists: 

Adam Goldstein, M.S., Senior Manager, Oceanside Clinical 

Operations, Genentech, Inc. 

Miriam Monge, Vice President, BioPharm Services, U.K. 

Justin Hutchinson, Bioprocess Systems Product Manager, 

Thermo Fisher Scientific 

Andrew Sette, Director of Quality and Regulatory Affairs, 

Sartorius-Stedim Biotech, France 

Jason Slinchak, Manufacturing Engineer, 



3 Recovery & Purification 


4 

Track Sponsor: 

8:00 Track Sponsor’s Introduction: 

Taking the Industry to the Next Level 

Thomas Isett, Vice President, 

BD Biosciences – Advanced Bioprocessing 


Dennis M. Kraichely, Ph.D., Principal Research 

Scientist, Expression Technologies, Centocor, Inc. 

Advances in Cell Line 

Development & Clone Selection 

8:15 Selecting GS-CHO Cell Lines for 

Antibody Manufacture 

After transfection, a sequential series of 

screens are typically used to select a ‘desirable’ 

cell line for antibody manufacture from the 

heterogeneous population. Cell line behavior 

in such a strategy was studied and compared 

with subsequent behavior in bioreactor culture. 

Although highly productive cell lines can be 

selected, potential strategies for improving the 

‘hit rate’ of identifying ‘good’ manufacturing cell 

lines will be discussed. 

Alison Porter, Science Leader, Cell Culture Process 

Development, Lonza Biologics 

8:45 Manufacturability Assessments 

CASE 

for Early Stage Therapeutic 

STUDY 

Candidate Screenings Using 

Biophysical Characterization 

Transferring lead molecules from research into 

process development at a relatively fast pace 

requires a process of candidate selection that 

assesses not only if a candidate is active and 

safe, but also “manufacturable.” Biophysical 

characterization of lead candidates prior to 

reaching process development helps rank 

candidates for conformational and colloidal 

stability. This assessment is especially useful when 

binding affinity and bio-activity are comparable 

among the candidates. Case studies of antibodies 

assessed for manufacturability under process 

conditions will be presented. 

Ranjini Ramachander, Ph.D., Senior Scientist, 

Amgen Inc. 


Uwe Gottschalk, Ph.D., Vice President, 

Purification Technology, Sartorius Stedim 

Biotech, Germany 

Overcoming Challenges of 

Large Scale Protein Production 

– Present and Future 

8:15 Development of a Precipitation 

Alternative and Improvements for 

Protein A for Impurity Reduction 

in Clarified Broth Containing a 

Monoclonal Antibody 

Improvements in titer have resulted in a potential 

bottleneck in downstream purification, which 

may be addressed by reduction in the number 

of chromatography steps or optimization of the 

existing unit operations. This presentation will 

discuss the evaluation of potential precipitants to 

reduce the level of impurities in clarified broth 

prior to capture chromatography, as well as 

various strategies and wash solutions on the initial 

Protein A step to maximize its efficiency. 

Judy K. Glynn, Ph.D., Senior Principal Scientist, 

Global Biologics, Pfizer Inc 

8:45 Scale-up Evaluation of Selective 

Antibody Precipitation and 

Continuous Recovery with a 

Disc-Stack Centrifuge 

Methods for selective precipitation of monoclonal 

antibodies with production bioreactor titers 

greater than 2 g/L have been developed at 

Biogen Idec as an alternative to chromatography 

for enhanced throughput and purification of 

antibodies. To demonstrate the scale-up of this 

process, antibody was precipitated from 200 L 

batches of clarified cell culture media and fed to 

the same continuous disc-stack centrifuge used 

for cell harvesting. Antibody precipitate was 

successfully collected with high recoveries in 

the solids discharge vessel while antibody-free 

supenatant was sent to waste. In summary, this 

precipitation technology will be compared to 

traditional chromatographic capture methods. 

Philippe de Vilmorin, Engineer, 

Biopharmaceutical Development, Biogen Idec 

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. 


Thursday, September 25, 2008 • Main Conference (continued) 

1 

2 

Afternoon Sessions 

Sessions #3 and #4 will take place concurrently from 

1:45 pm to 6:00 pm with a break at 3:30 pm. 

Participation will be limited to 35 participants on a 

first come, first served basis. 

Discussion Session #3 

Biosimilars: Where Are We Now? 

With patents covering many of the leading 

biopharmaceutical blockbuster products soon to expire, 

many companies are lining up to introduce biosimilar 

products into the marketplace. Unlike small molecules, 

where equivalency of a generic product to the innovator 

products can be easily established using chemical 

analysis and minimal animal and human clinical testing, 

the equivalency of a biosimilar product to the original 

biopharmaceutical product is not as readily demonstrated. 

In this panel discussion we will explore the significant 

technical, regulatory, and economic challenges faced by 

companies attempting to seamlessly transition biosimilar 

replacement products into the marketplace. 

Moderator: 

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


Panelists: 





Robert L. Garnick, Ph.D., Senior Vice President, 

Regulatory, Quality and Compliance, Genentech, Inc. 

Robert A. Baffi, Ph.D., Senior Vice President, Technical 

Operations, BioMarin Pharmaceutical Inc. 

Srinivasan Raman, General Manager, Operations, 

Biologicals Manufacturing, Biocon Limited, India 

Workshop Discussion Session #4 

Use of Scale-down Models in 

Non-Conformance Resolution 

Bench-scale investigations utilizing scale-down models to 

resolve non-conformances, specifically to identify root-cause 

and corrective actions, are among the most demanding 

and scrutinized applications of scale-down models. This 

interactive peer-to-peer discussion will explore the current 

and future state of scale-down models in the context of 

their use for non-conformance resolution towards a goal of 

increasing their exactness for this critical application. 

Facilitators will introduce the topic, and small workgroups 

will collaborate to consider in-depth hypothetical exercises. 

The groups will then each present a summary of their tables' 

perspectives to the room. 

Facilitators: 

Richard Francis, Director, Process Science, Protherics plc, 

United Kingdom 

David H. Reifsnyder, Ph.D., Principal Scientist, Process 

Development-Late Stage Purification, Genentech, Inc. 




4 

9:15 Approaches to Accelerate Speed to 

GMP Manufacturing 

Once antibody candidates are identified, cell 

line development and studies to select the lead 

candidate are usually on the critical path to 

clinical trials. Therefore, changes to the process 

that reduce timelines and risk can have a direct 

impact on the time to clinic. Strategies to increase 

speed and reliability will be discussed. 

Stephanie E. Rieder, Ph.D., Senior Scientist, 

Abbott Bioresearch Center 

9:45 Networking Refreshment Break in 

Exhibit and Poster Hall 

10:30 Discovery of Biomarkers Associated 

with Expression Stability during 

Metabolic Selection and Gene 

Amplification in Recombinant 

IgG-Producing Chinese Hamster 

Ovary Cells 

We used clonal CHO GS cell lines expressing 

a recombinant human IgG with different 

productivity and stability pre- and post-gene 

amplification mediated by MSX. We analyzed 

copy numbers and mRNA levels of IgG heavy/ 

light chains, transcription profiles using DNA 

microarray and protein expression profiles 

2-D Differential Gel Electrophoresis. Our 

biomarker discovery studies will shed light on cell 

engineering target selection. 

Nan Lin, Ph.D., Principal R&D Scientist, Cell 

Sciences and Development, SAFC Biosciences 

11:00 Comparison of a New Human 

Host Cell Line with CHO for the 

Development and Production of 

Recombinant Therapeutics 

A human cell line (F2N) engineered by somatic 

hybridization resulted in stable expression of 

inherited phenotypes. Optimal product quality 

could be achieved in transient or stable transfection 

formats with high-level protein expression. This 

presentation will cover development of F2N, in 

comparison with CHO, for the versatile production 

of recombinant therapeutics. 

Myung-Sam Cho, Ph.D., Senior Advisor, 

R&D Center, Celltrion, Inc., Korea 

11:30 Managing Cell Line Instability 

CASE 

and Its Impact during Rapid 

STUDY 

Cell Line Development 

Successful phase 1 cell line development relies 

on the ability to generate stable, high-producing 

clones in a short timeframe. While we consistently 

achieve this objective, we have observed 

expression instability in some of our clones. 

We will present data from independent case 

studies, describe the methods and tools we use 

to investigate instability, and discuss some of the 

operational consequences of instability upon our 

cell line development paradigm. 

Robin A. Heller-Harrison, Ph.D., 

Associate Director, Cell & Molecular Sciences, 


9:15 Impurity Removal during 

Clarification of Cell Culture 

Harvest with Continuous Flow 

Centrifugation and Depth Filtration 

Depth filtration is the preferred method of 

clarification for perfusion bioreactor cell cultures 

at Centocor. With the introduction of fed batch 

cell culture, alternative clarification methods were 

investigated to increase the processing efficiency. 

To perform this evaluation, fed-batch harvests of 

several Centocor products were processed through 

depth filtration with and without centrifugation. 

These clarification techniques were investigated to 

determine effect on product quality and recovery, 

specifically the host cell DNA and host cell protein 

(HCP) contents. 

Joseph Lepore, Associate Manager, 

Pharmaceutical Development, Development Pilot 

Plant, Centocor R&D 

9:45 Networking Refreshment Break in 

Exhibit and Poster Hall 

10:30 Challenges of Ultrafiltration 

Processing with High Concentration 

IgG Solutions 

Ultrafiltration has been extensively used for 

the concentration and diafiltration of protein 

solutions. As the target final concentration of 

biopharmaceutical antibody solutions approaches 

levels of 150g/L, challenges can arise associated 

with system operation and the recovery of viscous 

product solutions. Processing methods and 

product recovery strategies are presented. 

Jon Petrone, Global Technical Director, Technical 

Support Group, Pall Life Sciences 

11:00 Enhancement of Peptibody 

Downstream Platform: Direct 

Chromatography Capturing of 

Peptibody from Oxidation Pool 

For a product undergoing commercialization, 

we examined the possibility of using a direct 

capturing chromatography step from the oxidation 

pool to replace multiple unit operations including 

UF/DF, acid precipitation and clarification 

by centrifugation. This talk will present data 

comparing the two approaches in terms of process 

throughput, scalability, robustness and raw 

material and capital costs. In addition, process 

performance will also be compared. It will be 

shown that use of a direct capture step leads to 

increased throughput, lowered manufacturing 

costs and improved scalability. 

Yuefeng Lu, Ph.D., Principal Scientist, Global 

Proocess Engineering, Amgen Inc. 

11:30 Membrane-Based Primary Recovery 

Process for Perfusion Process 

Daily harvest and isolation of dilute and 

sometimes unstable product from a perfusion 

process require a fast and robust process. 

In-line cell removal and membrane-based 

chromatography process fits such unique 

requirements. The process decouples a continuous 

process from the downstream batch process and it 

“de-bottlenecks” the high liquid throughput from 

a typical perfusion process. 

Paul Wu, Manager of Protein Isolation, 

Bayer Healthcare 




Impact and Benefits of PAT in Industrial Downstream Processing 

A Case Study of 3 different technologies (In-line Dilution, Sequential Multi-Column 

Chromatography & Batch Chromatography) will be shown with Process Analytical 

Technologies which were developed, scaled-up and implemented at the industrial scale. An 

evaluation of the implementation impact and potential savings of COG’s will be presented. 

Michael LaBreck, Sales Manager, Novasep, Inc. 

The Best of Both Worlds – Performance, 

Consistency and Compliance: Advances in 

Defined, Animal-Free Supplements Allow You 

to Rethink Your Media Regime and Optimise Productivity 

The ideal media for today is robust, containing defined, animal-free supplements that deliver 

optimal cell growth, productivity and product consistency. In this study we compare recombinant 

forms of two key serum proteins, transferrin and IGF-I, to commonly used iron supplements. 

We report on their ability to stimulate cell growth and productivity and demonstrate that in 

combination rTransferrin and LONG®R3IGF-I achieve synergistic performance. 

Sally Grosvenor, Senior Scientist & Scientific Communications Manager, Applied R&D, 

Novozymes Biopharma AU Ltd, Australia 

Advances in Single Use 

Capture Chromatography 

Disposable buffer bags, tubing, aseptic connectors, and viral clearance filters have 

demonstrated their value vs conventional reusable technologies. Nysa has developed a 

membrane-based single use capture chromatography technology to provide users with 

further options for the implementation of single use systems in their bioprocesses. This 

workshop will discuss applications for single use capture chromatography technology with an 

emphasis on the interplay between applications, product format and membrane chemistries. 

Chris Shields, MBA, Marketing Director, Nysa Membrane Technologies, Inc. 

Overcoming Challenges in Contaminant Removal in Biomanufacturing 

High titer cell culture processes challenge the contaminant removal capacity of traditional 

downstream process technologies. It becomes obvious that new approaches and technologies 

are necessary to overcome these limitations. New technologies are in the pipeline to remove 

contaminations very early on in the downstream process. This presentation will focus on 

disposable chromatography and a new cellulose fiber based depth filter. 

Christian Manzke, Ph.D., Director, Purification Technologies, North America, 

Sartorius Stedim North America Inc. 

3 Cell Culture & Upstream Processing 


12:30 Panel Discussion 

Cell Engineering the Future - A Role for Media Innovation 

Over the last decade the productivity of mammalian cell culture processes have 

improved dramatically. Gene copy number and clonal selection strategies have 

underpinned this improvement. Is further improvement achievable from cell 

engineering? Novel media components including bio-active molecules could 

enhance productivity gains from cell engineering by favourably regulating cells' 

physiological responses. 

Panel Moderator: 

Geoffrey Francis, Ph.D., Chief Scientist, Applied R&D, 

Novozymes Biopharma AU Ltd, Australia 

Panelists: To be announced 

Sponsored by 

1:00 Networking Luncheon in Exhibit and Poster Hall 


Stephen Gorfien, Ph.D., Director, BioProduction Products and PD-Direct Media 

Services, Invitrogen Corporation 

Proven Strategies for Process Development & Optimization 

2:00 Case Study for the Replacement of a Conventional 

CASE 

Stainless-Steel Bioreactor with a 500-Liter 

STUDY 

Disposable Bioreactor for Antibody Production 

This presentation will review the experience of replacing a conventional stainlesssteel 

bioreactor with a 500-liter disposable system manufactured by Xcellerex® for 

an existing antibody production process. Challenges included risks associated with 

investing in a new technology, meeting production demands, extractable/leachable 

concerns, and the ability to meet project timelines. A review of the factory acceptance 

testing, installation and operational qualifications, and engineering runs will be 

discussed. A comparison of growth and productivity between a conventional 340- 

liter stainless bioreactor and the 500-liter disposable system will be reviewed as well 

as overall project timelines. 

Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, 


2:30 Applying Quality by Design in Cell Culture 

Development to Balance Target Product Quality 

and Process Robustness 

CASE 

STUDY 

Cell line changes can frequently lead to differences in product quality (PQ) 

between clinical phases and raise product comparability issues. To manage this 

risk, we use QbD tools such as DOE and risk assessment to study interactions 

and process variability and to identify key process parameters that impact PQ and 

process robustness. This presentation will use case studies to illustrate how we 

balance PQ and process robustness during cell line or process changes. 

Jian Wu, Ph.D., Principal Scientist, Cell Science and Technology, Amgen Inc. 

12:30 Networking Luncheon in Exhibit and Poster Hall 


Peter W. Wojciechowski, Director, Process and Analytical CMC, 

Johnson & Johnson Regenerative Therapeutics 

Approaches for Successful 

Process Development and Optimization 

2:00 PiP (Purification in Plate) – A Scale-Down Method 

CASE 

for High Throughput Chromatographic Purification 

STUDY 

Process Development: Two Case Studies 

The first case study is determination of step elution conditions for the cation exchange 

chromatography resin, SP Sepharose Fast Flow, using a scale-down wellplate based 

model. The second case study is measurement of static binding capacities for the 

Protein A affinity chromatography resins, MabSelect SuRe and ProSep-A high capacity, 

in microtiter filterplates and prediction of dynamic binding capacities using the pore 

diffusion controlled mass transfer model. Results show that PiP can be used to predict 

the column performance and used as a screening tool to narrow down design space and 

characterization space for chromatography purification process development. 

Junfen Ma, Ph.D., Engineer II, Oceanside Process Research & Development, 


2:30 Platform Development Approaches for Non-Platform 

Projects: How to Efficiently Develop Purification Processes 

for Non-Antibody Drugs 

Platform approaches have become a key element of industrial downstream 

process development. However, for a versatile product portfolio of non-antibody 

drugs, a generic, predefined column cascade does not exist. In this talk we 

describe a comprehensive ‘platform-like’ approach involving automated sorption 

parameter screening, custom affinity ligand design and scale-up modeling to 

facilitate lean process development for products which do not fit into a predefined 

purification platform. 

Tim Herrmann, Process Development Scientist, Global Biological Development / 

Purification, Bayer HealthCare LLC 

“IBC conference forums have always been 

a perfect peer platform, both for sharing one’s knowledge 

and learning from others at the same time. I am looking 

forward to being at BPI 2008.” 

– Srinivasan Raman, General Manager, Operations, Biologicals 

Manufacturing, Biocon Limited, India 



3 Cell Culture & Upstream Processing 


3:00 Efforts to Understand and Control Glycosylation in 

CHO Cell Culture Processes 

Maintaining consistent glycosylation may be important to ensure consistent 

rhuMAb biological activity. To enhance understanding of glycosylation, historical 

data from multiple products was analyzed to identify correlations between 

glycoform distribution and culture parameters and performance. Specific process 

parameters and culture additives were also tested to identify factors or cellular 

components that may be rate limiting and contribute to glycosylation variability. 

Melissa Mun, Engineer I, Late Stage Cell Culture Process Research & Development, 



– Final Opportunity for Poster and Exhibit Viewing 

4:00 Development of a Simplified Production 

CASE 

Bioreactor Small-Scale Model for a Monoclonal 

STUDY 

Antibody Manufacturing Process 

We compare a current mAb production bioreactor SSM with simpler aeration 

strategies. Two aeration strategies were tested: 1) a constant CO2/air overlay, and 2) 

a fixed CO2:O2 sparge ratio. The impact on cell culture performance and product 

quality attributes will be presented, as well as a discussion on the feasibility of 

implementing the modified aeration strategies based on equipment capability. 

Sara Gall, Associate Scientist, Process Development - Cell Sciences and Technology, 

Amgen Inc. 

4:30 Automation of GS-CHO Cell Line Development 

CASE 

Together with Pool Strategy Enables Rapid and 

STUDY 

Cost Efficient Biopharmaceutical Development 

Cell line development using the Cello robotic system and a transfection pool strategy 

for delivery of early pre-clinical material was performed in parallel to shorten timelines 

in biopharmaceutical development. Pre-clinical material was harvested within 10 weeks 

from a 20L-bioreactor containing ~3g/L. A clonal cell line producing 5g/L in 100ml 

fed-batch shake flask culture was achieved using the same expression plasmid. 

Kristina Lindgren, Ph.D., Scientist, BioProcess R&D, Upstream Development, 

AstraZeneca 

5:00 A High Throughput Platform Development for 

Clone Selection and Process Development 

CASE 

STUDY 

A high throughput system has been developed at Eli Lilly. Cell densities and titers 

in this HTP system are compatible to shake flasks in 14 days fed batch process, 

though differences were also observed in some projects. Multiple clones and 

process conditions can be tested simultaneously in this system and therefore, 

accelerate and improve the cell culture process development. 

Anli Ouyang, Ph.D., Research Scientist, Bioproduct Research and Development, 


5:30 Post-Approval Process Modification Strategies and 

CASE 

Challenges with a Perfusion Cell Culture Produced 

STUDY 

Recombinant Protein 

Learn about this media cost savings project and the validation strategies and 

challenges inherent in a perfusion cell culture process. With cell culture campaigns 

exceeding 4 months, traditional process development and validation strategies were 

not practical. The presentation will address process development study design, 

validation/regulatory/implementation strategies, selection of validation acceptance 

criteria, and risk management of non-insulin related validation discrepancies. 

Jin Wang, Ph.D., Manager, Manufacturing Sciences – Fermentation, 

Bayer Healthcare 

3:00 Solutions to Fusion Molecule Purification 

CASE 

STUDY 

EA2 is a unique, engineered fusion molecule composed of three 

domains: an enzyme, Fc, and an anionic peptide. As such, it presented challenges 

in its purification, as each of the domains had different binding properties and 

stabilities. For example, we found that standard platform purification steps such as 

Protein A chromatography required extensive modification. The presentation will 

cover evaluation of several different purification modalities and selection of a final 

process for production of clinical material. 

Thomas Loisel, Ph.D., Group Leader, Biology, Enobia Pharma, Inc. 

Michiel E. Ultee, Ph.D., Senior Director, Process Sciences, Laureate Pharma, Inc. 


– Final Opportunity for Poster and Exhibit Viewing 

4:00 Rapid Development of a Downstream Purification 

CASE 

Process for Production of a Monoclonal Antibody 

STUDY 

Screening of chromatography resins and operational conditions are done in 

parallel using High Throughput Process Development (HTPD) formats. The 

conditions are further optimized and verified in small column format, where after 

the purification process is transferred to a scale suitable for clinical Phase 1-2. 

Clinical material for these phases is produced in only a limited number of batches 

after which the used chromatography resins as well as other consumables are 

being discarded. A comparison between a conventional process and a process that 

utilizes ReadyToProcess (pre-packed) columns will be given. 

Kjell Eriksson, Ph.D., Senior Scientist, R&D, GE Healthcare, Sweden 

4:30 From 3 to 2 with DoE: 2-Step Process 

Development for Monoclonal Antibodies 

CASE 

STUDY 

Purification processes for monoclonal antibodies are usually based on 3 

chromatographic steps: Protein A affinity, ionic exchange and a polishing step. With 

the objective of productivity gains – higher yields, lower costs and less time – while 

maintaining good purification performance, we have challenged the generic approach 

and reduced the number of steps from 3 to 2. The successful implementation of a 

2-step purification will be demonstrated using a concrete example. 

Nora Eifler, Ph.D., Lab Head, Biotechnology Development, 

Novartis Pharma AG, Switzerland 

5:00 Off-Target Retentate pH Linked to Rejection of Buffer Species 

by Industry-Standard Ultrafiltration/Diafiltration Membrane 

An inherently uncharged ultrafiltration/diafiltration membrane has been demonstrated 

to accumulate enough charge under low ionic strength conditions to cause rejection of 

diafiltration buffer species, resulting in unequal retentate and buffer pH. This talk may 

be of interest to anyone responsible for the development, tech transfer, or validation of 

ultrafiltration/diafiltration processes or biopharmaceutical formulations. 

Bryan Holmes, Bioprocess Engineer, Purification Process Development, 


5:30 The “Eyes and Ears” of Successful Process Development 

Recombinant glycoproteins intended for therapeutic use may be complex in nature. 

The diversity is defined by the manufacturing process. The earlier an evaluation 

of specific biochemical characteristics begins during process development, the 

better the understanding of the process design space, and implications for process 

refinement or change. Such data are also critical in defining a robust manufacturing 

process that would ensure product quality and consistency. In this presentation we 

will discuss applications of selected orthogonal analytical methods that may be used 

to support process development and product characterization. 

John Harrahy, Ph.D., Staff Scientist II, Bioanalytical Development, 


Site Tour 

Irvine Scientific (Thursday Afternoon) 

Irvine Scientific is a world supplier of cell culture media which specializes in custom cell culture media. During the facilities tour 

at the BPI 2008 IBC Conference in Anaheim the participants will learn about Irvine Scientific’s large manufacturing capacity, the 

high quality product that we process using the highest standards of a class II medical device-licensed company and that our 

staff members are dedicated to the highest level of customer service for a full spectrum of collaborative services, with rapid turnaround times, from inception to commercialization. 

During our facility tour, the participants will be able to view the liquid and powder manufacturing areas, Quality Control and Research & Development laboratories, as well as have 

access to Irvine Scientific’s knowledgeable personnel that will be able to address any questions they may have. 

The buses will depart at 1:00 pm on Thursday and return by 5:00 pm. 

Please indicate your interest in the site tour on the registration form. Space is limited and available on a first come, first served basis. You will be notified if there is a space for you. 


Friday, September 26, 2008 • Main Conference 

7:00 Coffee 


Building Quality into High Performance Media and Supplement Design 

Building quality into bioprocessing development activities ensures a robust, consistent production process. Media and supplement 

selection can have a significant effect on the robustness of a process. Using a systematic approach to media design which incorporates 

Voice of the Customer, Design of Experiments, raw material selection, and manufacturing processes can produce a consistent, high 

performance medium in minimal time. 

Stacy Holdread, M.S., R&D Project Scientist, BD Biosciemces – Advanced Bioprocessing 

3 


4 



James W. Brooks, Ph.D., R&D Manager, 

BD Biosciences –Advanced Bioprocessing 

Keynote Address 

8:05 Manufacturing Support – Lessons Learned 

and Trends for the Future 

The complexity of commercial bioprocessing has impacted the 

organization and functioning of virtually all biotech companies. We 

will review the variety of existing models for Process Development 

and Manufacturing Support, and track their evolutionary path 

reflecting the growth and globalization of the industry. Several guiding principles 

can be extracted from past experiences. These are reviewed and illustrated with 

examples from large scale manufacturing of various recombinant proteins. 

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

Genzyme Corp. 

Evolution in Media Development & Feed Strategies 

8:45 Improving GS-CHO Process Performance and Robustness 

GS-CHO cell lines are widely used for the production of monoclonal antibodies. In 

order to meet an ever increasing demand in productivity and to improve process 

robustness, work was performed to upgrade Lonza’s generic fed-batch platform 

process. Focusing on optimizing pH, feeding strategy and feed composition, harvest 

titre was increased from 3.1 g/L to 6.8 g/L using a model cell line. 

Olof Larsson, R&D Scientist, Lonza Biologics plc, United Kingdom 

9:15 Deliberate Design of an Integrated Basal Medium, 

Feed Medium and Feed Strategy in a Fed-batch World 

CASE 

STUDY 

Case studies will be presented from scale-down models to Pilot Scale 

demonstrating how integrating basal media, feed and feed strategies can provide 

accelerated PD, titer enhancement, and process robustness/reproducibility 

required for therapeutic candidates to progress to clinical investigation and 

beyond. Discussion of why such shifts in philosophy are necessary for medium 

design and optimization will also be presented. 

Bryan D. Monroe, Process Science Fellow, Invitrogen PD-Direct BioServices 


10:15 Engineering of a Cholesterol-Independent, Non GS-NS0 

Cell Line and the High Titer (4.5 G/L) Fed-Batch Culture 

using Chemically Defined Media 

NS0 cells require exogenous cholesterol for growth. The cholesterol-dependent 

NS0 host was engineered and adapted to grow in cholesterol-free medium. The 

new host, as well as the wild-type, was transfected with a mAb, and in high cell 

density fed-batch cultures with chemically defined media, the top producing 

cholesterol-independent clone significantly out-performed the cholesteroldependent 

clone, with titer reaching 4.5 g/L vs 3.0 g/L, respectively, while key 

product quality attributes remained comparable. 

Jincai Li, Ph.D., Senior Engineer, Process R&D, Genentech, Inc. 


David W. Kahn, Ph.D., Director, Late-Stage Purification Development, 


Product Quality and Regulatory Considerations 

8:15 Comparison of Potential Monoclonal Antibody Purification 

Processes with Two Chromatography Steps 

Implementation of process platforms for the purification of monoclonal 

antibodies has improved throughput, decreased operational complexity, and 

decreased development time. Industry has traditionally used platforms consisting 

of three chromatography columns, but frequently minimal purification is needed 

following the Protein A affinity column. Previously, the use of anion-exchange 

chromatography as the sole polishing step has been shown to meet the product 

quality and viral clearance targets. This talk will compare other options for the 

sole polishing steps in a two-column process. 

John Moscariello, Ph.D., Senior Scientist, Purification Process Development, 

Amgen Inc. 

8:45 Isolation and Characterization of DNA from Cell Culture 

Bioreactors for Evaluation of Clearance through a 

Purification Process 

We have evaluated the nature of the DNA found in harvest filtrate from cell 

culture processes and prepared representative DNA pools for challenge studies. 

In particular we examine the effects of apoptotic CHO cell cultures and the 

clearance of fragmented DNA through the purification process. Changes in the 

DNA population for a monoclonal antibody during the course of target protein 

production will be described. 

Amanda Lewis, Senior Scientist, Purification Process Development, Amgen Inc. 

9:15 Evaluation of the Economical and Regulatory 

CASE 

Impact of Sequential Multi-Column 

STUDY 

Chromatography in Downstream Processing 

Technology principles and process know-how have been successfully 

extrapolated from continuous purification processes in petrol, food and small 

molecule industries to create powerful new tools for the downstream processing 

of biopharmaceuticals and help to “De-Bottleneck”. One example is Sequential 

Multi-Column Chromatography (SMCC), a semi-continuous purification 

technology, which can significantly increase purification productivity and 

reduce drastically buffer consumption and cost of goods compared to 

traditional approaches. A detailed explanation of SMCC will be given along 

with evaluation of the impact on cost of goods and process validation based on 

a case study. 

Margit Holzer, Ph.D., President, Biopharma Business Unit, Novasep Process, 

France 


Overcoming the Direct Impact of High Titer 

Processes on Downstream Processing 

10:15 Platform Facility Fit Issues for High Titer Processes 

Process development is challenged with designing purification processes that can 

fully recover the recent increase in cell culture titers at multiple manufacturing 

facilities. In addition, each monoclonal antibody brings its own set of unique 

challenges into the platform recovery process. This presentation will discuss 

fitting a high titer process into an existing facility by addressing the advantages 

and disadvantages of unit operation step order as well as the benefits gained from 

process optimization. 

Melody Trexler Schmidt, Ph.D., Scientist, Late Stage Purification, Genentech, Inc. 


Friday, September 26, 2008 • Main Conference (continued) 

3 


4 


10:45 Identification and Optimization of Peptone-Regulated 

Metabolic Pathways to Develop High-Performance 

Chemically-Defined Processes 

We have investigated the effects of replacing peptones with fully defined raw 

materials. CHO microarray analysis resulted in identification of hydrolysateregulated 

metabolic pathways. Substitution of hydrolysates with compounds 

aimed at modulating some of these pathways was instrumental in the successful 

development of chemically defined media. The media can be used in a highperformance 

platform approach for multiple antibody-producing CHO cell lines. 

Rebecca McCoy, Ph.D., Scientist, Cell Sciences and Technology, Amgen Inc. 

11:15 Next Generation Media Supplements: Beyond the Peptone 

toward Chemically Defined 

Until now, the industry has typically added hydrolysates to chemically defined 

media to achieve required process yields. Leveraging over 100 years of experience 

in peptone supplementation, BD has identified specific modulators of performance 

and is developing novel, next generation media supplements that deliver both 

breakthrough yield improvements and significantly greater definition. 

Jon C. Wannlund, Ph.D., Director of R&D, BD Biosciences – 

Advanced Bioprocessing 

"A great event that enabled me to 

get updated on all major aspects of bioprocess 

development and biopharmaceutical manufacturing, 

and to interact with technical experts/vendors 

in the most efficient way." 

– Dr. Jinyou Zhang, Executive Director, 

Immunomedics, Inc. 

10:45 Reconfiguration of a Commercial Biologics Facility to a 

Launch Facility for New Product Introductions: Balancing 

Process and Engineering Solutions 

As new products and processes are introduced in an existing manufacturing 

facility, gaps are identified in the facility capability and process requirements. 

Closing these gaps requires either addition of new capital to make the necessary 

engineering modifications or designing processes that fit into the existing facility. 

This case study will describe the evolution of a high volume, low cost production 

facility designed for a single mAb to a flexible plant with broad capabilities that is 

appropriate for rapid commercialization of several new mAbs. 

Shishir Gadam, Ph.D., Director, Manufacturing Sciences, Genentech, Inc. 

11:15 Interactive Panel Discussion 

Using BioSMB or Other Multi Column Approaches in High Titer 

Processes to Increase Efficiencies in Downstream Processing 

Sponsored by: 

• How can SMB and other multi column approaches help to streamline high 

titer processes? 

• What elements of BioSMB contribute increased flexibility when dealing with 

ever increasing (or changing) upstream titers? 

• How much savings in chromatographic media, buffer and WFI is realized? 

• What are the opportunities for an entire disposable process train? 

• How can overall process scale be reduced in terms of tank sizes and square feet 

of manufacturing space? 

• How can process monitoring aid in implementation of more continuous 

downstream processes? 

Moderator: 

Scott Fulton, Chief Technical Officer, Biosystem Development 

Invited Panelists: 

Marc Bisschops, Scientific Director, Tarpon Biosystems 

Jorg Thommes, Ph.D., Associate Director, New Technologies, Biogen Idec 


Advances in Downstream Process 

Development and Manufacturing to 

Accommodate PER.C6, a High Cell 

Density and Productivity Cell Line 

In this presentation, we will discuss: new advances 

in downstream process development for monoclonal 

antibodies based on improved conventional 

chromatography steps of extreme capacity but also 

based on novel single-use purification technologies; 

development of robust, scale-able methods for the 

clarification of such high cell density harvests; successful 

transfer, scale-up, and implementation of these 

technologies from bench scale to a cGMP manufacturing 

facility; effects of these process improvements on process 

economics and facility design. 

Gregory Zarbis-Papastoitsis, Ph.D., PERCIVIA LLC, 

and DSM Biologics, The Netherlands 

Impact of Hydrolysate Ultrafiltration 

on Cell Culture Performance and 

Filtration Characteristics 

Hydrolysates (peptones) are widely used in 

biopharmaceutical manufacturing to enhance 

cellular growth and productivity. Ultrafiltration is 

effective for removing large molecular weight entities, 

including endotoxin; however, some data suggest 

that ultrafiltration negatively impacts hydrolysate 

performance. In this study, multiple lots of LucraTone 

Soy P hydrolysate were evaluated in their ultrafiltered 

and non-ultrafiltered forms to determine their impact 

on performance. 

Michael Cunningham, Ph.D., Research Scientist 

Consultant, Millipore 

Performance of CellXpress Isolated 

Clones versus Traditional Limited 

Dilution Clones 

Selection of stable highly secreting recombinant cells 

is critical for robust biopharmaceutical manufacturing 

processes. If a high quality clone is not established 

serious issues can arise such as low or unstable protein 

yield and ineffective use of costly resources. The 

CellXpress platform combines in situ imaging with laser 

manipulation to efficiently identify, purify, and monitor 

expansion of high secreting clones. This presentation 

shows data comparing CellXpress to traditional limited 

dilution cloning to isolate and characterized mAb 

secreting single-cell clones. 

Genova Richardson, M.S., Senior Scientist, 

SAFC Biosciences 

12:15 Luncheon Presentation 

Improving Process-Flow in Schemes for Antibody Purification: Application of Hydrophobic 

Charge Induction Chromatography in Post-Capture Steps 

Conventional strategies for monoclonal antibody purification typically begin with affinity chromatography on a Protein-A sorbent 

followed by two additional chromatographic steps.This seminar will examine studies in which Mixed Mode Chromatography on MEP 

HyperCel is employed as the second step in the scheme, as an alternative to conventional HIC or other techniques. 

Warren Schwartz, Ph.D., Senior Technical Director, Pall Life Sciences 


3 

Friday, September 26, 2008 • Main Conference (continued) 



Thomas Seewoester, Ph.D., Director, Process Development, Amgen Inc. 

Impact of Upstream Advances on Downstream 

Processing and Product Quality – 

Act Locally but Think Globally 

1:45 Achieving 10+ Grams per Liter – Challenges in 

Process Development 

Effective development of a high-titer process 'platform' is greatly facilitated by an 

integrated, multifaceted approach. Technological advances beginning as early as 

molecular selection, and encompassing all aspects of cell culture and purification 

process design afford tremendous opportunity to both enhance performance 

and to assist in ready transfer, scale-up and implementation. Examples will be 

provided to illustrate the benefits of having a comprehensive toolkit of cuttingedge 

process options in achieving transformational production performance. 



2:15 Different Development Paths to Higher Productivity and 

Improved Quality 

Cell culture improvements may be obtained through multiple paths. A strategic 

improvement plan could include the examination of expression technologies, 

host cell selection, cell line development, media development and bioreactor 

operations. Most organizations must prioritize cell culture improvement activities 

to achieve a balance of both short-term and long-term benefits. This presentation 

examines the different aspects of cell culture improvement, providing a high level 

understanding of the complexity and benefits of the various initiatives. 

Gary Welch, Director, Process Development, Abbott Bioresearch Center 

2:45 The Impact of Sequence on Product Attributes and 

Process Outcome 

Similarities among monoclonal antibodies have enabled the implementation 

of efficient platform process development procedures leading to dramatically 

shortened process development timelines. Our diversified portfolio at Wyeth 

includes antibodies, Fc-fusion proteins and smaller, simpler, non glycosylated 

molecules. This talk will illustrate how the choice of product type and sequence 

can significantly impact the process development options and outcome. 

Martin Allen, Ph.D., Principal Research Scientist, Cell and Molecular Sciences, 



Overcoming Manufacturing Issues 

3:30 Avoiding Pitfalls in Quality by Design CASE 

Quality by Design (QbD) techniques have proven effective in evaluation 

STUDY 

and understanding of biologics manufacturing processes including identification 

of CQA’s and COP’s. However, there are pitfalls in the application of QbD 

techniques that can mislead the identification of “Design Space” with 

consequences for manufacturing control and consistency. In this presentation, 

examples will be used to illustrate best practices to avoid pitfalls in QbD. 

Graham McCreath, Ph.D., Senior Scientist, Avecia Biologics Limited, United Kingdom 

Mahesh Shivhare, Statistician, R&D, Avecia Biologics Limited, United Kingdom 

4:00 Towards More Modular, Compact, and Cost Effective 

Manufacturing Facilities: Combining the Latest Advances in 

Process Development with Bioreactor Technology Development 

We have successfully completed implementation of a fully disposable cell culture 

platform, both in development and in cGMP clinical manufacturing suites. This 

disposable platform encompasses media and harvest storage, cell expansion in 

preculture and seed bioreactors, and production bioreactors. This disposable platform 

is capable of making clinical and commercial supplies. We will share our experience 

with the disposable systems, discuss the design and implementation challenges, and 

elaborate on how disposable platforms can change the future of cell culture processes. 

Sadettin Ozturk, Ph.D., Head, Bioprocess Technology, Centocor R&D 

4:30 Impact of Impeller Design on Antibody Production 

CASE 

by Chinese Hamster Ovary Cells 

STUDY 

Large scale production of monoclonal antibodies has been accomplished using 

bioreactors with different length to diameter ratios, and diverse impeller and sparger 

designs. The differences in these physical attributes could result in dissimilar mass 

transfer, shear dynamics and mixing inside the bioreactor, which could lead to disparities 

in cell growth, antibody production and final product quality. The purpose of this study is 

to understand the impact of impeller designs on process and culture parameters. 

Sandeepa Sandadi, Scientist II, Biological & Sterile Product Development, 

Schering-Plough Research Institute 

5:00 Close of BPI 2008 

4 



Adam Goldstein, M.S., Senior Manager, Oceanside Clinical Operations, 


Protein A and Beyond 

1:45 Considerations for the Optimization of the Protein A 

Capture Step in Antibody Processes 

Abstract not available at press date. 

Please visit www.IBCLifeSciences.com/BPI/US for updates. 

Sanchayita Ghose, Ph.D., Manager, Process Sciences Downstream, 

Bristol-Myers Squibb 

2:15 Development and Scale Up of Q Membrane 

CASE 

Chromatography in Non-Affinity Purification 

STUDY 

Processes of HuMAbs 

Disposable membrane chromatography has been successful in replacing resin 

flowthrough chromatography and provides an efficient viral removal strategy 

for non-affinity purification processes of HuMAbs. Scaleability of membrane 

application has been tested up to 350 and 200L bioreactors to process harvests 

for different molecules. Loading capabilities on this single use chromatography 

were increased up to 10g/L to positively impact process economics without 

compromising viral clearance capability. HuMAbs case studies will be described. 

Gisela M. Ferreira, Ph.D., Senior Process Engineer, Purification Process 

Development, Medarex Inc. 

2:45 Reduction of Host Cell DNA Using Charged Filters at 

Protein A Capture for Monoclonal Antibody Production 

One of the products generated by perfusion cell culture at Centocor had higher 

than usual host cell DNA (~20 ug/mL) in the harvest. Bench-scale studies (~ 10 

liters) were performed using various positively charged depth filters to reduce the 

host cell DNA level. These filters were placed in-line during loading harvest onto 

the Protein A column. The CUNO charged filter 120ZA10A EXT was found to 

reduce the DNA by greater than 1 log when processing at 220 L of harvest/m2. 

John Wesner, Associate Scientist, Development Pilot Plant, Centocor R&D 


Improving Downstream Economies and Efficiencies 

Using Disposables in Chromatography 

3:30 Disposable Applications in Antibody Purification 

New advances in disposable technologies are creating a wider range for single-use systems 

in the upstream and downstream processing arenas, including cell-culture bioreactors, 

formulation and filling applications, new mixing technology, and disposable depth 

filters used in harvesting equipment. This talk will examine the development of recent 

improvements in the production of bulk antibodies. The benefits and limitations of these 

applications will be presented including the application of a new design for frozen bulk. 

Adam Goldstein, M.S., Senior Manager, Oceanside Clinical Operations, Genentech, Inc. 

4:00 Effective Incorporation of Disposables into mAb Drug 

Substance Production 

In this presentation, the incorporation or implementation of three disposable 

systems such as depth filtration, membrane chromatography, and nanometer 

filtration technology in first-in-human and commercial processes will be introduced. 

Integration of disposable systems into an existing process will be examined and 

an excellent data set of impurity removal and viral clearance will be presented. 

Advantages and disadvantages including cost analysis, validation and facility usage will 

be discussed. Possible future disposable systems such as mix mode membranes and 

monoliths in 2-column downstream purification will be further discussed. 

Joe Zhou, Ph.D., Scientific Director, Process Development, Amgen Inc. 

4:30 Minimizing Buffer Storage Requirements for Antibody 

Purification in High Titer Processes: Integration of 

Inline Dilution, Disposable Technology and Optimized 

Buffer Preparation 

A case study will be presented that illustrates how inline dilution of buffer concentrates 

and large volume disposable bag technology can be integrated, to effectively eliminate 

buffer capacity bottlenecks, significantly reduce the required tankage volume and 

introduce flexibility. Approaches to further reducing total volume requirements in 

buffer preparation and optimizing solids handling will also be discussed, together with 

select examples of challenges encountered as a 25,000 L mammalian cell culture facility 

employing these new technologies was brought online. 

Mark Smith, Ph.D., Process Support Engineer, Genentech, Inc. 

5:00 Close of BPI 2008 


Co-Located Conference 

IBC’s 8th Annual 

Formulation Strategies for Protein Therapeutics 

Formulating the Next Generation of Protein Therapeutics: Pre-Filled Syringes, High 

Concentration Proteins, Quality by Design and Novel Protein Structures 

September 23-25, 2008 • Disneyland® Hotel • Anaheim, CA 

www.IBCLifeSciences.com/formulation 

IBC’s Formulation Strategies for Protein Therapeutics is a must-attend conference each year for formulation, delivery and analytical 

development scientists from biotherapeutic development organizations around the world. 

This meeting, now entering its eighth year, presents 20 practical case studies that show you how to accelerate and improve your formulation 

development. The topics presented are determined through the input of people like you – formulation scientists working to overcome the 

challenges of advanced protein therapeutics and next-generation delivery methods. 

• Understand how to optimize formulations for pre-filled syringe 

products from early development to commercialization from 

Amgen, Biogen-Idec, Human Genome Sciences, Merck, 

West Pharmaceutical Services and the United States Food 

and Drug Administration 

• Overcome the challenges of formulating high concentration 

proteins - with case studies from Abbott Laboratories, Amgen, 

Genentech, Roche and Wyeth 

• Benchmark your formulation operation in a facilitated small group 

Best Practices Exchange for formulation scientists 

• Plus, sessions on Formulation Development for Lyophilized 

Products, Formulation Development for Novel Proteins, Measuring 

and Predicting Protein Aggregation, Improving the Stability of 

Protein Therapeutics and Predictive Methods for Formulation 

Development 

BPI conference delegates may attend the sessions of Formulation Strategies at no additional charge 

and conference materials for the Formulation meeting are included on the BPI CD-ROM. 

Distinguished Speaker Faculty 

Siddharth J. Advant, Ph.D. 


Advait Badkar, Ph.D. 

Pfizer Inc 

Anthony B. Barry, Ph.D. 


Steven Bishop, Ph.D. 

MedImmune, Inc. 

Jeffrey T. Blue 

Merck and Co., Inc. 

Jason Bock, Ph.D. 

Teva Biopharmaceuticals, USA 

Robert Yi-Te Chou, Ph.D. 

Amgen Inc. 

James Colandene, Ph.D. 


Tapan Das, Ph.D. 

Pfizer Inc 

Jesper Davidsen 

Genmab A/S, The Netherlands 

Adam Dinerman, Ph.D. 

Centocor, Inc. 

Osigwe Esue, Ph.D. 


David J. Geer, Ph.D. 

Merck and Co., Inc. 

Merrill Goldenberg, Ph.D. 

Amgen Inc. 

Nicholas Guziewicz 


David D. Hile, Ph.D. 

Stryker Biotech 

Carl "Charlie" Hitscherich Jr., Ph.D. 

Biogen Idec, Inc. 

Robin Hwang, Ph.D. 

Amgen Inc. 

Sonoko Kanai, Ph.D. 

F. Hoffmann-La Roche Ltd., Switzerland 

Angela Kantor 

Wyeth Biopharma 

Carol F. Kirchhoff, Ph.D. 

Pfizer Inc 

Tom Leach, Ph.D. 

MedImmune, Inc. 

Li Li, Ph.D. 


Michiel Lodder, Ph.D. 

OctoPlus Inc. 

Henryk Mach 

Merck Research Laboratories 

Haripada Maity, Ph.D. 

ImClone Systems 

Susan W. H. Martin, Ph.D. 

Pfizer Inc 

Thomas J. Nikolai 

Abbott Laboratories 

Joseph Phillips, Ph.D. 

Amgen Inc. 

Dov H. Pluznik, Ph.D. 

United States Food and Drug Administration 

Jennifer L. Riter 

West Pharmaceutical Services 

Niles Ron, Ph.D., MBA 

Seattle Genetics, Inc. 

Timothy J. Shea, Jr. 

Sterne, Kessler, Goldstein & Fox P.L.L.C. 

Thomas M. Spitznagel, Ph.D. 

Genome Sciences, Inc. 

Arvind Srivastava, Ph.D. 

ImClone Systems 

Ping Yeh, Ph.D. 

Biogen Idec, Inc. 

Gaozhong Zhu, Ph.D. 

Shire Human Genetic Therapies, Inc. 


IBC Professional Training Academy 

Two-Day Courses at BPI 

Tuesday, September 23, 2008 to Wednesday, September 24, 2008 

Maximize your learning experience at BPI … combine one of the following training courses with the 

scientific conference sessions on Thursday & Friday at a special rate. See registration page for details. 

For complete course agendas, please visit www.IBCLifeSciences.com/courses 

Introduction to 

Biopharmaceutical 

Manufacturing 

Managing Effective Biotech 

Programs and Projects 

Scalable Transient 

Protein Production in 

Mammalian Cells 

How Attending will Support Your 

Professional Development 

• Gain an overall perspective on the manufacture of 

biopharmaceuticals and the steps used in production 

• Gain an understanding of the technology employed 

in manufacturing, even if you have a non-technical 

background 

• Identify the major methods for testing and where they 

are used 

• Understand the concepts underlying process validation 

• Receive a comprehensive course book that serves as a 

future reference 

Course Description 

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. Also, you will 

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. 

Course Instructor 

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

Strategic Manufacturing Worldwide, Inc. 

Dr. Scott M. Wheelwright has over 20 years experience 

in biopharmaceutical manufacturing, both with startup 

biotech firms and with large biotech and pharmaceutical 

companies, including Abbott Laboratories, Chiron 

and Scios. Dr. Wheelwright has led the design and 

implementation of many manufacturing processes for 

biopharmaceuticals, including licensed products. Dr. 

Wheelwright holds a Ph.D. degree in chemical engineering 

from the University of California at Berkeley. He is 

the author of a book on protein purification and has 

authored numerous articles on manufacturing and process 

development. Dr. Wheelwright currently works with 

several large and small biotech and pharmaceutical firms, 

where he prepares strategic plans for manufacturing and 

development, audits the compliance of manufacturing 

operations (particularly in Japan; he reads and speaks 

Japanese), and assists with contract manufacturing. 

Course Schedule 


Professional Development 

• Learn the unique challenges of biotech projects and 

programs 

• Develop a greater understanding of how to apply project 

management approaches to biotech work and how to 

mature existing project and program strategies 

• Discover approaches to improve project and program 

efficiency 

• Explore how to be more effective in leading projects 

and programs 

• Apply your knowledge while working with other course 

participants in small group project challenges 

• Network with other biotech professionals 

Course Description 

The demands of biotechnology development programs are 

increasing at an amazing pace. Organizations are faced with 

increasingly complex activities and the need to be more 

efficient and more effective – delivering more results with 

fewer resources. 

This course is designed to explore the development and use 

of project management and program management strategies 

and tools in a life sciences environment. Participants 

will review the fundamental elements of projects and 

programs and explore the application of these elements in 

the industry, using both a theoretical teaching approach 

and through interactive team exercises. We will review 

key aspects of projects and programs, their application in 

biotechnology and science-based projects/programs and the 

most suitable approaches for applying project and program 

techniques. The course will also include a deeper analysis 

of the individual project foundational areas as we explore 

some of the challenges and opportunities for improvement 

in our business as it relates to effective and efficient project 

and program efforts. 


Staci M. Walker-Pence, M.B.A, M.S., SSBB, PMP, 

Global Strategic Projects 

Staci Walker-Pence holds a Master’s of Business 

Administration degree with an emphasis on business strategy 

and a Master’s of Science Degree with an emphasis on 

Organizational Leadership and Management. She is a Six 

Sigma Black Belt and a Project Management Professional 

who brings over a decade of program and project 

management experience spanning healthcare, biotechnology 

and information technology industries. Her most recent 

work focus is Global Strategic Projects including Global 

Analytical Sciences and Operational Excellence. She brings 

extensive working knowledge and experience partnered with 

theoretical knowledge of project and program management 

approaches. Staci has worked with many business leaders to 

develop the foundation of project and programs including 

developing business processes, project and program tools, 

and mentoring/training other project professionals. 

• Registration begins at 8:15 am on Tuesday, September 23, 2008. Please check in at the attendee 

registration desk to receive your badge and materials. 

• Each day the course begins at 9:00 am and concludes between 5:00 pm - 5:30 pm. Continental breakfast 

is served from 8:15 am - 9:00 am. There are two refreshment breaks at approximately 10:00 am and 3:00 

pm. Lunch is served each day at approximately 12:00 pm. Refreshment breaks, lunches, and meeting 

conclusion times may vary slightly based on delegate interaction and the instructor’s discretion. 


Professional Development: 

• Understand the rationale, advantages and considerations in 

deciding how and when to implement large-scale transient 

production as part of an overall drug discovery strategy 

• Learn technical details, equipment requirements, key factors 

for expression and cell culture, and various techniques used to 

maximize protein yield 

• Participate in classroom discussions and exercises to develop 

practical skills in transient production; understand time and 

effort required and estimate costs to produce a recombinant 

protein 

• Understand transfection, cell culture and equipment issues for 

scale-up into bioreactors 

Course Description: 

This course introduces fundamental concepts and teaches 

practical skills needed to establish small to large-scale transient 

protein production systems using mammalian cells. The 

class will examine in detail the four essential elements of any 

mammalian transient production system: cell lines, expression 

vectors, transient transfection and cell culture. You will learn 

the strengths and weaknesses of transient expression in order to 

make reasoned decisions about how and when to employ this 

rapid, cost-effective technique. 

The course will help participants to understand differences and 

tradeoffs in producing recombinant proteins in HEK293, CHO, 

or other mammalian cells. We will also review expression vector 

basics and delve into advanced vector optimization, cloning 

strategies and large-scale preparation of plasmids. Specific focus 

will be placed on expression vector design for production of 

antibodies. The most commonly used transfection reagents and 

transfection methods will be examined, leading to discussions 

on optimization of large-scale transient transfection and overall 

expression system design matching transfection reagent to cells 

to culture medium. 

Attendees will gain an understanding of the equipment needed 

to establish a transient production facility, methods to monitor 

culture conditions and how to assess transfection efficiency. The 

particular cell culture parameters and techniques that lead to 

maximal transient production will be explored and contrasted to 

culture strategies for production from stably engineered cell lines. 

A case study and in depth analysis of cell culture and transient 

transfection scale-up will be presented to give participants 

a working understanding of how to scale up production to 

benchtop bioreactors and beyond. 


Henry C. Chiou, Ph.D., Technology Area Manager, Research and 

Development, Invitrogen Corporation 

Dr. Henry Chiou has over 15 years of experience in mammalian 

expression technology and in nucleic acid delivery systems. He 

has broad expertise in expression vectors, cloning, cell biology 

and cell culture. Henry directs Invitrogen’s R&D efforts in the 

development of new transfection reagents and transfection 

applications. He recently led the FreeStyle MAX program to 

produce a scaleable, suspension culture system for transient 

protein production from CHO and HEK293 cells. He frequently 

provides guidance or collaborates with various bioproduction, 

bioprocess or protein production Core facilities from biotech 

and pharma to help establish or optimize transient protein 

production systems. Dr Chiou obtained a bachelor’s degree 

from Yale University in biochemistry and earned a doctorate 

in Molecular Pharmacology from Harvard University. He then 

completed a post-doctoral fellowship studying viral expression 

elements at the University of Pennsylvania. Prior to joining 

Invitrogen he worked for a number of years in small to mid-sized 

biotech companies developing biotherapeutics. 


The Largest Display of New Products & Technologies from Over 120 Exhibiting Companies 

Event Sponsors 

Executive Sponsor 

Associate Sponsor 

SAFC Biosciences is the world’s leading supplier of critical raw materials and specialized 

cell culture reagents to producers of marketed biological products. Fully dedicated 

to the needs of customers at every stage of the clinical pipeline, SAFC Biosciences 

has the expertise, manufacturing capabilities, quality systems and technical support 

necessary to accelerate customer success. SAFC Biosciences is not just a supplier, but 

an extension of our customers’ capabilities. A global organization with multiple cGMP 

facilities for cell culture applications in the United States, Europe and Australia, we 

supply the broadest range of highly customized services and products to companies 

involved in cell culture-based manufacturing. We have unique offers for those involved 

with industrial-scale biopharmaceutical research; process development, materials 

management; quality assurance; and manufacturing. We focus on tailored solutions 

and manufacturing processes designed to meet the specific needs of our customers. 

Visit www.safcbiosciences.com to view our unique Cell Culture Capabilities Cube. 

Corporate Sponsors 

GE Healthcare Bio-Sciences provides a broad range of products and services for 

protein separation, medical diagnostics and drug discovery. For bioprocess protein 

separation a wide range of products and services for chromatography and membrane 

separations, from lab to production scales are offered. Our products are used in the 

manufacture of the majority of all FDA-approved biopharmaceuticals on the market. 

Chief products include: • Chromatography systems and media • Filtration systems and 

devices • Disposable bioreactors and mixers • Cell separation for isolating and purifying 

cells, viruses, and sub-cellular particles • Fast Trak BioPharma Services. GE Healthcare 

Biosciences is a part of GE Healthcare, a General Electric company with more than 

42,000 employees, providing transformational medical technologies that are shaping a 

new age of patient care. 

Novozymes is the world leader in bioinnovation. Together with customers across a 

broad array of industries, we create tomorrow’s industrial biosolutions, improving our 

customers' business and the use of our planet's resources. With over 700 products 

used in 130 countries, Novozymes’ bioinnovations improve industrial performance 

and safeguard the world’s resources by offering superior and sustainable solutions for 

tomorrow’s ever-changing marketplace. Read more at: www.biopharma.novozymes.com 

We are a leading supplier of equipment and services for the biopharmaceutical 

industry offers Bioreactors, Fermenters, Crossflow, Integrity Test equipment, Housings, 

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

cassettes, membrane adsorbers, depth filters, sterilizing and prefilter cartridges and 

capsules, mycoplasma and viral filtration. A comprehensive Validation & Training 

services support our products. 

Track Sponsor 

Backed by the long-standing expertise of Difco and BBL brand supplements and 

media, BD Biosciences – Advanced Bioprocessing‘s novel portfolio of hydrolysates, cell 

culture media supplements and services is the optimal choice for your mammalian cell 

culture and bacterial fermentation bioprocessing needs. As a strategic platform of BD 

Biosciences – Advanced Bioprocessing 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. 

Tarpon Biosystems is the leading innovator of BioSMB continuous downstream 

processing technology. BioSMB brings the power of simulated moving bed 

chromatography to the Biomanufacturing environment. Disposable fluid contact 

elements and modular, flexible system designs are combined to bring convenience and 

economy to this tested multi column approach. BioSMB yields significant overall DSP 

cost reduction, along with decreased chromatographic media, buffer and water use. 

Association Sponsor 

Technology Workshop Sponsors 


BD Biosciences – Advanced 

Bioprocessing 

BIA Separations GmbH 

ForteBio 

GE Healthcare 

Invitrogen 

Millipore 

New Brunswick Scientific 

Panel Discussion Sponsors 

Novozymes 

Tarpon BioSystems, Inc. 

Reception Sponsor 


Luncheon Sponsors 

Invitrogen 

Pall Life Sciences 

Drive Your Global Sales & Marketing 

The best marketing vehicle to reach the Bioprocessing market is 

BioProcess International Conference & Exhibition – the largest and 

most recognized industry event of the year! 

Exhibiting and sponsorships include: 

• Exhibit Booths (Only a few still 

available) 

• Technology Workshops (Sold out!) 

• Track Sponsorships (3 still remaining) 

• Session Sponsorships 

• Receptions (Only 1 remaining) 

Novasep Process 

Novozymes 

Nysa Membrane Technologies 


Percivia LLC 


Sartorius Stedim North Amercia Inc. 

Thermo Scientific 

Tote Bag Sponsor 

Sartorius Stedim North America Inc. 

Badge and Lanyard Sponsor 


Product Demonstration 

Upfront Chromatography 

Site Tour Sponsor 

Irvine Scientific 

• Focus Groups 

• Tote Bags (Sold out!) 

• Lanyards/Badges (Sold out!) 

• Portfolios 

• Hospitality Suites (Only 2 remaining) 

• Site tours (Only 2 remaining) 

Additional avenues to raise awareness of your company's products or 

services can be tailored to meet your marketing needs. 

To learn more about sponsoring or exhibiting at BPI or other events 

within IBC’s Biopharmaceutical Production Series, please contact 

Kristen Schott, Sales Executive at (508) 614-1239 or kschott@ibcusa.com 

or Dave Garcia, Sales Director at (508) 614-1428 or dgarcia@ibcusa.com 


The Most Extensive Biopharmaceutical Marketplace – Over 120 Vendors! 

Exhibit Hall Hours 

Tuesday, September 23, 2008 5:30 pm - 7:00 pm 

Wednesday, September 24, 2008 9:45 am - 7:15 pm 

Thursday, September 25, 2008 9:45 am - 4:00 pm 

Exhibitor List (As of April 18, 2008) 

* The companies that plan to launch New Products at BioProcess 

International Conference & Exhibition are indicated with an asterisk * 

AAA/SCIENCE 

AdvantaPure/ New Age Industries* 

Alfa Laval, Inc. 

Alfa Wassermann Separation 

Technologies* 

Althea Technologies, Inc. 

Analiza, Inc. 


Applikon Biotechnology, Inc.* 

Asahi Kasei Medical America, Inc.* 

ATMI/LevTech 

ATR, Inc.* 

Avecia Biologics 

Avid Bioservices 

Baxter 

BD Biosciences-Advanced Bioprocessing* 

Bellco Biotechnology 

BIA Separations* 

BiOENGiNEERiNG, INC. 

Biolog* 

BioPharm Services* 

BioProcess International Magazine 

BioProcessors Corporation 

Bio-Rad 

BioReliance 

Bioresearch Online 

Boehringer Ingelheim 

Brightwell Technologies Inc.* 

Broadley-James Corporation 

CDI Bioscience* 

Celeros Separations* 

Cellexus Biosystems* 

Charles River Laboratories 

Charter Medical* 

Cinvention AG 

CMC ICOS Biologics, Inc. 

Cobra Biomanufacturing 

Colder Products Company* 

Cook Pharmica 

Corning Incorporated 

CRYOMETRIX 

CUNO Incorporated, a 3M company 

Cytovance Biologics 

DCI, Inc./DCI-Biolafitte* 

Development Center for Biotechnology 

Diosynth Biotechnology 

DMV International 

DSM Biologics and Crucell N.V. 

Eden Biodesign 

A Rapidly Growing Event 

In the four short years since its inception, this event has doubled in size from about 750 participants to 1500, and 

from 40 booths to over 100 companies exhibiting in more than 150 booth units. BPI continues to grow in sheer 

numbers and in the respect and praise it receives from the industry. You can not afford to miss this very important 

event in the industry – the largest forum for bioprocess development and manufacturing. 

Don't miss the opportunity to interact with a diverse group of industry experts 

Attendee Profile by Job Title 

25% Managers and Plant Managers 

22% Scientists 

18% Directors and Associate Directors 

11% Engineers 

8% CEOs/Presidents/Vice Presidents 

5% Research Associates 

4% Project Managers 

3% Development Specialists and Technical/Application Specialists 

2% Consultants and Analysts 

1% Professors/Biologists/Chemists 

EMD Chemicals 

Finesse Solutions* 

Florida Biologix 

FOGALE nanotech* 

ForteBio* 

GE Healthcare 

Genetix 

Goodwin Biotechnology, Inc. 

Gore & Associates* 

Groton Biosystems* 

INFORS USA* 

Innovatis Inc. 

Innovative Directions* 

InVitria 

Invitrogen 

Irvine Scientific 

KBI Biopharma, Inc. 

Kerry Bio-Science/Sheffield Pharma 

Ingredients 

Lancaster Laboratories, Inc. 

Laureate Pharma 

Lonza 

Mallinckrodt Baker, Inc. 

Mediatech, Inc. 

Medicel Oy* 

Metabolon Inc. 

MicroCal, LLC 

Millipore 

Nalgene and Nunc Brand Products* 

NCSRT* 

New Brunswick Scientific* 

Nova Biomedical 

Novasep Process* 

Novozymes* 

Nysa Membrane Technologies* 

Omnia Biologics 

optek-Danulat, Inc. 

PacificGMP* 


PendoTECH* 

Pneumatic Scale Angelus 

Polestar Technologies, Inc. 

Praxair, Inc.* 

PreSens Precision Sensing* 

ProMetic BioSciences Ltd.* 

QSV Biologics* 

Rentschler Inc. 

Research Organics, Inc.* 

Sachem, Inc. 


SANDOZ GmbH 

Sartorius Stedim Biotech* 

SciLog, Inc.* 

Scinomix* 

Sepragen Corporation* 

Spectrum Laboratories* 

TechniKrom, Inc.* 

The Automation Partnership* 

The IMPACT Marketing Group 

Thermo Scientific 

Tosoh* 

TTP LabTech* 

Upfront Chromatography A/S* 

VirTis, An SP Industries Brand* 

Westfalia Separator 

WuXi AppTec 

Xcellerex, Inc. 

Xenova Biomanufacturing 


Call for Poster Submissions 

Submit your abstract today at www.IBCLifeSciences.com/BPI/US 

The organizers of BioProcess International Conference & Exhibition recognize 

the significant educational value in poster presentations. Any registered and 

paid conference attendee may sign up to present a poster. The deadline to 

submit your abstract online, at www.IBCLifeSciences.com/BPI/US is July 18, 

2008 to be included in the BioProcess International Pre-Show and On-Site 

Event Guide. The final deadline to be included in the Conference CD-Rom is 

September 2, 2008. Poster fees: Industry: $100; Academic/Government: Free. 

• Space is limited to 75 posters 

• Poster will be displayed by conference track 

• Dedicated poster viewing times scheduled in the exhibit hall 

• 15 poster abstracts will be published in a special event preview 

• Visit www.IBCLifeSciences.com/BPI/US for more information 

Call for Poster Deadlines 

• For inclusion in Pre-Show and On-Site Event Guide: July 18, 2008 

• For inclusion in conference CD-ROM: September 2, 2008 

Poster abstracts and registrations received after Tuesday, September 2, 

2008 will be subject to availability for an onsite poster board and will not be 

included in the conference CD-ROM. Full payment of conference registration 

and poster fees must also be received by Tuesday, September 2, 2008 for the 

abstract to be included in the CD-ROM and poster assignment to be made. 

The size of the conference poster board is 4'h x 8'w. Please note: Poster 

presentations may not be used as exhibit displays or for marketing purposes. 

All posters are subject to approval by conference organizers. Poster abstracts 

must be submitted online at www.IBCLifeSciences.com/BPI/US. Only one 

poster presentation will be allowed per registered attendee/author. 

Dedicated Poster Viewing 

Wednesday, September 24, 2008 • 12:30 pm - 2:00 pm 

Poster and Exhibit Viewing Hours 

Tuesday, September 23, 2008 • 5:30 pm -7:00 pm 

Wednesday, September 24, 2008 • 9:45 am - 7:15 pm 

Thursday, September 25, 2008 • 9:45 am - 4:00 pm 

Founding Publication 

Media Partners 

BioProcess International is concerned with the application of biotechnology to industry, 

particularly to the development and manufacture of biopharmaceutical applications 

including: proteins, peptides, hormones, vaccines, oligonucleotides, gene therapies, cell 

and tissue therapies and biodiagnostics. BioProcess International provides biotechnology 

vendors with the most effective, most cost efficent print and online access to 30,020 

biotherapeutic decision makers working throughout the world. BioProcess International's 

advertisers are the leading suppliers of equipment, technologies, contract services 

and materials necessary for biotherapeutics companies to complete each phase of the 

biodevelopment process in the most timely, successful and economic matter. To learn 

more about BioProcess International visit www.bioprocessintl.com 

Hotel, Venue and Travel Information 

Disneyland® Hotel – located in the Disneyland® Resort (Host Hotel) 

1150 West Magic Way Anaheim, CA 92802 

Reservations: 714-520-5005 • Hotel Operator: 714-778-6600 

Disney’s Paradise Pier Hotel – located in the Disneyland® Resort 

1717 S. Disneyland Drive, Anaheim, CA 92802 

Reservations: 714-520-5005 

*This hotel is walking distance to the Disneyland® Hotel where the conference is taking place. 

TRAVEL RESERVATIONS: For all air travel arrangements, including international, 

please call or write IBC’s official air travel agency, Commonwealth Travel Advisors, 

to book your travel. E-mail: jdwyer@traveladvisors.com or call: USA: 888.703.4286 or 

508.366.3660; International: 1.508.366.3660. Please be certain to mention IBC along 

with the conference title, dates, and conference code B8171 when e-mailing or 

calling. Please note there is a $29.00 booking fee for using this service. 

DISCOUNTED HOTEL RESERVATIONS: Please call the hotel directly before August 

30, 2008 to be included in IBC's dedicated room block for this conference. Please be 

certain to mention IBC along with the conference title and date of the conference. By 

calling the Group Reservation number 714-520-5005 you can make reservations at 

both the Disneyland® Hotel and Disney’s Paradise Pier Hotel. 

Alternative Hotels 

Sheraton Anaheim (.5 mile to Disneyland® Hotel) 

900 South Disneyland Drive, Anaheim, CA 92802 • Phone (714) 778-1700 

IBC has created a group block at the Sheraton Anaheim. Please call the hotel directly 

before September 5, 2008 to be included in IBC’s dedicated room block. Please 

mention the Group Code: IBC121 or refer to the conference title. Rooms are limited 

so please make your reservations as soon as possible. 

All hotels listed below are less than 1 mile from the Disneyland® Resort. 

Please note that IBC does not have a group block so call the hotel directly 

sand ask for the best rate available. 

Hilton Anaheim 

Sheraton Park Hotel 

777 Convention Way 1855 South Harbor Boulevard 

Anaheim, CA 92802 Anaheim, CA 92802 

Phone (714) 750-4321 Phone (714) 750-1811 

Featured Web Partner 

Additional Registration Information 

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. 

Other Information: Main conference registration fee includes two luncheons, cocktail 

receptions, technology showcases, refreshments, access to exhibit hall and CD ROM 

with speaker documentation. 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 USA 

Conferences 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: In order to receive a prompt 

refund, your notice of cancellation must be received in writing (by letter or fax) 10 

business days before the conference. We regret cancellations will not be accepted after 

that date. However, we will be pleased to transfer your registration to another member of 

your company at any time. If you plan to send someone in your place, please notify us as 

soon as possible so that materials can be prepared. All cancellations will be subject to a 

$395 processing fee. If IBC cancels an event, IBC is not responsible for any airfare, hotel or 

other costs incurred by registrants. Speakers subject to change without notice. 

SPECIAL NEEDS: If you have a disability or special dietary needs, please let us know in 

order that we may address your special needs for your attendance at this show. 

Please send your special needs via email at custserv@ibcusa.com 

or fax 508-616-5522. 

For security precautions, a photo identification will be required of ALL attendees at 

check-in. 


Registration Form 

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. 

ORGANIZATION 

MAILING ADDRESS 

CITY 

DEPARTMENT 

STATE POSTAL CODE COUNTRY 

TELEPHONE FAX APPROVING MANAGER 

Data Protection: The personal information shown on this form, and/or provided by you, will be held on a database and may be shared with companies in the Informa group in the UK and internationally. Sometimes your details may 

be obtained from, or made available to, external companies for marketing purposes. If you do not wish for your details to be used for this purpose, please email data-admin@ibcusa.com. 

2 Select a Package Standard Rate 

4-Day Conference Pass Plus Workshop (Mon.-Fri.) – BEST VALUE l n o $2599 

(Includes Main Conference, Pre-Conference Afternoon Workshop) 

3-Day Conference Pass Plus Workshop (Mon.-Thur.) l n o $2399 

(Includes first 3 days of Main Conference, Pre-Conference Afternoon Workshop) 

4-Day Conference Pass Only (Tues.-Fri.) n o $2199 

3-Day Conference Pass Only (o Tues.-Thur. OR o Wed.-Fri.) n o $1999 

Training Course (Tues.-Wed.) & 2-Day Main Conference Pass (Thur.-Fri.) u n o $2499 

Training Course Only (Tues.-Wed.) u o $1599 

Academic/Government Special Rates 

Academic and government employees are eligible for over 40% savings off the above registration packages. 

Visit the registration page at www.IBCLifeSciences.com/BPI/US for packages, pricing and to register. Academic/Government rate is extended to 

full-time employees of government, universities, and university-affiliated hospitals only. 

3 

4 

5 

6 

7 

Reserve 

a Posterboard (space is limited) o $100 Commercial o FREE Academic/Government 

Poster abstract must be submitted online at www.IBCLifeSciences.com/BPI/US by July 18, 2008 for inclusion in the BioProcess Interntional 

Pre-Show and On-site Event Guide or by September 2, 2008 for inclusion on the conference CD-ROM. 

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

o Workshop A: Technology Transfer for Biopharmaceuticals 

o Workshop B: Single Use Bioprocess Systems: Intensive Update 

n Please indicate which track you primarily plan to attend: 

o 1.Production & Economics of Biopharmaceuticals 

o 2. Scaling Up from Bench through Commercialization 

u Please indicate which course you plan to attend: 

o 1. Introduction to Biopharmaceutical Manufacturing 

o 2. Managing Effective Biotech Programs and Projects 

Please indicate if you wish to attend the site tour: 

o 2. Irvine Scientific (Thursday Afternoon) 

o Workshop C: Process Characterization and Monitoring During Development 

and Commercialization of Biopharmaceuticals 

o 3. Cell Culture & Upstream Processing 

o 4. Recovery & Purification 

o 3. Scalable Transient Protein Production in Mammalian Cells 

Prices include lunches, refreshments and speaker documentation. For security precautions, a photo identification will be required of ALL 

attendees at check-in. For on-site registrations, please add $100 

8 Payment Information (Payment is required in advance of the conference) 

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 B8171, invoice number, person attending, name and date of 

the conference in the transfer instructions. Wire transfers and EFT payments: please contact accounts receivable at AR@ibcusa.com for banking details 

Card # 

Name (as appears on card) 

Exp. Date 

Signature 

B8171PDFBRO 

Unable to Attend? Purchase the Conference CD-ROM. The conference CD-ROM containing a selection of speaker presentations will be available for 

purchase following the event. 

o I cannot attend. Please send ______ CD-ROM(s). Enclosed is my payment for $399 each, plus shipping and handling ($25 in the U.S., $45 outside the U.S.). 

5 Easy Ways 

to Register! 

1. Phone: 

(800) 390-4078 

2. Fax: 

(941) 365-0104 

3. Email: 

reg@ibcusa.com 

4. Online: 

www.IBCLifeSciencescom/ 

BPI/US 

5. Mail: 

IBC USA Conferences, 

P.O. Box 414525, 

Boston, MA 02241-4525 

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. 

Pre-Schedule 

Meetings with 

Other Attendees 

This is just one of the many 

benefits of attending this 

event. Scheduling one-to-one 

meetings with colleagues, 

experts, and collaborators 

from around the world is 

time consuming and often 

prohibitive due to schedules, 

location and access to 

contacts. Well, not anymore. 

As a registered conference 

delegate you will gain 

access to the official Online 

Partnering system 4-6 weeks 

prior to the event. This system 

will allow you see a list of 

other attendees, correspond 

with them and schedule 

one-on-one meetings prior 

to the conference. A number 

of reservable meeting areas 

will be available during 

the conference for these 

meetings. Register today for 

the conference to receive 

further details and access to 

this system.

Cell Culture & Upstream Processing - IBC Life Sciences

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