BioProcess International™ Conference & Exhibition : Agenda

Agenda

Monday, October 12, 2009 - Pre-Conference Symposia and Sponsored Session

Monday | Tuesday | Wednesday | Thursday | Friday

12:00

Registration

Symposium #1

Technology Transfer for Biopharmaceuticals

1:00

Chairperson Opening Remarks
Jean Bender, Ph.D., Senior Engineer, Genentech, Inc.

1:10

Scale-Up and Tech Transfer of Bioreactor Production Processes
Claudia Buser, Ph.D., Director, Global Cell Banking, Technology Development, Genzyme Corp. (invited)

1:50

Case
Study

Unique Technical Challenges Encounteredfor a Commercial E. Coli Process Transfer
Fermentation processes present a distinctive set of challenges during process transfer. Compared to animal cell cultures, the fast metabolism of a high cell density E. coli culture heightens the demands on the fermentor environmental control capability as well as mixing and mass transfer efficiency in the fermentor. These challenges are enumerated in a case study on the transfer of a commercial E. coli fermentation process.
Jean (Jingjin) Harms, M.S., Engineer II, Process Research and Development, Genentech, Inc.

2:30

Foreseen and Unforeseen Technical Challenges Encountered in the Multi-Site Internal/External Transfer of a Drug Substance Manufacturing Process
Technology transfers often lead to proactive process changes to accommodate equipment and/or facility differences. Unforeseen challenges may arise due to the transferred process and product being more sensitive to the operating environment (in terms of temperature or flow), or the process having strict performance parameter acceptance criteria unearthing new understanding of the effects and limitations of the new facility and equipment. Furthermore, additional characterization work may yield valuable improvements in process robustness, yield or product quality. Key technical challenges encountered in the transfer of a drug substance manufacturing process to internal and external sites will be discussed for cell culture and purification process unit operations.
R. Michael Boychyn, Ph.D., Principal Engineer, Process Development, Amgen Inc.

3:10

Networking Refreshment Break

3:40

Site-to-Site Tech Transfer for Downstream Biopharmaceutical Processing: A Look into the Requirements for a Successful Process Transfer from an External Client into a CMO Facility
This presentation examines the requirements for technical transfer of a biopharmaceutical process from an external client into a CMO facility. Process transfer begins with bench scale verification and continues through the conformance campaigns into commercial manufacturing. Each step along this pathway presents unique challenges that when handled proactively using the proper tools and resources, result in a successful transfer.
Katherine Patton, Senior Scientist, Downstream Development, Diosynth Biotechnology, a part of Schering Plough

4:20

Case
Study

Tales from the Crypt: Transferring Biologic Processes to CMOs
For some, technology transfer is a mature discipline that follows a structured approach with predictable outcomes. For others, it is a new frontier with surprises at every turn. Several case studies will be examined to provide justification for the various formal elements of a universal technology transfer methodology.
Stephen Perry, President, Kymanox

5:00

Audience Interactive Panel Discussion

5:30

Close of Symposium

Symposium #2

Practical Aspects of Implementing Quality by Design (QbD)

1:00

Co-Chairpersons' Introduction to the Symposium
David H. Reifsnyder, Ph.D., Principal Scientist, Biopharmaceutical Development, Genentech, Inc.
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Eli Lilly and Company

1:10

Case
Study

Statistical and Risk Assessment in Industry/FDA CRADA Biotech QbD Case Study
The presentation will provide a step-by-step description of statistical and risk assessment approaches used in the Industry/FDA CRADA Biotech case study. Understand the application of the approaches to the definition of the process control strategy, scale-up, validation and manufacturing flexibility. Lifecycle management of validated state and continuous process verification will be discussed in the context of ASTM E55 WK20498.
Guillermo Miroquesada, Ph.D., Principal Research Scientist, Bioprocess R&D, Eli Lilly and Company

1:50

A Risk-Based Approach to Process Characterization: Translating QbD Principles into Experimental Designs
The first step in establishing a design space is identifying which parameters must be studied and which parameters must be studied together in multivariate DOEs. A risk ranking and filtering approach provides a framework for identifying parameters, listing the assumptions and data supporting the level of risk associated with each parameter, and establishing the threshold where multivariate studies are required.
Steven Meier, Ph.D., Senior Engineer, Late Stage Cell Culture, Genentech, Inc.

2:30

Utilization of Performance Constraints for Protein Drug Product Manufacturing Processes: A Case Study in Manufacturing Process Risk Assessment and QbD
In applying QbD to protein drug product manufacturing process, we estimate performance constraints to understand design space using worst case scenarios derived from statistical analyses with lot release and stability data. A process challenge study is then performed to identify unit operations posing relatively high risks to product quality. These results influence FMEA and process characterization. An antibody product example will be presented.
Ge Jiang, Ph.D., Principal Scientist, Drug Product & Device Development, Amgen Inc.

3:10

Networking Refreshment Break

3:40

For QbD, What Should a Small Company Do and Why?
QbD is seen by some as a "large company" driven initiative. It can, however, benefit small companies in both technical and business arenas (e.g. aid partnering). QbD can speed time to market; keep program focus; and help manage risks and knowledge appropriately. To accomplish this, small companies need to keep it simple and systems should be product lifecycle appropriate.
James Blackwell, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.

4:20

Considerations for Application of QbD for Analytical Programs
QbD principles have been traditionally applied during process development and manufacturing to gain flexibility in anticipation of changes to the manufacturing process. However not much attention has been to the application of QbD principles to analytical methods. This presentation will discuss what aspects of QbD are being applied during development of analytical methods, and the anticipated flexibilities gained by applying these principles.
Siddharth J. Advant, Ph.D., Head, Biotech Sector, Tunnell Consulting

5:00

Audience Interactive Panel Discussion

5:30

Close of Symposium

Symposium #3

Driving Out Cost from Biomanufacturing

The objectives of this workshop are to:

Provide an overview of the cost structure of biomanufacturing operations
Review the methodology and approaches taken to economic analysis of bioprocesses
Examine the opportunities to address cost effectiveness in process development and manufacturing
Look at the impact of new developments and their potential to deliver more cost effective processes

1:00

Chairperson's Opening Remarks
Miriam Monge, Vice President, Marketing & Disposables Implementation, Biopharm Services Ltd, United Kingdom

1:10

Case
Study

Biological Products Manufacturing: Cost Challenges and Opportunities Now and in the Future
The industry faces pressure to reduce costs in biomanufacturing. Here we examine the nature of those pressures, the challenges they pose and identify the key cost drivers in our processes. We examine how through understanding the cost contributors and those factors that influence them throughout the product lifecycle you can identify and prioritize opportunities for developing cost effective processes.
Andrew Sinclair, President and Founder, Biopharm Services Ltd, United Kingdom

1:50

Case
Study

Cost-Effectiveness Study on Disposable Technology Used in the Transfer of anAntibody Manufacturing Process between Two Production Sites
The cost modeling exercise compared the implementation of disposables in a cell culture pilot plant to a theoretical traditional stainless steel model in order to determine the savings made by using disposables. The results confirm that the pilot plant upgrade was a successful implementation of disposable strategies used in combination with existing facilities.
Aurelie Foulon, Project Engineer, Biotechnology, Cell Culture Production Support, F. Hoffmann-La Roche Ltd., Switzerland

2:30

Process Cost Modeling: Live Demonstration
Using a cost model configured with the latest bioprocess cost and process information, evaluate how to 1) demonstrate the impact of titre Improvements shift of costs to DSP, and see how improvements in DSP can redress the balance, 2) evaluate alternative expression systems for a given product (MAb vs. Fab) and 3) illustrate the effect of different disposable technologies. Participants will be able direct all aspects of the session.
Andrew Sinclair, President and Founder, Biopharm Services Ltd, United Kingdom

3:10

Networking Refreshment Break

3:40

Case
Study

A CMO Perspective on Driving out Costs in Biomanufacturing
DSM has applied innovative expression systems and other approaches to achieve cost-effective, responsive production. Hear case study details on the applications of disposable technologies including disposable bioreactors and look forward to the potential of continuous process based around high titre cell culture. The new technological process and product innovations allow possible reductions of capital expenditures and COG by 75% and 50% respectively, while increasing flexibility and speed.
Francis B. Maddalo, Vice President, Operations/Facilities Development, DSM Biologics

4:20

Case
Study

Economic Models Guiding Expression System Choices in Early Phase Clinical Development
Early in process development, cost models provide a useful tool for evaluating process design alternatives such as expression system choice. Preliminary development data can be used to test scenarios that facilitate resource allocation and provide focus for the project. A Biopharm Services cost model was used to compare phase I clinical manufacturing process alternatives for a recombinant protein therapeutic, PRM-151.
W. Scott Willett, Ph.D., Senior Director, Biopharmaceutical Development, Promedior

5:00

Audience Interactive Panel Discussion

5:30

Close of Symposium

Leveraging Advanced Technologies for Robust, Efficient Bioproduction and Development

1:00 pm – 5:30 pm

As part of the IBC's BioProcess International conference, we are pleased to bring you a half-day technology session featuring Lonza's top in-house technology experts with extensive case studies, the latest scientific research, and hands-on experience. In this session, we will highlight leading biomanufacturing procedures, advanced development pathways and key risk mitigation practices for establishing robust, efficient, high-value bioproduction and development. Speakers will focus on how to tackle development challenges and leverage the latest technology breakthroughs to establish industry-leading results. You will also learn about how cutting-edge platforms and step-change technologies can add high value, mitigate risks, increase speed to market and lower long-term total cost of goods.

Topics to be presented include:

Potelligent® CHOK1SV: A Further Improvement for the GS Gene Expression System™
Antibody-dependent cellular cytotoxicity activity is a critical effector function for many therapeutic antibodies. This activity is dramatically enhanced by a reduction in core-fucose on the antibody. This talk describes the development, in collaboration with BioWa Inc., of Potelligent® CHOK1SV cell lines expressing 100% non-fucosylated antibodies, suitable for cGMP manufacture.
Adrian Haines, Ph.D., Senior Group Leader, Cell Culture Process Development, Lonza

Manufacturing ADCs: Potent New Weapons for the Oncology Arsenal
Manufacturing antibody drug conjugates (ADCs) presents a series of unique engineering and chemistry challenges for even the most experienced biopharmaceutical manufacturer. Safe, high-quality and cost-effective production requires extensive experience in both biopharmaceuticals and small molecule drug process development and scale-up, as well as the appropriate procedures and equipment.
Tom Rohrer, Senior Director, ADC and Biochemical Technologies, Lonza

Finding the Best Fit: Microbial Expression Technologies
Manufacture of recombinant protein biopharmaceuticals has historically been dominated by two expression platforms (E.coli and S. cerevisiae). However, the diversity of microbially derived products requires a multiplicity of molecular expression tools to successfully overcome the challenges of productivity, localization and product structure/integrity. Adapting traditional expression hosts coupled with innovative approaches to generate powerful new systems results in a molecular toolbox capable of identifying the right expression system for any protein.
Chris Dale, Ph.D., Head of Microbial Technology, Lonza

Single-Use Bioreactors: A Flexible Solution
Singe-use Bioreactors present a unique biomanufacturing solution for small-scale and clinical materials thanks to their flexibility, easy maintenance and cost benefits. The challenges lie in ensuring product biocomparability, seamless scale-up and technology transfer between stirred bioreactors and single-use bioreactors while having a thorough understanding of the regulatory impact. In this presentation, Lonza will address some of these key issues.
Ashley Westlake, Ph.D., Global Director of Technology Transfer, Lonza

A cocktail reception will immediately follow for delegates who attended the session.

Tuesday, October 13, 2009 - Main Conference

Monday | Tuesday | Wednesday | Thursday | Friday

7:00

Registration and Coffee

Manufacturing Efficiency & Supply Chain Security

Supply Chain Integrity, Sourcing, Qualification and Management

8:00

Chairperson's Remarks
Jon T. Conary, Ph.D., Senior Director, Manufacturing, Human Genome Sciences, Inc.

8:15

Responsible Oversight in Outsourced Biotechnology Manufacturing
Outsourcing complex biotechnology production presents unique challenges to assure responsible oversight of manufacturing. The author will analyze responsible oversight using the science of System Dynamics. After an initial discussion of significant oversight variables, the author will demonstrate how to analyze and use a System Dynamic model to understand the relation of variables that effect responsible oversight decisions.
Robert Konopacz, Key Account Manager, Global Biopharmaceutical Operations, Novartis, Switzerland

8:45

Case
Study

Development and Evaluation of a Supply Chain Risk Assessment Methodology
A supply interruption to any market can come from many events ranging from non-performance of a component supplier to a major disaster at a manufacturing site. In order to help evaluate and prioritize efforts around minimizing supply chain risks, an assessment methodology was developed and piloted to evaluate its utility to the corporation. A summary of the methodology strengths and areas needing improvement and will be presented.
Armen Nahabedian, Director, Commissioning and Qualification, Wyeth

9:15

Case
Study

Providing Flexibility and Cost Savings through Supply Chain Strategy in Genentech's Pilot Plant
The industrialization of monoclonal antibody production has increased the pressure to reduce bioprocess development lead times and costs. This presentation will give a case study of how the Genentech Pilot Plant has developed its supply chain strategy to support these objectives through a strong focus on decreased cost of goods and increased flexibility.
David R. Volk, Manager, Process R&D Pilot Plant, Genentech, Inc.

9:45

Networking Refreshment Break

10:15

Case
Study

Improving Facility Fit: Integrating Process Design with Operational Data
Fitting new processes or products into existing plants is typically evaluated using chemical mass-balance models. However these 'facility fit' models are often poor estimators of actual process performance, since they fail to account for operational issues in the plant. We introduce a framework that integrates operational plant data into late-stage process design. This allows a much more accurate view of process fit, speeding technology transfer as well as accurately estimating key parameters like run rate.
Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley

10:45

In-Source or Outsource: CMO Concept of Boehringer Ingelheim: What is the Value of In-House Process Development?
Boehringer Ingelheim has established specific state-of-the-art technologies as a competitive asset of the biopharmaceutical business. A global alliance network with dedicated process development and manufacturing companies ensures high flexibility, short timelines and available capacity. A concept will be presented that allows for success of biopharmaceutical projects, considering investment burden, complexity in development and manufacturing as well as risk management, due to attrition rates during clinical development.
Helmut Hoffmann, Ph.D., Vice President, Process Science, Biopharmaceuticals, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

11:15

Globalization Initiatives for Biopharmaceutical Development and Production
Globalization strategies and considerations for biopharmaceutical technical development and manufacturing as enablers for global clinical trials and growth in emerging markets will be analyzed in this presentation.
Yuan Xu, Ph.D., Global Head/VP of Process Sciences, Production and Quality, Novartis Biologics, Switzerland

Scaling Up from Bench through Commercialization

Product Lifecycle Management

8:00

Chairperson's Remarks
David H. Reifsnyder, Ph.D., Principal Scientist, Biopharmaceutical Development, Genentech, Inc.

Featured Presentation

8:15

Case
Study

Comparability Case Studies: Lessons Learned over 13 Years of Experience
A significant amount of experience has been gained in the 13 years since the regulatory concept of comparability for post-approval changes for biopharmaceutical protein products was first developed. Lessons learned from experience with multiple products, including monoclonal antibodies, will be described. Regulatory pathways, global aspects and supply chain considerations will be discussed.
Mary B. Sliwkowski, Ph.D., Vice President, Regulatory CMC and Information Systems, Genentech, Inc.

8:45

Use of Knowledge Management to Support Product Lifecycle Management and QbD
Processes to produce biopharmaceutical products change over time out of necessity. Managing that change requires retention and use of essential knowledge accrued over the lifetime of the product. Aspects of knowledge management have been and continue to be extensively used throughout government and industry for that express purpose. The relevance and utility of existent knowledge management systems and approaches will be discussed in the context of application to biopharmaceutical development and manufacture.
Roger A. Hart, Ph.D., Scientific Director, Process Development, Amgen

9:15

Micro Scale Chromatography for Scouting and Predictive Method Development
We have adopted a parallel micro-scale purification platform to screen for purification leads as well as for method development. Scale up from the micro-scale (microliter) to bench top (milliliter) scale has proven predictive, qualitatively and quantitatively. Data from the screening of mammalian proteins in E. coli and insect cell expression systems will be presented along with method development case studies.
Bill Gillette, Ph.D., Senior Scientist, Protein Expression Lab, SAIC-Frederick, Inc.

9:45

Networking Refreshment Break

10:15

Phase Appropriate Analytical Method Progression to Meet the Needs of the Product Development Lifecycle
To meet the changing product development requirements, various strategies have been implemented for the development of analytical technology for the characterization of a protein, specifically monoclonal antibodies (mAbs). For the analysis of mAbs, a Platform Analytical approach has been developed. As part of the Analytical Platform, a phase appropriate strategy for method verification, qualification and validation process was developed and implemented.
Charles W. Demarest, Director, Analytical R&D, Pfizer

10:45

Analytical Strategy for Late Stage Clinical/Commercial Readiness
While demonstrating product safety is critical for entering Phase I clinical studies, monitoring additional product specific critical quality attributes become essential at the late clinical development stage. Regulatory requirements and knowledge gained during early stages of development were taken into consideration to identify the analytical needs for Phase III/commercial stage readiness for a complex glycosylated enzyme product. The analytical activities selected and specifications strategy will be discussed during this presentation.
Shanthini Jeyarajah, Manager, Analytical Development, Shire HGT

11:15

Advanced Data Analysis Benefits within Small Scale and Production Scale Cell Culture Processes
This presentation will provide an overview of advanced analysis techniques and their uses within cell culture process monitoring and understanding. The presentation will focus on the improved monitoring capability of production scale processes, small scale analysis, and process predictive modeling.
Greg Stromberg, MBA, Senior Associate Scientist, Biogen Idec

Strategy Discussion Forums

The most popular element of all recent IBC programs are these small group, extremely interactive conversations focusing on critical industry challenges. Here is your opportunity to voice your opinion and question the experts. Each forum is approximately 90 minutes and participation is limited to the first 50 who arrive. (Workshop Forum G is limited to 30.)

10:15

Concurrent Technology Workshops

11:45

Best Practices and Risk Management as Applied to Technology Transfer
Best practices and risk management begin with product development and mature with the process as it progresses through the product life cycle. Examples of problems encountered at different stages along with specific examples will be presented to show that meticulous planning and execution are of paramount importance to ensure a seamless transition of processes.
Divya Parekh, Senior Process Engineer, Process Sciences, Diosynth Biotechnology, a part of Schering-Plough Corporation
Clark Harter, Senior Engineer, Process Sciences, Diosynth Biotechnology, a part of Schering-Plough Corporation

Pipeline Management: Impact of Organism on Manufacturing
While the number of products in an average company's pipeline increases, the costs and time spent per product in terms of process development and GMP manufacturing need to be reduced. This presentation discusses the impact the production organism has on pipeline management, showing that E. coli is not an ideal production organism. Alternatives can significantly reduce overall timelines and costs, including the cost of goods for eventual commercial manufacturing.
Marcel Thalen, Ph.D., Scientific Officer, SynCo Bio Partners B.V., The Netherlands

A Platform for rCHO Cell Line Generation and Culture Producing Multiple Grams of mAbs in 12 Weeks
Results from a collaborative program between Irvine Scientific, Inc., Santa Ana, CA., and Selexis, S.A., Geneva, Switzerland will be presented.
Scott D Storms, Ph.D., Director of Research and Development, Industry Cell Culture, Irvine Scientific
Pierre-Alain Girod, Ph.D., Group Leader, R&D, Selexis SA, Switzerland

Luncheon Presentation

12:15

Single-use is here. Are you Ready?
Plastic. You can pay with it, drink out of it and improve your biomanufacturing process with it. Find out how new single-use technologies, systems, products and solutions can lead to big gains in performance and throughput. We will explore what's new, what works and what's next for single-use and how companies can use single-use as a way to optimize their processes.
Andrew Bulpin, Vice President of Upstream Processing, Millipore Corporation
Paul Chapman, Vice President of Downstream Processing, Millipore Corporation

Manufacturing Efficiency & Supply Chain Security

Disruptive Technologies Shape the Facilities of the Future

1:45

Chairperson's Remarks
James M. Robinson, Vice President Technical and Quality Operations, Novavax, Inc.

2:00

The Future of Biologics Manufacturing
Several technologies have recently been developed and investigated that can potentially revolutionize manufacturing facilities and processes. A new toolbox of technologies may allow for significantly less expensive and more modular facilities which can match production needs just in time. Portable clean room technology, cell culture perfusion for production, sequential multicolumn chromatography, and extensive in-line dilution of buffer concentrates will be particularly useful for small to mid-size biologics companies.
Timothy Matthews, Senior Engineer, Group Leader, Process Development Engineering, Genentech, Inc.

2:30

Cell-Free Production of Pharmaceutical Proteins
We have demonstrated linear scalability of an E. coli based, batch mode, cell-free protein expression system to 100L. Standard process equipment and low cost energy sources are used. The protein produced is fully bioactive and of high quality. The protein can be recovered by conventional means. Rapid transition from research to production is feasible.
Henry Heinsohn, Vice President, Development and Manufacturing, Sutro Biopharma, Inc.

3:00

Demonstrating an Influenza Manufacturing Process with 100% Single-Use Systems
Novavax is operating a pilot plant facility that is capable of producing 10M doses of pandemic influenza vaccine in 6 months for a small capital investment using single-use manufacturing systems. This facility demonstrates the process capabilities, the low cost and speed of establishing capacity, and the ability to construct an in-border vaccine solution.
James M. Robinson, Vice President Technical and Quality Operations, Novavax, Inc.

3:30

Networking Refreshment Break

Scaling Up from Bench through Commercialization

The Nuts and Bolts of Quality by Design (QbD)

1:45

Chairperson's Remarks
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Eli Lilly and Company

2:00

Case
Study

Challenges Faced while Developing a Small-Scale Model for a Perfusion-Based Cell Culture Bioreactor Process
This talk will focus on the approach used to demonstrate comparability between commercial and lab-scale bioreactor processes. The discussion will include selection of appropriate process parameters and measures of product quality and will conclude with a comparison of approaches between small-scale model development for cell culture and affinity chromatography.
Jayanth Sridhar, Ph.D., Associate Director, Cell Culture Manufacturing Sciences, BioMarin Pharmaceutical Inc.

2:30

Application of Multivariate Analysis as a Scale Down and Batch Verification Tool
This presentation will outline how a multivariate approach can be used to qualify a scale down model needed for conducting statistically designed bench scale studies targeted to understand the effect of various inputs. This approach, based on PCA (Principal Component Analysis), together with PLS (Projection to Latent Structures) can be used to to define the allowable space for batch evolution and can be effectively used to monitor and control the bioprocess.
Sanjeev Ahuja, Ph.D., Senior Scientist, Process Cell Culture, MedImmune LLC

3:00

Submission Strategy for a QbD-Based License Application
QbD is a science- and risk-based approach to developing in-depth product and process understanding. QbD will streamline process development and allow companies to self-manage many types of post-approval changes. To obtain more flexibility to manage a product post-licensure, product and process understanding must be clearly demonstrated in the license application. In this presentation, the submission strategy being taken with a product being filed globally including QbD principles will be discussed.
Ron Taticek, Ph.D., Director, Regulatory CMC, Genentech, Inc.

3:30

Networking Refreshment Break

Strategy Discussion Forums

1:45

B: Plant Capacity: Successful Strategies to Deal with Too Much of It
As process efficiencies increase and funding becomes harder to find, companies are looking for ways to fully utilize/capitalize their manufacturing assets (facilities and people). Approaches range from seeking external projects (partnering, contract services, government contracting) to pursuing flexible operations to accommodate more internal projects with existing resources. This discussion focuses on the strategies companies are using to fully utilize their capacity and the challenges that these strategies introduce.

How companies have increased efficiency/flexibility to handle more internal projects with existing resources
How companies have found and closed external relationships for capacity utilization
How companies have managed external projects in your facility and the challenges these have presented
How companies have used alternative opportunities for capacity utilization (government etc.) and the issues these have presented

Moderator: Peter Latham, President, BioPharm Services US
Panelists:
Lisa Cozza, Senior Director, Manufacturing Alliances, Human Genome Sciences, Inc.
Dr. Jan Feuser, Associate Director, Pilot Plant Downstream, Boehringer Ingelheim GmbH & Co. KG, Germany
Robert V. House, Ph.D., President, DynPort Vaccine Company LLC
Robert Konopacz, Key Account Manager, Global Biopharmaceutical Operations, Novartis, Switzerland
Jenifer L. Wheat, Senior Director, Commercial Development, Diosynth Biotechnology, a part of Schering-Plough Corporation

3:30

Networking Refreshment Break

3:35

Event Introduction and Welcome from North Carolina Biotechnology Center
Bill O. Bullock, Vice President, Bioscience Industrial Development, North Carolina Biotechnology Center

Keynote Presentations

4:00

Reinventing Biologics Pharmaceutical Development and Marketed Product Support
Today's development groups are tasked with moving diverse and complex pipelines forward in record time with undivided attention required for both product quality and safety as well as cost of manufacturing. These challenges don't require incremental change in the development operating model but revolutionary change in our model. In this talk, we will discuss activities ongoing at Centocor to meet these challenges. We will discuss the changes required for the processes, plants and people to ensure successful commercial products.
Paul F. McKenzie, Vice President, BIO Pharmaceutical Development and Marketed Product Support, Centocor R&D

4:45

Operational Excellence: The Opportunity in the Life Sciences Industry
In this presentation, the speaker will describe the operational excellence opportunity in the life science industry. A "science" perspective to:

Highlight the Strategic Role of Operations
Describe its Current State ("Here")
Envision its Desired Future State ("There")
Identify barriers in getting from "Here" to "There"
Summarize Current Approaches to Overcome These Barriers

Initiatives such as PAT and QbD will be put into this context.
G.K. Raju, Ph.D., Executive Director, Manufacturing Initiatives, MIT Center for Biomedical Innovation

5:30

Opening Night Cocktail Reception in the Exhibit and Poster Hall Sponsored by

Wednesday, October 14, 2009 - Main Conference

Monday | Tuesday | Wednesday | Thursday | Friday

7:00

Registration and Coffee

Technology Workshop

7:15

Defining Hydrolysates: An Approach for Generating a Chemically Defined Alternative
Hydrolysates are used in cell culture processes as components of a complete medium formulation or part of a feeding supplement for fed-batch bioreactor processes. Due to the undefined nature of hydrolysates, there is a push to develop a chemically defined alternative. The data will be results of studies performed to elucidate the essential components of commercially available hydrolysates.
Zachary W. Deeds, Senior R&D Scientist, Cell Sciences & Development, SAFC Biosciences

Manufacturing Efficiency & Supply Chain Security

Maximizing Process and Facility Efficiency

8:00

Chairperson's Remarks
Wolfgang Noe, Ph.D., Vice President, Strategic Development and Technical Alliance, Biogen Idec

8:15

Strategies for Disposable Usage at Mid and Large Scale Downstream Processing at Boehringer Ingelheim
The presentation will analyze the types of disposables used at Boehringer Ingelheim in biopharmaceuticals at different scales in downstream including the rationale for usage and their risks and benefits. Hear reports of storage of buffers and bulks and their limitations, the BI concept for extractables and leachables, and requests to the suppliers of disposables from the viewpoint of the operating industry.
Dr. Jan Feuser, Associate Director, Pilot Plant Downstream, Boehringer Ingelheim GmbH & Co. KG, Germany

8:45

An Analysis of Technology Gaps in the Biopharmaceutical Industry
The manufacturing of biotherapeutics, based on cell culture technology, has been a success story for more than 20 years. Impressive progress has been made during that time in all involved faculties (cell culture, purification, formulation) and in our knowledge of the corresponding protein products. This presentation will focus on a recent survey with industry opinion leaders on "technology gaps" which may still exist despite efforts in technology development for cell culture based systems over the past years.
Wolfgang Noe, Ph.D., Vice President, Strategic Development and Technical Alliance, Biogen Idec

9:15

Effective Long-Range Capacity Planning and Decision Making
As biotechnology companies have grown, the challenges associated with managing their manufacturing capacity have grown as well. Genentech has put in place a number of processes to assure timely and robust decision making for its drug product and drug substance production network. Key learnings around productivity improvements, the balance between out-sourcing and in house production and other critical questions will be shared.
Robert L. Larson, Director, GT Strategic Planning, Genentech, Inc.

9:45

Networking Refreshment Breakin Exhibit and Poster Hall

10:00-12:00

Career Development Seminar

10:30

Facility Optimization: Experience of a Custom Contract Manufacturer from Broad Scope to the Details
Effective facility utilization begins at the highest level with broad feasibility analysis of short and long term program requirements well before program commitment. It continues through logistics planning in support of evolving product forecasts and culminates with operational excellence planning at a finer level of detail, such as reducing turn around time for test results in analytical laboratories.
Jenifer L. Wheat, Senior Director, Commercial Development, Diosynth Biotechnology, a part of Schering-Plough Corporation

11:00

Case
Study

A Case Study on Technical Transfer with an Emphasis on Risk Management for Improved Process Robustness and Reliability
Talecris Biotherapeutics, a global biotherapeutic company that discovers, develops and produces critical care treatments for people with life-threatening disorders, has developed a modified process for production of Prolastin® to treat Alpha1-antitrypsin deficiency. This case study will cover elements of quality by design, failure modes and effects analyses, pathogen safety risk assessment, and document error-proofing for improved process robustness and reliability.
Doug Burns, Ph.D., Manager, Technical Operations Support, Process Development and Technology, Talecris Biotherapeutics

11:30

Generic Biotechnology: Are Discussions Scientific or Political?
Arguments about "the new boy on the block" ...generic biotechs...are more political than scientific. More than twenty-five generic companies in Europe and Southeast Asia are meeting regulatory requirements and several are marketing products. Current proposed legislation provides acceptable scientific criteria to move ahead. One generic biotech company, in its preliminary batches, created enough product by its innovations in product and procedure to unexpectedly provide for the entire first round of sales.
William Haddad, Chairman and CEO, Biogenerics, Inc.

Scaling Up from Bench through Commercialization

Minimizing Variability of Process and Product

8:00

Chairperson's Remarks
Ellen L. McCormick, Director, BioProcess R&D, Pfizer, Inc

8:15

"Omics" Technologies for Cell and Process Development
Despite the various positive features, further improvements are expected by understanding the biology and responses of Chinese Hamster Ovary (CHO) cells in bioreactors in more detail. In this paper we report strategies and results of CHO gene expression profiling experiments. The aim is to systematically collect "Omics" data from cell lines under various conditions and to investigate the impact on product quality, quantity, and reproducibility.
Wolfgang E. Budach, Ph.D., Fellow, Bioprocess Development, Novartis Pharma AG, Switzerland

8:45

Case
Study

ImmunoGen's Approach to Conjugate Production Processes
ImmunoGen develops conjugates consisting of one of its proprietary derivatives of the cytotoxic agent maytansine attached to tumor-targeting antibodies. The process for producing these conjugates is key to reliable achievement of essential product attributes. A case study is presented on the development of a production process that consistently and cost-effectively achieves necessary product attributes.
Deborah Meshulam, Director, Process Science and Engineering, ImmunoGen, Inc.

9:15

Case
Study

Controlling Variation across the Development / Manufacturing Interface
The control strategy is the mechanism by which variation is controlled in a manufacturing process. Recently ISPE has proposed a three-level model for such control strategies. This approach places particular emphasis on the interfaces between each level. This presentation will discuss the interface at the process/equipment interface. In particular it will discuss how unit operation capability is being used to ensure that the requirements of the process are synchronized with the capability of the equipment, thereby increasing the assurance of in control and capable commercial operations.
Bernard M. McGarvey, Ph.D., Engineering Advisor, Eli Lilly and Company

9:45

Networking Refreshment Break in Exhibit and Poster Hall

10:00-12:00

Career Development Seminar

10:30

Case
Study

Integration of Simcell™ Micro Bioreactor Automation with On-line Analytics toward Cost Effective Statistical Process Development Screening
Multivariate experiments are essential to deeper understanding of cell culture processes. Simcell with associated HTS analytics enables relevant, statistically valid experiments to be done efficiently. Data rich Simcell experiments serve to prioritize interactions for confirmation at larger scale, whereby variation can be minimized if the interactions among process parameters are known, monitored and controlled.
Russell H. Robins, Research Fellow, Pfizer

11:00

Case
Study

Creation of a Well-Characterized Small-Scale Model for High-Throughput Process Development
Streamlining process development has been the focus of the biotechnology industry over the last several years. We will discuss our characterization strategy for 2L, 15L, and 110L bioreactors. We will present a case study in which the characterization information in conjunction with specific oxygen uptake rate (OUR) successfully predicted large scale reactor performance.
David Zhang, Ph.D., Scientist I, Upstream Process Development, Diosynth Biotechnology, a part of Schering-Plough Corporation

11:30

Analytics to Support Process Characterization and Validation
An important consideration to establish an acceptable process design space is the effect of changing process variables on the product quality. This presentation will discuss strategies to employ faster alternative assays compared to the lot release methods to assess this impact, thus enabling the selection of process parameters to ensure the manufacture of API with suitable product quality.
Mary E. M. Cromwell, Ph.D., Associate Director and Senior Scientist, Protein Analytical Chemistry, Genentech, Inc.

Strategy Discussion Forums

8:00

Concurrent Technology Workshops

12:00

Nutrient Supplementation Strategies in a High Throughput World
Nutrient supplementation has traditionally been employed to replace depleted media components to extend productive culture lifespan. Frequently 10X concentrates of whole basal media formulations are used resulting in hyper-osmolality. This workshop examines proven approaches to nutrient supplement design, screening, bioreactor-based feeding strategies and process parameter optimization. Both commercial nutrient supplements and custom formulation development work flows will be presented, including nutrient utilization studies and Design-of-Experiment (DoE) methods in flask culture, bioreactors and the SimCell™ high-throughput microfluidic system.
David (Xiaojian) Zhao, Ph.D., Technical Area Manager, Research & Development, Life Technologies

Technical and Economic Considerations Regarding Design and Application of Single Use Mixing Systems
Bioprocessing mixing operations represent some of the most challenging applications of single-use technology. This presentation examines the design of Thermo Scientific HyClone Single-Use Mixer (S.U.M.) systems based on stirred-tank principles and other commercially available conventional and single-use mixing technologies using computational fluid dynamics (CFD) and 3D animations of methods of use. Technical and economic guidance is given on selection of systems for applications ranging from simple rehydration of cell culture media to preparation of critical sterile solutions. Case study results will be presented to demonstrate expected process times.
Cory J. Card, M.S., Associate Director, Cell Culture R&D, Thermo Fisher Scientific

POROS® Chromatography Media: A Tool for High-Performance Downstream Purification Solutions
The features and benefits of POROS® chromatography media as they relate to improving downstream purification process performance and productivity will be discussed. Performance benchmarking of a new high capacity cation exchange media and other POROS medias will be highlighted. Applications data and process productivity modeling will be used to demonstrate the benefits of utilizing POROS media for purification unit operations.
Christine Gebski, M.S., Director, POROS Applications and R&D, Applied Biosystems

Moving to the Next Generation of Manufacturing
Biopharmaceuticals are the most successful product group in the Pharma industry with the challenge producing them cost effectively. DSM Biologics has developed the XD® , Extreme Density process addressing this. The XD® technology boosts the titer and bioreactor output by a factor 5 - 10 for CHO, PER.C6® and other cell-lines for both high and low producing clones. XD® can be applied on existing bioreactors with minor modifications while maintaining good product quality.
Rolf Douwenga, Vice President, Global R&D, DSM Biologics

12:30

Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their posters to be available for discussions.

Plenary Session - Regulatory and Quality Updates

2:00

Chairperson's Remarks
Jeffrey C. Baker, Ph.D., Senior Director, Manufacturing Sciences, MedImmune

2:15

Structure and Function of Heparin Polysaccharide Chains: Update on Recent Contamination Issues
Heparin has been receiving much attention lately due to a contamination issue with oversulfated chondroitin sulfate that was brought to light in 2008. This discussion will highlight some of the underlying structural features of heparin and how the highly sulfated and negatively charged polysaccharide chains contribute to biological activity.
Ali Al-Hakim, Ph.D., Branch Chief, Office of New Drug Quality Assessment, CDER, US FDA

2:45

In Pursuit of Quality: Continual Improvement, Innovation, and Regulatory Oversight
A culture of quality for pharmaceutical development and manufacturing requires continual assessing, learning and implementing, from design to packaging. Fundamental to all the areas are knowledge management, continual improvement, optimization and innovation. The industry's research and development sector has championed innovation for decades; however, the manufacturing and quality assurance sector have not had the same attention. With regulators being open to innovation and continual improvement and the current worldwide financial situation, the time and milieu for a step change is most propitious.
Ali M. Afnán, Ph.D., Senior Staff Fellow, OPS, CDER, US FDA

3:15

Case
Study

Development of a Monoclonal Antibody Using QbD: Results from the Industry Consortium Case Study
A consortium of biopharmaceutical companies have developed a case study detailing the use of QbD principles, tools and practical examples based on a model monoclonal antibody. Sufficient detail will be presented to guide the path from Target Product Profile to process characterization and scale-up. The case study received feedback from FDA leads and moves the dialog beyond recent general QbD discussions to a more concrete proposal for lifecycle knowledge management.
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Eli Lilly and Company

3:45

Networking Refreshment Break in Exhibit and Poster Hall

Keynote Presentations

4:15

Future Trends in Biopharmaceutical Operations and Facilities
This presentation will analyze current and future biopharmaceutical products and review history and technology trends in process development and operations. Based on these analyses and trends, potential conclusions will be drawn for the future of biopharmaceutical operations, manufacturing capacity and manufacturing technology. Finally, the impact of these trends on design, cost and operation of biopharmaceutical facilities will be discussed.
Johannes R. Roebers, Ph.D., Senior Vice President, Biologic Strategy, Planning & Operations, Elan Pharma International Limited, Ireland

5:00

ObamaCare: Stimulus Spending, System Reform and Market Change
Could it happen this time? Decades of a hybrid private market and government health care system have resulted in one of the most costly and least efficient health care systems in the world. Combine this moment with a renewed belief that government may be able to fix what deregulated markets cannot, and serious, systemic health reform may be signed into federal law by the end of 2009. What will the plan look like? Will it work? What does it mean for the pharmaceutical industry and particularly biotech drugs? This keynote session examines probable new policies and outcomes for the pharmaceutical industry under ObamaCare.
J.D. Kleinke, Medical Economist and Author, Oxymorons: The Myth of a U.S. Health Care System

5:45

Networking Cocktail Reception in Exhibit and Poster Hall

7:30

Optional: Networking Dinner
Space is limited. Additional fees apply.

Site Tour to Diosynth Biotechnologyc
Wednesday, October 14 · 8:15 am- 12:00 pm

Diosynth Biotechnology, a full-service cGMP contract manufacturer of complex recombinant proteins, invites you to tour our state-of-the-art manufacturing facility in Research Triangle Park, NC! During the tour you will view the microbial and mammalian fermentation halls, recovery and purification areas, media/buffer preparation and QC/analytical laboratories where more than 80 clinical and commercial products have been successfully developed, scaled-up and produced for numerous clinical trials and commercial sale. The facilities are licensed by CDER/CBER, HPB, EMEA and certified by the JMHLW. Light refreshments will be served.
The buses will depart convention center at 8:15 am on Wednesday, October 14 and return by 12:00 pm.
Diosynth Biotechnology is part of Schering-Plough Corporation.
Space is limited and available on a first come, first served basis. Please indicate on registration form if you wish to attend.

Thursday, October 15, 2009 - Main Conference

Monday | Tuesday | Wednesday | Thursday | Friday

7:00

Registration and Coffee

Technology Workshop

7:15

AssayMAP™ - A New Platform Enabling Rapid, High Throughput Bioprocess Analytics
AssayMAP is a new system based on disposable micro-chromatography cartridges packed with a wide range of resins, designed for use in automated liquid handling systems or a high throughput spin column format. Key applications in bioprocessing include high precision product titer in cell culture or downstream (up to 384 results in <30 minutes with no robotics), automated, high sensitivity process impurity ELISAs (96 results in <30 minutes), product variant analysis and chromatography design space experiments.
Scott P. Fulton, CEO, BioSystem Development, LLC

Cell Culture & Upstream Processing

8:00

Track Sponsor's Introductions
Tom Isett, Vice President, BD Biosciences - Advanced Bioprocessing

8:05

Chairperson's Opening Remarks
James W. Brooks, Ph.D., R&D Manager, BD Biosciences - Advanced Bioprocessing

Approaches to Reduce Investment and Accelerate Process Development

8:15

High-Throughput Strategies for the Efficient Selection of High Antibody Producing Recombinant CHO Cell Lines
This talk will focus on two complementary high-throughput selection strategies that have been developed for generating HuMAb expressing CHO cell lines using a universal animal component-free media: 1. BASE-HIT: Batch Amplification and Selection - HIgh Throughput. 2. The use of semi-solid media and automated picking of high producing clones, where plating efficiency at various stages of development has been optimized.
Joel Goldstein, Ph.D., Associate Director, Process Development, Medarex

8:45

High Expressing CHO Transient System for Producing Multi-Gram Amounts of IgGs
We have developed a simple, efficient, scalable and high yielding proprietary CHO transient expression system capable of rapidly producing multi-gram amounts of IgG for early drug development studies. This presentation will summarize data from the extensive optimization of the whole process which resulted in a system capable of expressing several hundred mg/L and successful scale-up to 250L SUB. The CHO transient system is now routinely used to provide gram amounts of research grade material.
Lekan Daramola, Head of Early Expression and Supply, Cell Sciences, MedImmune Limited, United Kingdom

9:15

Using Perfusion Process to Reduce Investment and Accelerate Process Development - Advantages and Limitations
Due its low capital investment requirement, perfusion process has been used as an early development tool, and increasingly, the "early launch" option. Perfusion process provides a stable cell culture environment that is suitable for both unstable and stable products. However, some operational and logistical challenges do exist for a commercial scale perfusion process. Early focus on process set-up such as the proper identification of raw material "lineage" will significantly reduce operational complexity and aid incident investigation.
Paul Wu, Ph.D., Director of Upstream Development, Global Biological Development, Bayer HealthCare

9:45

Networking Refreshment Break in Exhibit and Poster Hall

10:30

Use of Site-Specific Recombination (AttSite™ Recombinase Technology) for Cell Line Development
The AttSite® Recombinase Technology, Intrexon, Blacksburg, VA, utilizes gene-targeting enzymes that catalyze stable and irreversible insertions, deletions or inversions of DNA at specific locations in the host cell genome. Using this technology, we developed CHO cell lines that contain a site-specific recombination point at a high-expressing site within the cell genome. We used these AttSite® -containing cell lines to replace pre-selected ‘targeting sequences' with genes encoding a monoclonal antibody or other therapeutic proteins being developed by Centocor. Importantly, the exchanged genes preferentially integrated into the transcriptionally active site or ‘hot spot' resulting in very consistent high-levels of protein expression.
Susanne Corisdeo, MS, Research Scientist, Gene Expression, Centocor R&D
Marguerite Campbell, MS, Senior Associate Scientist, Gene Expression, Centocor R&D

Innovations in Media Development

11:00

A Systematic Approach to Develop Chemically-Defined Cell Culture Platform Media
A systematic approach will be described to illustrate how to develop chemically-defined media and feeding strategies across multiple model cell lines. The presentation will focus on key features of the fed-batch media development to meet different development goals for harmonized and enhanced processes. A few examples will be presented to demonstrate that significant titer improvement (>8g/L) can be achieved by applying this systematic media development approach.
Feng Li, Ph.D., Senior Engineer, Process Research and Development, Genentech, Inc.

11:30

Metabolism-Targeted Media Optimization: A Rational Approach to CHO Media Development
Metabolism-targeted media optimization involves balancing of nutrients involved in primary CHO energy metabolism. Interactions of key amino acids, monosaccharides, glycolytic intermediates and vitamins to optimize cell growth and/or productivity were evaluated. Numerous experiments evaluating media components were performed using shake flasks and a novel high-throughput cell culture system. Results across several CHO cell lines indicated significant increase in product titer when balancing ratios of media components involved in primary CHO energy metabolism.
Christina T. Petraglia, Senior Research Associate, Late Stage Cell Culture, Process Research & Development, Genentech, Inc.

Recovery & Purification

8:00

Chairperson's Opening Remarks
Sanchayita Ghose, Ph.D., Manager, Process Sciences Downstream, Bristol-Myers Squibb

Overcoming Bottlenecks in Downstream Processing

8:15

Use of High Throughput Screening Approaches to Evaluate Potential Improvements to Wyeth's Monoclonal Antibody Platform Purification Process
The use of HTS methods has enabled rapid assessment of potential improvement in selectivity and capacity for impurities (HMW) on the anion exchange AEX step of the two-column monoclonal antibody platform process. This presentation will focus on the approaches used to evaluate AEX resins with respect to both product and impurity binding.
Mary B. Switzer, Ph.D., Senior Research Scientist II, Drug Substance Development, Wyeth BioPharma

8:45

Maximizing Throughput - Technology vs. Facility: Utilization of Best Process Technology versus Facility Capacity and Strategies for Maximizing Kg Out the Door, Minimizing $/Dose, While Keeping Company Harmony
Abstract not available at press date.
Joost Quaadgras, M.S., Research Fellow, Global Biologics, Pfizer Inc

9:15

Process Portability to Fit a Diverse Manufacturing Network
Development scientists and engineers are not only challenged to deliver the pipeline with titers >5 g/L, but are also faced with enabling the best fit within a diverse network of manufacturing facilities. This talk will discuss development strategies to make purification processes more portable. In addition, it will describe manufacturing/process bottlenecks for a "proof of concept" purification, bringing to light facility capabilities and constraints.
Jean Bender, Ph.D., Senior Engineer, Genentech, Inc.

9:45

Networking Refreshment Break in Exhibit and Poster Hall

Advances in Process Monitoring and Control

10:30

Impacts and benefits of Process Analytical Technology (PAT) in Industrial Downstream Processing
Process Analytical Technology (PAT) is intended to support innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. Through this initiative the FDA wants to encourage the effective use of the most current pharmaceutical sciences, knowledge and engineering principles, which can improve efficiencies of manufacturing and regulatory processes. Case studies of 3 different technologies will be shown with Process Analytical Technologies which were developed, scaled-up and implemented at the industrial scale.
Margit Holzer, Ph.D., Vice President, Technologies, Novasep Process, France
Abdelaziz Toumi, Ph.D., Project Leader, Downstream Processing - Large Scale Biotech, Laboratoires Serono SA, Switzerland

11:00

Case
Study

Practical Aspects of On-Demand Access to Critical Process Data from Paper Records for Monitoring and Control of a Biopharmaceutical Manufacturing Process
Review methods used and benefits gained when manufacturers have on-demand access to data stored in paper records combined with production data from disparate sources in one integrated, validatable environment. Presenters will outline requirements for capturing paper records and accessing other data, as well as organizational considerations, such as collaboration required with internal support groups. Examples will show how Merck Serono leveraged manufacturing process data to automate trending and reviews of Critical Process Parameters and to enable investigations of cause-and-effect relationships when needed. Results included reduced costs and risks from less expenditure of staff time and increased data reliability, with the expectation of increased ease of avoiding unacceptable process variability and implementing process improvements when needed.
Monika Jungen, Process Engineer, Production Compliance Manager, Merck Serono International S.A., Switzerland
Justin Neway, Ph.D., Executive Vice President and Chief Science Officer, Aegis Analytical Corp.

11:30

Implementation of New Technology to Remove the Log Jam of Process-Related Impurity Testing
With an ever-increasing portfolio to support, it can be difficult for analytical groups to supply test results in a timely fashion to facilitate critical process decisions. This talk will discuss the implementation of new technology to increase the throughput of process related impurity testing.
Eric Bishop, Scientist I, Analytical Biochemistry, MedImmune

Strategy Discussion Forums

8:00

E: Adopting New Technology - Take II
With high therapeutic margins and an excess of capacity, implementation of new manufacturing technologies can be difficult to justify. This session discusses the steps that companies take to justify, and then implement a new process or manufacturing approach. Also discussed will be the role of the supplier in supporting the process for process development. For manufacturing professionals considering the use of a novel approach, or a vendor introducing a new technology, this session will provide insight on how to make the process run more smoothly.

How are new technologies justified? What are the drivers of change?
The role of cost modeling
The role of the vendor and the information/support that they provide
The issues/challenges with implementation and how they were overcome

Moderator:
Peter Latham, President, BioPharm Services US
Panelists:
Üwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
Dr. Günter Jagschies, Senior Director R&D, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden
Timothy Matthews, Senior Engineer, Group Leader, Process Development Engineering, Genentech, Inc.
Tom Ransohoff, Senior Consultant, BioProcess Technology Consultants, Inc.
Jayanth Sridhar, Ph.D., Associate Director, Cell Culture Manufacturing Sciences, BioMarin Pharmaceutical Inc.

10:30

F: Flexible, Small Scale Manufacturing Facility Scenarios
Shrinking capital budget, potential price controls and the enduring uncertainty of clinical success are driving companies to more flexible capacity options. This discussion session looks at the variety of ways to achieve flexibility in process development in manufacturing, ranging from disposables implementation, to modular facilities to multi-expression design. Additionally, we will discuss the benefits, weaknesses, and challenges of implementing greater flexibility into your capacity.

Disposables implementation - how much flexibility do they really provide?
Modular facility design - what does this really mean and how does it add flexibility?
What are the challenges, regulatory and operational, that must be overcome to make your facility multi-expression capable?
What are the potential benefits/tradeoffs of flexibility?
How much flexibility do you really need?

Moderator:
Tom Ransohoff, Senior Consultant, BioProcess Technology Consultants, Inc.
Panelists:
Parrish Galliher, Founder & Chief Technology Officer, Vaccine Manufacturing, Xcellerex, Inc.
Dr. Günter Jagschies, Senior Director R&D, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden
Joseph K. McLaughlin, Associate Research Fellow, Pfizer Inc.
James M. Robinson, Vice President Technical and Quality Operations, Novavax, Inc.
Christina Scully, Director of Manufacturing, Bristol-Myers Squibb

Concurrent Technology Workshops

12:00

Robust Quality Systems for Cell Culture Media Product Design and Risk Management
Building quality into product starts at the very nascent stages of product concept and design. The application of quality systems such as supplier quality management and enterprise risk management systems are essential to ensuring consistent product performance and supply. With new regulatory challenges, manufacturers of cell culture media are leaning towards effective Quality Systems as the nucleus of product proposition and development. This focus, in turn, materializes into reducing the regulatory risks, cost of quality control testing and lead time into progression of product from development to commercialization.
Asiya Imam, Ph.D., CQA, Senior Manager, Quality Systems, BD Biosciences - Advanced Bioprocessing

Accelerating Cell Line and Cell Culture Development Workflows: Maximizing Success by Integration of Select Automation Platforms
By utilizing a combination of automation technologies and statistical DOE approaches we have streamlined and improved both cell line development and cell culture medium development workflows. Flow cytometry, ClonePixFL robotics, label-free biosensor technologies and liquid handling have been integrated into our workflows for real time measurement of cell proliferation and protein production. We will discuss how these combined technologies have improved the success rate in developing robust cell culture platforms for therapeutic protein production.
Peggy Lio, Senior Process Sciences Fellow, PD-Direct Bioprocess Services, Life Technologies

Costs and Savings Options in Building and Operating a Biopharmaceutical Manufacturing Facility
This case study will use public information about an existing facility and model its construction costs, present the capital breakdown for different components, and identify the key savings opportunities together with the market context that will lead to a change of manufacturing strategies. Based on the model, a COGS breakdown will be presented and both fixed and variable costs will be discussed. Participants will receive a comprehensive overview of economical aspects of bulk drug substance manufacturing.
Dr. Günter Jagschies, Senior Director R&D, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden

Rethinking Capture Chromatography for Monoclonal Antibodies
Upstream processes with the PER.C6® cell line have achieved 27 grams of antibody per liter in the XD® format, and more recently over 10 grams per liter in a fed-batch process. Such advances require purification processes with higher capacity to be able to use same equipment and, ideally, shorter processing cycle-times. This talk will cover the development of a high capacity capture step for monoclonal antibodies. Design of experiments was used to maximize capacity, recovery, and obtain a purity comparable to that of Protein-A.
Blanca Lain, Ph.D., Scientist III, Downstream Process Development, Percivia LLC

12:30

Networking Luncheon in Exhibit and Poster Hall

Cell Culture & Upstream Processing

Recovery & Purification

Plenary Session: Integrating Upstream & Downstream Processing

1:45

Chairperson's Remarks
Paul Wu, Ph.D., Director, Upstream Development, Global Biological Development, Bayer HealthCare

2:00

Integrating Upstream and Downstream Bioprocess Development: What Can or Should Cell Culture Do?
As the effort to obtain higher titers in cell culture intensifies to 10 g/L and above, bioprocesses contend with challenges of ensuring consistent cell culture outputs, as well as challenges downstream in purifying such significant masses of protein. Upstream process conditions can have significant impact on downstream concerns such as host cell impurities, as well as on product quality attributes. A unified definition of design space will help identify crucial links between upstream and downstream processes, and drive better overall bioprocess design in delivering antibodies at industrial scale. Important to providing substantial benefit to the industry will be the integration of upstream and downstream operations in approach, equipment, and operational efficiency in delivering final product of consistent quantity and quality.
Srikanth Chary, Ph.D., Senior Engineer, Cell Culture Process R&D, Genentech, Inc.

2:30

A View of Integration of Upstream and Downstream
Manufacturing efficiency calls for seamless interfaces between unit operations. The interface between upstream and downstream calls for careful consideration since different teams often drive the development and implementation of each side. The development of higher titers for new products and existing products puts a strain on this interface. The challenges that result from integrating upstream and downstream process development will be described from a holistic process perspective.
Jonathan Coffman, Ph.D., Principal Engineer II, Drug Substance Development, Wyeth Biopharma

3:00

Networking Refreshment Break in Exhibit and Poster Hall
Final opportunity to consult with suppliers and view new data in posters.

3:45

Case
Study

Upstream - Downstream: Elucidation of the Cause and Mechanism of Aggregation of an IgG4 Antibody
Upstream process modifications can have a significant impact on quality attributes of proteins, with consequences not fully realized until the drug substance is placed on stability. This case study describes how modification of cell culture conditions resulted in an increase in the oxidation of an IgG4 antibody, leading to a higher rate of soluble aggregate formation in the purified protein.
Thomas C. Furman, Research Advisor, Bioprocess Purification Development, Eli Lilly and Company

Keynote Presentation

4:15

Integrating New Technologies in Upstream and Downstream Processing -When to Innovate? What are the Barriers? What are the Challenges?
Genzyme has developed and implemented several large scale continuous processes for manufacturing of therapeutic proteins and synthetic molecules. While the corresponding technology platforms have evolved independently, there are multiple essential concepts and approaches that are compatible. We will review these similarities, and will explore the synergistic opportunities to bridge knowledge in these two areas, including process design concepts, new technologies, and logistics.
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corp.

Plenary Panel Discussion

5:00

What More Can Be Done to Increase the Integration of Upstream and Downstream Processing

Can the Two Areas be Combined into one Continuous Process?
Integrated QbD Approach
Can (how will) Downstream Handle 10+ g/L Going Forward?
Impact of Cell Harvest Step on Product Quality
Harmonization of Equipment and Operational Practices
How Media Development Affects Analytics
Benefits/Disadvantages of Higher Expression Levels on Purity
Filtration Step - Clarifying Challenges Between Upstream and Downstream Processing

Moderator:
Tim Charlebois, Ph.D., Senior Director, Drug Substance Development, Wyeth Biopharma
Panelists:
Srikanth Chary, Ph.D., Senior Engineer, Cell Culture Process R&D, Genentech, Inc.
Jonathan Coffman, Ph.D., Principal Engineer II, Drug Substance Development, Wyeth Biopharma
Thomas C. Furman, Research Advisor, Bioprocess Purification Development, Eli Lilly and Company
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corp.

5:30

Close of Shared Plenary Session

Vaccine Manufacturing Technology Summit

1:15

Chairperson's Opening Remarks
James M. Robinson, Vice President Technical and Quality Operations, Novavax, Inc.

1:30

Development of a New Vaccine for Plague
To meet the immediate requirement of the US Government Department of Defense (DoD) for a stockpile of an efficacious prophylactic vaccine for Yersinia pestis, the aetiological agent for pneumonic plague, a concerted fast-track development program between the UK Health Protection Agency and The US DoD Prime Contractor, DynPort Vaccine Company, has resulted in a new vaccine manufacturing process to support advanced clinical trials and commercial manufacture.
John Brehm, Ph.D., Scientific Program Manager, Centre for Emergency Preparedness and Response, Health Protection Agency, United Kingdom

2:00

Economic Manufacture of Recombinant Protein and DNA Vaccines in Microbial Systems: Technology Driven Solutions
Vaccines (protein and DNA) manufactured using microbial expression systems must meet stringent COG expectations in order to meet global market requirements. Recent advances in microbial expression of soluble proteins, cellular/extracellular localization, control mechanisms, post-translational modification coupled with universal high cell density fermentation cultures have driven improvements in volumetric productivity and product quality.
Christopher Dale, Ph.D., Head of Microbial Technology, Lonza

2:30

Scale-up of an Intensified rAd35 Vaccine Production Process in Disposable Bioreactors
In order be able to produce an affordable PER.C6®based rAd35 tuberculosis vaccine for global demand, a process intensification development program was started at Crucell. In order to fit the manufacturing process in our current facilities, the focus of this program is intensification of volumetric productivities and implementation of disposable technologies. This presentation will highlight our strategy and progress.
Ciska Dalm, Ph.D., Scientist, Upstream Process Development, Crucell Holland BV, The Netherlands

3:00

Networking Refreshment Break in Exhibit and Poster Hall
Final opportunity to consult with suppliers and view new data in posters.

3:45

Case
Study

GMP Vaccine Manufacturing in Single Use Stirred Tank Bioreactors: Case Studies with Microcarriers and Various Vaccine Types
The paper will present a case study of a viral vaccine for a tropical disease produced in single use stirred tank bioreactors by attachment dependent cells on microcarriers in serum free medium, as well as a variety of other vaccine types. A discussion of the challenges for bioreactor scale up will be included. The possibility of more universal "generic" vaccine plants will also be discussed.
Parrish M. Galliher, Founder & Chief Technology Officer, Xcellerex, Inc.

4:15

Case
Study

Manufacture of Live Attenuated Biodefense Vaccines Using Disposable Technology in a Virtual Environment
To address the complex and urgent needs of biodefense vaccine production, a portfolio of manufacturing approaches must be used. For live attenuated viral vaccines grown in stationary cell culture, we have found that disposable technology yields excellent results in terms of speed, flexibility, and cost. Another advantage is that this technology is simple and easily transferrable between manufacturers, making it ideal for use in a virtual environment in which biodefense vaccine development is done using multiple specialty subcontractors. This presentation will describe the technology and give examples of two vaccines in which this approach was utilized.
Robert V. House, Ph.D., President, DynPort Vaccine Company LLC

Audience Interactive Panel Discussion

5:00

Critical Vaccine Manufacturing Challenges
Moderator: James M. Robinson, Vice President Technical and Quality Operations, Novavax, Inc.
Panelists: All Vaccine Summit presenters

5:30

Close of Vaccine Summit

Strategy Discussion Forums

1:15

Workshop Forum G: Measurement Uncertainty: Acknowledging, Analyzing, and Managing
Understanding and managing variability in the measurement of inputs and outputs is important to the definition, development and control of all bioprocesses. Management of measurement uncertainty and rational incorporation of measurement uncertainty into product control strategies will be examined through group discussion of several case studies. Calibration, "guard-banding," P.A.T., calculation methods, and related topics will be examined in the context of their practical application to bioproduct manufacturing. Attendance will be limited to 30 to aid participation and discussion.
Facilitators:
Jeffrey C. Baker, Ph.D., Senior Director, Manufacturing Science and Technology, MedImmune
Bernard M. McGarvey, Ph.D., Engineering Advisor, Eli Lilly and Company

Site Tour to Biogen Idec
Thursday, October 15 · 8:15 am - 11:30 am

Conference participants will have an opportunity to tour Biogen Idec's manufacturing site in Research Triangle Park. The plant is one of the largest mammalian cell culture facilities in the world. The tour will consist of a walk through of the company's 2,000 liter Small Scale facility as well as its 20,000 liter Large Scale facility and central warehouse and dispensary areas. Closed toed shoes are required.
The buses will depart convention center at 8:15 am on Thursday, October 15 and return by 11:30 am.
The tour is currently full but a waiting list is being created. Please call customer service at 800-390-4078 to add your name to the list. Additional spaces may become available.

Friday, October 16, 2009 - Main Conference

Monday | Tuesday | Wednesday | Thursday | Friday

7:00

Registration and Coffee

Technology Workshop

7:15

A Novel Technology for Simultaneous Clarification & Capture
Natrix Separations has developed a membrane-based, crossflow chromatography technology that allows users to capture target molecules directly from unclarified feedstreams. Simultaneous clarification and capture streamlines downstream processing, improves yields and purities and reduces manufacturing costs. This workshop present case studies for the production of a range or proteins and viruses directly from unclarified feedstreams.
Lisa Crossley, President & CEO, Natrix Separations, Inc.

Cell Culture & Upstream Processing

8:00

Chairperson's Opening Remarks
Dennis Kraichely, Ph.D., Principal Research Scientist, Expression Technologies, Centocor Inc.

Technologies to Analyze, Measure and Control Processes

8:15

Case
Study

Revitalizing a Legacy Cell Culture Process in Fitting it to a New Facility: A Case Study
This presentation will discuss optimization performed with legacy fed-batch processes alongside their transfer for manufacture in new facilities. A case study on optimization of inoculum expansion, seed bioreactors, and production bioreactor will be discussed. Improvements in inoculum expansion included replacement of spinner flasks with shake flasks and replacement of multiple flasks by single disposable bioreactors. Seed bioreactor optimization included provision of partial transfers. Production bioreactor changes lead to feeding strategies based on metabolite measurement and pH control via blood gas analyzer measurements. All of these changes helped improve consistency or scheduling of batches and improved the likelihood of batches being harvested successfully.
Douglas Osborne, Scientist I, Cell Culture Development, Biogen Idec

8:45

Case
Study

Real Time Analysis to Aid Media and Process Development
BaychroMAT is a platform that automates analyzers. Additional automation components enable high operational availability. This system includes an innovative sterile Online Port, an automated sample transport, an integrated sample preparation module, online analyzers and communication interfaces to process automation systems. Real-time data will be presented and benefits for media optimization and process development will be demonstrated.
Stefan Steigmiller, Ph.D., Senior Project Manager, PAT, Bayer Technology Services GmbH, Germany

9:15

Advanced Monitoring and Process Control of Biological Processes
This presentation delves into a practitioner viewpoint on multivariate data analysis and advanced process monitoring as it applies to process validation. You will also learn about Biogen Idec's approach to concepts of scale-up verification through advanced monitoring and analytical techniques.
Joydeep Ganguly, Associate Director, Manufacturing Sciences, Biogen Idec

9:45

Networking Refreshment Break

Application of Genomic, Proteomic and Metabolomic Technologies

10:15

Global Biochemical Profiling for Upstream Bioprocess Optimization: Challenges and Opportunities
Global metabolic profiling is an unbiased approach to understand the metabolic state of cells and their surrounding environment. This presentation will discuss specific applications of this technology as a tool to provide traction in upstream process development activities. Attendees will learn how this technology was used to determine the metabolic changes induced by variations in process conditions.
Susan Casnocha, Ph.D., Associate Research Fellow, Global Biologics, Pfizer Inc.

10:45

Metabolic Flux Analysis in Mammalian Cell Culture
Metabolic flux analysis is an elegant approach to quantitatively characterize cell metabolism and substantially enhance our understanding of cell physiological state both in process development and manufacturing-scale bioreactors. Data from both the metabolite balancing and isotope tracer methods for flux analysis will be presented and application of metabolic flux analysis to process development and manufacturing-support scenarios will be demonstrated.
Chetan T. Goudar, Ph.D., P.E., Head, Cell Culture Development, Global Biological Development, Bayer HealthCare

11:15

RNAi Mediated Gene Silencing of Recombinant IgG Leads to Gene Expression Profile Changes in CHO Cells
Small interfering RNAs (siRNAs) against a recombinant human IgG were transfected into a CHO cell line stably expressing the IgG. Transcriptional profiling of the cell cultures, comparing IgG siRNA-treated cells to cells treated with a non-targeting siRNA, revealed 151 genes that were differentially expressed. Many of these genes have functions in protein secretion and folding, immunoglobulin production and protein glycosylation.
Trissa Borgschulte, Ph.D., Senior R&D Scientist, Cell Sciences and Development, SAFC Biosciences, Sigma-Aldrich

Recovery & Purification

8:00

Chairperson's Opening Remarks
David W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human Genome Sciences, Inc.

Applying Analytical Methods in Downstream Processing

8:15

Next Generation Membrane Adsorbers - Meeting Process Development Challenges
While commercially available anion-exchange (AEX) membrane adsorbers provide host cell protein clearance (HCP) comparable to columns at lower conductivities than that used for columns, the larger dilution of feedstreams can present plant fit challenges. To facilitate wider adoptions of AEX membrane chromatography at commercial scale, there certainly is a need for high salt tolerant membrane adsorbers. In this study, membrane adsorber properties such as ligand density, pore size and membrane chemistry were evaluated to explore their impact on HCP clearance over a wide range of salt concentrations using a manufacturing scale therapeutic monoclonal antibody feedstream.
Amit Mehta, Ph.D., Engineer II, Late Stage Purification, Genentech, Inc.

8:45

Case
Study

High Throughput Analytical Methods for Downstream Bioprocessing Development
To facilitate the acceleration of downstream bioprocess development, we have developed several novel analytical approaches, including high throughput methods for host cell protein, leached Protein A, product size and charge heterogeneity. We further developed a novel interfacing system for on-line analysis of column recovery operations. With these approaches, critical analytical end points can be generated to enable accurate and timely process decisions.
Judy H. Chou, Ph.D., Group Leader, Oceanside Process Research & Development, Genentech, Inc.

9:15

Analytical Tools in Support of Optimization of the Manufacturing Process of Immunoconjugates
Immunoconjugates are antibodies armed with cytotoxic agents. During manufacturing, the chemical reactions used for attaching cytotoxic agents to antibodies create by-products that need to be eliminated and, under certain conditions, they can yield undesired species. We developed analytical tools capable of monitoring the quality of the products obtained during process optimization, assuring the development of robust manufacturing processes.
Alex Lazar, Ph.D., Senior Scientist, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

9:45

Networking Refreshment Break

Alternatives to Traditional Column Purification

10:15

Polyethylene Glycol Precipitation of Monoclonal Antibodies and the Impact on Column Chromatography
This talk will discuss PEG precipitation as an alternative to chromatography in an antibody purification process. The effects of PEG concentration, pH and conductivity on precipitation performance were evaluated. PEG precipitation removed impurities including host cell proteins, aggregates, leached Protein A and DNA. We will discuss the impacts of implementing PEG precipitation in a two chromatography step purification process.
Glen Giese, Research Associate, Early Stage Purification, BioProcess Development, Genentech, Inc.

10:45

Case
Study

Application of a Cationic Membrane Adsorber for the Purification of Recombinant Proteins
Ion exchange membrane adsorbers are gaining popularity due to the benefits they present compared to traditional chromatography resins. In this study, a membrane adsorber was evaluated as an alternative to column chromatography for the purification of a recombinant protein. The membrane adsorber showed improved protein recovery with increased clearance of host cell protein impurities. The study demonstrates the feasibility of replacing a chromatography column with a membrane adsorber.
Rao Koduri, Ph.D., Senior Scientist, Purification Development Group, Genzyme Corporation

11:15

Evaluation of a New Synthetic Depth Filter for Monoclonal Antibody Purification
This presentation will provide an overview and data from extensive evaluation of a new completely synthetic depth filter (still under development) for antibody purification applications which could have a profound effect on the standard monoclonal antibody platform.
Judy Glynn, M.S., Senior Principal Scientist, Pfizer Inc

Strategy Discussion Forums

8:15

H: Process Validation for the 21st Century
In November last year the FDA issued a new Draft Guidance on Process Validation: General Principles and Practices. It is intended to reflect some of the goals of the FDA's Initiative on Pharmaceutical GMPs for the 21st Century. Major changes in the approach to process validation are proposed and the response from industry has been spirited.
Key topics for discussion in the session will be:

Do we need a clearer definition of key terms and concepts in the Guidance?
Can the new approach be better aligned with ICH Q7, 8, 9 and 10?
How many process qualification batches will suffice?
How does one determine whether sufficient data have been collected for statistical analysis of the qualification runs?
What will be the effect of the "Continued Process Verification" requirement on production costs?

Moderator: Alex D. Kanarek, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
Panelists:
Ali M. Afnán, Ph.D., Senior Staff Fellow, OPS, CDER, US FDA
Joydeep Ganguly, Associate Director, Manufacturing Sciences, Biogen Idec
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Eli Lilly and Company

9:45

Networking Refreshment Break

10:15

I: Navigating the Pathway to Regulatory Approval from Phase I to PAI
Experience based guidance will be offered by the panelists, beginning with application of an Incremental Approach to cGMPs as products advance from preclinicals through all phases of clinical development, validation & conformance. Step by step analysis of PAI preparedness, including examples of inspection readiness plans, such as moving from a single product to multi product facility and bringing a new manufacturing site online and working with CMOs, will be presented.

Side by Side Comparison of cGMP applied to clinical vs. commercial production
PAI Readiness with a CMO vs. in-house Manufacturing
Interpreting FDA Guidance on "Process Validation and General Principles"

Moderator:
Kathryn D. Simon, Ph.D., Director, Upstream Production & Development, Diosynth Biotechnology
Panelists:
Christopher Hartnett, Ph.D., Director, Process Sciences, Savient Pharmaceuticals, Inc.
Michele D. Jones, Director, QA Compliance, Human Genome Sciences, Inc.
Stewart McNaull, Ph.D., Section Leader, Upstream Development, Diosynth Biotechnology, a part of Schering Plough
Ned Wyman, Senior Manager, Validation, MedImmune, Inc.

Concurrent Technology Workshops

11:45

Strategies for Single Use in Tangential Flow Filtration Applications
Single use technology has become well established in the biopharmaceutical industry. The Novasep offers the first pre-sanitized, purpose built, single-use tangential flow filtration cassette for biopharmaceutical applications. Each SIUS™ cassette arrives pre-sanitized, ready to be equilibrated with buffer and used for processing. This presentation will identify the key points for utilizing a single use strategy for tangential flow filtration application.
Michael LaBreck, Sales Manager, Novasep, Inc.
Michael Xenelis, Senior Development Associate, Purification, EMD Serono Biotech Center

Single-Use Technology from New Brunswick Scientific
As single-use technology continues to increase in acceptance and demand as an alternative to traditional steel and glass bioprocess vessels, New Brunswick is proud to offer its own unique single-use bioreactor system. Designed for ease of use and true scalability, the CelliGen® 315s with its optional packed bed perfusion configuration is a system that can provide the results advocates of single-use technology have been demanding.
Richard Mirro, Product Manager, New Brunswick Scientific

Novel, Single-Use Bioreactors Using a Pneumatic Mixing Mechanism
Our innovative bioreactor platform employs a pneumatic mixing mechanism to convert the buoyancy of inlet gas bubbles into rotational energy, achieving efficient liquid/gas mixing without any external mechanical devices. This next generation disposable bioreactor is compact, simple, and scalable from 2 to 5,000 L. It's mixing characteristics, computational fluid dynamics, and biological evaluations will be presented.
Brian Lee, Ph.D., President, PBS Biotech

Luncheon Presentation

12:15

Rethinking Tangential Flow Filtration: Design, Operation and Processes using Single Pass Systems
Single Pass TFF (SPTFF) is a new form of tangential-flow filtration (TFF) delivering high-conversion separations without a recirculation loop, thereby providing the performance of TFF with the simplicity of direct-flow filtration. In addition to offering multiple economic benefits, SPTFF delivers important operational benefits and new capabilities such as increased yield, lower hold-up volume, very high concentration factors, and low exposure time. SPTFF is easily integrated with other downstream processes, such as chromatography and virus removal.
Steven Pearl, Vice President of Biopharmaceutical R&D, Pall Life Sciences

Cell Culture & Upstream Processing

1:30

Chairperson's Opening Remarks
Kelly Wiltberger, Senior Manager, Biopharm Development, Biogen Idec

Process Quality and Characterization

1:45

Case
Study

Effects of Cell Culture Conditions on Antibody N-linked Glycosylation -What Affects High Mannose 5 Glycoform
The glycosylation of recombinant monoclonal antibodies frequently has impact on in vivo biological activity. Cell culture conditions such as cell line characteristics, culture media, and process parameters can impact glycoform distribution during production. The results to be presented improve our understanding of how to achieve a consistent product quality profile with respect to glycosylation by controlling important cell culture conditions.
Efren Pacis, Senior Research Associate, Process Research and Development, Genentech Inc.

2:15

Identification of Critical Quality Attributes during Cell Culture and Upstream Processing
Identification of critical quality attributes is essential for the implementation of suitable testing plans and process controls for biopharmaceutical products. This presentation will describe a rationale for determining critical quality attributes during product development. The focus will be on cell culture and upstream processing CQA identification and determination of the likelihood of occurrence and impact on efficacy or safety.
Patricia Cash, Ph.D., Senior Director, Analytical Biochemistry, MedImmune

2:45

Case
Study

Gain Process Understanding Using Design of Experiments (DOE)
Abstract not available at press date.
Jim Reynolds, M.S., Scientific Fellow, Center for Mathematical Sciences, Merck & Co., Inc.

3:15

Networking Refreshment Break

Scale-Down Models and Scaling Up Case Studies - Lessons Learned

3:30

Case
Study

Agitation, Aeration, and their Effects on Cell Culture Performance in Stirred-Tank Bioreactors
A unified model of agitation and aeration in stirred-tank bioreactors was developed in response to poorer-than-expected performance observed upon scale-up of a mammalian cell culture process. This unified model has led to significant benefits including (1) more consistent performance across scales; (2) improved cell culture performance (e.g. - higher productivities); (3) improved product quality; and (4) "cleaner" conditioned media resulting in improved downstream processes.
Jose M. Gomes, Senior Research Scientist, Manager, Bioreactor Process Development, Wyeth Biopharma

4:00

Case
Study

Impact of Specific Power of Agitation on Host Cell Impurity Generationby a Mammalian Cell Culture in a Perfusion Bioreactor System
Perfusion bioreactors of different volume expressed different levels of host cell impurities. Many millions of dollars were potentially at risk due to the generation of out of specification material. It was discovered that specific power of agitation was the root cause for the difference. This case study covers the discovery, understanding and correction of the problem, including agitation experiments.
Scott Probst, Ph.D., Principal Technology Specialist, Biopharma Technology Solutions, Bayer Technology Services

4:30

Case
Study

Cell Culture Process Scale Up, Technology Transfer and Assessment of Process Comparability Using Multivariate Analysis: A Case Study
A CHO antibody production process was developed and transferred from a cell culture process development laboratory to a cGMP pilot plant facility for clinical manufacturing. Eight 1200L culture production batches were successfully executsed. Multivariate Data Analysis was used to assess comparability of the CHO cell culture process across scales and among batches. Process scale-up and batch comparability were demonstrated with respect to product quality and titer.
Hang Yuan, Ph.D., Senior Scientist, Mammalian BioProcess Research & Development, Global Research & Development, Pfizer Inc.

5:00

Close of BPI 2009

Recovery & Purification

1:30

Chairperson's Opening Remarks
Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany

New Approaches and Technologies for Downstream Processing

1:45

Case
Study

Straight Through Processing (STP) of Monoclonal Antibody Purification
Straight Through Processing (STP) for DSP is a proposed concept to automate process buffer preparation and to combine three purification steps, a DSP1 Chromatography step, a DSP2 Chromatography step, and a Virus Removal Filtration (VF) step into a streamlined single unit of operation. This would shorten the overall operation time, improve facility utilization, and eliminate certain intermediate hold and in-processing testing requirements for MAB manufacturing.
Bin Lin, Ph.D., Senior Research Scientist, Purification Science, Centocor R&D, Inc.

2:15

Case
Study

Innovative, Non-Traditional Approach to Purification & Scale Up of a Fusion Protein: A Case Study of an Enzyme-Fc-D10 Fusion Protein
Tech transfer & scale up is an essential part of the development of every biopharmaceutical product as it moves from discovery to clinical and commercial production. EA2 is a novel, engineered fusion molecule composed of three domains: an enzyme, Fc portion of IgG, and an anionic peptide. The presentation will cover evaluation of several different purification modalities and selection of a final process for production of high quality clinical material. We will describe our ongoing effort to scale up this process to kilogram scale as well as touch briefly on the softer side - team chemistry, forward planning, open communications, flexibility and professional trust that is an integral part of any successful tech transfer and scale up project.
Jayant Aphale, Ph.D., Vice President, CMC Manufacturing & Process Sciences, Enobia Pharma

2:45

Case
Study

Integration of New Technologies and Approaches to Accommodate Large-Scale Multi-Product Clinical Manufacturing
Creating the flexibility necessary to operate a large-scale multi-product facility that can accommodate purifying 8-20kg of antibody mass per week, using traditional stainless steel dedicated equipment, has required the integration of new technologies and approaches. The inherent design and capacity limitations of the facility have been addressed by implementing a flex-bag bulk fill system, sterile connectors, disposable filters, process optimization, and operating scenario evaluations.
Stuart Green, Associate Director, Purification, BB50 Commercial Manufacturing, ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company

3:15

Networking Refreshment Break

New Therapeutic Modalities

3:30

The Role of Biopharmaceutical Process Development in Regenerative Medicine
Regenerative Medicine is a field based on therapeutic strategies that help patients to permanently regenerate tissue structure and organ function as opposed to implanting medical devices or temporarily treating symptoms with drugs. Technologies include stem cell therapies, growth factors, resorbable tissue scaffolds and controlled release of biologically active agents. This presentation will focus on how traditional biopharmaceutical industry skills in cell culture and purification intersect with the needs of regenerative medicine.
Peter W. Wojciechowski, Ph.D., Director, Process Development, Advanced Technologies and Regenerative Medicine LLC

4:00

Peptide-Protein Conjugates
Peptide-monoclonal antibody conjugates are effective vehicles to reduce toxicity and to enable site-specific drug delivery. In this presentation, we will discuss the strategies used to meet the challenges to generate the conjugates, and to develop analytical methods, including functional bioassays.
Wei Liao, M.D., Project Team Leader, Biotherapeutics Center of Emphasis, Pfizer Inc

4:30

Case
Study

NPro Autoprotease Fusion Technology (NAFT) - The Key to Cost Effective Manufacture of Peptides?
A new system for expression of fusion proteins in E. coli with autocatalytic cleaving properties (NAFT) as a platform technology for cost effective manufacture of peptides will be presented. High fermentation yields (up to 10 g/L) for NPro fusion proteins were reached. Process upscaling to 13,000 L and advantages compared to classical fusion protein approaches are discussed in a case study.
Friedrich Nachtmann, Ph.D., Head, Biotech Cooperations, Sandoz Biopharmaceuticals, Austria

5:00

Close of BPI 2009

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BPI China

Document Title

Agenda

Agenda

Monday, October 12, 2009 - Pre-Conference Symposia and Sponsored Session

Technology Transfer for Biopharmaceuticals

Practical Aspects of Implementing Quality by Design (QbD)

Driving Out Cost from Biomanufacturing

Leveraging Advanced Technologies for Robust, Efficient Bioproduction and Development

Tuesday, October 13, 2009 - Main Conference

Manufacturing Efficiency & Supply Chain Security

Supply Chain Integrity, Sourcing, Qualification and Management

Scaling Up from Bench through Commercialization

Product Lifecycle Management

Featured Presentation

Strategy Discussion Forums

Concurrent Technology Workshops

Luncheon Presentation

Manufacturing Efficiency & Supply Chain Security

Disruptive Technologies Shape the Facilities of the Future

Scaling Up from Bench through Commercialization

The Nuts and Bolts of Quality by Design (QbD)

Strategy Discussion Forums

Keynote Presentations

Wednesday, October 14, 2009 - Main Conference

Technology Workshop

Manufacturing Efficiency & Supply Chain Security

Maximizing Process and Facility Efficiency

Scaling Up from Bench through Commercialization

Minimizing Variability of Process and Product

Strategy Discussion Forums

Concurrent Technology Workshops

Plenary Session - Regulatory and Quality Updates

Keynote Presentations

Site Tour to Diosynth BiotechnologycWednesday, October 14 · 8:15 am- 12:00 pm

Thursday, October 15, 2009 - Main Conference

Technology Workshop

Cell Culture & Upstream Processing

Approaches to Reduce Investment and Accelerate Process Development

Innovations in Media Development

Recovery & Purification

Overcoming Bottlenecks in Downstream Processing

Advances in Process Monitoring and Control

Strategy Discussion Forums

Concurrent Technology Workshops

Cell Culture & Upstream Processing

Recovery & Purification

Plenary Session: Integrating Upstream & Downstream Processing

Keynote Presentation

Plenary Panel Discussion

Vaccine Manufacturing Technology Summit

Audience Interactive Panel Discussion

Strategy Discussion Forums

Site Tour to Biogen IdecThursday, October 15 · 8:15 am - 11:30 am

Friday, October 16, 2009 - Main Conference

Technology Workshop

Cell Culture & Upstream Processing

Technologies to Analyze, Measure and Control Processes

Application of Genomic, Proteomic and Metabolomic Technologies

Recovery & Purification

Applying Analytical Methods in Downstream Processing

Alternatives to Traditional Column Purification

Strategy Discussion Forums

Concurrent Technology Workshops

Luncheon Presentation

Cell Culture & Upstream Processing

Process Quality and Characterization

Scale-Down Models and Scaling Up Case Studies - Lessons Learned

Recovery & Purification

New Approaches and Technologies for Downstream Processing

New Therapeutic Modalities

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Site Tour to Diosynth Biotechnologyc
Wednesday, October 14 · 8:15 am- 12:00 pm

Site Tour to Biogen Idec
Thursday, October 15 · 8:15 am - 11:30 am