Cell Culture & Upstream Processing - IBC Life Sciences

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Thursday, September 25, 2008 • Main Conference 7:00 Coffee 7:15 Technology Workshop Technology Workshop still available. Please contact Kristen Schott at (508) 614-1239 or kschott@ibcusa.com for more information. 1 2 Production & Economics of Biopharmaceuticals Scaling Up from Bench through Commercialization Choose from these Small Group Discussion Sessions and Workshops Sessions #1 and #2 will take place concurrently from 8:00 am to 12:00 pm with a break at 9:45 am. Participation will be limited to 35 participants on a first come, first served basis. Workshop Discussion Session #1 Lean Six Sigma in a Biotech Setting: Constraint or Enabler? Six Sigma is a well known program for compressing process variability and eliminating non-value adding work that has been applied in many business settings. Six Sigma has been applied with mixed success in the biotech industry. It has been suggested that Six Sigma is inappropriate for the biotech setting because it is a constraint upon creativity, hinders continuous improvement, and adds an administrative burden that slows speed to market endeavors. It has also been observed that, in a period where QBD and platform technologies are becoming more important to biotech, Six Sigma can provide a structure and shared vocabulary between business units and companies that aids innovation and speed to market. This workshop will explore both perspectives through facilitated discussion and examples of Six Sigma practices in the biotech industry. Note: This same discussion will be run two times in a row, first from 8:00 am to 9:45, then again from 10:30 am to noon. Participation in each section will be limited to 35 participants on a first come, first served basis. Facilitators: Jeffrey C. Baker, Ph.D., Senior Research Advisor and Six Sigma Black Belt, Eli Lilly and Company Paul W. Allen, Vice President, Managing Partner, Life Sciences, Clarkston Consulting Discussion Session #2 Standards for Disposables: What would End-Users Like to See? Disposable technology has made significant gains in popularity in recent years, based improvements in technology and on drivers such as convenience, flexibility, and capital deferral. However, there are user concerns over sourcing, disposal, and the proliferation of differing solutions to the same problems. Industry groups such as ISPE, PDA and BPSA have formed groups to address these concerns. In this workshop we will attempt to have a balanced discussion on the pros and cons of disposable technology and discuss where standards are required and what kind users would like to see. Moderator: Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen Inc. Panelists: Adam Goldstein, M.S., Senior Manager, Oceanside Clinical Operations, Genentech, Inc. Miriam Monge, Vice President, BioPharm Services, U.K. Justin Hutchinson, Bioprocess Systems Product Manager, Thermo Fisher Scientific Andrew Sette, Director of Quality and Regulatory Affairs, Sartorius-Stedim Biotech, France Jason Slinchak, Manufacturing Engineer, Human Genome Sciences, Inc. Cell Culture & 3 Recovery & Purification Upstream Processing 4 Track Sponsor: 8:00 Track Sponsor’s Introduction: Taking the Industry to the Next Level Thomas Isett, Vice President, BD Biosciences – Advanced Bioprocessing 8:05 Chairperson’s Opening Remarks Dennis M. Kraichely, Ph.D., Principal Research Scientist, Expression Technologies, Centocor, Inc. Advances in Cell Line Development & Clone Selection 8:15 Selecting GS-CHO Cell Lines for Antibody Manufacture After transfection, a sequential series of screens are typically used to select a ‘desirable’ cell line for antibody manufacture from the heterogeneous population. Cell line behavior in such a strategy was studied and compared with subsequent behavior in bioreactor culture. Although highly productive cell lines can be selected, potential strategies for improving the ‘hit rate’ of identifying ‘good’ manufacturing cell lines will be discussed. Alison Porter, Science Leader, Cell Culture Process Development, Lonza Biologics 8:45 Manufacturability Assessments CASE for Early Stage Therapeutic STUDY Candidate Screenings Using Biophysical Characterization Transferring lead molecules from research into process development at a relatively fast pace requires a process of candidate selection that assesses not only if a candidate is active and safe, but also “manufacturable.” Biophysical characterization of lead candidates prior to reaching process development helps rank candidates for conformational and colloidal stability. This assessment is especially useful when binding affinity and bio-activity are comparable among the candidates. Case studies of antibodies assessed for manufacturability under process conditions will be presented. Ranjini Ramachander, Ph.D., Senior Scientist, Amgen Inc. 8:00 Chairperson’s Opening Remarks Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany Overcoming Challenges of Large Scale Protein Production – Present and Future 8:15 Development of a Precipitation Alternative and Improvements for Protein A for Impurity Reduction in Clarified Broth Containing a Monoclonal Antibody Improvements in titer have resulted in a potential bottleneck in downstream purification, which may be addressed by reduction in the number of chromatography steps or optimization of the existing unit operations. This presentation will discuss the evaluation of potential precipitants to reduce the level of impurities in clarified broth prior to capture chromatography, as well as various strategies and wash solutions on the initial Protein A step to maximize its efficiency. Judy K. Glynn, Ph.D., Senior Principal Scientist, Global Biologics, Pfizer Inc 8:45 Scale-up Evaluation of Selective Antibody Precipitation and Continuous Recovery with a Disc-Stack Centrifuge Methods for selective precipitation of monoclonal antibodies with production bioreactor titers greater than 2 g/L have been developed at Biogen Idec as an alternative to chromatography for enhanced throughput and purification of antibodies. To demonstrate the scale-up of this process, antibody was precipitated from 200 L batches of clarified cell culture media and fed to the same continuous disc-stack centrifuge used for cell harvesting. Antibody precipitate was successfully collected with high recoveries in the solids discharge vessel while antibody-free supenatant was sent to waste. In summary, this precipitation technology will be compared to traditional chromatographic capture methods. Philippe de Vilmorin, Engineer, Biopharmaceutical Development, Biogen Idec Group Discounts for Significant Savings! Delegates can enjoy significant savings on standard registration fees when registering for the BioProcess International Conference and Exhibition by sending teams to the event. IBC Life Sciences offers competitive discounted rates for companies sending groups of 3 or more. For more information, contact 646-895-7445. Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event 11
Thursday, September 25, 2008 • Main Conference (continued) 1 2 Afternoon Sessions Sessions #3 and #4 will take place concurrently from 1:45 pm to 6:00 pm with a break at 3:30 pm. Participation will be limited to 35 participants on a first come, first served basis. Discussion Session #3 Biosimilars: Where Are We Now? With patents covering many of the leading biopharmaceutical blockbuster products soon to expire, many companies are lining up to introduce biosimilar products into the marketplace. Unlike small molecules, where equivalency of a generic product to the innovator products can be easily established using chemical analysis and minimal animal and human clinical testing, the equivalency of a biosimilar product to the original biopharmaceutical product is not as readily demonstrated. In this panel discussion we will explore the significant technical, regulatory, and economic challenges faced by companies attempting to seamlessly transition biosimilar replacement products into the marketplace. Moderator: Howard L. Levine, Ph.D., President, BioProcess Technology Consultants, Inc. Panelists: Production & Economics of Biopharmaceuticals Scaling Up from Bench through Commercialization Robert L. Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc. Robert A. Baffi, Ph.D., Senior Vice President, Technical Operations, BioMarin Pharmaceutical Inc. Srinivasan Raman, General Manager, Operations, Biologicals Manufacturing, Biocon Limited, India Workshop Discussion Session #4 Use of Scale-down Models in Non-Conformance Resolution Bench-scale investigations utilizing scale-down models to resolve non-conformances, specifically to identify root-cause and corrective actions, are among the most demanding and scrutinized applications of scale-down models. This interactive peer-to-peer discussion will explore the current and future state of scale-down models in the context of their use for non-conformance resolution towards a goal of increasing their exactness for this critical application. Facilitators will introduce the topic, and small workgroups will collaborate to consider in-depth hypothetical exercises. The groups will then each present a summary of their tables' perspectives to the room. Facilitators: Richard Francis, Director, Process Science, Protherics plc, United Kingdom David H. Reifsnyder, Ph.D., Principal Scientist, Process Development-Late Stage Purification, Genentech, Inc. Cell Culture & 3 Recovery & Purification Upstream Processing 4 9:15 Approaches to Accelerate Speed to GMP Manufacturing Once antibody candidates are identified, cell line development and studies to select the lead candidate are usually on the critical path to clinical trials. Therefore, changes to the process that reduce timelines and risk can have a direct impact on the time to clinic. Strategies to increase speed and reliability will be discussed. Stephanie E. Rieder, Ph.D., Senior Scientist, Abbott Bioresearch Center 9:45 Networking Refreshment Break in Exhibit and Poster Hall 10:30 Discovery of Biomarkers Associated with Expression Stability during Metabolic Selection and Gene Amplification in Recombinant IgG-Producing Chinese Hamster Ovary Cells We used clonal CHO GS cell lines expressing a recombinant human IgG with different productivity and stability pre- and post-gene amplification mediated by MSX. We analyzed copy numbers and mRNA levels of IgG heavy/ light chains, transcription profiles using DNA microarray and protein expression profiles 2-D Differential Gel Electrophoresis. Our biomarker discovery studies will shed light on cell engineering target selection. Nan Lin, Ph.D., Principal R&D Scientist, Cell Sciences and Development, SAFC Biosciences 11:00 Comparison of a New Human Host Cell Line with CHO for the Development and Production of Recombinant Therapeutics A human cell line (F2N) engineered by somatic hybridization resulted in stable expression of inherited phenotypes. Optimal product quality could be achieved in transient or stable transfection formats with high-level protein expression. This presentation will cover development of F2N, in comparison with CHO, for the versatile production of recombinant therapeutics. Myung-Sam Cho, Ph.D., Senior Advisor, R&D Center, Celltrion, Inc., Korea 11:30 Managing Cell Line Instability CASE and Its Impact during Rapid STUDY Cell Line Development Successful phase 1 cell line development relies on the ability to generate stable, high-producing clones in a short timeframe. While we consistently achieve this objective, we have observed expression instability in some of our clones. We will present data from independent case studies, describe the methods and tools we use to investigate instability, and discuss some of the operational consequences of instability upon our cell line development paradigm. Robin A. Heller-Harrison, Ph.D., Associate Director, Cell & Molecular Sciences, Wyeth BioPharma 9:15 Impurity Removal during Clarification of Cell Culture Harvest with Continuous Flow Centrifugation and Depth Filtration Depth filtration is the preferred method of clarification for perfusion bioreactor cell cultures at Centocor. With the introduction of fed batch cell culture, alternative clarification methods were investigated to increase the processing efficiency. To perform this evaluation, fed-batch harvests of several Centocor products were processed through depth filtration with and without centrifugation. These clarification techniques were investigated to determine effect on product quality and recovery, specifically the host cell DNA and host cell protein (HCP) contents. Joseph Lepore, Associate Manager, Pharmaceutical Development, Development Pilot Plant, Centocor R&D 9:45 Networking Refreshment Break in Exhibit and Poster Hall 10:30 Challenges of Ultrafiltration Processing with High Concentration IgG Solutions Ultrafiltration has been extensively used for the concentration and diafiltration of protein solutions. As the target final concentration of biopharmaceutical antibody solutions approaches levels of 150g/L, challenges can arise associated with system operation and the recovery of viscous product solutions. Processing methods and product recovery strategies are presented. Jon Petrone, Global Technical Director, Technical Support Group, Pall Life Sciences 11:00 Enhancement of Peptibody Downstream Platform: Direct Chromatography Capturing of Peptibody from Oxidation Pool For a product undergoing commercialization, we examined the possibility of using a direct capturing chromatography step from the oxidation pool to replace multiple unit operations including UF/DF, acid precipitation and clarification by centrifugation. This talk will present data comparing the two approaches in terms of process throughput, scalability, robustness and raw material and capital costs. In addition, process performance will also be compared. It will be shown that use of a direct capture step leads to increased throughput, lowered manufacturing costs and improved scalability. Yuefeng Lu, Ph.D., Principal Scientist, Global Proocess Engineering, Amgen Inc. 11:30 Membrane-Based Primary Recovery Process for Perfusion Process Daily harvest and isolation of dilute and sometimes unstable product from a perfusion process require a fast and robust process. In-line cell removal and membrane-based chromatography process fits such unique requirements. The process decouples a continuous process from the downstream batch process and it “de-bottlenecks” the high liquid throughput from a typical perfusion process. Paul Wu, Manager of Protein Isolation, Bayer Healthcare 12 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
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