Cell Culture & Upstream Processing - IBC Life Sciences

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Wednesday, September 24, 2008 • Main Conference Improving Competitiveness and Quality of Biopharmaceutical Manufacturing 8:00 Chairperson’s Remarks Abhinav Shukla, Ph.D., Associate Director, Manufacturing Sciences, Bristol-Myers Squibb Company 8:15 Financial Advantages of Quality by Design (QbD): Making the Business Case for Process Improvements in Biopharmaceutical Manufacturing Regulations and philosophies in the pharmaceutical/biopharmaceutical industry have evolved to enable modern methods of process development, optimization and control. This study provides evidence of the financial advantages to be realized with QbD/PAT/Lean methods. Enhanced product quality can be achieved with concurrent improvements in process and supply chain velocity. James K. Drennen, III, Ph.D., Associate Dean for Graduate Programs and Research, Director, Center for Pharmaceutical Technology, Mylan School of Pharmacy, Duquesne University 8:45 Disposables: Process Economics – Selection, Supply Chain and Purchasing Strategies CASE STUDY A new facility project implemented disposables for a broad spectrum of process applications. Key considerations included establishing a disposables use philosophy to meet the needs of the engineering project, strategy decisions to manage disposable vendors, and an integrated supply chain approach including product standardization. Other key considerations included lifecycle and risk management analysis along with development of a disposables validation strategy. Miriam Monge, Vice President, Biopharm Services Ltd, United Kingdom 9:15 Disposables vs. Stainless Steel: Human Genome Sciences’ Cost Analysis of a Clinical Production Facility This presentation will focus on a cost analysis of a traditional hard-piped versus disposable clinical production facility at a 500L production scale. The scope of the analysis will include conceptual design through equipment validation and provide a discussion of predictive facility annual operating costs. Jason Slinchak, Manufacturing Engineer, Human Genome Sciences, Inc. 9:45 Networking Refreshment Break in Exhibit and Poster Hall 10:30 Managing an Agile and Cost-Effective Supply Chain with Evolving Biologics Processes CASE STUDY Does your supply chain continuously implement timely process improvements without extensive and costly supply segregation? Learn how Bristol-Myers Squibb took advantage of its first internally-discovered large molecule to create an agile biologics supply chain with cost-effective processes. Christele Hadjadj, Biologics Supply Chain Director, Bristol-Myers Squibb Company 11:00 “Profitability vs. Affordability” of Biosimilars The talk will cover the current Biosimilars scenario, delving upon the debate around balancing the aspects of "profit for sponsors" vs. "affordable medicine for patients;" and discuss innovative approaches to enhance the cost effectiveness of biosimilars. Srinivasan Raman, General Manager, Operations, Biologicals Manufacturing, Biocon Limited, India 11:30 How Similar Is a Biosimilar? Tissue plasminogen activator (t-PA) is a well characterized product. The biosimilar recently approved in India shows significantly high similarity in the carbohydrate moiety. However, the impurity profile and aggregates are significantly higher. The thrombolytic activity in various arrays is significantly below the innovative t-PA. From a protein analytical perspective and the consequences for the patient benefit the biosimilar cannot be considered to be similar. Barbara Esch, Ph.D., Director, Industrial Customer Business, Corporate Division Biopharmaceuticals, Boehringer Ingelheim GmbH, Germany 7:00 Coffee 7:15 Technology Workshop Rapid Molecular Methods for Pharmaceutical Quality Control and Process Development With recent regulatory recommendations and acceptance of Genotypic-based methods, these highly accurate and rapid technologies are being adopted for routine monitoring of biopharmaceutical products from process development through final product release. This workshop will provide an overview on rapid assays for broad species detection of Mycoplasma and monitoring of Residual DNA using a Real-Time PCR approach along with comparative DNA sequencing for accurate microbial identification using the MicroSeq® Microbial Identification system. James Bruce, Senior Product Manager, Applied Biosystems 1 Production & Economics of Biopharmaceuticals 2 Scaling Up from Bench through Commercialization Use of Scale Down Models throughout Product Lifecycle: Early to Late to Post Registration: Case Studies 8:00 Chairperson’s Remarks David H. Reifsnyder, Ph.D., Principal Scientist, Process Development-Late Stage Purification, Genentech, Inc. 8:15 Use of Computational Fluid Dynamics (CFD) to Identify and Resolve Cell Culture Issues Observed at Production Scale during Technology Transfer CASE STUDY We present a numerical case study on the environment to which cells are exposed in mechanically agitated and sparged bioreactors. The most relevant parameters are compared for two modeled production scale bioreactors with different designs and process conditions. Such information helps us to understand the culture process performance issues encountered during technology transfer, and to identify an optimal operating parameter design space. Zhiwu Fang, Ph.D., Principal IS Informatics Analyst, Amgen Inc. 8:45 Application of CFD Modeling for Process Optimization in a New Large Scale Mammalian Facility CASE STUDY During start-up of HGS’s 20,000 L scale facility, cell growth and titer were lower than previously observed at pilot scales. This presentation will show how computational fluid dynamic modeling was utilized to determine the cause of and solution to the scaling issue. Stefanie Brady, Bioprocess Engineer, Human Genome Sciences, Inc. 9:15 Use of a Scale-Down Model to Troubleshoot Cell Damage in Large Bioreactors CASE STUDY We have developed a scale-down model to investigate the effect of high gas sparger velocity on cholesterol-independent NS0 cells. The model correlates well with our observations of low cell viability and low antibody titer in some 600 L fed-batch cell cultures. This model has been used to develop design criteria for gas spargers in large bioreactors (e.g. 10k L) for high cell density antibody production. Ying Zhu, Ph.D., Scientist II, Upstream Processing, PDL BioPharma 9:45 Networking Refreshment Break in Exhibit and Poster Hall 10:30 Scale-Up of a Mammalian Cell Culture Process: Internal and External Technology Transfers CASE STUDY Scale-down models enable robust process characterization studies and aid in process trouble-shooting and resolution of issues prior to commercial manufacturing. This presentation addresses some of the limitations of scale down models in terms of achieving all end points for product quality and process performance. Examples for both upstream and downstream unit operations are provided to illustrate key concepts. Sushil Abraham, Principal Engineer, Process Development, Amgen Inc. 11:00 Using Scale Down Models at Various Stages during Commercialization of Biopharmaceuticals CASE STUDY Scale down models are not just a good idea, but they are essential during product transfers and during the entire commercial life cycle. This case study will present interesting examples and learning from both upstream and downstream processes where scale down models were used, sometimes successfully and sometimes not so successfully, to enable rapid product transfer, troubleshooting during commercial production and to drive continuous improvement of commercial processes. Aimee Lehman, Manufacturing Technical Specialist, Genentech, Inc. 11:30 Development of a High Throughput Manufacturing Process for an Ovine Polyclonal Fab Fragment CASE STUDY In the original conception small scale process studies’ multi-factorial design considerations were purely related to the actual experiment. Their meaning now is to expand the design space, product characterization forced degradation studies as well as comparability elements to support perhaps several manufacturing sites and multiple sourced raw materials. This presentation will cover these aspects in relation to a large scale (> 120 Kg IgG per purification batch) ovine Fab fragment process and the process development linkage with the establishment of a commercial supply chain. Richard Francis, Director, Process Science, Protherics plc, United Kingdom Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event 9
Wednesday, September 24, 2008 • Main Conference (continued) 12:00 Concurrent Technology Workshops Human Monoclonal Antibody Production Using a Disposable, Stirred-Tank Bioreactor and Novel Process Analytics This presentation looks at application-specific modeling systems for individual applications using the following as examples: storage and shipping systems, mixing systems, and bioreactor systems. The modeling systems are intended to address key areas of concern, to assess the direct and indirect benefits, and to give simple but customer-specific guidance. Process modeling systems which cover the whole manufacturing flow are also discussed. Cory Card, Senior Technical Services Manager, Thermo Scientific Modern Equipment for the CASE Management of Today’s High Titers and STUDY Perceived Downstream Processing Bottlenecks Productivity improvements from high expression levels and efficient capture of biomolecules need to be fully harvested. Next step is to upgrade equipment and product flow for optimized productivity during early product development. This presentation describes how to manage bottlenecks in existing and future facilities with focus on solutions that enable savings in time, resources and floor space to increase flexibility, robustness, scalability and quality. Roger Nordberg, Product Manager/Marketing, GE Healthcare, Sweden Sara Corin, Product Manager/Marketing, GE Healthcare, Sweden 2:00 Chairperson’s Remarks Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen Inc. Featured Presentations 2:15 FDA Manufacturing Initiatives in Biotechnology Products Quality by Design (QbD), Pharmaceutical cGMPs for the 21st Century, and Process Analytical Technology are initiatives being applied to small molecule pharmaceutical development and there is significant interest in using QbD for biotechnology products. Although the principles are applicable, there may be some unique considerations for these products. The FDA critical path initiative may also provide opportunities for enhancing the development of biotechnology products. Steven Kozlowski, Ph.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA 2:45 Biomanufacturing 2008: Where We’ve Been, Where We’re Going, and Why Randy Maddux, Ph.D., Vice President, Manufacturing Operations, Human Genome Sciences, Inc. 3:15 Post-Registration Process Changes: Considerations for Comparability Post-approval changes to manufacturing processes may be driven by the need to scale up to meet market demand, to enhance the overall robustness and reproducibility of the process or to stay abreast of evolving technology or regulatory requirements. Comparability protocol design strategy is an integral component of a successful post-registration process change. Strategies that may be employed for different types of process changes will be discussed. Robert A. Baffi, Ph.D., Senior Vice President, Technical Operations, BioMarin Pharmaceutical Inc. 3:45 Networking Refreshment Break in Exhibit and Poster Hall Plenary Session Bringing Downstream Productivity into Phase with Cell Culture Production with Monolithic Chromatography Supports Monolithic anion exchangers have recently demonstrated 50 times more effective DNA removal than traditional ion exchangers and twice the capacity of membranes. They have also demonstrated monoclonal antibody binding capacities greater than 40 mg/mL in high resolution bind-elute applications at linear flow rates greater than 3,000 cm/hr. This presentation will clarify the distinction between diffusive and convective chromatography supports and demonstrate the ability of convective supports to relieve the current bottleneck in downstream processing. Pete Gagnon, Chief Consultant, Validated Biosystems Inc. Qualification of the Octet System for Rapid IgG Titer Determination to Streamline Clone Selection and Cell Line Optimization Accurate titer determination remains a challenge, for cell line development, with less than desirable precision, accuracy, and throughput. A new technology was evaluated that provides a > 10x decrease in hands-on time and turnaround time vs. both HPLC and ELISA while providing accuracy and precision comparable to that of Protein A HPLC without the HPLC waste or maintenance. Keith A. Davis, Ph.D., Scientist, WPGRD, Global Biologics, Pfizer Inc 12:30 Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing Keynote Presentations 4:15 Paths to Flexible Regulatory Notification of Large Molecule Life-Cycle Changes The seeds allowing for more flexible reporting options are sown early in the large molecule development process with an eye on reaping the benefits throughout the product lifecycle. This talk will focus on the unique aspects of large molecules in the generation and demonstration of this enhanced knowledge in the initial registration to best facilitate innovation and process improvements post-registration. John K. Towns, Ph.D., Director, Global CMC Regulatory Affairs, Eli Lilly and Co. 5:00 Biosimilars – Follow-on Biologics – Subsequent Entry Biologics – Biogenerics? This presentation will discuss the current regulatory issues surrounding Biosimilars, Follow-on Biologics and Biogenerics. Specific concerns will be addressed with respect to how significant molecular differences will be identified and adjudicated as part of this process. The utility of bioassays and human clinical trials as compared to current analytical capabilities will be discussed and opportunities for regulators, the academic community as well as the generic and ethical pharmaceutical industry to work together to resolve these issues will be explored. Robert L. Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc. 5:45 Networking Cocktail Reception in Exhibit and Poster Hall Exhibit Hall Keynote 6:30 The Treacherous Path to Success in the Biotech Industry After three decades of phenomenal scientific discovery in biotechnology, substantial uncertainty remains in the path of translating science into commercial success. Lessons from summiting the 7,000m Nepalese peak of Ama Dablam help in defining the goals and managing the risk of innovation in commercializing biological products. Setting the right goals and correct metrics is essential to mapping an efficient route to navigate the technical and regulatory uncertainty in manufacturing tomorrow’s products today. Prof. Charles L. Cooney, Robert T. Haslam (1911) Professor, Department of Chemical Engineering, and Faculty Director, Deshpande Center of Technological Innovation, Massachusetts Institute of Technology 10 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Page 1 and 2: THE Meeting Place for the Bioproces
Page 3 and 4: September 23-26, 2008 Disneyland®
Page 5 and 6: "IBC’s BioProcess International C
Page 7 and 8: Tuesday, September 23, 2008 • Mai
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Page 17 and 18: Friday, September 26, 2008 • Main
Page 19 and 20: Co-Located Conference IBC’s 8th A
Page 21 and 22: The Largest Display of New Products
Page 23 and 24: Call for Poster Submissions Submit

Cell Culture & Upstream Processing - IBC Life Sciences

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