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Agenda
| Pre-Conference Workshops Monday, September 22, 2008 | DAY ONE | DAY TWO | DAY THREE | DAY FOUR | | ||||
| Workshop A Technology Transfer for Biopharmaceuticals | ||||
| 1:00 | Chairperson's Opening Remarks Eric Ford, Manufacturing Technical Specialist, Late Stage Process Development, Genentech, Inc. | |||
| 1:10 | Effective Data Management for Technology Transfer James Myers, Ph.D., Process Engineer, Engineering Science, Avecia Biologics Ltd., United Kingdom | |||
| 1:50 | Achieve Full Integration of the Technology Transfer Process across Process Development through to Filing Patrick J. Watters, Principal Project Manager, Biotech Technology and Engineering, Wyeth Biotech | |||
| 2:30 | Challenges Faced During Optimization and Transfer of Legacy Processes Eric Ford, Manufacturing Technical Specialist, Late Stage Process Development, Genentech, Inc. | |||
| 3:10 | Refreshment Break | |||
| 3:40 | Process Optimization and Technology Transfer Dicky Abraham, Principal Scientist, Merck & Co., Inc. | |||
| 4:20 | Challenges of International Transfers Siddharth J. Advant, Ph.D., Principal, Tunnell Consulting | |||
| 5:00 | Audience Interactive Panel Discussion | |||
| 5:30 | Close of Workshop | |||
| Workshop B Single Use Bioprocess Systems: Intensive Update | ||||
| 1:00 | Chairperson's Opening Remarks Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Director and Chair, Technology Committee, Bio-Process Systems Alliance | |||
| 1:10 | Regulatory Requirements for Manufacturing and Validation of Single-Use Systems Andrew Sette, Director of Quality and Regulatory Affairs, Sartorius-Stedim Biotech, France | |||
| 1:50 | Evaluation of Bioreactors and Single-Use Bioprocessing Supplies Leigh N. Pierce, President, PacificGMP | |||
| 2:30 | Advances in Disposable-Format Downstream Processing Technologies Thomas C. Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. | |||
| 3:10 | Refreshment Break | |||
| 3:40 | Analyzing the Carbon Footprint Left by a Company's Use of Disposables Lindsay Leveen, Associate Director Strategic Planning and Lytics CMC Team Lead, Genentech, Inc. | |||
| 4:20 | Working with Vendors - Setting up GMP Supplier Relationships under GMP Hélène Pora, Ph.D., Senior Director, Single-Use Systems, Pall Life Sciences, France | |||
| 5:00 | Audience Interactive Panel Discussion | |||
| 5:30 | Close of Workshop | |||
| Workshop C Process Characterization and Monitoring during Development and Commercialization of Biopharmaceuticals | ||||
| 1:00 | Chairperson's Opening Remarks Siddharth J. Advant, Ph.D., Principal, Tunnell Consulting | |||
| 1:10 | Use of Statistical Tools during Process Characterization Jason Kamm, Managing Consultant, Tunnell Consulting | |||
| 1:50 | Development of Scale Down Models to support Process Validation for Cell Culture Processes Helena Yusuf-Makagiansar, Ph.D., Associate Director, Biopharmaceutical Development, BiogenIdec | |||
| 2:30 | Refreshment Break | |||
| 3:00 | Industrial Experiences with the Continuum of Process Characterization, Validation & Process Monitoring During/Post-commercialization Neslihan DelaCruz, Principal Engineer, Amgen Inc. | |||
| 3:40 | Quality by Design: A Biologics Case Study in Formulation & Process Development Carol F. Kirchhoff, Senior Principal Scientist, Pfizer Inc | |||
| 4:20 | Audience Interactive Panel Discussion | |||
| 5:00 | Close of Workshop | |||
| About the Presenters: Siddharth J. Advant, Ph.D., Principal & Head, West Coast Office, Tunnell Consulting Jason J. Kamm, Managing Consultant, Tunnell Consulting Carol F. Kirchhoff, Senior Principal Scientist, Pfizer Inc | ||||
| Main Conference - Day One Tuesday, September 23, 2008 | PRE-CONFERENCE WORKSHOPS | DAY TWO | DAY THREE | DAY FOUR | | ||||
| Production & Economics of Biopharmaceuticals | ||||
| 7:00 | Registration and Coffee | |||
| Strategic Planning for Biopharmaceuticals: Challenges for a Maturing Industry | ||||
| 8:00 | Chairperson's Remarks Joanne T. Beck, Ph.D., Plant Manager, Abbott Bioresearch Center | |||
| Keynote Presentation | ||||
| 8:15 | How to Motivate Staff to Implement Lean Manufacturing to Raise the Bottom Line  Experience from over 1,000 process improvements has demonstrated the elements necessary for success of a lean program: passionate executive sponsor, endorsed project charter, engaged team, and a phased approach with realistic goals. Gain strategic tips for incorporating value stream mapping, design of experiments (DOE), mistake-proofing, failure modes and effects analysis (FMEA), Root Cause/Risk Analysis, statistical process control (SPC), process mapping, process management performance metrics, trend analysis, process re-engineering, analysis of variation (ANOVA), benchmarking and more.Rob Bryant, MBA, Vice President, Quality, Lean/Six Sigma Program Lead Master Blackbelt, Computer Sciences Corporation | |||
| 8:45 |
Lean Six Sigma can be creatively applied to significant business opportunities to yield better and faster business outcomes. This presentation will review case study examples of the use of Lean Six Sigma to drive optimization and significant financial benefits for some common manufacturing business initiatives. Beth Whitacre, Quality Control Team Leader, Certified Six Sigma Black Belt, Eli Lilly and Company | |||
| 9:15 |
The process economics and life-cycle management of ultra-orphan biologics will differ greatly from larger market drug products. Patient accrual numbers and drug demand for clinical, launch and lifetime supply will shape strategies for process development, clinical production and qualification stages leading to launch. In this talk we will discuss these and other challenges unique to small market products. Jonathan Blackie, Director, Manufacturing, BioMarin Pharmaceutical Inc. | |||
| 9:45 | Networking Refreshment Break | |||
| 10:15 | Concentration and Dispersion in a Global Industry: The Geography of Biomanufacturing Based on data collected since 2000, this presentation will examine trends in the location of biomanufacturing capacity, specifically for mammalian cell culture production. Many factors influence companies' location decisions: firm size and stage of development, product and technology maturity, and public policy. This research will posit some hypotheses as to what is driving the location dynamics of this industry. Elisabeth Reynolds, Industrial Performance Center, Massachusetts Institute of Technology | |||
| 10:45 | Outsource or Do It Yourself: Making the Manufacturing Decision for Phase 3 and Beyond Should companies spend the money to manufacture in-house or should they contract it to an outside vendor? The decision-making behind manufacturing is critical because companies must consider multiple variables before coming to a smart business solution. This session addresses the manufacturing aspect of outsourcing and covers complex challenges such as safety and FDA oversight. Gustavo Mahler, Ph.D., Vice President, Technical Operations, Berkeley Supply Center, Bayer HealthCare | |||
| 11:15 | Managing a Biologics Supply Chain Using A Fully-Outsourced Manufacturing Model Millennium has managed the supply of several different biologics at all stages of clinical development using a fully outsourced manufacturing model including drug substance, drug product and release assays. Experiences related to process transfer and documentation, facility fit, demand planning and validation activities for launch will be presented. The importance of maintaining a fully functional internal process development group and pilot plant will be emphasized. Michael W. Glacken, Ph.D., Director of Biologics Process Development, Millennium Pharmaceuticals, Inc. | |||
| Scaling Up from Bench through Commercialization | ||||
| 7:00 | Registration and Coffee | |||
| Strategic Scale Up Decisions to Accelerate Process Development | ||||
| 8:00 | Chairperson's Remarks Roger A. Hart, Ph.D., Scientific Director, Process Development, Amgen Inc. | |||
| 8:15 | Knowledge Management at the Jet Propulsion Laboratory: Reuse for Innovation, Process Improvement, and Risk Reduction Knowledge Management (KM) Systems offer the potential to increase innovation, improve processes, and reduce risk. Realizing this potential, however, requires careful attention to people, processes, and products. This presentation synthesizes results from KM research and practice at JPL in our quest to explore our solar system and beyond, and offers suggestions for application to biopharmaceutical production. Lynne Cooper, Ph.D., Knowledge Strategist, Office of Opportunity Development, Jet Propulsion Laboratory, California Institute of Technology | |||
| 8:45 | Knowledge Management Supporting QbD Regulatory Submissions Quality by Design (QbD) is an initiative aimed at streamlining process development efforts required to license a new product and Regulatory submissions required during a product's lifecycle without sacrificing safety and efficacy. A key element of QbD is leveraging pre-existing data from similar molecules to facilitate establishing a design space. This presentation will provide an overview of the knowledge management approach Genentech will be taking as part of its implementation of QbD. Ron Taticek, Ph.D., Associate Director, CMC Regulatory Affairs, Genentech, Inc. | |||
| 9:15 |
Scale-up of cell culture production processes and their consistent performance in manufacturing present challenges due to their high level of complexity and the large number of process parameters involved. Large data management systems can capture and present the process data, but for their analysis and meaningful interpretation, the input from process experts is needed. A process was put in place to link the data management and data interpretation function to successfully identify root causes for process scale-up and consistency issues. Bernhard M. Schilling, Ph.D., Group Leader, Manufacturing Sciences, Bristol-Myers Squibb Company | |||
| 9:45 | Networking Refreshment Break | |||
| 10:15 |
Removal of intermediate steps between unit operations of biological purification processes lowers cost, simplifies operations and facilitates technical transfer. The development of a seamless process for purification of a monoclonal antibody and the tools used to improve the manufacturability and technical transfer will be discussed. Communication between Development and Manufacturing regarding criticality of timelines, data and problem solving will be presented. Pedro J. Alfonso, Ph.D., Associate Director, Centocor R&D, Inc. | |||
| 10:45 |
To maximize the value of a robust and varied portfolio, processes must be inherently robust to facilitate technology transfer. Recent examples of the integration of multiple groups with a common goal illustrate the challenges and accomplishments of deliberately limiting options while maximizing the probability of success. E. Morrey Atkinson, Ph.D., Director, Bioprocess Research and Development, Eli Lilly and Company | |||
| Audience Interactive Panel Discussion | ||||
| 11:15 | Platform Development: Leveraging Informational Sciences to Compound and Use Process Performance Characterization Data Moderator: Roger A. Hart, Ph.D., Scientific Director, Process Development, Amgen Inc. Panelists will include all morning session presenters. | |||
| 11:45 | Concurrent Technology Workshops | |||
POROS® Chromatography Media: Transforming Your Downstream Process The features and benefits of POROS® chromatography media as they relate to improving downstream purification will be discussed. Learn how POROS media are differentiated and the benefits to downstream purification. Process modeling will be used to highlight potential productivity gains.Christine Gebski, Process Applications Manager, Applied Biosystems | ||||
Optimizing Cell Culture Data Management and Process Control through OPC Technology Rapidly becoming an industry standard, OPC enables real-time data exchange between multiple vendors' devices and the control systems that support them. We'll show how NBS' new software can integrate your fermentor to metabolite analyzers, turbidity probes, scales, or third party software. The possibilities are endless and the advantages are clear - optimizing process control and improving quality control in support of PAT initiatives, with less time, effort and cost.Richard Mirro, Product Manager, New Brunswick Scientific | ||||
Economic Modeling of Single-Use Systems The potential economic benefits of single-use systems over traditional stainless steel systems are of increasing interest to the bioprocessing industry. This presentation examines modeling systems for specific applications including liquid storage, mixing, bioreactor processing and entire manufacturing flows. The return on investment models shown address key areas of operational, strategic and economic benefits. The models also provide customer-specific guidance concerning both direct and indirect benefits.Eric Isberg, Manager, Single-Use Process Systems, Thermo Fisher Scientific | ||||
| 12:15 | Lunch on Your Own | |||
| Production & Economics of Biopharmaceuticals | ||||
| Production Planning for Cost-Efficient Manufacture | ||||
| 1:45 | Chairperson's Remarks Rhona M. O'Leary, Ph.D., Director, BioProcess Development, Genentech, Inc. | |||
| 2:00 | Research in Biopharmaceutical Operations: Advancing the State of the Art Biopharmaceutical research has traditionally focused on drug discovery, but with a maturing industry facing cost pressures there is increased need for pre-competitive research into wider issues around manufacturing and logistics, an approach that has greatly benefited other high-technology industries. We review several projects underway at the UC Berkeley Center for Biopharmaceutical Operations, focusing on explorations of risk and its impact across the supply chain. Philip Kaminsky, Ph.D., Associate Professor, Department of Industrial Engineering and Operations Research, University of California, Berkeley Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley | |||
| 2:30 | Managing Production in Light of Uncertain Demand Forecasts During the first few years of commercial production in a new market, there can be significant uncertainty in demand forecasts. The relationship between demand and capacity for biologics can be very linear, so to accommodate some variability, elasticity can be added in the form of plant utilization choices and inventory control which can help to moderate the impact of demand swings. These approaches will be presented. Alison Moore, Ph.D., Vice President and Site Head, Amgen Inc. | |||
| 3:00 |
ZymoGenetics launched a hospital-based product with entirely outsourced manufacturing. Robust quality and supply agreements with flexible forecasting mechanisms were critical. Close management of release cycle times and the impact on inventory levels and response time to changes in forecasts will be discussed. Finally, a case study of an expedited launch involving detailed planning and coordination between various contract manufacturers and internal resources will be presented. Joe McKinstry, Associate Director, Production Planning & Inventory Control, ZymoGenetics, Inc. | |||
| Scaling Up from Bench through Commercialization | ||||
| Regulatory Updates: Tools for QbD (Quality by Design) Implementation | ||||
| 1:45 | Chairperson's Remarks Jeffrey C. Baker, Ph.D., Senior Research Advisor, Manufacturing Sciences and Technology, Eli Lilly and Co. | |||
| 2:00 | Approaches to Defining Design Space for Bioprocesses Defining the design space for a bioprocess is an essential component of the Quality by Design approach to product development. Pfizer has implemented a comprehensive "Right First Time" approach to the development and commercial manufacture of biological products. This approach includes a structured methodology for risk assessment and experimental prioritization that facilitates the establishment of functional relationships between process parameters and quality attributes. This presentation will focus on implementation of this approach for a biologic product candidate, and demonstrate possible approaches to defining design space for bioprocesses. Natarajan Ramasubramanyan, Ph.D., Senior Principal Scientist, Pfizer Inc | |||
| 2:30 |
This talk addresses pairwise comparison of fermentation and cell culture batches. In early development, there may only be a few batches available, from which performance guidelines must be set for manufacturing. Similarity factors from PCA/PLS models can be used for comparison of batches. This technique compares process models to look for differences in input-output relationships. The talk will discuss the similarity factor approach and include examples using pilot data. Jeremy Conner, Ph.D., Senior Engineer, Amgen Inc. | |||
| 3:00 | Application of Multivariate Analysis (for Large Scale Data) and DOE (at Small Scale) to Understand Key Process Inputs for a Cell Culture Process Multivariate analysis (MVA) of large scale data was used to study the relationships between various offline, online, and raw material parameters. The resulting effects and interactions were further studied via small scale studies using univariate experimentation as well as by DOE. The raw material DOE study confirmed that interactions do exist between various raw materials and demonstrated the value of performing comprehensive DOE studies as part of qualification of a raw material for the process. Sanjeev Ahuja, Ph.D., Senior Scientist, Cell Culture Process Development, MedImmune | |||
| Special Strategy Discussion Forum: Adopting New Technology: The Cost of Change | ||||
| Participation is limited to the first 40 attendees for each part of the discussion, on a first come, first served basis. | ||||
| 1:45 | Moderator's Introduction Peter Latham, President, BioPharm Services US | |||
| 2:00 | Part One: Why Adopt New Technology? Exploring the Drivers and Successful Strategies for the Adoption of New Technologies In an industry where high margins make it difficult to risk product supply, the decision to implement new technology can be a difficult one to make. Despite this, there have been a variety of new biomanufacturing approaches ranging from novel expression systems to membrane chromatography and disposables which have made their way into commercial processes. So how does this happen; what are the drivers and decision processes that lead to the implementation of new technologies? This interactive panel session endeavors to answer these questions through feedback from people who have taken the risk to improve their processes. Additionally, we will look at some of the roadblocks to successful implementation and explore how they can be overcome. Whether you are a process development or manufacturing professional considering the use of a novel approach, or a vendor introducing a new technology, this session will provide invaluable insight on how to make the process run more smoothly. Panelists: Thomas C. Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. R. Andrew Ramelmeier, Ph.D., Vice President, Manufacturing and Process Development, BioMarin Pharmaceutical Inc. Bradley Wolk, Distinguished Engineer and Director of Process Development Engineering, Genentech, Inc. | |||
| 2:45 | Part Two: Industry-Supplier Forum on Needs for New Technology Development for Downstream Processing With titers reaching record levels in the up-stream, the bottleneck and cost drivers for new bioprocesses are now shifting to purification. But are the current purification approaches good enough? This panel will start by discussing the potential need for advancement in purification processes and what the drivers are for that need. Against this backdrop, we will then discuss some of the new technologies and approaches and take a critical look at if and how they address these drivers. Discussions will also include feedback on how mature some of these technologies really are including the level of their current implementation. This panel will provide uncensored insight for people developing/optimizing purification processes as well as companies developing new purification technologies. Panelists: Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany Brian R. Hubbard, Ph.D., Scientific Executive Director, Process and Product Development, Amgen Inc. Günter Jagschies, Ph.D., Senior Director R&D, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen Inc. Thomas C. Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. Abhinav Shukla, Ph.D., Associate Director, Manufacturing Sciences, Bristol-Myers Squibb Mark A. Snyder, Ph.D., Manager, Process R&D Applications Group, Bio-Rad Laboratories | |||
| 3:30 | Networking Refreshment Break | |||
| Keynote Presentations | ||||
| 4:00 | The Challenges and Successes of Creating a Biologics Organization within Pfizer The presentation will examine the trials and challenges of establishing a Biologics Pharmaceutical Sciences and Manufacturing organization in a company that has a historical small molecule mind set. Hear details of the current status of biologics at Pfizer. Understand the major challenges with biologics formulations, process technology and manufacturing and how Pfizer is trying to leverage its extensive small molecule manufacturing experience to creatively resolve these issues.Rick Rutter, Ph.D., Vice President, Pharmaceutical Sciences, Biologics, Pfizer Inc | |||
| 4:45 | Using Knowledge Management for Technical Collaboration across Generations The focus of NASA's knowledge management architecture is looking at how to facilitate access to and reuse of the knowledge gathered over the many NASA missions to support future missions and to help drive innovation. NASA's Knowledge Management Team looks to understand trends, technologies, and new learning that will help to better deliver systems, process improvements, and solutions of knowledge transfer to the people exploring space. Perspectives on knowledge management to modernize bioprocesses across generations will be offered.Jeanne Holm, Ph.D., Chief Knowledge Architect, NASA Jet Propulsion Laboratory | |||
| 5:30 | Exhibit and Poster Hall Opens with Cocktail Reception Network with your peers, learn about new products and services from over 100 exhibiting companies, and see cutting-edge data in a large group of posters. Sponsored by  | |||
| Main Conference - Day Two Wednesday, September 24, 2008 | PRE-CONFERENCE WORKSHOPS | DAY ONE | DAY THREE | DAY FOUR | | ||||
| 7:00 | Coffee | |||
| Technology Workshop | ||||
| 7:15 | 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 | |||
| Interactive Workshop and Discussion on Cell Line Stability and Heterogeneity | ||||
| Participation will be limited to the first 60 attendees, on a first come, first served basis. | ||||
| 9:00 am - 11:00 am | Workshop Leaders: Genotypic and phenotypic variability are central features in the use of mammalian cells for the development and production of biopharmaceuticals. Cell culture practitioners in the field continue to be challenged to attain ever-higher yields, while maintaining a level of consistency of process and product compatible with a drug manufacturing environment. The availability of tools to study the dynamics of cell populations has led to improved insight into the behavior and characteristics of cells, which in turn may afford opportunities to realize better control during production and to recognize and leverage heterogeneity for improved cell lines. This workshop will utilize an interactive, discussional format to exchange experiences and explore mechanisms and directions in cell line stability and heterogeneity. Several brief invited presentations by leading investigators are planned to serve as departure points for discussion, and participants will be encouraged to contribute instructive examples and perspective of their own. Questions to be discussed include:
| |||
| Production & Economics of Biopharmaceuticals | ||||
| Improving Competitiveness and Quality of Biopharmaceutical Manufacturing | ||||
| 8:00 | Chairperson's Remarks To be announced | |||
| 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 |
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 |
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 | |||
| 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 |
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 |
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 |
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-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 |
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 |
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 | |||
| 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 | ||||
 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. Per Karlberg, Senior Product Manager, GE Healthcare, Sweden | ||||
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. | ||||
 Abstract to come.Speaker to be Determined | ||||
| 12:30 | Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing | |||
| Plenary Session | ||||
| 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 Are We Now? The biotechnology industry has been manufacturing products for over 25 years and has presumably learnt lessons that are being executed today. How much these 'improvements' to manufacturing processes have been influenced by business needs, technology advancement or current regulatory guidance is dependant on the process and type of product. There has to be a rational evaluation of the utility of manufacturing changes to either improve product quality and/or process robustness versus cost, time and risk mitigation if 'modernization' of bioprocesses is to be value added.Anthony Mire-Sluis, Ph.D., Executive Director, Global Product Quality and External Affairs, Amgen 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 | |||
| 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 | |||
| Main Conference - Day Three Thursday, September 25, 2008 | PRE-CONFERENCE WORKSHOPS | DAY ONE | DAY TWO | DAY FOUR | | ||||
| 7:00 | Coffee | |||
| Technology Workshop | ||||
| 7:15 | High Throughput Process Development: Promises, Myths, and Truths The ultimate goal of the process development team is to stay off the critical path to drug approval. To increase the effectiveness of the development process, many companies are turning to the use of high throughput (HT) technologies within their development platforms. In this workshop we will describe our experience with the implementation of three such HT technologies. We have learned that there are at least four keys to successful automation implementation, some of which could be anticipated and some of which are less obvious. Our experience will be shared.Peggy Lio, Process Science Fellow, Invitrogen Corporation | |||
| Production & Economics of Biopharmaceuticals | ||||
| Scaling Up from Bench through Commercialization | ||||
| 8:00 am - 12:00 pm | Choose from these Small Group Discussion Sessions and Workshops Sessions #1 and #2 will take place 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: | ||||
| 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. | ||||
| 1:45 pm - 6:00 pm | Afternoon Sessions Sessions #3 and #4 will take place 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. | ||||
| 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: | ||||
| Cell Culture & Upstream Processing | ||||
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 |
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. | |||
| 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 |
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 | |||
| Recovery & Purification | ||||
| 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 | |||
| 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 | |||
| 12:00 | Concurrent Technology Workshops | |||
Impact and Benefits of PAT in Industrial Downstream Processing A Case Study of 3 different technologies (In-line Dilution, Sequential Multi-Column Chromatography & Batch Chromatography) will be shown with Process Analytical Technologies which were developed, scaled-up and implemented at the industrial scale. An evaluation of the implementation impact and potential savings of COG's will be presented.Margit Holzer, Biopharma BU President, Novasep Process | ||||
The Best of Both Worlds - Performance, Consistency and Compliance: Advances in Defined, Animal-Free Supplements Allow You to Rethink Your Media Regime and Optimise Productivity The ideal media for today is robust, containing defined, animal-free supplements that deliver optimal cell growth, productivity and product consistency. In this study we compare recombinant forms of two key serum proteins, transferrin and IGF-I, to commonly used iron supplements. We report on their ability to stimulate cell growth and productivity and demonstrate that in combination rTransferrin and LONG®R3IGF-I achieve synergistic performance.Sally Grosvenor, Senior Scientist & Scientific Communications Manager, Applied R&D, Novozymes Biopharma AU Ltd, Australia | ||||
Advances in Single Use Capture Chromatography Disposable buffer bags, tubing, aseptic connectors, and viral clearance filters have demonstrated their value vs conventional reusable technologies. Nysa has developed a membrane-based single use capture chromatography technology to provide users with further options for the implementation of single use systems in their bioprocesses. This workshop will discuss applications for single use capture chromatography technology with an emphasis on the interplay between applications, product format and membrane chemistries.Chris Shields, MBA, Marketing Director, Nysa Membrane Technologies, Inc. | ||||
Overcoming Challenges in Contaminant Removal in Biomanufacturing High titer cell culture processes challenge the contaminant removal capacity of traditional downstream process technologies. It becomes obvious that new approaches and technologies are necessary to overcome these limitations. New technologies are in the pipeline to remove contaminations very early on in the downstream process. This presentation will focus on disposable chromatography and a new cellulose fiber based depth filter.Christian Manzke, Ph.D., Director, Purification Technologies, North America, Sartorius Stedim North America Inc. | ||||
| Cell Culture & Upstream Processing | ||||
| Panel Discussion | ||||
| 12:30 | Cell Engineering the Future - A Role for Media Innovation Over the last decade the productivity of mammalian cell culture processes have improved dramatically. Gene copy number and clonal selection strategies have underpinned this improvement. Is further improvement achievable from cell engineering? Novel media components including bio-active molecules could enhance productivity gains from cell engineering by favourably regulating cells' physiological responses. Panel Moderator: Geoffrey Francis, Ph.D., Chief Scientist, Applied R&D, Novozymes Biopharma AU Ltd, Australia Panelists: To be announced Sponsored by | |||
| 1:00 | Networking Luncheon in Exhibit and Poster Hall | |||
| 1:45 | Chairperson's Remarks Stephen Gorfien, Ph.D., Director, BioProduction Products and PD-Direct™ Media Services, Invitrogen Corporation | |||
| Proven Strategies for Process Development & Optimization | ||||
| 2:00 |
This presentation will review the experience of replacing a conventional stainless-steel bioreactor with a 500-liter disposable system manufactured by Xcellerex® for an existing antibody production process. Challenges included risks associated with investing in a new technology, meeting production demands, extractable/leachable concerns, and the ability to meet project timelines. A review of the factory acceptance testing, installation and operational qualifications, and engineering runs will be discussed. A comparison of growth and productivity between a conventional 340-liter stainless bioreactor and the 500-liter disposable system will be reviewed as well as overall project timelines. Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, Genzyme Corporation | |||
| 2:30 |
Cell line changes can frequently lead to differences in product quality (PQ) between clinical phases and raise product comparability issues. To manage this risk, we use QbD tools such as DOE and risk assessment to study interactions and process variability and to identify key process parameters that impact PQ and process robustness. This presentation will use case studies to illustrate how we balance PQ and process robustness during cell line or process changes. Jian Wu, Ph.D., Principal Scientist, Cell Science and Technology, Amgen Inc. | |||
| 3:00 | Efforts to Understand and Control Glycosylation in CHO Cell Culture Processes Maintaining consistent glycosylation may be important to ensure consistent rhuMAb biological activity. To enhance understanding of glycosylation, historical data from multiple products was analyzed to identify correlations between glycoform distribution and culture parameters and performance. Specific process parameters and culture additives were also tested to identify factors or cellular components that may be rate limiting and contribute to glycosylation variability. Melissa Mun, Engineer I, Late Stage Cell Culture Process Research & Development, Genentech, Inc. | |||
| 3:30 | Networking Refreshment Break in Exhibit and Poster Hall - Final Opportunity for Poster and Exhibit Viewing | |||
| 4:00 |
We compare a current mAb production bioreactor SSM with simpler aeration strategies. Two aeration strategies were tested: 1) a constant CO2/air overlay, and 2) a fixed CO2:O2 sparge ratio. The impact on cell culture performance and product quality attributes will be presented, as well as a discussion on the feasibility of implementing the modified aeration strategies based on equipment capability. Sara Gall, Associate Scientist, Process Development - Cell Sciences and Technology, Amgen Inc. | |||
| 4:30 |
Cell line development using the Cello™ robotic system and a transfection pool strategy for delivery of early pre-clinical material was performed in parallel to shorten timelines in biopharmaceutical development. Pre-clinical material was harvested within 10 weeks from a 20L-bioreactor containing ~3g/L. A clonal cell line producing 5g/L in 100ml fed-batch shake flask culture was achieved using the same expression plasmid. Kristina Lindgren, Ph.D., Scientist, BioProcess R&D, Upstream Development, AstraZeneca | |||
| 5:00 |
A high throughput system has been developed at Eli Lilly. Cell densities and titers in this HTP system are compatible to shake flasks in 14 days fed batch process, though differences were also observed in some projects. Multiple clones and process conditions can be tested simultaneously in this system and therefore, accelerate and improve the cell culture process development. Anli Ouyang, Ph.D., Research Scientist, Bioproduct Research and Development, Eli Lilly and Company | |||
| 5:30 |
Learn about this media cost savings project and the validation strategies and challenges inherent in a perfusion cell culture process. With cell culture campaigns exceeding 4 months, traditional process development and validation strategies were not practical. The presentation will address process development study design, validation/regulatory/implementation strategies, selection of validation acceptance criteria, and risk management of non-insulin related validation discrepancies. Tae Kyun Kim, Senior Process Development Engineer, Manufacturing Sciences - Fermentation, Bayer Healthcare | |||
| Recovery & Purification | ||||
| 12:30 | Networking Luncheon in Exhibit and Poster Hall | |||
| 1:45 | Chairperson's Remarks Peter W. Wojciechowski, Director, Process and Analytical CMC, Johnson & Johnson Regenerative Therapeutics | |||
| Approaches for Successful Process Development and Optimization | ||||
| 2:00 |
The first case study is determination of step elution conditions for the cation exchange chromatography resin, SP Sepharose Fast Flow, using a scale-down wellplate based model. The second case study is measurement of static binding capacities for the Protein A affinity chromatography resins, MabSelect SuRe and ProSep-A high capacity, in microtiter filterplates and prediction of dynamic binding capacities using the pore diffusion controlled mass transfer model. Results show that PiP can be used to predict the column performance and used as a screening tool to narrow down design space and characterization space for chromatography purification process development. Junfen Ma, Ph.D., Engineer II, Oceanside Process Research & Development, Genentech, Inc. | |||
| 2:30 | Platform Development Approaches for Non-Platform Projects: How to Efficiently Develop Purification Processes for Non-Antibody Drugs Platform approaches have become a key element of industrial downstream process development. However, for a versatile product portfolio of non-antibody drugs, a generic, predefined column cascade does not exist. In this talk we describe a comprehensive 'platform-like' approach involving automated sorption parameter screening, custom affinity ligand design and scale-up modeling to facilitate lean process development for products which do not fit into a predefined purification platform. Tim Herrmann, Process Development Scientist, Global Biological Development / Purification, Bayer HealthCare LLC | |||
| 3:00 |
EA2 is a unique, engineered fusion molecule composed of three domains: an enzyme, Fc, and an anionic peptide. As such, it presented challenges in its purification, as each of the domains had different binding properties and stabilities. For example, we found that standard platform purification steps such as Protein A chromatography required extensive modification. The presentation will cover evaluation of several different purification modalities and selection of a final process for production of clinical material. Thomas Loisel, Ph.D., Group Leader, Biology, Enobia Pharma, Inc. Michiel E. Ultee, Ph.D., Senior Director, Process Sciences, Laureate Pharma, Inc. | |||
| 3:30 | Networking Refreshment Break in Exhibit and Poster Hall - Final Opportunity for Poster and Exhibit Viewing | |||
| 4:00 |
Screening of chromatography resins and operational conditions are done in parallel using High Throughput Process Development (HTPD) formats. The conditions are further optimized and verified in small column format, where after the purification process is transferred to a scale suitable for clinical Phase 1-2. Clinical material for these phases is produced in only a limited number of batches after which the used chromatography resins as well as other consumables are being discarded. A comparison between a conventional process and a process that utilizes ReadyToProcess™ (pre-packed) columns will be given. Kjell Eriksson, Ph.D., GE Healthcare, Sweden | |||
| 4:30 |
Purification processes for monoclonal antibodies are usually based on 3 chromatographic steps: Protein A affinity, ionic exchange and a polishing step. With the objective of productivity gains - higher yields, lower costs and less time - while maintaining good purification performance, we have challenged the generic approach and reduced the number of steps from 3 to 2. The successful implementation of a 2-step purification will be demonstrated using a concrete example. Nora Eifler, Ph.D., Lab Head, Biotechnology Development, Novartis Pharma AG, Switzerland | |||
| 5:00 | Off-Target Retentate pH Linked to Rejection of Buffer Species by Industry-Standard Ultrafiltration/Diafiltration Membrane An inherently uncharged ultrafiltration/diafiltration membrane has been demonstrated to accumulate enough charge under low ionic strength conditions to cause rejection of diafiltration buffer species, resulting in unequal retentate and buffer pH. This talk may be of interest to anyone responsible for the development, tech transfer, or validation of ultrafiltration/diafiltration processes or biopharmaceutical formulations. Bryan Holmes, Bioprocess Engineer, Purification Process Development, Human Genome Sciences, Inc. | |||
| 5:30 | The "Eyes and Ears" of Successful Process Development Recombinant glycoproteins intended for therapeutic use may be complex in nature. The diversity is defined by the manufacturing process. The earlier an evaluation of specific biochemical characteristics begins during process development, the better the understanding of the process design space, and implications for process refinement or change. Such data are also critical in defining a robust manufacturing process that would ensure product quality and consistency. In this presentation we will discuss applications of selected orthogonal analytical methods that may be used to support process development and product characterization. John Harrahy, Ph.D., Staff Scientist II, Bioanalytical Development, Genzyme Corporation | |||
| Site Tours | ||||
| Please indicate your interest in either site tour on the registration form. Space is limited and available on a first come, first served basis. You will be notified if there is a space for you. | ||||
| Genentech, Oceanside, CA (Friday Morning)
On the tour, the participants will be able to view the operations, buffer prep, media prep, fermentation, and also develop an understanding of the supporting functions and buildings on this biopharmaceutical manufacturing campus. The buses will depart at 8:00 am on Friday and return by 1:30 pm. | ||||
| Irvine Scientific (Thursday Afternoon)
During our facility tour, the participants will be able to view the liquid and powder manufacturing areas, Quality Control and Research & Development laboratories, as well as have access to Irvine Scientific's knowledgeable personnel that will be able to address any questions they may have. The buses will depart at 1:00 pm on Thursday and return by 5:00 pm. | ||||
| Main Conference - Day Four Friday, September 26, 2008 | PRE-CONFERENCE WORKSHOPS | DAY ONE | DAY TWO | DAY THREE | | ||||
| 7:00 | Coffee | |||
| Technology Workshop | ||||
| 7:15 | Building Quality into High Performance Media and Supplement Design Building quality into bioprocessing development activities ensures a robust, consistent production process. Media and supplement selection can have a significant effect on the robustness of a process. Using a systematic approach to media design which incorporates Voice of the Customer, Design of Experiments, raw material selection, and manufacturing processes can produce a consistent, high performance medium in minimal time. Stacy Holdread, M.S., R&D Project Scientist, BD Biosciemces - Advanced Bioprocessing | |||
Genentech's Oceanside, California, facility was given the "2007 Facility of the Year" Award by ISPE, INTERPHEX and Pharmaceutical Processing Magazine. The NIMO biologics manufacturing facility, encompassing six buildings, 550,000 sq. ft. including Manufacturing, Lab/Office and Utility space, is one of the most advanced facilities of it's kind in the world, and is located on 60 acres about 35 miles north of San Diego.
Irvine Scientific is a world supplier of cell culture media which specializes in custom cell culture media. During the facilities tour at the BPI 2008 IBC Conference in Anaheim the participants will learn about Irvine Scientific's large manufacturing capacity, the high quality product that we process using the highest standards of a class II medical device-licensed company and that our staff members are dedicated to the highest level of customer service for a full spectrum of collaborative services, with rapid turnaround times, from inception to commercialization.