BioProcess International™ Asia Pacific 
Event Information
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October 20 - 22, 2008 Grand Hyatt Hotel · Mumbai, India |
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Document Title
Agenda
| Pre-Conference Summit Monday, October 20, 2008 | DAY ONE | DAY TWO | DAY THREE | | |
| Developing Your Biosimilars Strategy for the International Market | |
| 7:30 | Registration & Coffee |
| 8:30 | Chairperson's Opening Remarks Dianne Jackson-Matthews, B.Sc.(Hons), Ph.D., R.A.C., Director of Regulatory Affairs, ERA Consulting (Australia) Pty. Ltd. |
| 8:35 | Moving from India to Europe - Addressing the Regulatory Expectations - the Intas Experience As companies make the transition from developing products for India to developing them for the European market, they need to modify their product development and marketing strategies to meet enhanced regulatory expectations. The presentation will go over the strategy adopted by Intas in making this transition. The expectations regarding quality, comparability as well as non-clinical and clinical studies will also be covered including a comparison of the regulatory systems of India and Europe for biosimilars. The relative advantages of operating from India will also be discussed. Dhanajay Patankar, Ph.D., Chief Technical Officer, Intas Biopharmaceuticals Ltd., India |
| 9:05 | Growth via the Biosimilar Market: A Case Study In this case study on biosimilars we discuss how to determine which follow-on proteins could be developed with a competitive advantage. We analyzed 200 approved protein therapeutics to develop a short list of candidates. We considered 12 parameters, not just market size and IP issues to select a prime candidate. Cori Gorman, Ph.D., MBA, President & CEO, DNA Gateway International, USA |
| 9:35 | Biosimilar Medicines - Science and Regulation for Development and Approval While a scientific approach for the development and assessment of products claimed to be similar to approved biological medicines is well established, policy decisions and regulatory frameworks are not fully determined or implemented in all the major market regions. The central concept of comparability is widely applied in biosimilar programs and comprises a common basis on which standards and expectations can be built. This presentation will provide an overview of the current legal, political and regulatory landscape for biosimilar product development in the key regions, including Europe and the US, and discuss product comparability and manufacturing challenges. Dianne Jackson-Matthews, Ph.D., R.A.C., Director of Regulatory Affairs, ERA Consulting (Australia) Pty. Ltd. Samir Sangitrao, B.V.Sc & A.H.. R.A.C.-U.S., Senior Manager of Regulatory Affairs, Intas Biopharmaceuticals Ltd., India |
| 10:30 | Networking Refreshment Break |
| 11:00 | Analytical Characterisation Strategies for Biosimilars to Satisfy Regulatory Requirements A variety of physicochemical analytical methods are required to characterize biosimilar products and compare these with the innovator product. Changes in post-translational modifications should be assessed, as well as process- and product-related impurities. A combination of techniques for protein and carbohydrate analysis of glycoproteins will be shown, including using the sensitivity of LC/MS and MS/MS. Fiona Greer, Ph.D., Director, Biochemistry, M-Scan, United Kingdom |
| 11:30 | Unwanted Immunogenicity of Biological Therapeutics Assessment of unwanted immunogenicity is important for ensuring safety of biotherapeutic products. Such assessment requires an appropriate testing strategy, validated methods for antibody detection and impact of the induced antibodies on clinical response(s). This presentation will cover these aspects and review the guidance available for assessment of unwanted immunogenicity. Meenu Wadhwa, Ph.D., Head, Cytokine and Growth Factor Section, Biotherapeutics Group, National Institute for Biological Standards and Control (NIBSC), United Kingdom |
| 12:00 | Analytical Methods for Immunogenicity Assessment of Biosimilars: Insulin and G-CSF as Case Studies Assay for the immunogenicity of biotherapeutics is an important part of the clinical trial testing. Antibodies to the biotherapeutic proteins need to be confirmed with confirmatory assays and to be characterized using a potency cell based assay or other appropriate formats. This presentation will discuss the efforts made by Biocon Limited in developing a series of sensitive assay formats for immunogenicity testing of insulin and G-CSF. M.N Dixit, MS, DVM, Scientific Manager, Bioanalytical, Clinigene, Biocon Limited, India |
| 12:30 | Close of Pre-Conference Summit and Networking Luncheon in Exhibit & Poster Hall |
| Main Conference - Day One Monday, October 20, 2008 | PRE-CONFERENCE SUMMIT | DAY TWO | DAY THREE | | |
| 12:30 | Main Conference Registration and Networking Luncheon in Exhibit & Poster Hall |
| 2:00 | Conference Session Opens |
| Keynote Plenary Session Exploring the Growth Opportunities in India - Landscape Overview of India's Market Dynamics, Players and Capabilities | |
| 2:00 | Session Moderator's Remarks Shrikumar Suryanarayan, Director-General, ABLE to Association for Biotechnology-Led Enterprises (ABLE), India |
| 2:05 | Current State of Affairs for Biosimilars in India and Its Future in the Global Biopharmaceuticals Market Gerhard Klement, CEO & President, Reliance Biopharmaceutical Pvt. Ltd., India |
| Current State of Affairs for Vaccines in India and Its Future in the Global Vaccines Market | |
| 2:30 | Prasad Kulkarni, M.D.., Additional Medical Director, Serum Institute of India Limited, India
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| 2:50 | Rayasam (Ray) Prasad, Chief Operating Officer - Global Biologics, Biological E. Limited, India |
| 3:10 | India's Prescription for Growth into the Next Decade Shrikumar Suryanarayan, Director-General, ABLE to Association for Biotechnology-Led Enterprises (ABLE), India Shrikumar is currently the Director-General of the Association of Biotechnology Led Enterprises of India ( ABLE), headquartered at Bangalore. He is also an Adjunct Professor at the Department of Biotechnology at the Indian Institute of Technology Madras, with research interests in Bioprocess technology and Biofuels. In addition, he is a visiting faculty at the Department for Molecular Medicine at the Karolinska Institute, Sweden, with research interests in Diabetes and Inflamation. After finishing his undergraduate studies in Chemical engineering from the Indian Institute of technology Madras, Shrikumar specialized in Biochemical engineering at the Indian Institute of Technology Delhi following which he joined Biocon Limited , in Bangalore in 1984 to startup their R&D division. During this period Shrikumar was responsible for several projects including the development of many processes for industrial enzyme production, the design and construction of a novel bioreactor for Solid State Fermentation , several process for the development of pharmaceutical small molecules by fermentation and synthetic chemistry and a Biotherapeutics program which included injected and oral insulin and monoclonal antibodies. During the 23 plus years that he spent at Biocon, the company grew from a small company manufacturing industrial enzymes to a specialized Biopharmaceutical company with market capitalization in excess of a billion dollars. In October 2007, he stepped down from his administrative role of Biocon's President of Research and Development to pursue his personal interests in public health, bioenergy and education. |
| 3:25 | Keynote Panel Q&A |
| 3:45 | Networking Refreshment Break in Exhibit & Poster Hall |
| Regulatory Compliance & Viral Safety | |
| 4:15 | Session Moderator's Remarks Wassim Nashabeh, Ph.D., Director, CMC Regulatory Affairs, Genentech, Inc., USA |
| 4:20 | Global Regulatory Considerations in Conducting Comparability Studies: An Industry Perspective Comparability is an essential activity required to support product lifecycle management, to facilitate timely regulatory approval and to ensure consistent delivery of product to the patients. This presentation will describe proven strategies for planning, prioritizing and executing successful comparability exercises. Special emphasis will be devoted to the use of a risk-based approach in determining the required comparability studies in support of manufacturing process and site transfers. We will also discuss the role of QbD in implementing broad-based comparability studies and the unique regulatory aspects in submitting comparability studies. Wassim Nashabeh, Ph.D., Director, CMC Regulatory Affairs, Genentech, Inc., USA |
| 4:50 | Virus Safety Evaluation of Products in Development in Europe New regulations for virus safety evaluation of products in development have been established in Europe recently. A draft guideline was published by the EMEA in June 2006. Enormous responses from industry and others have resulted in further discussions. The guideline, if established, will implement a new strategy for the virus safety assessment of biopharmaceuticals. Hannelore Willkommen, Ph.D., Vice President, Regulatory Affairs, NewLab Bioquality AG, Germany |
| 5:10 | Benefit-Risk Evaluation of Biotechnology Products Benefit-risk evaluation at various stages of clinical development and reassessment post marketing is an essential aspect of the development of biologicals. In case of biologicals, the manufacturing and quality aspects along with immunogenic potential play a more important role. The presentation shall discuss the benefit-risk evaluation of recombinant proteins. Deepa Arora, M.D., Ph.D., Medical Advisor, International Clinical Research, Wockhardt Limited, India |
| 5:45 | Opening Night Cocktail Reception in Exhibit & Poster Hall Sponsored by:  |
| Main Conference - Day Two Tuesday, October 21, 2008 | PRE-CONFERENCE SUMMIT | DAY ONE | DAY THREE | | |
| 8:30 | Chairperson's Opening Remarks Howard L. Levine, Ph.D., President and Principal Consultant, BioProcess Technology Consultants, USA |
| Intellectual Property | |
| 8:35 | Beyond Sourcing - Effective Partnering in Asia for Biotech/Pharma Firms To Minimize Intellectual Property Risk Biotech/Pharma research and development activities in Asia have progressed along two parallel tracks - building facilities and partnering with local entities. Focusing primarily on the partnering model, relevant contract, intellectual property, competition, and licensing issues will be discussed. Alternative collaborative business structures will be discussed as tools to enhance partnership and minimize intellectual property risk. Christopher Slavinsky, MSc., JD, Director, Science & Technology Business Development, Pfizer Inc., USA |
| 9:05 | IP Protection: India, U.S. and Europe Intellectual property (IP) protection is an integral driver of growth in the biotechnology sector in India, Asia and around the world. Some Asian countries have recently taken steps to reform their IP laws. This talk will focus on key aspects of IP protection and will also provide a comparison of IP protection in India as well as the U.S. and Europe. Select case laws will also be highlighted. Rena Patel, Ph.D., J.D., Principal, RP Consulting, India/USA |
| Quality by Design | |
| 9:30 | Quality by Design - Gaining a Better Understanding of the Product and Process Abstract to come. Rohin Mhatre, Ph.D., Head of Regulatory Affairs and Analytical, Biogen Idec, USA |
| 10:00 | The Use of Critical Process Parameters and Quality by Design to Improve Biopharmaceutical Product Quality Abstract to come. Howard L. Levine, Ph.D., President and Principal Consultant, BioProcess Technology Consultants, USA |
| 10:30 | Networking Refreshment Break in Exhibit & Poster Hall |
| Partnering & Outsourcing Strategies | |
| 11:00 | Effective Methods for the Selection and Management of Contract Manufacturing Organizations (CMOs) for Biopharmaceutical Manufacturing Companies must insure that the selected CMO has sufficient resources to develop a robust manufacturing process and to meet requirements of global regulatory authorities. The project should be closely managed through frequent meetings with the CMO, weekly data review, and communication of program goals and activities to insure a unified and efficient approach to product development. Concurrence on timelines and quality issues is essential. Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants, USA |
| 11:30 | Panel Discussion: Perspectives from Global Biotech
Panelists: Christopher Slavinsky, MSc., JD, Director, Science & Technology Business Development, Pfizer Inc., USA Maninder Hora, Ph.D., Vice President, Process Development, PDL BioPharma, Inc., USA Dhanajay Patankar, Ph.D., Chief Technical Officer, Intas Biopharmaceuticals Ltd., India Jay Madan, Vice President, Business Development, Biopharmaceuticals, Reliance Life Sciences, Inc., USA |
| 12:30 | Networking Luncheon in Exhibit & Poster Hall |
| Technology Transfer & Scale Up Case Studies | |
| 2:00 | Chairperson's Remarks Gautam Ganguly, M.S., MBA, Manager, Facility Projects & Services, Genentech, Inc., USA |
| 2:05 | Technology Transfer, Scale-Up and Analytical Comparability Issues when Transitioning Mammalian Cell Culture Processes from Clinical Scale to Very Large Scale Production Abstract to come. Crawford Brown, Ph.D., Chief Executive Officer, Eden Biodesign, Inc., USA Lisa Cozza, Director, Manufacturing Alliances, Human Genome Sciences, Inc., USA |
| 2:35 | Transfer of An E. Coli-Derived Biologics Manufacturing Process - A Case Study A direct transfer of an existing commercial process to a same-scale manufacturing facility designed for that process is straightforward, though inevitable differences from the original production process systems complicates the situation. This presentation discusses an example of a bacterial-derived process, the differences that have been identified, and the risk control strategies that have been used to manage the risk. L. Harry Lam, Ph.D., Director, ECP1 Manufacturing & Technology, Genentech, Inc., Singapore |
| 3:05 | Live Biologicals: The Next Generation Rather than using a purified biological, the next generation biologicals often directly use a specific micro-organism to exert a biological effect. The organism can be used as a delivery system or the metabolic characteristics are used to produce a biological effect. As with any live therapeutic, lyophilisation is required, which has quite an impact on the production logistics. For example it is vital to have production and lyophilization capability in the same facility. This presentation addresses two case studies of technology transfers of live therapeutics and the typical pitfalls associated with tech transfers. Marcel Thalen, M.Sc., Scientific Officer, Business Development, SynCo Bio Partners B.V., The Netherlands |
| 3:35 | Networking Refreshment Break in Exhibit & Poster Hall |
| 4:05 | Technology Transfer: A Key Building Block for Establishing Robust Processes for Biopharmaceuticals Development of robust processes is a critical requirement for successful launch of biopharmaceuticals. Technology transfer from a development lab to production site is a key step in creating an efficient and robust process for manufacturing. Various inputs (e.g., process knowledge) and outputs (e.g., demonstration runs, comparability) for successful technology transfers will be discussed with examples. Maninder Hora, Ph.D., Vice President, Process Development, PDL BioPharma, Inc., USA |
| 4:35 | From Lab to Production: Requirements for Efficient Technology Transfer The effectiveness of technology transfer is one of the key determinants in the success of a biopharmaceutical manufacturing project. The challenge of technology transfer is to implement the process with different sets of equipment, systems and people, while maintaining the quality requirements of the process/product. The talk will address some of the key aspects of technology transfer to deliver results in an efficient and cost effective manner. Swapnil Ballal, Head Biopharmaceutical Bulk Manufacturing, Intas Biopharmaceuticals Ltd., India |
| 5:05 | Trials and Tribulations of Technology Transfers and Lessons Learned Abstract to come. Jay Madan, Vice President, Business Development, Biopharmaceuticals, Reliance Life Sciences, Inc., USA |
| 5:35 | Close of Day Two |
| Main Conference - Day Three Wednesday, October 22, 2008 | PRE-CONFERENCE SUMMIT | DAY ONE | DAY TWO | | |
| 8:30 | Chairperson's Opening Remarks Guenter Jagschies, Ph.D., Director R&D, Customer Applications, Protein Separations, GE Healthcare, Sweden |
| cGMP Facility Design & Implementation | |
| Keynote Presentation | |
| 8:35 | Impact of High Titers on Commercial Manufacturing of Antibodies and Future Design of Processes and Facilities Wolfgang Berthold, Ph.D., Chief Technical Officer, Biogen Idec |
| 9:00 | Design Features of a Biopharmaceutical cGMP Facility to Reduce the Time and Cost to Market Reducing the cost and time-to-market for a client's product is crucial for a CMO. This presentation will discuss some of the specific design features that can be incorporated to allow products to move quickly through the facility while maintaining high quality standards. Some of these design features that will be discussed include:
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| 9:25 | Current Status of R&D and Large Scale Production of Therapeutic Antibodies in China This lecture will focus on the general introduction of research and small to large scale production facilities in China, as well as an introduction of the products in clinical trials and those already available in the Chinese market. Yajun Guo, Ph.D., Professor & Director, Shanghai Center for Cell Engineering and Antibody, SMMU Cancer Institute, China |
| 9:50 | Modular Construction - A Case Study of Genentech Singapore This presentation will focus on a modular bulk biotech facility constructed for Genentech in Singapore. Discussion topics will include the benefits of this approach, details of the execution approach and information on the setting and interconnection process. Kelly Keen, Senior Project Manager, Genentech, Inc., Singapore Paul Hochi, Manager of Project Development, Jacobs, USA |
| 10:30 | Networking Refreshment Break |
| Achieving High Expression Levels | |
| 11:00 | Genetic Stability Studies of Recombinant Cell Lines Genetic stability studies are necessary for successful registration of human recombinant therapeutic proteins, to establish that the correct coding sequence of the product has been incorporated into the host cell, and is maintained to the end of production. This presentation describes our general strategy and improvements made to solve throughput and Health Authority issues in over twenty GLP studies. Emiliano Toso, Ph.D., Head, Molecular Biology Lab, MerckSerono, Italy |
| 11:25 | A New Genetic Element that Enables Rapid Production of High-Performance Stable Production Cell Lines An analysis of the integration pattern of the new synthetic element shows a single site of insertion within the chromosome that leads to high levels of stable protein production from a pool of cells. Sub-cloning is no longer required to obtain high stable levels of protein production. Due to the lack of heterogeneity between clones, this system allows for the selection of clonal cell lines within 12 weeks of transfection. Our case study data, gathered in concert with Merrimack Pharmaceuticals, will include data on protein production from 96 wells to 2 liters and finally at 1000 liters scale. Igor Fisch, Ph.D., Chief Executive Officer, Selexis, USA |
| 11:50 | High-Throughput Screening for Antibody-Producing Cell Lines A fully-integrated high-throughput screening platform is presented for recombinant antibody cell line development in mammalian cells. Multiple technologies have been incorporated, including the use of ClonePix FL for high-throughput screening of up to 1 million single-cell colonies, enabling rapid identification of high-titer clones within 60 days, which is a significant reduction of time and cost for antibody drug development. Cheng Liu, Ph.D., Chief Executive Officer, Eureka Therapeutics, USA |
| 12:15 | Networking Luncheon |
| 1:30 | Chairperson's Opening Remarks Uwe Gottschalk, Ph.D., Group Vice President, Purification Technologies, Sartorius Stedim Biotech GmbH, Germany |
| Purification & Recovery | |
| Technology Presentation | |
| 1:35 | Increasing Downstream Processing Capacity: New Technologies For Purification and Contaminant Removal Advances in cell culture development have created the challenge of how to process an increasing mass of proteins both economically and in a time-efficient manner. New advances in downstream processing technology will be presented. These technologies will enable an increased level of contaminant removal and improved process efficiency, thereby leading to an increase in downstream processing capacity.Richard Pearce, M.D., Ph.D., Program Director, Purification Technologies, Millipore Corporation, USA |
| 2:00 | State of mAb Purification Processes: Challenges & Solutions Process development and manufacturing operations strive to apply best practices to accelerate product to clinic and market, increase process efficiency and productivity while managing cost. Molecular properties ultimately govern the applicability of generic purification platform approaches. Increasing cellular expression levels and high performance cell culture processes, furthermore, impacts downstream facility fit and cost of goods. This talk will broadly discuss the current mAb purification processing challenges and potential solutions to those challenges. Ganesh Vedantham, Ph.D., Director, Purification Process Development, Amgen Inc., USA |
| Technology Presentation | |
| 2:25 | Protein Folding Case Studies- Yield, Volume and Process Stability 25% of today's blockbuster drugs are produced in E. coli and all of them are manufactured by in vitro folding. Biosimilars as well as new drugs will face this old but critical hurdle. The folding step not only affects decisively the overall process recovery but also has a major impact on the later downstream purification and formulation of the purified API.Andreas Anton, Ph.D., Director, Scil Protein Services, Scil Proteins GmbH |
| 2:50 | Networking Refreshment Break |
| Technology Presentation | |
| 3:15 | 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, Pall Life Sciences, USA |
| 3:45 | Multiple Modes of Fab Purification with Hdyroxyapatite This presentation will describe purification of Fab from papain digestion of monoclonal IgG by hydroxyapatite (HA) with conditions designed to isolate or emphasize the effects of HA�s various retention mechanisms, and characterize their interactions with intact IgG, Fab, and Fc fragments. Experimental data indicate that Fab interacts with HA chiefly by phosphoryl cation exchange. Fc fragments bind dominantly by calcium chelation. Intact antibody binds more strongly than either through a combination of both mechanisms. Three different strategies offer effective FAb purification: elution by phosphate gradient, elution by chloride gradient at constant low phosphate concentration, and selective Fab elution with calcium. Data will be presented comparing the purification performance, method development requirements, and manufacturing logistics of all three strategies. Peter Gagnon, Chief Scientific Officer, R&D, Validated Biosystems, USA |
| 4:15 | Close of Conference |
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