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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Forecasting Industry-wide Biopharmaceutical Manufacturing Capacity Requirements


    The biopharmaceutical industry is dynamic and its product development, commercialization, and financing poses many significant risks. The ability of biopharmaceutical companies to manufacture sufficient quantities of their products to meet market demand is a critical risk factor. Concern over capacity forecasting has been a driving force, leading to a number of analyses on the topic of supply and demand for manufacturing capacity. In the late 1990ís and early 2000ís, manufacturing capacity concerns were heightened by several high profile capacity shortages for individual products when both Immunex and Berlex were unable to manufacture sufficient amounts of their products to meet market demand. Because of the enormous uncertainties associated with development of a biopharmaceutical product, the estimates for future supply and demand for manufacturing capacity is continually changing as new data from clinical trials, market penetration rates for new products, and progress on construction projects emerge. Any analysis of manufacturing capacity must be updated on a regular basis in order to provide a current and accurate picture of industry-wide utilization rates with a historical perspective. Additionally, a detailed analysis of manufacturing supply and demand enables the identification of capacity drivers and long-term trends in biopharmaceutical manufacturing. An industry-wide analysis of manufacturing capacity also allows tracking and validation of industry-wide statistics such as probability of success at various clinical stages and commercialization. Finally, recognizing that the biopharmaceutical industry is a global one, ongoing analysis of manufacturing supply and demand enables tracking of geographical trends in manufacturing capacity. The approaches outlined in the chapter can generally be applied to a wide range of biologic products. Our work focuses on manufacturing facility limitations, especially bioreactor capacity limitations. Recent increases in expression levels, particularly for monoclonal antibodies produced in mammalian cell culture, are now pushing facility bottlenecks downstream.

    About the Authors

    Howard L. Levine, Ph.D., President and Founder
    Dr. Levine has over 20 years of experience in the biopharmaceutical industry. Prior to founding BioProcess Technology Consultants to provide process development, manufacturing, quality control and quality assurance assistance to biopharmaceutical clients, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation. There, he was responsible for all process development and manufacturing activities, including production of therapeutic proteins and monoclonal antibodies and recombinant Protein A. Dr. Levine previously held positions of increasing responsibility in process development and manufacturing at Genentech, Amgen, and Xoma. Dr. Levine is currently a member of the Editorial Advisory Boards of BioPharm Magazine, BioProcess International, and Bio/Pharmaceutical Outsourcing Report. He is also a member of the Neose Technologies, Inc. GlycoAdvance Advisory Board, and is on the Scientific Advisory Boards of AsepCo and the Boston Area Chapter of the International Society of Pharmaceutical Engineering (ISPE). He was chairman of the Parenteral Drug Associationís (PDA) Task Force on Chromatography Validation; has lectured extensively on manufacturing strategy, downstream processing, and manufacturing in biotechnology; and is co-editor of a directory of biologics contract manufacturers. Dr. Levine holds a Ph.D. in chemistry from the University of Chicago and completed a postdoctoral fellowship at Harvard University.

    Thomas C. Ransohoff, Senior Consultant
    Mr. Ransohoff is a Senior Consultant with over 15 years of experience in the biopharmaceutical industry. Mr. Ransohoffís areas of expertise include development and scale-up of biopharmaceutical processes; separations and purification technologies; cGMP manufacturing; and process economics. Before joining BioProcess Technology Consultants, Mr. Ransohoff was Vice President, Operations at TranXenoGen, Inc., responsible for purification process development and facilities. Prior to that he was Vice President, Bioseparations at Dyax Corp, where he was instrumental in establishing a business unit to develop novel affinity separations products using phage display technology. At Repligen, Mr. Ransohoff was Senior Director, Manufacturing, responsible for cGMP pilot plant operations producing material for clinical trials and reagent products such as Protein A for commercial sale. He is a member of the Editorial Advisory Board of BioPharm Magazine and has served on a number of scientific advisory boards, including the National Research Council Committee on Opportunities in Biotechnology for Future Army Applications and the Boston Area Chapter of ISPE. Mr. Ransohoff has a Bachelorís degree from MIT and a Masterís degree from UC-Berkeley, both in Chemical Engineering.

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