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Challenges and Solutions for Biopharmaceutical Manufacturing

Presented at: Cambridge HealthTech PepTalk Conference San Diego, CA, January 15, 2009

The biopharmaceutical industry is a dynamic one with many risks and uncertainties associated with product development and commercialization. The ability of a company to manufacture sufficient quantities of their product when they need it, whether for early stage clinical trials or to meet commercial market demands, present significant challenges throughout the lifecycle of a biologic product. Worry over “capacity crunches” resulting from notable capacity shortages for individual products in the past spurred dramatic improvements in manufacturing processes, the emergence of standardized processes and facilities for the production of biopharmaceutical products, and the massive expansion of manufacturing capacity industry-wide. This presentation reviews strategies for ensuring access to adequate capacity and reviews future trends in biopharmaceutical manufacturing.