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faster rate potentially resulting in capacity shortages by 2021. We have noted that the industry is already experiencing some capacity constraints at the clinical scales due to very high clinical demand. The type and scale of capacity being installed will also be important as the demand for 50% of products in mid-to-late stage development can be met with 5,000L of capacity or less; while the other 50% of products will need larger, and potentially much larger, capacity to meet future demand. How the industry responds to these demands for capacity will certainly be critically important to ensure these products are available to the patients.


References


1. Ecker DM, Ransohoff TC, Jones SD, Levine HL. The state of mammalian cell culture biomanufacturing. Woburn (MA): BioProcess Technology Consultants, Inc.; 2011 Dec 12. 150 p. Available from: http://www.bptc.com/reports.php.


2. Pavlou AK, Reichert JM. Recombinant protein therapeutics-success rates, market trends and values to 2010. Nat Biotechnol. 2004 Dec;22(12):1513-9.


3. DiMasi JA, et al. Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther. 2010 Mar;87(3):272-7.


Author Biographies


Patricia Seymour, M.B.A., CSCP, is a Senior Consultant with BioProcess Technology Consultants and has over 25 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development, quality, regulatory and manufacturing, supply chain strategy, and management and operations leadership. Ms. Seymour was formerly Sr. Director, Global Investigational Supply Operations at Millennium. She previously held positions at Covance, Collaborative BioAlliance, ImmunoGen, Dana Farber Cancer Institute and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University and is a Certifi ed Supply Chain Professional (APICS).


Dawn M. Ecker, M.S., is a consultant with BioProcess Technology Consultants, and has 25 years of experience in the biotechnology industry. At BPTC she is responsible for maintaining the company’s bioTRAK® database for biopharmaceutical products, manufacturing capacity, and related topics, as well as for developing client-specifi c analyses based on this data. Ms. Ecker holds a B.S. in Microbiology/Biotechnology from Quinnipiac University and a M.S. in Biology from Worcester Polytechnic Institute.


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