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Successful CMO Selection
August 28, 2009
•Feature Article: Successful CMO Selection
CMC Strategies for Outsourcing Biopharmaceutical Product Manufacturing
By Patricia M. Seymour, Howard L. Levine, and Susan Dana Jones
Outsourcing of biopharmaceutical product manufacturing has grown significantly in the past several years, and the trend is predicted to continue. Of several explanations why this growth in outsourcing has occurred are increases in the number of biopharmaceutical products being developed and commercialized as well as the availability of highly qualified contract manufacturing organizations (CMOs).
Companies choose to outsource biopharmaceutical product manufacturing because, tactically, they do not have the capacity, capability, or expertise in-house to manufacture such products and do not want to invest in facilities. Alternatively, outsourcing may be part of a larger overall strategic plan. A CMC (chemistry, manufacturing and control) strategic plan must take into consideration several issues, including intellectual property, stage-gated investment, risktolerance levels, and access to specialized biopharmaceutical manufacturing capacity, both in-house and in the outsourcing marketplace. Many companies, after completing the strategic planning process specifically for CMC, include outsourcing as a key strategic element.
Reprinted with permission from BioProcess International 4(8):S26-S29 (September 2006)
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