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Successful CMO Selection: CMC Strategies for Outsourcing Biopharmaceutical Product Manufacturing

By: Patricia M. Seymour, Howard L. Levine, Ph.D., and Susan Dana Jones, Ph.D.
Reprinted with permission of BioProcess International, September 2006

The outsourcing of biopharmaceutical product manufacturing has grown significantly over the past several years, and the trend is predicted to continue. There are several reasons behind this growth. First, the sheer number of biopharmaceutical products being developed and commercialized has increased. Second, there are more highly qualified Contract Manufacturing Organizations (CMOs). Third, companies are choosing to outsource their biopharmaceutical product manufacturing because: (1) tactically, they do not have the capacity, capability or expertise in-house to manufacture such products and do not want to invest in facilities; or (2) outsourcing is 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; risk tolerance levels; and finally, 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 element. In this article, we discuss certain CMC strategic planning considerations which lead to an outsourcing decision and then how to successfully manage the CMO selection process in an outsourcing scenario.