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Effective Methods for Selection and Management of Contract Manufacturing Organizations (CMOs) for Biopharmaceutical Manufacturing

Presented at: IBC’s Bioprocess International Asia Pacific Conference, Mumbai, India, October 21, 2008

Companies must insure that the selected CMO has sufficient resources to develop a robust manufacturing process and to meet requirements of global regulatory authorities. The project should be closely managed through frequent meetings with the CMO, weekly data review, and communication of program goals and activities to insure a unified and efficient approach to product development. Concurrence on timelines and quality issues is essential.