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A large part of biopharmaceutical companies now rely on outsourcing partners for the development and manufacture of biological drug substance and drug product for clinical studies and commercial supply. The CMC section of a biopharmaceutical project is typically on the time critical path and this can prove a challenge for both the Client (contract giver) and the Contract Manufacturing Organization or CMO (contract acceptor). To ensure a successful collaboration and outcome, client expectations must be aligned with the contracted CMO. A mutual understanding of risk is a prerequisite for designing the right development and manufacturing program. In addition, a sense of “co-ownership” of the project adds value in facilitating a seamless contract execution and completion.
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