<br/>The biotech community relies greatly on the ability and capacity of external CMOs for the manufacture of their biologics. However, there are instances in which the plans of long-term manufacture of a commercial biologic at an external CMO change to meet the needs of the program and/or business strategy, and the manufacture must be tech transferred back internally. As anticipated, this comes with some complexity, such as the need to identify and de-risk long lead time items, addressing potential facility fit issues, and understanding the regulatory and comparability strategies to facilitate approval.

Bringing a commerical process back home: Tech transferring from an external CMO for internal manufacture

2019 Spring National Meeting

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