cGMP Compliant Protein Production

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  • Published date: May 30, 2019
  • Modified date: October 17, 2019
    • Shirley, New York, United States

Current Good Manufacturing Practice (cGMPs) is the main regulatory standard for ensuring human pharmaceutical quality, which is enforced by FDA. These practices provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Normally, cGMP manufacturing follows after process development procedure. Scientific staffs will transmit the process that is validated from the first Feasibility Study step to cGMP manufacturing staff and QC in a collaborative manner. The manufacturing process will not be changed when clinical trials initiate.

Anna Camp
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