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Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” You also want your reference method to reflect the manufacturing process.
Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” Meeting Report: Joint BWP/QWP Workshop with Stakeholders in Relation to Prior Knowledge and Its Use in Regulatory Applications.” 5 , 13 , 27 , 32 1 US Food and Drug Administration. Advanced Manufacturing.”
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