Breaking News, Collaborations & Alliances

AGC Biologics Completes PPQ Mfg. Campaign with Provention Bio

For type 1 diabetes product candidate, teplizumab.

By: Contract Pharma

Contract Pharma Staff

AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), achieved the on-schedule completion of a drug substance Process Performance Qualification (PPQ) campaign, focused on teplizumab (PRV-031) for partner Provention Bio. The PPQ campaign consisted of three commercial scale runs required for the validation of Provention Bio’s drug substance manufacturing process and the demonstration of its ability to manufacture consistently, batch-to-batch, a...

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