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, at commercial scale.
 
Teplizumab, Provention Bio’s lead drug candidate, is an anti-CD3 monoclonal antibody (mAb) being developed for the delay or prevention of type 1 diabetes (T1D). In clinical studies, teplizumab has been shown to delay the onset of T1D by a median of approximately three years compared to placebo. Provention Bio has initiated a rolling Biologic License Application (BLA) to the U.S. Food and Drug Administration for teplizumab and expects to complete the process by year-end.
 
“We commend the outstanding efforts and excellent work of our strategic manufacturing partner, AGC Biologics, over the past 18 months,” said Ashleigh Palme, chief executive officer, Provention Bio. “AGC completed an engineering run at the end of 2019 and successfully completed a cGMP run in the first quarter of 2020. We are pleased to report that we have achieved yet another mission critical milestone with the on-schedule completion of our drug substance PPQ manufacturing campaign that will serve as the foundation for our BLA’s Chemistry, Manufacturing and Controls module.”
 
Mark Womack, CBO of AGC Biologics, said, “AGC Biologics is pleased to have successfully achieved another milestone with Provention Bio. Concurrent with the challenges of the COVID-19 pandemic, we have successfully manufactured the validation batches and are preparing for commercial manufacturing of teplizumab by the end of this year.”