AGC Biologics, a leading 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, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases. 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,” says Provention Bio CEO Ashleigh Palmer. “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.”

“AGC Biologics is pleased to have successfully achieved another milestone with Provention Bio,” says Mark Womack, CBO of AGC Biologics. “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.”

About Provention Bio:

Provention Bio, Inc. is a biopharmaceutical company leveraging a transformational drug development strategy focused on the prevention or interception of immune-mediated disease. Provention’s diversified portfolio includes teplizumab, a clinical-stage candidate that has been shown in a clinical study to delay the onset of insulin-dependent type 1 diabetes (T1D) in at-risk patients during the presymptomatic phase of the disease as compared to placebo. The company’s portfolio includes additional clinical product development candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus.

About AGC Biologics:

AGC Biologics is a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 1,300 professionals worldwide. AGC Biologics has decades of experience in development and manufacturing, including providing commercial market supply with FDA, PDMA and EMA approvals. AGC Biologics offers deep industry expertise and unique customized services, including development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. AGC Biologics’ global network spans three continents, with GMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan and Bresso, Italy and Chiba, Japan.

AGC Biologics integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression, including the proprietary CHEF Expression System for mammalian production.

AGC Biologics is committed to continuous innovation and offers the technical creativity to solve clients’ most complex challenges.