AGC Biologics strives to offer scaled expertise in the manufacturing of protein-based therapeutics through its integrated service offerings. Its interest begins right from the pre-clinical stages to commercial production and works together with Provention Bio Inc (NASDAQ: PRVB). Innovations, excellence, diversity, and integrity are some of the company’s guiding values to bring new biopharmaceuticals to market. In its cGMP-compliant facilities in Europe, the US, and Japan, AGC has incorporated high standards of quality and execution of projects, which deliver its clients’ unmet needs.
Talking of manufacturing, AGC Biologics says it has accomplished the on-schedule drug substance Process Performance Qualification (PPQ) campaign targeting teplizumab (PRV-031). This was for its partner Provention Bio, Inc.
An Important Foundation for the Company’s Biologic License Application (BLA)
‘’…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,” Provention Bio CEO Ashleigh Palmer reported.
Teplizumab is an anti-CD3 monoclonal antibody (mAb) and Provention Bio’s lead drug candidate. Through its clinical studies, it has demonstrated the potential to delay the onset of type 1 diabetes (T1D). With that in place, Provention Bio is expectant of completing the BLA process by year-end. The validation of the drug substance manufacturing process required three commercial-scale runs and its ability to manufacture consistently and on a commercial scale.
AGC Biologics has Decades of Experience in Commercial Market Supply
AGC Biologics employs more than 1,300 professionals globally. With its massive experience and exposure over the years, the company has obtained commercial supply approvals from the PDMA, the FDA, and EMA. Its presence can be found in three continents, which take on Germany, Italy, Copenhagen, Seattle, Denmark, Colorado, Milan, Washington, and Chiba, among others.
CBO of AGC Biologics, Mark Womack, explains that despite the challenges of the COVID-19 pandemic, the new milestone’s achievement is a clear indicator that the company is headed for bigger things. This comes at a time when the world is fighting hard against the pandemic, which has left the health systems and the economy almost on their knees.