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AGC Biologics Completes PPQ Manufacturing Campaign with Provention Bio for Type 1 Diabetes Product Candidate, Teplizumab

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(SEATTLE), August 25, 2020 -- 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. (Nasdaq: PRVB), 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.

AGC Biologics Enters into Partnership as a CDMO with Ono Pharmaceuticals to Manufacture Biopharmaceuticals at Clinical Development Stage

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(SEATTLE), August 13, 2020 – AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced it is partnering with Ono Pharmaceutical Co., Ltd. (ONO) to manufacture new, innovative biopharmaceuticals at the clinical development stage. ONO is a R&D-oriented pharmaceutical company committed to discovering and developing innovative drugs.

AGC Biologics Expands Partnership with Novavax

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Manufacturing of Novavax’ Matrix-M™ Adjuvant for Novel COVID-19 Vaccine Expands to Seattle

(SEATTLE), August 10, 2020 -- AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced it has expanded its partnership with Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases. AGC Biologics is currently preparing to manufacture Matrix-M™, the adjuvant component of Novavax’ coronavirus vaccine, NVX-CoV2373, from its facility in Copenhagen. AGC Biologics will now expand supply of Matrix-M adjuvant for the vaccine from its facility in Seattle to ensure supply for the United States.

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