prnasiaMarch 04, 2021
Tag: CMAB , FDA , Innovent , COVID-19
CMAB Biopharma (Suzhou) Inc. congratulates its partner Innovent Biologics, Inc. on the U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for its antibody candidate which targets the COVID-19 virus, an independently-developed project by Innovent. Utilizing its state of the art facility and robust quality systems, CMAB provided integrated CDMO services for this program from cell bank construction to cGMP production of drug substance at the 2,000 L upstream scale.
"It has been our great pleasure to have this opportunity to collaborate with a preeminent organization like Innovent on such a critical product, and be able to contribute to its projects meanwhile", said Dr. Yongzhong Wang, CEO of CMAB, "Throughout the project, the two organizations worked collaboratively together to successfully complete the CMC activities efficiently, rapidly and according to international regulatory standards. Both organizations are very proud of this accomplishment and CMAB looks forward to continuing provide high-quality and fast CDMO services to Innovent and other biopharmaceutical companies in the future."
About CMAB Biopharma (Suzhou), Inc.
CMAB is a flexible full-service CDMO dedicated to providing bespoke development manufacturing services of antibodies and biologics for clients in China and across the globe. CMAB complies with global quality standards, we get European commission EudraLex (EMA) Vol 4. GMP guidelines which is a successful external QP Audit by Parexel.
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