02 March 2022 | News
Nanjing manufacturing facility granted the drug manufacturing license for CAR-T cell therapy products
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IASO Biotherapeutics, a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, has announced that the company's commercial manufacturing facility in Nanjing successfully passed a comprehensive inspection by the Medical Products Administration of Province Jiangsu (JSMPA) and was granted a drug manufacturing license.
The cell production workshop, as a core facility area, is designed in the form of a workstation according to the cGMP requirements and NMPA/EMA/FDA regulations with the capacity of producing 3000 batches of CAR-T cell products per year. The approval of the drug manufacturing license for IASO Bio's Nanjing commercial manufacturing facility marks a solid step of transition from clinical development to commercialization.
Dr David He, Chief Technology Officer and Executive Vice President of IASO Bio said, "The approval of the drug manufacturing license is a milestone before the launch of the new drug. It is of great significance for the launch of the first chimeric antigen receptor (CAR)-T cell therapy drug developed by IASO Bio. It marks that IASO Bio has the full in-house capabilities to manufacture GMP compliant Plasmids, Lentiviral vectors, and CAR-T cell therapy products. We will take it as a new starting point to bring our first CAR-T product for the treatment of Multiple myeloma to the market, and provide patients with safe, effective, and reliable cell immunotherapy as soon as possible, and strive to bring hope to patients."