Cancer Treatment New Drug Developer
Nanjing, Shanghai, and San Francisco, USA, March 20222PR Newswire / -- IASO Bio, an innovative biopharmaceutical company at the clinical stage dedicated to the development and industrialization of cell therapy and antibody drugs,TodayNanjing IASO Biotherapeutics Co., Ltd. announces that its commercial production base in Nanjing has successfully passed the comprehensive inspection by the Jiangsu Provincial Medical Products Administration (JSMPA) and has been granted the "Drug Production License."
IASO Bio's Nanjing Commercial Production Base was put into operation in November 2020, located in the biopharmaceutical valley industrial zone of Jiangbei New District, Nanjing, with a total area of nearly 10,000 square meters.Square meter, with complete plasmid, lentiviral vector, and CAR-T cell production capabilities, as well as the ability to ensure quality control of the corresponding products. The cell production workshop, as a core facility area, adopts a workstation format, designed according to China's GMP standards, and also referencing EU GMP and FDA cGMP. The designed production capacity can achieve an annual output of 3000 batches of CAR-T cells. Obtaining the "Drug Production License" marks a further step forward for IASO Bio in the industrialization of cellular immunotherapy and in benefiting cancer patients.
Chief Technology Officer and Executive Vice President of IASO BioDavid HeDr. stated:
"The approval of the 'Drug Production License' is a milestone event before the new drug launch, which is of great significance for the market entry of IASO Bio's first self-developed and produced CAR-T cell therapy drug. This means that IASO Bio has established the full industrial chain capability covering plasmids, lentiviral vectors, and cell therapy products. We will take this as a new starting point to accelerate the market launch of our self-developed cellular products, providing patients with safe, effective, and quality-assured cellular immunotherapy drugs as soon as possible, striving to realize the company’s vision of bringing the hope of cure to patients."