OBiO Technology (Shanghai) Corp., Ltd. ('OBiO', 688238.SH), a gene and cell therapy-focused contract research organization (CRO) and contract development and manufacturing organization (CDMO), recently announced that the United States Food and Drug Administration (FDA) has accepted its GMP plasmid DNA drug master file (DMF), DMF Number 037766. The DMF acceptance enables a direct reference for investigational new drug (IND) filing for lentiviral vectors, autologous cell therapy, allogeneic cell therapy and stem cell therapy products, and helps shorten the communication, review and evaluation time to accelerate the filing of related products.

DMF is a submission to the FDA by the holder that contains confidential information about the facilities, processes or articles used in the manufacturing, handling, packaging and storage. DMF policy facilitates an optimized solution for pharmaceutical companies, drug manufacturers and regulatory agencies. Drug manufacturers are permitted to submit the DMF information to the FDA without having to disclose the technical secrets. In addition, drug developers could be authorized to reference all or part of the content of a DMF in support of its IND application, thus saving time and communication costs for the application filing process.

In 2022, OBiO successfully supported its clients to obtain 12 IND clearances, including 3 FDA IND approvals, and 13 IND filing acceptances in total. With years of successful IND-supporting experience in China and the United States for various gene and cell therapy products, OBiO leverages valuable know-how in IND-enabling chemistry, manufacturing and control (CMC) services to offer its clients a faster and more reliable access to manufacturing and regulatory filing, thereby advancing gene therapy, cell therapy and oncolytic virotherapy products from bench to clinic and bringing benefit to more patient populations.

"The acceptance of DMF filing for our GMP plasmid relies on the experienced technical team and established quality system of OBiO, and it will further enable us to provide clients with holistic CDMO solutions from DNA to IND," said Dr. Qingrui You, Vice General Manager of OBiO. "OBiO has been supporting its clients in IND applications for the adeno-associated virus, CAR-T therapy, stem cells, and oncolytic virus with high quality, all-inclusive CMC services from bank construction to GMP production. We are filing DMFs with the FDA for other products, and will continue to invest in a pipeline of innovations from manufacturing technology to process development and quality control."

In 2020, OBiO has built the OBiO Intelli-M site, a 77,000 m² GMP production base with global service capability in the Lin-gang Special Area of China (Shanghai) Pilot Free Trade Zone, which will be put into trial operation in Q1 of 2023. In this zone, OBiO will empower the development of global gene and cell therapy through the construction of a world-class facility of 15 vector production lines covering capacities from 50 to 2,000L, 11 cell therapy production lines, and 3 cell therapy production lines for pathogen carriers.