- Porton Advanced has received a Class C Drug Manufacturing License from China’s National Medical Products Administration (NMPA), enabling commercial contract manufacturing of cell and gene therapy products.
- The license extends the company’s CDMO services from process development and clinical production to commercial manufacturing.
Porton Advanced Solutions Ltd. has been granted a Class C Drug Manufacturing License by China’s National Medical Products Administration (NMPA), enabling the company to provide commercial contract manufacturing services for cell and gene therapy (CGT) products. The approval extends the company’s contract development and manufacturing organization (CDMO) capabilities beyond process development and clinical manufacturing to include commercial production.
According to the company, the Class C license permits contract manufacturing on behalf of a Marketing Authorization Holder (MAH) under China’s drug manufacturing regulations. The approval follows a successful regulatory inspection of Porton Advanced’s GMP-compliant commercial manufacturing facilities in China, authorizing the company to undertake commercial-scale manufacturing projects at these sites.
Porton Advanced said it has served more than 200 clients globally and maintains a quality system aligned with NMPA, FDA, and EMA requirements. The company reported a 100% success rate for IND submissions and stated that it has supported 26 global IND approvals from the NMPA, FDA, and Medsafe, including the first in vivo CAR-T therapy to receive IND clearance in China. It has also managed 12 Phase I/II or commercial-stage process modification programs.
The company provides CDMO and contract manufacturing services for CGT products including plasmids, lentivirus, cell therapies, in vivo CAR-T, mRNA, and exosomes. “The acquisition of the Drug Manufacturing License demonstrates that Porton Advanced now holds the essential license to offer commercial manufacturing as a CDMO partner,” the company said, adding that it is currently supporting a cell therapy project approaching a biologics license application (BLA) submission.
