Porton Advanced, a Cranbury, New Jersey-based contract development and manufacturing organization (CDMO) specializing in cell and gene therapies (CGTs), has received a Class C Drug Manufacturing License from China’s National Medical Products Administration (NMPA), allowing the company to provide commercial contract manufacturing services for approved therapies.

The license authorizes Porton Advanced to manufacture commercial-scale products on behalf of marketing authorization holders, extending the company’s CDMO services from process development and clinical manufacturing through commercial production. According to the announcement, the approval follows a successful regulatory inspection of its two GMP sites in Suzhou, China.

Porton Advanced said the license enables its China manufacturing sites to accept commercial projects across its CGT platform, which includes plasmid DNA, viral vectors, cell therapies, gene therapies, nucleic acid therapeutics, and exosome manufacturing. The company operates more than 20,000 square meters of research and manufacturing space, including 10 viral vector production lines and 12 GMP cell therapy suites, two of which are dedicated to commercial production.

According to the CDMO, its quality management system is designed to meet NMPA, U.S. Food and Drug Administration (FDA), and European Medicines Agency standards. Porton Advanced said it has supported more than 200 customers globally, including 26 investigational new drug (IND) approvals from the NMPA, FDA, and Medsafe, and is currently supporting a cell therapy program approaching biologics license application (BLA) submission.