Porton Advanced Solutions has secured a Drug Manufacturing License (Class C) from China’s National Medical Products Administration, a milestone that allows the company to undertake commercial contract manufacturing for cell and gene therapy products. The license extends Porton Advanced’s CDMO services from process development and clinical production into the commercialization stage.
The authorization follows a successful regulatory inspection of its GMP commercial production facilities and permits the company to accept commercial-scale manufacturing projects at its China GMP sites. Porton Advanced said the Class C designation is a mandatory legal requirement for contract manufacturing under China’s CDMO model and formally recognizes the company’s quality and manufacturing systems.
Porton Advanced said the license validates an integrated platform spanning plasmids, viral vectors, cell therapy, gene therapy, nucleic acid therapeutics and exosomes. The company operates more than 20,000 square meters of R&D and manufacturing space, including 10 viral vector production lines and 12 GMP cell therapy suites, two of which are commercial production lines. With the new license, those capabilities move from supporting R&D and clinical sample preparation to fully GMP-compliant commercial readiness.
The company said its quality management system is built to meet NMPA, FDA and EMA standards and has supported a 100% IND submission success rate. Porton Advanced has served more than 200 clients globally and has supported 26 global IND approvals from NMPA, FDA and Medsafe, including China’s first in vivo CAR-T therapy to receive IND clearance. It also said it currently supports a cell therapy project nearing BLA submission.
Chief Executive Officer Andrew Chen said the license is a pivotal milestone that validates Porton Advanced’s quality system and fulfills commitments to clients. He said the company will align with product launch schedules to prepare for commercial supply and continue helping innovators bring advanced therapies to patients more efficiently.
Porton Advanced said it will continue expanding its one-stop CGT CDMO services across the full product lifecycle, from process development and IND filing through clinical production and commercial manufacturing.