Porton Advanced 获得 NMPA C 类许可证，可将 CDMO 业务扩展到商业化阶段

Porton Advanced Secures Drug Manufacturing License (Class C), Expanding CDMO Services to Commercialization
CRANBURY, N.J. and SUZHOU, China, Aug. 5, 2026 /PRNewswire/ -- Recently, Porton Advanced Solutions Ltd. ("Porton Advanced") has officially been granted a Drug Manufacturing License (Class C) by the National Medical Products Administration (NMPA). This milestone qualifies Porton Advanced to undertake commercial contract manufacturing for Cell and Gene Therapy (CGT) products, extending its CDMO services from process development and clinical production through to the commercialization stage.
Under China's drug manufacturing license administration regulations, a Class C license permits a company to engage in contract manufacturing on behalf of a Marketing Authorization Holder (MAH). This license is a mandatory legal requirement for entities operating in the contract development and manufacturing organization (CDMO) model.
Following successful regulatory inspection of its GMP‑compliant commercial production facilities in China, Porton Advanced is now formally authorized to take on commercial‑scale manufacturing projects at these sites.
Porton Advanced has served more than 200 clients globally. Its quality system is built to align with NMPA, FDA and EMA requirements to ensure compliant, high‑quality project delivery, boasting a 100% success rate for IND submissions. As of now, we have successfully supported our clients to secure 26 global IND approvals from NMPA, FDA, and Medsafe, including the first in vivo CAR-T therapy to receive IND clearance in China. Additionally, Porton Advanced has accumulated extensive experience managing 12 programs in Phase I/II or commercial-stage process modification.
Porton Advanced provides CDMO services for CGT products, including plasmids, lentivirus, cell therapies, in vivo CAR-T, mRNA, and exosomes. Currently, we are supporting a cell therapy project that is nearing a BLA submission. The acquisition of the Drug Manufacturing License demonstrates that Porton Advanced now holds the essential license to offer commercial manufacturing as a CDMO partner.
About Porton Advanced
Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has dual-headquarters in Cranbury, New Jersey, and Suzhou, China, providing end-to-end CDMO solutions for ATMPs including plasmids, viral vectors, cell therapy and nucleic acid therapies. We offer services from cell banking, process, and analytical method development, cGMP production to fill & finish, covering different stages of drug development from early research, IITs, Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), to commercialization. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector production lines, 12 cell therapy production suites and a multitude of clean rooms.