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.

The license authorizes Porton Advanced to formally accept commercial-scale manufacturing projects at its China GMP facilities, following the successful regulatory inspection of its GMP commercial production facilities.

Milestone: Official Recognition of Manufacturing and Quality Systems

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.

Porton Advanced has established comprehensive CRO and CDMO platforms covering plasmids, viral vectors, cell therapy, gene therapy, nucleic acid therapeutics, and exosome. With over 20,000 m² of R&D and manufacturing facilities, the company operates 10 viral vector production lines and 12 GMP cell therapy suites (including 2 commercial production lines). The attainment of the Class C license transitions these advanced capabilities from "supporting R&D and clinical sample preparation" to a fully "GMP-compliant, commercial-ready" status.

The company's quality management system, built to meet NMPA, FDA, and EMA standards, ensures compliant and high-quality project execution, with 100% IND submission success.

End-to-End CDMO Services: Coverage Across the CGT Product Lifecycle

Committed to the mission of "Enabling Earlier Access to Good Medicines," the attainment of the Class C license validates Porton Advanced's quality systems and manufacturing expertise, confirming the effectiveness of its integrated, end-to-end CDMO platform.

Porton Advanced provides CDMO services for a broad spectrum of CGT products, including plasmids, lentivirus, cell therapies (CAR-T, TCR-T, UCAR-T, NK, CAR-NK, MSC, TIL, iPSC, etc.), in vivo CAR-T, mRNA, and exosomes. This supports clients across the entire CGT product lifecycle, from IND filing and clinical research through to commercialization, effectively reducing the costs and risks associated with technology transfer and scale-up.

Client Portfolio and Pipeline: Advancing Clinical and Commercial Programs

Porton Advanced has grown rapidly, serving over 200 clients globally. 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.

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.

Industry Impact: Improving Patient Accessibility of CGT Product

Commercial-scale manufacturing is a critical factor in ensuring the reliable supply of CGT drugs from the lab to the clinic. By establishing a compliant, stable commercial supply framework, Porton Advanced aims to mitigate pricing pressures often associated with capacity limitations or high production costs, thereby improving patient access to advanced therapies.

Andrew Chen, CEO of Porton Advanced, commented, "Obtaining the Class C Drug Manufacturing License is a pivotal milestone for Porton Advanced. It is not only a validation of our quality system but a fulfillment of our commitments to our clients. We will align with our clients' product launch schedules to prepare for commercial supply. Moving forward, we will continue to uphold our customer-centric values, leveraging our operational and delivery excellence to partner with innovators in safely and efficiently bringing more advanced therapies to patients, and accelerating their access to the public."

Going forward, Porton Advanced will continue to deepen its focus on the gene and cell therapy CDMO services, offering a comprehensive, one-stop CDMO solution covering process development, IND filing, clinical production and commercial manufacturing. The goal remains to accelerate the clinical translation of CGT drugs and extend their benefits to patients worldwide.

About Porton Advanced

Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, providing end-to-end CDMO solutions for ATMPs. 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, Investigator-initiated Clinical Trial Services (IITs), and Investigational New Drug (IND) applications to clinical trials, New Drug Applications (NDA), and commercialization.

Porton Advanced has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors (lentiviral vector, adenoviral vector, AAV, etc.), cell therapy CMC services including CAR-T, TCR-T, CAR-NK, HSC, exosome, etc., bacterial vector and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector GMP-compliant production lines, 12 cell therapy GMP-compliant production suites (2 for commercial products). As of now, we have successfully supported our clients to secure 26 global IND approvals from NMPA, FDA, and Medsafe, with 12 ongoing Phase I/II ATMP projects. Additionally, Porton Advanced has supported the successful transition of several overseas clinical-stage pipelines into China.

Porton Advanced is committed to a customer-centric approach, offering excellent global, end-to-end CDMO services to our clients, enabling earlier access to good medicines.

SOURCE Porton Advanced