Porton Advanced Expands CDMO Services to Commercialization with China Manufacturing License

Editor’s Take: Extending CDMO services to a “one-stop shop” approach can streamline regulatory and clinical steps, not to mention commercial.

Porton Advanced Solutions is officially granted a Drug Manufacturing License (Class C) by China’s National Medical Products Administration (NMPA). Headquartered in Cranbury, NJ, Porton Advanced has two good manufacturing practice (GMP) sites in Suzhou, China. These sites provide end-to-end CDMO solutions for advanced therapy medicinal products.

CDMO Services in China

What the license means is, Porton Advanced can now undertake commercial contract manufacturing for cell and gene therapy (CGT) products. This extends the company’s CDMO services from process development and clinical production on to the commercialization stage.

“Obtaining the Class C Drug Manufacturing License is a pivotal milestone for Porton Advanced,” CEO Andrew Chen said. “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.”

On this last point, Chen added Porton Advanced can safely and efficiently bring more advanced therapies to patients. Not only that, but the company can accelerate the public’s access to these therapies.

Deeper Look at Porton Advanced

Porton Advanced’s CDMO and CRO platforms cover plasmids, viral vectors, CGT, nucleic acid therapeutics, and exosome. The company operates over 20,000 square meters of R&D and manufacturing space. Contained therein, 10 viral vector production lines and 12 GMP cell therapy suites. Their quality management system is built to satisfy NMPA, U.S. FDA, and European Medicines Agency standards.

The rapid growth of Porton Advanced now sees the company serving more than 200 clients globally. Following the NMPA clearance, the company plans to deepen its focus on CGT CDMO services. This means a comprehensive, one-stop shop for process development, Investigational New Drug filing, clinical production, and commercial manufacturing.