The regulatory approval follows a successful inspection of the company’s GMP-compliant facilities in China. By obtaining this license, Porton Advanced can now manage large-scale production projects, bridging the gap between initial process development and the final commercialization of advanced therapies. This expansion complements the company’s existing service portfolio, which spans plasmids, lentivirus, mRNA, and various cell therapy platforms.
In section Releases
Porton Advanced Gains Class C License for Commercial Drug Manufacturing
Porton Advanced Solutions has secured a Class C Drug Manufacturing License from China’s National Medical Products Administration, allowing the firm to transition from clinical-stage production to full commercial contract manufacturing for cell and gene therapy developers operating under the Marketing Authorization Holder model.
With dual headquarters in Cranbury, New Jersey, and Suzhou, China, the company has established a track record of supporting over 200 global clients. Its quality systems are built to meet the standards of the NMPA, FDA, and EMA. To date, the organization has facilitated 26 global IND approvals, including the first in vivo CAR-T therapy to clear regulatory hurdles in China. The firm currently manages 12 programs in late-stage development and is supporting a cell therapy project nearing a Biologics License Application submission.
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