Porton Advanced has announced that its Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSCs) Cell Bank intended for exosome manufacturing received acceptance for filing from the U.S. FDA's Center for Biologics Evaluation and Research (CBER). The filing is under Drug Master File (DMF) number 32973.

This achievement bolsters Porton Advanced's standing in the growing field of exosome-based therapeutics. By filing the DMF, companies developing exosome therapies can cite DMF #32973 in their regulatory filings, which helps speed up FDA reviews and minimizes repeated paperwork.

Comprehensive Exosome Manufacturing Platform

Building on its GMP-compliant infrastructure in cell and gene therapy, Porton Advanced has developed strong manufacturing and quality control processes to deliver exosomes with superior purity, activity, and stability. Key features of the platform include:

Adaptable Cell Culture Systems: accommodates various cell lines such as HEK293, MSC, K562, and iPSC, allowing selection of the best source for specific therapies.
Scalable Production Processes: capable of scaling from 2L to 50L bioreactors for smooth progression from research to commercial scale.
High Yield Output: achieves exosome concentrations of at least 1E+11 particles per mL.
Fast Turnaround: provides GMP-grade exosomes in as little as one month to expedite clinical advancement.
Rigorous Quality Control: extensive tests for identity, purity, potency, and safety to maintain consistency across batches.

Porton Advanced aims to further integrate exosome technology into drug development and regenerative medicine, supplying global collaborators with complete services ranging from material customization to formulation.

About Porton Advanced

Porton Advanced Solutions operates as a subsidiary of Porton Pharma Solutions, a prominent CDMO. With headquarters in Cranbury, New Jersey, and Suzhou, China, it delivers full-spectrum CDMO services for advanced therapy medicinal products (ATMPs) such as plasmids, viral vectors, cell therapies, and nucleic acid treatments. Services encompass cell banking, process and analytical development, cGMP manufacturing, and fill-finish operations, supporting all phases from early research through commercialization. The facilities cover 215,000 sq ft with 10 viral vector lines, 12 cell therapy suites, and multiple clean rooms, all GMP compliant.