Porton Advanced’s UC-MSCs Cell Bank for Exosome Manufacturing Receives U.S. FDA Drug Master File (DMF) Acceptance

Recently, Porton Advanced proudly announced that its Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSCs) Cell Bank for exosome manufacturing has been accepted for filing by the FDA's Center for Biologics Evaluation and Research (CBER), under Drug Master File (DMF) #32973.

This milestone further strengthens Porton Advanced's position in the rapidly evolving exosome therapeutics market. With the DMF filing, sponsors advancing exosome programs can now directly reference DMF #32973 in their own regulatory submissions, significantly accelerating U.S. FDA review pathways and reducing duplicative documentation.

End-to End Exosome Manufacturing Platform

Leveraging its GMP-compliant platform built in the cell and gene therapy field, Porton Advanced has established robust manufacturing and quality control systems to ensure high purity, high activity, and high stability of its exosome products. The platform is characterized by:

• Flexible Cell Culture Systems: supports multiple cell lines including HEK293, MSC, K562, and iPSC, enabling sponsors to select the optimal cell source for their therapeutic application.
• Scalable and Robust Processes: scalable from 2L to 50L bioreactors, enabling a seamless transition from R&D to commercial production.
• High Yield: final exosome product concentration ≥1E+11 particles/mL
• Rapid Delivery:GMP-grade exosomes available within one month, helping sponsors accelerate their path to the clinic.
• Stringent QC Testing: comprehensive testing for identity, purity, potency, and safety ensuring batch-to-batch consistency.

UC-MSCs are among the most clinically validated cell sources for exosome production, and securing regulatory acceptance of our cell bank is a critical enabler for our global partners advancing exosome-based programs toward the market.

Porton Advanced will continue to advance the application of exosome technology in drug development and broader regenerative medicine, offering global partners integrated exosome services from raw material customization to formulation development.

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) and a multitude of cleanrooms. 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.