CRANBURY, N.J. and SUZHOU, China, July 8, 2026 /PRNewswire/ -- 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 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 clients accelerate their path to the clinic.
- Stringent QC Testing: comprehensive testing for identity, purity, potency, and safety ensuring batch-to-batch consistency.
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 dual-headquarters in Cranbury, New Jersey, and Suzhou, China, providing end-to-end CDMO solutions for ATMPs including plasmids, viral vectors, cell therapy and nucleic acid therapies. 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, IITs, Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), to commercialization. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector production lines, 12 cell therapy production suites and a multitude of clean rooms.
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