Porton Advanced 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.
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.