- Porton Advanced announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) Cell Bank Drug Master File (DMF #32973) for exosome manufacturing.
- The company said the filing enables sponsors to reference the DMF in regulatory submissions and complements its end-to-end exosome development and CDMO manufacturing platform.
Porton Advanced has announced that its Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) Cell Bank for exosome manufacturing has been accepted for filing by the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) under Drug Master File (DMF) #32973. According to the company, sponsors developing exosome-based therapies can reference the DMF in their own regulatory submissions, with the aim of reducing duplicate documentation and supporting the FDA review process.
The company said the filing strengthens its end-to-end exosome manufacturing platform, which supports contract manufacturing services from process development through commercial production. The platform includes flexible cell culture systems compatible with HEK293, mesenchymal stem cell (MSC), K562, and induced pluripotent stem cell (iPSC) lines, as well as scalable manufacturing processes ranging from 2-liter to 50-liter bioreactors.
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.
According to Porton Advanced, its platform is designed to deliver GMP-grade exosomes within one month and includes quality control testing covering identity, purity, potency, and safety to support batch-to-batch consistency. The company also stated that its manufacturing process can produce exosome concentrations of at least 1E+11 particles per milliliter.
Porton Advanced said it will continue expanding the application of exosome technology in drug development and regenerative medicine by providing integrated services ranging from raw material customization to formulation development for global partners.
