Porton Advanced has achieved a major regulatory milestone. 

This, after the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) accepted its Drug Master File (DMF) for an Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) Cell Bank designed for exosome manufacturing.

The acceptance of DMF #32973 strengthens Porton Advanced’s position in the fast-growing exosome therapeutics sector and provides drug developers with a critical regulatory resource. 

Sponsors developing exosome-based therapies can reference the DMF in their own FDA submissions, helping streamline review processes and reduce repetitive documentation requirements.

The newly accepted DMF supports Porton Advanced’s broader end-to-end exosome manufacturing platform, built on its GMP-compliant cell and gene therapy manufacturing expertise.

The company’s platform is designed to support a wide range of therapeutic programs through flexible cell culture systems, scalable manufacturing processes, and comprehensive quality controls.

Porton Advanced said it will continue advancing exosome technology applications in drug development and regenerative medicine, providing global partners with integrated services spanning raw material customization, manufacturing, and formulation development.