CRANBURY, New Jersey / SUZHOU, China | July 9, 2026
Porton Advanced, a leading Advanced Therapy Medicinal Products (ATMP) Contract Development and Manufacturing Organization (CDMO), 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 (FDA) Center for Biologics Evaluation and Research (CBER) under Drug Master File (DMF) #32973. The milestone represents a significant advancement for the rapidly expanding exosome therapeutics sector, enabling biotechnology and pharmaceutical sponsors to directly reference the approved DMF in future regulatory submissions, streamlining U.S. regulatory pathways while reducing redundant documentation. The FDA acceptance further strengthens Porton Advanced’s global leadership in cell and gene therapy manufacturing, reinforcing its commitment to accelerating the development of next-generation regenerative medicines through high-quality, GMP-compliant manufacturing platforms.
FDA DMF Acceptance Accelerates Exosome Drug Development
The acceptance of Drug Master File (DMF) #32973 provides an important regulatory resource for developers of exosome-based therapeutics, allowing sponsors to leverage Porton Advanced’s validated UC-MSC Cell Bank throughout their own Investigational New Drug (IND) and future biologics submissions. Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) are widely recognized as one of the most clinically validated sources for therapeutic exosome production due to their excellent safety profile, regenerative potential, and scalability.
By establishing an FDA-recognized master file, Porton Advanced significantly simplifies regulatory documentation for partners while accelerating review timelines for innovative exosome therapies targeting oncology, inflammatory diseases, regenerative medicine, neurological disorders, and other complex conditions. The achievement demonstrates the company’s robust quality systems and regulatory expertise while reinforcing confidence among global biotechnology innovators seeking reliable manufacturing partners for advanced biologics.
Integrated GMP Manufacturing Platform Supports Commercial Scale Production
Advertisement
Built upon extensive expertise in cell and gene therapy manufacturing, Porton Advanced has developed a comprehensive end-to-end GMP-compliant exosome manufacturing platform capable of supporting every stage of product development from research through commercialization. The platform supports multiple therapeutic cell sources, including HEK293, Mesenchymal Stem Cells (MSC), K562, and induced Pluripotent Stem Cells (iPSC), allowing developers to select the optimal manufacturing strategy for their therapeutic programs.
Its highly scalable manufacturing process enables seamless transition from laboratory development using 2-liter bioreactors to commercial-scale production in 50-liter bioreactors, while maintaining exceptional product quality and manufacturing consistency. The platform is capable of producing high-concentration exosome products exceeding 1×10¹¹ particles per milliliter, with GMP-grade exosomes available within one month, helping sponsors significantly shorten development timelines. Comprehensive quality control testing covering identity, purity, potency, stability, sterility, and safety ensures consistent batch-to-batch performance while meeting stringent international regulatory expectations for advanced biologic products.
Strengthening Global Leadership in Cell and Gene Therapy CDMO Services
The latest FDA milestone further enhances Porton Advanced’s growing position as a global CDMO specializing in advanced therapies, including cell therapy, viral vectors, plasmids, bacterial vectors, nucleic acid therapeutics, and exosome technologies. Operating from headquarters in Cranbury, New Jersey, alongside two large-scale GMP manufacturing facilities in Suzhou, China, the company provides comprehensive development services spanning cell banking, analytical development, process optimization, cGMP manufacturing, fill-and-finish operations, clinical trial support, IND applications, New Drug Applications (NDA), and commercial manufacturing. Its 215,000-square-foot manufacturing network includes 10 GMP viral vector production lines, 12 GMP cell therapy manufacturing suites, and advanced cleanroom infrastructure supporting global clinical and commercial programs.
To date, Porton Advanced has supported clients in securing 26 global IND approvals from the FDA, China’s NMPA, and Medsafe, while actively supporting multiple ongoing Phase I and Phase II ATMP clinical programs. The FDA acceptance of the company’s UC-MSC Cell Bank Drug Master File represents another important step toward accelerating the commercialization of innovative exosome-based therapies, enabling global partners to deliver transformative regenerative medicines to patients more efficiently while advancing the future of cell therapy, biologics manufacturing, regenerative medicine, and precision healthcare.
Source: Porton Advanced press release
