BioInformant

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Porton Advanced’s UC-MSCs Cell Bank for Exosome Manufacturing Receives U.S. FDA Drug Master File (DMF) Acceptance

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CRANBURY, N.J. and SUZHOU, China, July 8, 2026 — 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. [Read more…]

A Complete List of All Publicly Announced RMAT Designations (164)

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To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?

The answer is that 164 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 388 requests and issued 193, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately half of RMAT applications get approved (193 approvals / 388 applications = 49.7%).

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Exosomes: Company Spotlights from “A” to “Z”

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Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells. In recent years, exosomes have gained attention as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering the cells to patients.

With at least 26,805 scientific articles published about exosomes and 301 clinical trials underway, these small vesicles have intriguing potential to be used within a range of therapeutic applications. The term “exosomes” has become an increasingly common Search Term on Google over the past 10 years, as shown in the graph below: [Read more…]

RoosterBio and Applied StemCell Partner to Advance Scalable iPSC-Based Bioprocess Solutions

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Partnership pairs Applied StemCell’s induced pluripotent stem cell technology with RoosterBio’s engineered media, reagents, and scalable bioprocess systems to accelerate development and manufacturing of advanced therapies

MILPITAS, Calif. and FREDERICK, Md., July 8, 2026 — Applied StemCell, Inc., a biotechnology company with deep expertise and intellectual property in induced pluripotent stem cell (iPSC) technology, and RoosterBio, Inc., a leading supplier of cellular starting materials, bioprocess media, and advanced therapy manufacturing solutions, today announced a strategic partnership to develop and commercialize scalable iPSC-based bioprocess solutions. The collaboration combines Applied StemCell’s GMP-compatible iPSC technology with RoosterBio’s engineered media systems and scalable manufacturing expertise to provide advanced therapy developers with a unique bioprocess solution supporting research through clinical manufacturing. [Read more…]

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