On August 7, 2017, RoosterBio, Inc. and Exopharm Pty Ltd announced a formal heads of agreement under which they will work together on a Stem Cell Exomere Program, aimed at bringing high-grade therapeutic extracellular vesicles/exosomes derived from adult stem cells into clinical practice. Exosomes secreted by stem cells are a new class of therapeutic product well suited to be used in regenerative medicine (“RM”) applications, but large-scale stem cell manufacturing bottlenecks impede broad clinical use of these natural bioactive nanoparticles. RoosterBio, based in Frederick, Maryland, USA, has strengths in human mesenchymal stem/stromal cells (hMSC) technology-based process and product design innovation, and develops commercially-viable biomanufacturing processes that support both upstream processing (USP) and downstream processing (DSP), offered as “acceleration services” to customers. Exopharm is a Melbourne, Australia-based biotechnology company specializing in its patent-applied-for LEAP isolation technology, Exomere manufacturing and clinical development, and commercialization of its Exomere technology. Exomeres are a pharma-grade fraction of cell-derived bilayer lipid membrane extracellular vesicles in a size range of around 40-200 nm purified using Exopharm’s LEAP ligand technology. Recent small-scale human studies have demonstrated that purified extracellular vesicles/exosomes derived from adult stem cells are safe and effective – yet there is no accepted and standardized commercial-scale manufacturing process for these submicroscopic particles. RoosterBio and Exopharm have complementary technologies, competencies, and commercial objectives – were proud to announce the establishment of their joint Stem Cell Exomere Program.
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