Lonza agreed to provide cGMP manufacturing and technical support for commercial scale production of RION’s Purified Exosome Product (PEP) drug substance for late phase clinical supply and beyond.
RION officials say the company developed a proprietary biomanufacturing platform enabling scaled production of platelet-derived exosomes. This platform allows for the advancement of RION’s pipeline of exosome-based therapeutics across multiple indications, they add.
Lonza will manufacture PEP drug substance at its manufacturing facility in Houston. RION will leverage Lonza’s extracellular vesicle expertise and capabilities to operationalize its process at scale, notes Atta Behfar, cofounder and CEO, RION.
PEP is an exosome-based therapeutic platform candidate with immunomodulatory, anti-inflammatory, and tissue regenerative properties, formulated as a shelf-stable lyophilized powder, according to a RION spokesperson. Stabilized regenerative exosomes have been shown to promote tissue repair and can be administered through multiple routes, enabling use across a set of indications. The company is advancing clinical programs in advanced tissue regeneration, immune-mediated dermatology diseases, musculoskeletal disease, pulmonary disease, cardiovascular health, and women’s health.
“This collaboration with Lonza ensures that our proprietary exosome manufacturing platform can be scaled to meet clinical and future commercial demand,” says Behfar. “RION’s breakthrough in exosome biomanufacturing now paired with Lonza’s global infrastructure allows us to bring this biologics-based innovation to patients rapidly and reliably, while staying true to our mission of affordable access.“
“Through our collaboration with RION, we will apply our expertise to support the manufacture of PEP drug substance, aiming to help accelerate the availability of innovative treatments to patients worldwide,” adds Davide Zocco, commercial development head for exosomes and mRNA technologies.
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