RION, a commercial and clinical-stage regenerative medicine company pioneering platelet-derived exosomes for both human and animal health applications, has announced a collaboration with Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), to provide cGMP manufacturing and technical support for commercial scale production of its Purified Exosome Product^™ (PEP^™) drug substance for late phase clinical supply and beyond.

RION 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. Under the terms of the agreement, Lonza will manufacture PEP^™ drug substance at its manufacturing facility in Houston (US). RION will leverage Lonza’s world-leading, state-of-the-art extracellular vesicles expertise and capabilities to operationalize its process at scale.

PEP^™ is an exosome-based therapeutic platform candidate with immunomodulatory, anti-inflammatory and tissue regenerative properties, formulated as a shelf-stable lyophilized powder. Stabilized regenerative exosomes promote tissue repair and can be administered through multiple routes, enabling use across a broad set of indications. RION is advancing clinical programs in advanced tissue regeneration, immune-mediated dermatology diseases, musculoskeletal disease, pulmonary disease, cardiovascular health and women’s health.

Atta Behfar, Cofounder and CEO, RION, said: “This collaboration with Lonza ensures that our proprietary exosome manufacturing platform can be scaled to meet clinical and future commercial demand. 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.”

Davide Zocco, Commercial Development Head for Exosomes and mRNA Technologies, Specialized Modalities, Lonza, added: “We are pleased to support RION’s groundbreaking work in exosome-based therapies. Through our world-leading capabilities in exosome development, characterization, and manufacturing, we enable our customers to progress their innovative therapies efficiently and reliably. 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.”