PARIS, FRANCE, December 18, 2024 – AGS Therapeutics, a preclinical-stage biotech company pioneering Microalgae Extracellular Vesicles (MEV) as a novel, universal delivery system, announced today the appointment of Dr. Kristin Luther as an Operating Partner for Chemistry, Manufacturing, and Controls (CMC) and Analytics.
MEV manufacturing is inherently sustainable, leveraging light, fresh water, and minerals to create a process that is environmentally, and literally, green. The approach eliminates the need for toxic organic solvents or mammalian-derived materials, ensuring a simple, safe, and cost-effective process. Strikingly, MEVs are a common, general-purpose envelope that can be used with diverse payloads, formulations, and routes of administration (RoA). Thus, MEVs can be produced in bulk, quality-controlled, released, and stored for off-the-shelf use, with loading achievable at later stages.
Dr. Kristin Luther brings a wealth of first-hand experience, extensive expertise, and a proven track record in the field of extracellular vesicles. With over eight years of focused experience in biopharmaceutical CMC development, she offers in-depth knowledge of downstream processes, analytics, regulatory filings, and tech transfer to CDMOs for extracellular vesicle-based therapeutics. Dr. Luther has held key roles at leading companies, including Vesigen Therapeutics (USA), Nanoview Biosciences (USA), and Capricor Therapeutics (USA). Her contributions have played a critical role in the successful filing of Investigational New Drug (IND) applications with the FDA for extracellular vesicle-based product candidates. To know more
