Cryoport's MVE Biological Solutions Registers All Manufacturing Facilities with the U.S. Food and Drug Administration ("FDA")
CryoportCryoport(US:CYRX) Prnewswire·2025-01-06 13:30

Core Insights - Cryoport, Inc. announced that MVE Biological Solutions has registered all three of its manufacturing facilities with the FDA, enhancing its compliance and credibility in the life sciences sector [1][2][3] Company Overview - Cryoport, Inc. is a global leader in supply chain solutions for cell and gene therapies, providing a wide range of services including temperature-controlled packaging and bio-logistics [4] - MVE Biological Solutions is recognized as the leading manufacturer of cryogenic storage and shipping devices, with over 60 years of experience in the industry [6] Regulatory Compliance - MVE adheres to stringent FDA requirements, including 21 CFR Part 820 and Good Manufacturing Practices (GMP), in addition to holding an ISO 13485 certification [2][3] - The FDA registration and product listing signify MVE's commitment to meeting high global regulatory standards [2][3] Manufacturing Facilities - MVE's manufacturing facilities are located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China, with products distributed globally in 88 countries [1][7] Commitment to Quality - The CEO of Cryoport emphasized the company's dedication to delivering high-quality supply chain solutions and bringing lifesaving therapies to patients [3]

Cryoport's MVE Biological Solutions Registers All Manufacturing Facilities with the U.S. Food and Drug Administration ("FDA") - Reportify