Cryoport’s MVE Biological Solutions Achieves FDA Registration Across Three Sites

• Cryoport’s subsidiary MVE Biological Solutions has registered its three global manufacturing facilities with the FDA.

• All applicable MVE-manufactured cryogenic freezers and dewars are now FDA-listed, complementing the company’s ISO 13485 certification.

Cryoport, Inc., a global provider of supply chain solutions for the life sciences industry, has announced FDA registration of its subsidiary, MVE Biological Solutions, across three manufacturing facilities. The registered sites are located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China.

The registration ensures compliance with stringent regulatory standards, including 21 CFR Part 820 and Good Manufacturing Practices (GMP). In addition, all applicable MVE-manufactured cryogenic freezers and dewars are now FDA-listed. This development adds to the company’s existing ISO 13485 certification, further enhancing its quality assurance credentials.

“MVE’s achievement underscores our commitment to delivering the highest-quality and most reliable supply chain solutions for the life sciences industry,” said Jerrell Shelton, CEO of Cryoport.

MVE is a leading manufacturer of cryogenic freezers and dewars used in supply chain solutions critical for life sciences, including the storage and transportation of biological materials. This FDA registration is part of Cryoport’s strategy to ensure regulatory compliance while supporting its clients in delivering lifesaving therapies.

The company highlighted its dedication to meeting global regulatory standards, a commitment reflected across its business units.