MVE Biological Solutions Registers Production Plants with the FDA
The move—one that meet’s industry standards—confirms the Cryoport company’s commitment to providing quality and safety in the cold chain solutions space.
MVE Biological Solutions, who is not only a producer of high-quality cryogenic freezers and dewars, but a Cryoport company as well, has registered all three of its manufacturing facilities (located in Ball Ground, GA; New Prague, Minnesota; and Chengdu, China) with the FDA.1 All of the company’s pertinent MVE-manufactured cryogenic freezers and dewars are now listed with the organization.
In an effort to adhere to FDA standards regarding facilities, MVE has noted that it complies to various requirements, such as good manufacturing practices (GMPs), along with 21 CFR Part 820. MVE also currently holds ISO 13485 certification.
"MVE's achievement underscores our commitment to delivering the highest-quality and most reliable supply chain solutions for the life sciences industry," commented Jerrell Shelton, CEO, Cryoport. "Our MVE team's dedication to serving our clients' needs and bringing lifesaving therapies to patients is consistent with the high standards we practice in all business units companywide. This FDA registration reflects MVE's commitment to excellence by meeting the strictest of global regulatory standards."
Late last year, Cryoport—a temperature-controlled supply chain solution provider for the life sciences industry—opened its newest IntegriCell facility in Villers-le-Bouillet, Liege, Belgium.2,3 IntegriCell is the company’s branded standardized bioprocessing, cryopreservation, and distribution solution for the cell therapy market. The solution is designed to enhance cell therapy manufacturing efficiency and flexibility, while providing safety, quality and product stability for these treatments in the process.
The 13,400 square-foot plant is GMP compliant, with the ability to cryopreserve over 1,100 leukapheresis products per year, including cryopreserved leukopaks that are manufacture-ready. Being that the Belgium location is considered Cryoport Systems’ European Center of Excellence, the facility will then allocate some cryopreservation processes to other Cryoport facilities.
"Our new IntegriCell Belgium facility extends our global reach and strengthens our ability to deliver consistent, high-quality cryopreservation solutions for the cell therapy community," said Shelton. “This Center of Excellence, together with our Houston, TX facility, provides the industry with a critical resource to standardize and improve how we preserve cellular starting materials, helping bring transformative therapies to patients more efficiently. With room for future expansion, this facility is designed to adapt and expand with our clients’ and the market’s evolving needs.”
References
1. Cryoport's MVE Biological Solutions Registers All Manufacturing Facilities with the US Food and Drug Administration (FDA). Cryoport. January 6, 2025. Accessed January 6, 2025. https://ir.cryoportinc.com/news-events/press-releases/detail/384/cryoports-mve-biological-solutions-registers-all-manufacturing-facilities-with-the-u-s-food-and-drug-administration-fda
2. Saraceno N. Cryoport Opens New CoE in Europe. Pharmaceutical Commerce. November 13, 2024. Accessed January 6, 2025. https://www.pharmaceuticalcommerce.com/view/cryoport-opens-new-coe-europe
3. Cryoport Expands IntegriCell Cryopreservation Services Solution with Opening of New Center of Excellence in Europe. Cryoport. November 12, 2024. Accessed November 13, 2024. https://ir.cryoportinc.com/news-events/press-releases/detail/383/cryoport-expands-integricell-cryopreservation-services-solution-with-opening-of-new-center-of-excellence-in-europe
