Cryoport's MVE Biological Solutions Secures FDA Registration for All Manufacturing Facilities
Cryoport, Inc. (NASDAQ: CYRX), a leading global provider of supply chain solutions for the life sciences sector, has made significant strides in regulatory compliance. Recently, it announced that its wholly-owned subsidiary, MVE Biological Solutions, has successfully registered all three of its manufacturing facilities with the U.S. Food and Drug Administration (FDA). This pivotal action not only confirms the credibility of MVE's operations but also enhances its reputation as a supplier of high-quality cryogenic equipment.
The registered facilities are located in three strategic locations: Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China. Each of these facilities is equipped to produce essential cryogenic freezers and dewars needed for safe biological material storage. The fact that all MVE-manufactured products are now officially listed with the FDA illustrates a commitment to maintaining rigorous manufacturing standards.
Meeting FDA registration standards involves upholding stringent requirements, including compliance with 21 CFR Part 820 and Good Manufacturing Practices (GMP). MVE Biological Solutions also boasts an ISO 13485 certification, evidencing its ongoing dedication to excellence in quality management within the industry. The CEO of Cryoport, Jerrell Shelton, highlighted that this achievement mirrors their dedication to providing reliable supply chain solutions that enhance the delivery of life-saving therapies to patients.
This registration serves as a guarantee to Cryoport's clients and partners that the equipment they receive not only meets but exceeds global regulatory details. Organizations that wish to verify MVE’s registration can easily do so through the FDA's database or by reaching out directly to Cryoport.
Cryoport's breadth of services aims to support various players in the life sciences field, including manufacturers, contract development and research organizations (CDMOs and CROs), and researchers working on breakthrough therapies. With over 60 years of focused experience, MVE Biological Solutions stands at the forefront of cryogenic storage solutions, catering to several important sectors, including biopharma, medical research, and fertility treatment centers.
In addition to its regulatory victories, Cryoport's international reach further solidifies its place in the global market, with over 50 locations across 17 countries including key sites in Europe, Asia, and North America. This diverse geographical footprint allows Cryoport to leverage local expertise and regulatory understanding while maintaining the stringent quality assurance standards that buyers expect from a premium supplier.
As the life sciences industry continues to expand rapidly, Cryoport's advancements signify a pivotal moment not only for the company but also for the field it serves. As patient-centric solutions become paramount, Cryoport remains committed to advancing the standards of care and ensuring that the supply chain for critical therapies is as robust and certified as possible. The recent FDA registration of all MVE biological facilities is an exciting development that promises even greater operational readiness and client assurance moving forward.
For more information about Cryoport and MVE Biological Solutions, welcome to their websites or check out their latest updates on social media platforms such as LinkedIn and X (formerly Twitter). Their commitment to supporting healthcare through technological advances ensures they remain an essential partner in today's complicated health environment, enabling the future of medicine across the globe.
The registered facilities are located in three strategic locations: Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China. Each of these facilities is equipped to produce essential cryogenic freezers and dewars needed for safe biological material storage. The fact that all MVE-manufactured products are now officially listed with the FDA illustrates a commitment to maintaining rigorous manufacturing standards.
Meeting FDA registration standards involves upholding stringent requirements, including compliance with 21 CFR Part 820 and Good Manufacturing Practices (GMP). MVE Biological Solutions also boasts an ISO 13485 certification, evidencing its ongoing dedication to excellence in quality management within the industry. The CEO of Cryoport, Jerrell Shelton, highlighted that this achievement mirrors their dedication to providing reliable supply chain solutions that enhance the delivery of life-saving therapies to patients.
This registration serves as a guarantee to Cryoport's clients and partners that the equipment they receive not only meets but exceeds global regulatory details. Organizations that wish to verify MVE’s registration can easily do so through the FDA's database or by reaching out directly to Cryoport.
Cryoport's breadth of services aims to support various players in the life sciences field, including manufacturers, contract development and research organizations (CDMOs and CROs), and researchers working on breakthrough therapies. With over 60 years of focused experience, MVE Biological Solutions stands at the forefront of cryogenic storage solutions, catering to several important sectors, including biopharma, medical research, and fertility treatment centers.
In addition to its regulatory victories, Cryoport's international reach further solidifies its place in the global market, with over 50 locations across 17 countries including key sites in Europe, Asia, and North America. This diverse geographical footprint allows Cryoport to leverage local expertise and regulatory understanding while maintaining the stringent quality assurance standards that buyers expect from a premium supplier.
As the life sciences industry continues to expand rapidly, Cryoport's advancements signify a pivotal moment not only for the company but also for the field it serves. As patient-centric solutions become paramount, Cryoport remains committed to advancing the standards of care and ensuring that the supply chain for critical therapies is as robust and certified as possible. The recent FDA registration of all MVE biological facilities is an exciting development that promises even greater operational readiness and client assurance moving forward.
For more information about Cryoport and MVE Biological Solutions, welcome to their websites or check out their latest updates on social media platforms such as LinkedIn and X (formerly Twitter). Their commitment to supporting healthcare through technological advances ensures they remain an essential partner in today's complicated health environment, enabling the future of medicine across the globe.
Topics Health）
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