All Three MVE Biological Solutions' Manufacturing Facilities Are Registered With the FDA and All Applicable MVE Products Are Now Listed
NASHVILLE, Tenn., Jan. 6, 2025 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX), a global leader in supply chain solutions for the life sciences industry, today announced that MVE Biological Solutions ("MVE"), a Cryoport company and the leading global manufacturer of high-quality cryogenic freezers and dewars, has officially registered all three of its manufacturing facilities (located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China) with the U.S. Food and Drug Administration ("FDA"). Additionally, all applicable MVE-manufactured cryogenic freezers and dewars are now listed with the FDA.
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To meet the standards of FDA-registered facilities, MVE adheres to stringent requirements, including but not limited to 21 CFR Part 820 and Good Manufacturing Practices ("GMP"). This FDA registration and product listing is in addition to MVE's existing 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," said 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."
Cryoport clients, customers and/or partners who wish to verify MVE's registration may do so through the FDA's database or by contacting the Company at customerservice.usa@mvebio.com.
About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX), is a global leader in supply chain solutions for cell & gene therapies that enable manufacturers, contract development manufacturers (CDMOs), contract research organizations (CROs), developers, and researchers to carry out their respective business with certainty. We provide a broad array of supply chain solutions for the life sciences industry. Through our platform of critical products and solutions, which include advanced temperature-controlled packaging, informatics, specialized bio-logistics services, bio-storage, bio-services, and cryogenic systems, we are "Enabling the Future of Medicine™" worldwide, through our innovative systems, compliant procedures, and agile approach to superior supply chain management.
Its corporate headquarters, located in Nashville, Tennessee, is complimented by over 50 global locations in 17 countries, with key sites in the United States, United Kingdom, France, the Netherlands, Portugal, Germany, Japan, Australia, India, and China.
MVE Biological Solutions® is the global leading manufacturer of cryogenic storage and shipping devices. For over 60 years, we set the standard for storing biological materials at low temperatures. MVE is the preferred brand for cryogenic equipment in various application areas, including biopharma, cell and gene therapies, storage of cord blood and stem cells, medical research facilities, government institutions, IVF centers, hospitals and clinics, and animal husbandry and livestock.
MVE's headquarters and manufacturing facility is located in Ball Ground, Georgia, with additional manufacturing facilities in New Prague, Minnesota, and Chengdu, China. MVE products are distributed globally in 88 countries.
Statements in this press release which are not purely historical, including statements regarding Cryoport's intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, those related to Cryoport receiving FDA registration for MVE Biological Solutions' manufacturing facilities, including the potential impact on future revenue and revenue streams. It is important to note that Cryoport's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic and geopolitical conditions, supply chain constraints, inflationary pressures, the effects of foreign currency fluctuations, trends in the products markets, variations in Cryoport's cash flow, market acceptance risks, and technical development risks. Cryoport's business could be affected by other factors discussed in Cryoport's SEC reports, including in the "Risk Factors" section of its most recently filed periodic reports on Form 10-K and Form 10-Q, as well as in its subsequent filings with the SEC. The forward-looking statements contained in this press release speak only as of the date hereof and Cryoport cautions investors not to place undue reliance on these forward-looking statements. Except as required by law, Cryoport disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
