Cryoport's MVE Biological Solutions Registers All Manufacturing Facilities with the U.S. Food and Drug Administration ("FDA")
Cryoport (NASDAQ: CYRX) announced that its subsidiary MVE Biological Solutions has successfully registered all three manufacturing facilities with the FDA. The facilities are located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China. Additionally, all applicable MVE-manufactured cryogenic freezers and dewars are now FDA-listed.
The registration requires adherence to stringent requirements, including 21 CFR Part 820 and Good Manufacturing Practices (GMP). This FDA registration and product listing complements MVE's existing ISO 13485 certification. MVE is a leading global manufacturer of high-quality cryogenic freezers and dewars.
Cryoport (NASDAQ: CYRX) ha annunciato che la sua controllata MVE Biological Solutions ha registrato con successo tutti e tre gli stabilimenti di produzione presso la FDA. Gli stabilimenti si trovano a Ball Ground, Georgia; New Prague, Minnesota; e Chengdu, Cina. Inoltre, tutti i freezers e dewars criogenici prodotti da MVE sono ora elencati dalla FDA.
La registrazione richiede il rispetto di requisiti rigorosi, tra cui il 21 CFR Parte 820 e le Buone Pratiche di Fabbricazione (GMP). Questa registrazione FDA e l'elenco dei prodotti completano la già esistente certificazione ISO 13485 di MVE. MVE è un produttore globale leader di freezers e dewars criogenici di alta qualità.
Cryoport (NASDAQ: CYRX) anunció que su subsidiaria MVE Biological Solutions ha registrado exitosamente sus tres instalaciones de fabricación ante la FDA. Las instalaciones están ubicadas en Ball Ground, Georgia; New Prague, Minnesota; y Chengdu, China. Además, todos los congeladores y dewars criogénicos fabricados por MVE ahora están listados en la FDA.
El registro requiere el cumplimiento de estrictos requisitos, incluyendo el 21 CFR Parte 820 y las Buenas Prácticas de Fabricación (GMP). Este registro de la FDA y el listado de productos complementan la actual certificación ISO 13485 de MVE. MVE es un fabricante global líder de congeladores y dewars criogénicos de alta calidad.
크라이오포트(Cryoport) (NASDAQ: CYRX)는 자회사인 MVE 바이오로지컬 솔루션즈가 FDA에 세 개의 제조 시설을 성공적으로 등록했다고 발표했습니다. 이 시설들은 조지아주 볼 그라운드, 미네소타주 뉴 프라하, 그리고 중국 청두에 위치하고 있습니다. 또한, MVE에서 제조한 모든 관련 냉동기와 듀어도 이제 FDA에 등재되었습니다.
등록 과정은 21 CFR 820과 우수 제조 기준(GMP)을 포함한 엄격한 요구 사항을 준수해야 합니다. 이 FDA 등록 및 제품 목록은 MVE의 기존 ISO 13485 인증을 보완합니다. MVE는 고품질의 냉동기와 듀어의 글로벌 선도 제조업체입니다.
Cryoport (NASDAQ: CYRX) a annoncé que sa filiale MVE Biological Solutions a réussi à enregistrer ses trois installations de fabrication auprès de la FDA. Les installations sont situées à Ball Ground, Georgie; New Prague, Minnesota; et Chengdu, Chine. De plus, tous les congélateurs et dewars cryogéniques fabriqués par MVE sont maintenant répertoriés par la FDA.
Cette inscription exige le respect de normes strictes, y compris le 21 CFR Partie 820 et les Bonnes Pratiques de Fabrication (BPF). Cet enregistrement FDA et la liste des produits complètent la certification ISO 13485 existante de MVE. MVE est un fabricant mondial de premier plan de congélateurs et dewars cryogéniques de haute qualité.
Cryoport (NASDAQ: CYRX) gab bekannt, dass seine Tochtergesellschaft MVE Biological Solutions erfolgreich alle drei Produktionsanlagen bei der FDA registriert hat. Die Anlagen befinden sich in Ball Ground, Georgia; New Prague, Minnesota; und Chengdu, China. Darüber hinaus sind alle relevanten von MVE hergestellten kryogenen Gefriergeräten und Dewars jetzt bei der FDA gelistet.
Die Registrierung erfordert die Einhaltung strenger Vorgaben, einschließlich 21 CFR Teil 820 und gute Herstellungsverfahren (GMP). Diese FDA-Registrierung und Produktauflistung ergänzt die bestehende ISO 13485-Zertifizierung von MVE. MVE ist ein führender globaler Hersteller von hochwertigen kryogenen Gefriergeräten und Dewars.
- All three manufacturing facilities received FDA registration
- All applicable MVE products are now FDA-listed
- Facilities comply with stringent FDA requirements (21 CFR Part 820 and GMP)
- Company maintains ISO 13485 certification
- None.
Insights
The FDA registration of MVE Biological Solutions' manufacturing facilities represents a strategic regulatory milestone for Cryoport. This development strengthens MVE's market position in the highly regulated medical device and life sciences sector. Compliance with 21 CFR Part 820 and GMP requirements demonstrates robust quality management systems and manufacturing controls. The tri-continental facility registration (U.S. and China) positions MVE to better serve global markets while maintaining consistent quality standards. Combined with the existing ISO 13485 certification, this creates a comprehensive regulatory framework that enhances product reliability and market access. For life sciences companies seeking cryogenic storage solutions, this regulatory achievement provides additional quality assurance and compliance confidence.
The FDA registration significantly enhances Cryoport's competitive advantage in the life sciences cold chain market. With all three manufacturing facilities now FDA-registered, MVE can offer seamless, compliant solutions across major global markets. This regulatory milestone particularly strengthens MVE's position in serving pharmaceutical and biotech companies developing cell and gene therapies, where regulatory compliance is crucial. The strategic placement of facilities in Georgia, Minnesota and Chengdu creates a robust global manufacturing network that can better manage supply chain risks and meet regional demand variations. This regulatory achievement could potentially lead to increased market share in the regulated medical device segment and stronger partnerships with major pharmaceutical companies.
All Three MVE Biological Solutions' Manufacturing Facilities Are Registered With the FDA and All Applicable MVE Products Are Now Listed
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
For more information, http://www.cryoportinc.com or follow via LinkedIn at https://www.linkedin.com/company/cryoportinc or @cryoport on X, formerly known as Twitter, at www.twitter.com/cryoport for live updates.
About MVE Biological Solutions®
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
For more information, http://www.mvebio.com or follow via LinkedIn at https://www.linkedin.com/company/mvebio or @mvebiosolutions on X, formerly known as Twitter, at www.twitter.com/mvebiosolutions for live updates.
Forward-Looking Statements
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.
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SOURCE Cryoport, Inc.
FAQ
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