Cryoport Continues to Set New Benchmarks for the Global Regenerative Medicine Supply Chain

Rhea-AI Summary

Cryoport (NASDAQ: CYRX) announced that Cryoport Systems achieved ISO 21973:2020 certification, the international standard for transport of human cells for therapeutic use, on October 30, 2025.

The company participated in developing the standard, says the certification strengthens traceability, environmental control, and chain-of-custody safeguards for cell and gene therapies and is applied across regenerative, reproductive medicine, and animal health operations. Cryoport also cites its 2025 CPHI Award for Supply Chain Excellence and points investors to a company whitepaper and website for more details.

Positive

• First global supply chain solutions company to achieve ISO 21973 certification
• Cryoport Systems participated in developing ISO 21973 requirements
• Certification strengthens temperature control, traceability, and chain-of-custody practices
• Applies ISO 21973 standards across regenerative, reproductive, and animal health markets
• Won the 2025 CPHI Award for Supply Chain Excellence

Negative

• None.

Insights

Supply Chain Certification Analyst

Cryoport's ISO 21973 certification strengthens operational credibility for cell and gene therapy logistics on Oct 30, 2025.

Cryoport achieved ISO 21973:2020 certification, the international transport standard for human therapeutic cells. This confirms formal third‑party recognition of the company’s environmental control, traceability, and chain‑of‑custody processes described in the release.

The business impact centers on reduced execution risk when transporting living cells, which the text links directly to therapy viability and patient outcomes. The certification supports Cryoport Systems’ claim of leadership and may lower client onboarding friction for regenerative medicine programmes that require strict documentation.

Key dependencies and risks remain tied to maintaining these processes across all customer workflows and markets the company serves, including reproductive medicine and animal health. Monitor uptake by customers, references to broader commercial contracts, and any public metrics on shipment volumes or service adoption over the next 6–12 months as indicative milestones.

First Global Supply Chain Solutions Company to Achieve ISO 21973 Certification, Ensuring Highest Transport Safety, Traceability, and Integrity Standards for Cell and Gene Therapies

NASHVILLE, Tenn., Oct. 30, 2025 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or "the Company"), a global leader in temperature-controlled supply chain solutions for the life sciences, today announced that Cryoport Systems, a Cryoport company, has successfully achieved certification under ISO 21973:2020, the international standard for transportation of human cells for therapeutic use published by the International Organization for Standardization (ISO). This milestone underscores Cryoport Systems' commitment to safety and traceability within supply chain management of the rapidly expanding cell and gene therapy industry.

First introduced in 2020, Cryoport Systems participated in the Standards Coordinating Body working group that developed the ISO 21973 requirements. The final ISO 21973 standard provides comprehensive guidelines for managing the environmental control, equipment, processes, logistics, and information involved in transporting therapeutic cells, where any deviation could mean the loss of a life-changing or life-saving treatment. Living cells require precise conditions to remain effective. Therefore, monitoring those specific conditions and ensuring the shipping environment has been maintained is crucial for the viability of regenerative medicine therapies and patient outcomes. The ISO 21973 requirements minimize the risks associated with temperature excursions, contamination, and chain of custody breaches.

Jerrell Shelton, Chairman & CEO of Cryoport, stated, "With the first and only ISO 21973 certification in the global supply chain solutions market, this achievement further solidifies our position as a pioneer in the life sciences industry. Having helped develop this industry standard with the ISO, we have long adhered to it with our proprietary Chain of Compliance^®. Now, we're proud to lead the industry in our successful certification of these rigorous requirements. This comes on the heels of winning the 2025 CPHI Award for Supply Chain Excellence for Cryoport Systems' integrated Supply Chain Platform and is yet another example of Cryoport's leadership in the regenerative medicine industry, providing novel supply chain solutions to better serve patients."

While the ISO 21973 standard is specifically tailored to the unique demands of regenerative medicine supply chain, Cryoport Systems applies these same standards across the life sciences spectrum, including its reproductive medicine and animal health markets. 

For more details on Cryoport Systems' ISO 21973 certification and its impact on the regenerative medicine supply chain, visit www.cryoport.com or download the company's whitepaper on the standard. 

About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX), is a leading global provider of temperature-controlled supply chain solutions for the Life Sciences, with an emphasis on regenerative medicine. We support biopharmaceutical companies, contract manufacturers (CDMOs), contract research organizations (CROs), developers, researchers, and the Life Sciences, in general, with a comprehensive suite of services and products designed to minimize risk and maximize reliability across the temperature-controlled supply chain. Our integrated supply chain platform includes the Cryoportal^® Logistics Management Platform, advanced temperature-controlled packaging, informatics, specialized biologistics, biostorage, bioservices, and cryogenic systems, which, in varying combinations, deliver end-to-end solutions that meet the rigorous demands of the Life Sciences. With innovation, regulatory compliance, and agility at our core, we are "Enabling the Future of Medicine™."

Headquartered in Nashville, Tennessee, our company maintains a strong global presence with operations across the Americas, EMEA, and APAC.

For more information, visit 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.

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. 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

What does Cryoport's ISO 21973 certification mean for CYRX shareholders?

The certification positions Cryoport as a certified provider of transport standards for cell therapies, potentially strengthening competitive differentiation and customer trust.

When did Cryoport announce ISO 21973 certification for Cryoport Systems?

Cryoport announced the ISO 21973:2020 certification on October 30, 2025.

How does ISO 21973 certification affect Cryoport's services for cell and gene therapies (CYRX)?

The certification confirms adherence to international guidelines for environmental control, monitoring, and chain-of-custody during transport of therapeutic cells.

Did Cryoport help develop the ISO 21973 standard (CYRX)?

Yes; Cryoport Systems participated in the Standards Coordinating Body working group that developed ISO 21973 requirements.

Will Cryoport apply ISO 21973 standards beyond regenerative medicine (CYRX)?

Yes; the company states it applies the same standards across reproductive medicine and animal health markets.

Where can investors find more details on Cryoport's ISO 21973 certification (CYRX)?

Investors can visit www.cryoport.com or download the company's whitepaper on ISO 21973 for further details.