Supply Chain Archives
12/17/2025
2025 Year in Review: Turning Standards and Resilience into Outcomes
If you work within the advanced therapy ecosystem, you already know the story of 2025 from an industry standpoint, where science continued accelerating while funding and commercialization hinged on whether the supporting systems could keep up. For Cryoport Systems, that reality was a catalyst. This year, we raised the bar yet again and demonstrated how having the right strategic partnership behind your end-to-end supply chain can turn logistics into leverage, can transform compliance into confidence, and can spin scale into speed.
12/16/2025
Driving Compliance and Standardization in CGT Supply Chains
As cell and gene therapies (CGTs) continue to advance and more therapies reach late-stage clinical trials and commercialization, the complexity of the related logistics is only increasing. Therapies are crossing borders, reaching broader patient populations, and expanding into global distribution, all of which introduces risk if standards are inconsistent. Compliance and standardization, as a result, are essential for ensuring both scalability and patient safety.
12/11/2025
Setting the Benchmark for Quality in Cell and Gene Therapy Logistics
Quality in cell and gene therapy (CGT) is the foundation that determines whether a therapy reaches a patient intact and effective. As the industry increasingly scales from early development of CGTs to global commercialization, the margin for error narrows as volume and complexity increase. Standards like ISO 21973 provide a framework, but true industry leadership comes from how those standards are applied. In this, Cryoport Systems is setting that benchmark.
12/09/2025
What is ISO 21973 and Why It Matters for Cell and Gene Therapy
Cell and gene therapies (CGTs) are transforming medicine, but the complexity of these treatments introduces new challenges for supply chain management. Every shipment represents a therapy that could change or save a life, which is a level of responsibility that demands precision and transparency, as well as standards that leave absolutely no room for error. ISO 21973:2020 was created to meet that need.
10/28/2025
Built or Bought? Why Biotechs are Outsourcing Supply Chain Infrastructure
For companies developing advanced therapy medicinal products (ATMPs), building an in-house end-to-end supply chain may seem like the ultimate sign of maturity. But in today’s resource-constrained market, biotech leaders are increasingly asking themselves whether it’s better to build, or to buy. From startups operating on limited funding to global biopharma players scaling into new markets, outsourcing supply chain infrastructure is becoming more than just a cost saving tactic. By partnering with specialized providers, developers gain instant access to global networks, regulatory expertise and compliance, and technical capabilities that would take years and significant capital to build internally.
08/29/2025
The Hidden Risks in Your Supply Chain: How Regulatory Support Can Save Your CGT Program
The temperature-controlled supply chain has become so much more than a straightforward logistics function, especially for advanced therapies. It has quickly evolved into a critical extension of your manufacturing process, your clinical trials, and your path to commercialization. Every step, from sourcing raw materials to delivering the final drug product to patients, must operate within strict regulatory and quality parameters where even the smallest oversight can cascade into regulatory delays, product loss, or even compromised patient safety.
07/31/2025
Earning the Next Trial: How Supply Chain Strategy Helps CROs Build Sponsor Trust
Contract Research Organizations (CROs) play a critical role in the biopharmaceutical industry, often executing clinical trials on behalf of sponsors. They’re tasked with wide-ranging expectations that span numerous functions, including maintaining the balance of operational excellence against regulatory compliance and cost efficiency. This complexity is compounded when clinical trial sites grow to span the globe, additional therapeutic areas, and expanded client populations. In such a competitive market, it’s not enough to simply deliver results. CROs must also build trust.
07/28/2025
Turning Risk into Resilience with Supply Chain Resilience for CDMOs
Contract Development and Manufacturing Organizations (CDMOs) are under more pressure than ever to deliver reliable results in an unpredictable world. From geopolitical instability to material shortages to increasingly complex regulatory expectations, the risks facing clinical and commercial programs have intensified. For CDMOs, these risks don’t just affect their own operations, they directly impact their clients’ ability to bring therapies to patients.
07/25/2025
