Supply Chain Archives
Managing the Cold Chain
04/21/2026
Accelerate Your Trials Without Losing Control With an End-to-End Supply Chain Model
As programs shift from Phase I to Phase II, the workload starts to overlap in new ways. Sample volumes increase as more sites operate in parallel, and activities that once occurred in sequence now run at the same time. The work itself is largely the same, but keeping it coordinated requires more time and attention.
Managing the Cold Chain
02/26/2026
Building Investor Confidence Through an Intentional Supply Chain Strategy
In early investment conversations, scientific innovation used to carry most of the weight. A compelling mechanism of action, a clear unmet need, and solid early data together were enough to advance the discussion and give investors a sense of potential. In today’s funding environment, however, that has shifted. Today, investors quickly move past the science and begin investigating whether a program can operate with the discipline and scalability required to grow.
Industry Insights
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.
Navigating Logistics
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.
Navigating Logistics
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.
Managing the Cold Chain
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.
Managing the Cold Chain
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.
Managing the Cold Chain
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.
Managing the Cold Chain
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.Categories
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