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
03/19/2026
Advance Program Stability by Building Cryopreservation Into the System, Not Around It
Cryopreservation has become a practical way for early programs to give themselves more room to plan, especially when collection schedules don’t line up neatly with manufacturing availability. How the material actually enters the frozen state, though, has a noticeable influence on what teams see later in development. When sites follow their own methods or adapt the process to local routines, those differences show up in the frozen material and stay with it.
Managing the Cold Chain
03/18/2026
The Slow Drift Toward Variability and the Case for Standardization
Teams in mid-phase development often look back at their operational processes and see that they carry the imprint of every decision made along the way. No single choice felt significant in the moment, and each helped to keep the program moving. But as more sites are added and new regions open, the one-off decisions made along the way become part of a broader system that begins to show its unevenness variability as the program expands.
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.
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
10/15/2025
The Connected Chain: Why Supply Chain Integration Matters in Advanced Therapy Manufacturing
Contract Development and Manufacturing Organizations (CDMOs) are at the heart of the advanced therapy ecosystem, managing complex, high-stakes programs that demand speed and compliance. As therapies move from early development into clinical trials and through to commercialization, every stage of manufacturing, packaging, biostorage, and final drug delivery need to align perfectly for seamless execution. Yet in many cases, these functions are managed by multiple vendors, each operating in isolation. The result is a fragmented supply chain that increases risk while slowing execution due to layers of operational burden.
Managing the Cold Chain
09/10/2025
Scale Smarter: How Global Supply Chain Centers Amplify CGT Program Growth
Cell and gene therapy (CGT) programs are among the most complex and sensitive operations in the life sciences. From cryopreservation and biostorage to logistics and regulatory compliance, every step in the supply chain can influence product integrity, clinical timelines, and the scalability of the program. For program heads as well as clinical and technical operations teams, the challenge becomes bigger than merely moving materials. It quickly becomes a challenge of scaling efficiently while maintaining compliance and supporting growth across a global network.
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.Categories
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