Supply Chain Archives
Managing the Cold Chain
07/07/2026
Expand Trial Footprints Without Expanding Cryopreservation Risk
For many cell therapy programs, the move from fresh to frozen starting material is treated as the moment when variability starts to come under control. And in many ways, that’s true. Fresh leukapheresis-derived starting material is inherently difficult to build around. It is biologically active, time-sensitive, and highly dependent on how quickly and consistently it can move from collection into the next step of the process. Even under strong operational oversight, additional variables around timing, handling, transport duration, pre-processing wait time, and local execution can all influence the condition of the material before manufacturing ever begins.
Managing the Cold Chain
07/07/2026
When Local Variation Becomes Global Risk in Phase III
By the time an advanced therapy program reaches Phase III, the supply chain is no longer being judged only by whether material can move from one point to another. It is being judged by whether that movement can be repeated across sites, regions, service providers, and regulatory environments in a way that produces a consistent and defensible record of execution.
Managing the Cold Chain
07/07/2026
“Regulatory Readiness is Built Early” and Other Lessons for CGT Developers
Advanced therapy developers are used to making hard decisions under pressure. In early development, the priority is often clear: reach the clinic, generate meaningful data, and keep the program moving. This was the central theme of the recent webinar, “Prevent Advanced Therapy Program Delays with Early Supply Chain Strategy.” The expert panel explored why early supply chain decisions deserve strategic attention long before a program reaches pivotal trials or filing preparation.
Managing the Cold Chain
05/12/2026
Why Risk Analysis and Lane Qualification Matter for Regulatory Confidence
As programs move from mid-phase into later development, expectations around compliance change in both scale and tone. Early filings may tolerate explanation, but later submissions expect evidence. Teams preparing for Phase II transitions, Phase III trials, or global commercialization begin to encounter a different level of scrutiny, where regulators are less interested in intent and more focused on whether processes behave consistently under real operating conditions.
Industry Insights
04/14/2026
Building Global Readiness: Key Takeaways from Matthew Frazzetta at Hope Is Not a Workflow
As cell and gene therapies continue to advance scientifically, operational readiness is increasingly determining whether those therapies reach patients at scale. During a presentation at Hope Is Not a Workflow, Matthew Frazzetta, Vice President of Global Accounts for BioServices at Cryoport Systems, addressed a question that is becoming impossible for the industry to ignore: How do we build a global, standardized, and scalable supply chain capable of supporting the next generation of advanced therapies?
Managing the Cold Chain
04/09/2026
Where Innovation Is Moving the Advanced Therapies Supply Chain: A Q&A with Alison Pritchard
Following the Advanced Therapies Congress 2026, where Alison Pritchard delivered a keynote and participated in a panel discussion, she sat down for a brief conversation to expand on some of the themes that emerged during this year’s event. Alison’s perspective captures a few of the ideas she believes are shaping the next phase of supply chain design in advanced therapies.
Industry Insights
03/19/2026
ATC 2026 Panel Recap: Harnessing Technological Innovation to Optimize Supply Chain and Logistics in Advanced Therapies
Advanced Therapies Congress 2026 hosted a panel discussion, Harnessing Technological Innovation to Optimize Supply Chain and Logistics in Advanced Therapies, that centered on a reality the field continues to confront... while the desire for digital acceleration is strong, the industry’s underlying infrastructure is not yet positioned to fully benefit from it. Alison Pritchard, VP Business Development, joined fellow panelists to examine where technology can make a meaningful impact today and where foundational alignment must come first.
Industry Insights
03/19/2026
ATC 2026 Keynote Recap: Building Global Readiness for Advanced Therapies
Alison Pritchard, VP of Business Development – EMEA at Cryoport Systems, delivered the Keynote Address at the Advanced Therapies Congress 2026, grounding the discussion in the accelerating pace of global expansion across the cell and gene therapy industry. Clinical trials now commonly stretch across regions, and manufacturing networks are distributed in ways that require constant coordination. These patterns have become the norm rather than the exception. As she described it, the operating environment for advanced therapies has already become global, and every program is expected to function within that reality much earlier than in the past.
Managing the Cold Chain
03/19/2026