Articles Archives

Cryoport Systems with ISCT on Why Early-Phase Development is Starting to Strain

As advanced therapy programs move faster toward first-in-human (FIH), the pressure isn’t just showing up at commercial scale. It’s appearing much earlier than many teams expect.   A recent article Cryoport Systems published with ISCT takes a closer look at that shift, highlighting why execution (not feasibility) is increasingly becoming the constraint in early development.

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Matthew Plaud on Building Supply Chains that Actually Scale

In a recent conversation with Contract Pharma, Matthew Plaud, COO of IntegriCell® at Cryoport Systems, discussed where advanced therapy supply chains stand today, and where they start to strain as programs move toward commercialization.

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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.

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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?

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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.

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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.

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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.

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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.

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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.

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