Supply Chain Archives
Managing the Cold Chain
05/18/2026
Integrate Cryopreservation into the End-to-End Supply Chain
Early‑phase therapy developers rarely think about cryopreservation as a standalone decision. In practice, it sits between collection and manufacturing, shaped by how material moves, how it is documented, and how responsibility is transferred from one group to the next. Despite that reality, cryopreservation is often implemented as a discrete step, managed separately from the rest of the supply chain that supports development execution. That separation may feel manageable early on. It becomes harder to sustain as programs progress.
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.
Managing the Cold Chain
04/28/2026
A Conversation with Yashu Sarna, President of PDA West Coast Chapter
At this year’s PDA (Parenteral Drug Association) West Coast Chapter conference in Las Vegas, leaders across quality, manufacturing, and operations came together to discuss digital transformation and the evolving demands facing the biopharmaceutical industry. We spoke with Yashu Sarna, President of the PDA West Coast Chapter and Director of Business Development, Cryopreservation at Cryoport Systems, about what the conference revealed, how those insights align with what he’s seeing across the market, and where the industry appears to be heading next.
Managing the Cold Chain
04/21/2026
Validate Cryopreservation as a Defined Input, not a Variable
Most early‑stage cell therapy programs continue to rely on fresh starting material, particularly in pre‑clinical and Phase I development. That reliance is often driven by habit rather than data. Fresh workflows are familiar, but they also embed variability into the earliest experiments, where reproducibility is hardest to restore later. As development pressure increases, teams begin looking for ways to stabilize inputs without introducing new unknowns.
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
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.
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.
Managing the Cold Chain
02/26/2026