Supply Chain Archives
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
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.
Managing the Cold Chain
02/18/2026
Build Standardization Where It Matters Most: Turning Stability into True Consistency
There is a quiet assumption that many early-phase teams make when they transition to cryopreserved starting material... that freezing alone will solve their variability problem. On the surface, it feels true. Cryopreservation stops the clock, stabilizes the cells, and removes the minute-to-minute fragility of fresh material. But the stability that teams expect isn’t guaranteed by freezing itself, it’s created by how the freezing is done. And in practice, this is where programs often get surprised.
Managing the Cold Chain
01/27/2026
Establish Stability from the Start with Frozen Starting Materials for Cell Therapy Development
For many years, cell therapy programs defaulted to fresh leukapheresis-derived starting material. The assumption was that if you could minimize the time from collection to manufacturing, you would maximize viability. As a result, fresh apheresis became not only a scientific preference but an operational tradition, shaping how clinical teams would schedule donors, how manufacturing suites would allocate capacity, and how programs would structure day-to-day execution. Program leaders treated any deviation from “fresh” as a risk to be justified rather than a choice to be evaluated. But reality keeps getting in the way.Categories
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