Supply Chain Archives
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
04/21/2026
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
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
12/22/2025
Celebrating Innovation at the Cryoport Systems Grand Opening in Louvres, France
Cryoport Systems recently opened the doors of its newest Global Supply Chain Center (GSCC) in Louvres, France, marking a major step forward in how cell and gene therapies move safely and compliantly across Europe and the world. Strategically located just outside Paris and minutes from Charles de Gaulle Airport (CDG), this GSCC strengthens our integrated network and brings critical capabilities closer to sponsors, CROs, CDMOs, and clinical sites throughout the region, and strengthens our support of regional animal health and reproductive medicine organizations.
Industry Insights
12/19/2025
Expert Q&A: Is Standardization the Bottleneck or Breakthrough to Building Scalable and Cost-Effective CGT Programs?
Cell and gene therapy (CGT) companies are under constant pressure to do more while hitting milestones earlier. Demonstrate manufacturability. Ensure regulatory readiness. Design for scalability and patient access. And do all of this with more constrained resources and increasingly aggressive timelines. Building on our recent panel discussion, we gathered extended perspectives from Dr. Don Fink (Dark Horse Consulting Group), Audrey Greenberg (Mayo Venture Partners), Dr. Dominic Clarke (Cryoport Systems), and Kurtis Carlisle (Cabaletta Bio).
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.
Navigating Logistics
12/16/2025
Driving Compliance and Standardization in CGT Supply Chains
As cell and gene therapies (CGTs) continue to advance and more therapies reach late-stage clinical trials and commercialization, the complexity of the related logistics is only increasing. Therapies are crossing borders, reaching broader patient populations, and expanding into global distribution, all of which introduces risk if standards are inconsistent. Compliance and standardization, as a result, are essential for ensuring both scalability and patient safety.
Navigating Logistics
12/11/2025