Articles Archives
Articles
07/21/2026
What it Takes to Launch a Modern Supply Chain Operation
As we move closer to launch on August 17, 2026, the Santa Ana facility is transitioning from a construction project to an operational asset representing a milestone that required months of coordinated work across engineering, facilities, operations, product, quality, IT, and supply chain teams. A facility may represent the physical footprint, but true operational readiness is measured by systems, processes, people, equipment, compliance, and execution.
Articles
07/20/2026
Expert Q&A: Going Deeper on Early Supply Chain Strategy for CGT Programs
Advanced therapy developers rarely have the luxury of perfect timing. Programs are often moving toward the next milestone with limited resources, data that’s evolving in real time, and pressure to make decisions before every variable is fully understood. That reality was at the center of the recent webinar, “Prevent Advanced Therapy Program Delays with Early Supply Chain Strategy,” where panelists discussed how early decisions around logistics, cryopreservation, packaging, site readiness, documentation, and cross-functional alignment can influence everything downstream.
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.
Articles
07/06/2026
Building the Foundation: Our New Global Supply Chain Center in Santa Ana, California
End-to-end supply chain execution is a competitive advantage. Speed, reliability, and adaptability define how businesses deliver for customers. That’s why we’ve invested in a consolidated 86,500‑square‑foot Global Supply Chain Center (GSCC) in Santa Ana, California, a strategic step forward in strengthening the backbone of our global operations.
Articles
06/17/2026
New ISCT Thought Leadership Explores Why Growth in CGT Demands a Different Operating Model
The way the industry thinks about scale is starting to shift. For decades, growth in biopharmaceutical development has followed a familiar pattern. As programs advance, manufacturing expands and throughput increases, allowing therapies to move from limited, early-phase clinical trial settings into broader patient populations. A new article from Cryoport Systems published through the International Society for Cell & Gene Therapy (ISCT) explores how scale behaves differently in advanced therapies and why the industry may need to rethink the operating models used to support it.
Articles
05/26/2026
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.
Articles
05/26/2026