How to build a robust cryogenic clinical trial supply chain
The development of advanced therapies, including cell and gene therapies, mRNA-based products, and other biologics, is delivering substantial leaps forward in human health – offering significant potential to transform patient outcomes across key therapeutic areas from oncology to autoimmune conditions.
Yet unlocking this potential depends on the supply chains behind the science.
With the high costs and increasing complexity that advanced therapies bring, particularly those demanding end-to-end cryogenic or ultra-low temperature management, supply chain failure is quickly becoming a leading risk factor in modern clinical trials.
To uphold patient safety and keep trial timelines on track, sponsors must prioritise optimised, compliant, and patient-centric clinical supply chains from the outset.
For many sponsors of advanced therapy trials, robust cryogenic supply chain management is a core enabler of trial success. And getting it right requires deliberate, early planning. Here’s how to get started…
Know the difference
Cryogenic supply chains demand a completely different level of precision. Materials must be maintained at ultralow temperatures, often ≤-150°C, using specialised packaging, liquid nitrogen vapour phase systems, and rigorously validated shippers. There is very little tolerance for delay or deviation, and traditional buffer stock strategies don’t apply when managing small batch or patient-specific material.
Advanced therapies are particularly vulnerable. Many are irreplaceable – patient-derived, bespoke, and biologically fragile. A single handling error can render material unusable, meaning lost doses, missed treatment windows, and patients who can no longer participate.
Recognising these distinctions early and designing your supply chain infrastructure around them rather than retrofitting standard models, is the foundation of a cryogenic supply chain that’s built to protect both product and patient.
Figure out your failure points
The most common supply chain failure points include breaks in temperature integrity during transit, limited visibility once material leaves a single provider’s control, and inadequate contingency planning for returns, resupply, or reshipment.
Failures can spiral quickly. Missed dosing can trigger site shutdowns and protocol deviations. Material loss can force repeat manufacturing and expedited rescue shipments. Delays can lead to resupply, reconsenting, and re-enrolment; all of which can extend timelines, escalate costs, and negatively impact patients.
Mapping these failure points at protocol stage, with precision and honesty about where gaps exist, gives sponsors the opportunity to build contingencies into the supply chain from the outset. It also makes a compelling case for end-to-end ownership over fragmented, multi-vendor models.
Prioritise integration
For cryogenic material, every handoff between vendors is a point of exposure that increases the risk of temperature excursions.
Almac’s Cryogenic Service Solution is purpose-built to overcome the risk of fragmented supply chains. In our state-of-the-art, fully contained cGMP suite in Durham, NC, three segregated processing rooms safely handle, package, and label advanced therapies under cryogenic conditions.
Cutting-edge liquid nitrogen vapour phase freezers offer -190°C top box capability, with capacity for 42,000 vials and 100% redundancy to maximise product integrity. A 24/7 building management system provides continuous monitoring of both vessels and environmental conditions, while custom storage solutions and segmented racks accommodate client-specific requirements.
From storage through to distribution, our robust cryogenic shipping service utilises specialist vapour and validated shippers to guarantee product integrity throughout transit and provide an unbroken chain of custody from production line to patient. Every movement documented, every condition verified, and full traceability provided throughout.
When evaluating your supply chain model, ask whether your current set-up can offer this same level of unbroken oversight. If it can’t, it’s time to make integration the priority.
Plan early
Building cryogenic supply chain planning into protocol design from the outset is a frequently overlooked, yet incredibly important step.
Early alignment between manufacturing, supply, and clinical operations teams allows contingency planning to be embedded from day one, covering delays, returns, and global variability.
Almac’s Cryogenic Service Solution brings 30 years of experience, global infrastructure, and expert people, processes, and technology to this challenge, including Almac Adapt, a demand-led, just-in-time manufacturing solution designed to facilitate lean production. Custom storage solutions ensure the model flexes to meet client-specific needs as trials scale across regions and patient volumes.
Essentially, the earlier cryogenic supply chain planning begins, the greater the opportunity to anticipate risk, build in contingency, and design a model that is shaped around your protocol from the ground up.
Discover more about our Cryogenic Service Solution
