The Logistics of Delivering Cell and Gene Therapy Medicines – from Clinical to Commercialization | Clinical Trial & Cold Chain Logistics
The first cell therapies were approved about 10 years ago, and since then, the research and use of these advanced therapy medicinal products have evolved rapidly. This includes both autologous and allogeneic therapies, each of which brings particular supply chain logistics challenges.
Alogeneic therapies can be manufactured in large batches, from unrelated donor sources, making the supply chain more predictable. On the other hand, autologous therapies are vein-to-vein with a circular supply chain starting and ending with the patient, adding a layer of complexity to logistics.
Regardless, as with most drugs, the challenge is to move from the clinical stage to commercialization quickly and affordably. No easy task, considering a clinical trial for cell and gene therapies could start with as few as 15 or 30 patients with the goal of eventually scaling up to tens of thousands in commercialization.
“What works on a small, clinical phase is not always practical, or possibly even necessary at a much larger scale.” ~Adrian Lee-Mohan
A sound logistics plan must also consider external factors. On a global level, COVID-19 brought many supply chains around the world to a standstill almost overnight – not an option when delivering life-saving medication, whether in the clinical stage or not. The pandemic has also resulted in structural changes to the airline industry, likely to have repercussions on logistics for years. Regional challenges arise as well. It’s still unknown, for instance, how Brexit will ultimately impact the flow of goods – including medicinal products – between the EU and the UK.
That’s why to align clinical and commercial phases, to plan for all scenarios, it’s critical to involve an experienced logistics partner from the beginning. This not only allows for more streamlined, reliable solutions – logistics partners can also play a role in educating all those involved in the supply chain – airlines, ground handlers and more.
“If you involve a logistics partner early on, even before the clinical stage, you can flush any issues out, mitigate risk and come up with creative ideas on how to approach things.” ~David Murphy