Article: Experience in Cell and Gene Therapy Assures Success
By World Courier |
It’s Never Too Soon to Start Personalizing the Supply Chain
As explained in our previous article, rapid advances in disease therapies based on living genes and cells hold the potential to cure the body, rather than simply treat a disease -- but only if they arrive in perfect condition, on time, every time. To achieve that, the logistics industry has to evolve with the science.
Cell and gene therapies are produced one-by-one under strictly controlled conditions, using live bio-materials. Time and temperature variation could destroy them, so they must arrive at the clinical site on time and in pristine condition.
In theory, that’s a tough job. In the real world, it’s much harder.
Weather, air traffic, road conditions, climate zones, customs regulations and processing times can’t be allowed to delay delivery, or affect the temperature-controlled packaging of the samples and therapeutic materials.
To ensure success, World Courier starts working with study sponsors years in advance. Our dedicated project team plans a personalized supply chain, develops customized operating procedures, trains all personnel who come in contact with the shipments from lab to clinic, and works with airlines personnel and international customs agents to make sure everyone knows what is at stake and how to handle the shipments.
In real life: a case study
World Courier planned and executed all logistics for a developer of immuno-oncology products during a Phase II clinical trial. Under evaluation was an autologous, dendritic cell-based therapy for cancer patients, to extend remission time and possibly overall survival. The therapy was granted an orphan drug designation by the FDA and EMA, and received fast track designation by the FDA after the Phase II trial.
The therapy owner’s manufacturing sites were located in Europe and in Australia. Shipments of starting cell material had 24 hours to travel from the clinical sites in Europe and Asia to the central manufacturing sites. Over a period of 20 months, World Courier delivered 245 shipments containing more than 2,000 kilograms of materials to treat 63 patients. Therapeutic materials traveled by air freight and road, and were hand carried to their final destination.
Our clinical sample delivery success rate was 100%. The best logistics partner for your clinical trial is one who has been down that road before. To learn how we do it and what to look for in a personalized supply chain provider, please download our free e-book.