ATMP storage and distribution
A cell therapy product has a very short shelf life at ambient temperature conditions. This must be considered for the collection of starting material, transportation to the manufacturing site, shipment of the finished product to the clinical trial site and administration to the patient.
NHS Blood and Transplant (NHSBT) Stem Cells and Immunotherapy (SCI) laboratories are ideally positioned to support existing cell therapies, cell therapy clinical trials and also commissioned CAR-T cell therapies. We have:
- Excellent links with surrounding hospitals, clinicians and therapeutic apheresis teams
- Strong experience in cryopreservation processes using controlled rate freezers
- Logistics networks and established procedures in place to transport fresh or frozen product between our laboratories and clinical sites
- Fully trained operational staff to handle and process fresh cells and cryopreserved products
- Vapour phase liquid nitrogen storage tanks, temperature monitored and alarmed 24/7 with out of hours staff always on-call
- Dedicated quality assurance teams and an overarching quality management system to support routine services and clinical trial application, initiation and completion
- HTA licences and JACIE accreditation for each of our laboratories
We provide direct support to the hospitals we serve through the Service Level Agreements we have in place. There is usually no requirement for additional contracts to be put in place to support ATMP and stem cell clinical trials.