GMP cell manufacture

We have four laboratories licensed by the MHRA for manufacture of advanced cell therapies in Barnsley, Birmingham, Bristol and Liverpool.

Each has a skilled team of GMP-qualified advanced therapy and quality control scientists. The teams are experienced in cell culture, isolation and selection, bioreactor expansion, cryopreservation and 'fill and finish'. We also employ a dedicated Advanced Therapy Quality Assurance team and qualified person (QP).

There are many challenges in the transfer of manufacturing processes for advanced therapy medicinal products (ATMPs) including documentation of starting materials, quality assurance and critical controls.

Recognising these challenges, NHS Blood and Transplant (NHSBT) offers over 15 years' experience to our customers in de-risking this process with a proven outcome in the successful delivery of GMP-grade cell therapy products for clinical trials.

We develop, optimise and validate product-specific assays and stability studies, enabling us to offer a complete range of analytical testing services. Using our quality control services, we are able to establish identity, potency, purity and safety of your products.  

We also partner with qualified service providers for specialist testing including karyotyping and sterility. 

We can generate Certificates of Analysis for all products, providing a comprehensive package of analytical testing results to support product batch release.  

All our Cellular and Molecular Therapies (CMT) laboratories are equipped with cryostorage capabilities. These include vapour phase, liquid nitrogen storage tanks, automated, alarmed and always monitored with staff on call 24/7 so you can be assured of the safety of your products.

NHSBT have validated shipping methods and selected couriers in place for transport of cellular products. Our locations in Liverpool, Birmingham and Bristol are also ideally situated close to major airports for international transport.