GMP cell manufacture
Using our wealth of expertise and experience, we develop and manufacture advanced therapy medicinal products (ATMPs) for a variety of research, pre-clinical and clinical campaigns, for healthcare, academic and commercial customers.
Our Medicines and Healthcare products Regulatory Agency (MHRA) licensed laboratories in Liverpool, Birmingham and Bristol are involved at all stages of developing novel therapies from translating research protocols, to GMP-compliant procedures, to release by a Qualified person (QP) and delivery to a patient. These are soon to be joined by our new facility near Barnsley.
We provide process development, technology transfer to GMP, manufacture and storage and logistical support, all regulated by an overarching quality management system.
We have three laboratories licensed by the MHRA for manufacture of advanced cell therapies in Liverpool, Birmingham and Bristol.
Each have 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).
If you would like more information about our manufacturing capability and capacity, please contact us.
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.
If you would like to discuss a process you would like to develop or to transfer your process to meet GMP compliance please contact us.
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.
For additional information on our quality control services, including any bespoke tests, please contact us.
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.
If you would like more information about our storage and logistics solutions, please contact us.