Viral vector
A flexible platform for viral vector manufacture from the Clinical Biotechnology Centre
Backed by years of cell and gene therapy expertise, the Clinical Biotechnology Centre provides viral vector manufacturing services for clinical trial programmes.
We offer validated protocols for lentivirus (LV) and adeno associated virus (AAV) production to support the development of advanced therapies.
Our scale of manufacturing and integration in the UK healthcare system make us ideally suited to support manufacturing for rare and orphan diseases.
Why work with NHS Blood and Transplant?
Cell and gene therapy expertise
Our highly qualified staff are experts in good manufacturing practice (GMP) compliant cell and gene therapy manufacture, and can support your product with best practices in viral vector manufacture.
Our viral vector manufacturing capability was established as part of the Innovation Hubs for Gene Therapies, and we continue to draw on expertise from this network.
We provide tailored advice, specific to your product needs, ensuring material is manufactured to the appropriate grade and quantity.
Competitive pricing
We are an industry partner for viral vector manufacturing, offering streamlined support at an affordable price.
We work closely with our clients to bring viral vectors to early-stage clinical trials, from pre-clinical development to GMP clinical supply.
Efficiency in viral vector development
Our clinical trial knowledge and experience of GMP manufacture allows us to minimise timelines in your viral vector development programme.
Our viral vector manufacture process
We use flexible manufacturing processes that can be optimised for each product specification and batch size requirement.
Process development
A scaled down development model will be executed to optimise the manufacturing process, including plasmid ratios and quantities for transient transfection and refinement of downstream polishing steps, with the objective of maximising recovery and product quality.
A small-scale development run (up to 10L bioreactor) will generate material for analysis and quality control testing, which may be made available to the client.
Cell line expansion
Suspension cells are cultured in shaker flasks and scaled up to stirred-tank bioreactors, to expand the number of cells. These packaging cells are then used to produce viral vectors.
Transfection
Plasmids are transfected into the packaging cells, to initiate the viral vector production process. Find out about our plasmid DNA service.
Vector production
Vectors are assembled and released into the culture medium. The culture medium containing the viral vectors is then collected.
Clarification and purification
Downstream purification methods are performed to remove cell debris and process-related impurities.
Formulation
Purified bulk is formulated in a relevant buffer using tangential flow filtration (TFF), ready for fill and finish activities.
Aseptic fill and finish
The product is filled under aseptic conditions using dedicated filling equipment and isolators. Read about our fill and finish service.
Quality control testing
Our quality control team test the final product to confirm it meets specifications.