Frequently Asked Questions
The Hubs manufacture recombinant adeno-associated viral vector (rAAV) up to 50L and lentiviral (LV) vector at both GMP and non-GMP grade to support both clinical and pre-clinical gene therapy development.
The Sheffield Hub utilises highly efficient processes to manufacture GMP-grade recombinant adeno-associated viral vector (rAAV) up to 50L and provides all the necessary quality assurance, regulatory certification and governance.
The Bristol Hub manufactures GMP-grade lentiviral (LV) vectors and rAAV vectors at 10L and 40L batches using HEK293 suspension cells grown in stirred tank bioreactors. The Hub is flexible to support other scales and cell culture formats and also offers high-quality non-GMP vector manufacturing to support developers at pre-clinical stages.
The London Hub currently makes use of a transient production/transfection system, using adherent cells with multi-layer cell factories to produce LV and will begin manufacturing AAV in early 2024 using an adherent cell line system.
The Innovation Hubs have highly experienced staff in the clinical development and manufacture of gene therapies and can offer a wide range of support to academics wishing to take their therapy further along the development pathway. This includes (but is not limited to): plasmid sourcing (as needed), assay development, pilot studies, small-scale pre-run testing, engineering test-runs, QC testing and batch release, regulatory support, clinical trial support. To find out how else the Hubs may be able to help you, please contact us at .
The Hubs are not able to provide access to clinical trials. If you’re a patient or carer seeking to take part in medical research, please visit Be Part of Research (nihr.ac.uk).
Medical advice: The Innovation Hubs for Gene Therapies are not able to offer medical advice. Instead, please contact NHS Choices.