The London Innovation Hub for Gene Therapies hosts state of the art facilities specialising in the manufacture of GMP vector products.
The Gene Therapy Vector Facility (GTVF), at Kings College London provides world-leading expertise in GMP vector manufacture and has over the last few years manufactured the highest number of retro- and lentiviral vectors for clinical trials in Europe The GTVF has broad experience in gene therapy pre-clinical development and clinical trials developed over many years which is available to academic groups seeking to enter the clinic.
The GTVF offers the manufacture of the following GMP products:
- Lentiviral vectors (LV)
- Retroviral vectors (RV)
- Adeno-associated viral vectors (AAV) – coming soon
The GTVF holds the following MHRA manufacturing licenses:
- Investigational Medicinal Products (IMPs) (for use in clinical trials)
- “Specials” (manufacture & import of unlicensed medicines)
The GTVF holds a growing number of state-of-the-art, MHRA accredited GMP facilities over multiple sites, which are available for lentiviral vector (LV), retroviral vector (RV) and adeno-associated viral vector (AAV) production (coming soon).
Specifically, the GTVF has four active, fully equipped production cleanrooms offering significant GMP lab space for concurrent manufacture of viral vector. Combining extensive cleanroom space with a large team of ~50, the GTVF is able to service a high volume of client projects, getting projects into production fast. Over the next 12-24 months, a further four brand new, fully-equipped, independent production cleanrooms are set to be opened which will further enhance available capacity for client projects.
Lentiviral Vector (LV) and Retroviral Vector (RV)
The London Innovation Hub for Gene Therapies hosts state of the art facilities for GMP-grade LV and RV vector manufacture.
The GTVF is staffed by a large, dedicated production team dedicated to LV and RV. Combined with the significant, and expanding GMP production facilities, the GTVF is equipped to handle a high volume of concurrent projects and address timeline challenges.
The team currently makes use of a transient production/transfection system, using adherent cells with multi-layer cell factories. The GTVF LV/RV infrastructure is tried and tested over the production of >100 batches of viral vector. Clients benefit from access to years of experience in addressing vector manufacture challenges. Internally, GTVF production and process development teams work to ensure that assays and processes are kept up-to-date and ahead of the curve.
Adeno-associated Viral Vector (AAV)
The London Innovation Hub for Gene Therapies hosts state of the art facilities for GMP-grade AAV manufacture.
The GTVF is set to begin servicing clients with AAV vector in early 2024 with a dedicated team. The team will be fully integrated into the wider operations and management team within the GTVF and will operate under the same QMS. The team will initially make use of a well-characterised adherent cell line system, and with ongoing process development work will gradually move to adopt adherent/suspension bioreactor technology. There will be an initial focus on delivering the AAV9 serotype, with plans to expand into other serotypes in the next phase of the project.