The Kings College London Gene Therapy Vector Facility (GTVF) is a state-of-the-art facility established to support the scientific community in their delivery of the latest cutting-edge gene therapies into the clinic. With a legacy dating back to 2006, the GTVF is now one of the largest suppliers of GMP-grade viral vectors for clinical trials across Europe, offering:
- Lentiviral vector
- Retroviral vector
- Adeno-associated viral vector (coming soon)
The GTVF is run by a large, professionalised team of ~50 people who have extensive experience in delivering end-to-end viral vector manufacture for both academic and commercial clients, with a focus on early stage clinical activity.
Lentiviral Vector (LV) and Retroviral Vector (RV)
The GTVF hosts four MHRA accredited, fully-equipped production cleanrooms for GMP vector production. With plans to open a further two cleanrooms in 2023, and more in 2024, the facility is purpose-built to handle a high volume of concurrent projects and get projects into the lab fast. The team currently makes use of a transient production/transfection system, using adherent cells with multi-layer cell factories. The GTVF has delivered >100 batches of LV and RV over it's long history, and has extensive experience with supporting UK, European and US projects.
Adeno-Associated Viral Vector (AAV)
The GTVF is set to begin servicing clients with AAV vector in early 2024 with a large, dedicated team and state-of-the-art facilities. 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, though with wide-ranging expertise across a range of AAV serotypes, the team will expand into other serotypes over time.
End-to-End Service
The GTVF offers a client-driven end-to-end service, and is on hand to support with some or all of the following activities:
- Project management
- Plasmid sourcing (as needed)
- Assay development
- Up-front pilot studies
- Small-scale pre-run testing
- Engineering test-runs
- Full-scale GMP manufacture
- QC testing and batch release
- Regulatory support
Facility staff
Professor of Human Molecular Genetics
Head of Business Development
Operations Director
Head of Production
Head of Quality
Head of Process Development
Head of AAV Delivery
Head of Projects
Business Manager
Director of Research Platforms
Operations Officer
GMP Cleanrooms:
The GTVF holds a growing number of state-of-the-art, MHRA accredited GMP facilities over multiple sites, which available for lentiviral vector (LV), retroviral vector (RV) and soon adeno-associated viral vector (AAV) production.
Specifically, the GTVF has four active, fully equipped production cleanrooms offer 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 three brand new, fully-equipped, independent cleanrooms are set to be opened which will further enhance available capacity for client projects.
MHRA manufacturing licenses:
- Investigational Medicinal Products (IMPs) (for use in clinical trials)
- “Specials” (manufacture & import of unlicensed medicines)
Both commercial and academic clients choose to work with the GTVF for a number of reasons:
-
A large, highly skilled team with extensive expertise to support all vector manufacture needs, including production, QA/QC, process development and regulatory support
-
Multiple fully equipped production cleanrooms and the flexibility to use them concurrently to deliver vector quickly
-
An alignment with early phase development with extensive knowledge of complex clinical development
-
The strategic backing and alignment with Kings – an internationally renowned University
-
Experience culminated over the manufacture of >100 batches of viral vector for clinical trials across Europe
Production
The production team currently makes use of a transient production/transfection system, using adherent cells with multi-layer cell factories. The system has been validated over the production of >100 batches of lentiviral vector and retroviral vector. The AAV facility will also initially make use of an adherent cell line system.
With ongoing process development work, the teams will look to move to suspension lines and adherent/suspension bioreactor systems over time.
Process Development and Process Innovation
This team are dedicated to the continuous development of process and assays. The team is on hand to support requested client analytical work, and is focused on developing our own internal processes, with a particular focus on:
- Advanced bioprocessing methods
- Scale-up
Quality Control (QC) and Quality Assurance (QA)
The GTVF has a dedicated in-house quality team who are able to carry out assay development in conjunction with the process development team, and also titrations (flow-based/ PCR/ ELISA). The GTVF has established, long-term relationships with external third parties for carrying out all required characterisation, safety, or purity assays.
The quality team also ensure regulatory compliance is maintained across all GMP and GLP facilities. A major component of the end-to-end service provided by the GTVF is the support around regulatory submissions (CTA and IND). This makes the GTVF very much a one-stop shop for supporting its clients on anything they may need all the way to batch release, and the clinic.
Lentiviral Vector (LV) and Retroviral Vector (RV)
The GTVF hosts four MHRA accredited, fully-equipped production cleanrooms for GMP vector production. With plans to open a further two cleanrooms in 2023, and more in 2024, the facility is purpose-built to handle a high volume of concurrent projects and get projects into the lab fast. The team currently makes use of a transient production/transfection system, using adherent cells with multi-layer cell factories. The GTVF has delivered >100 batches of LV and RV over it's long history, and has extensive experience with supporting UK, European and US projects.
Adeno-Associated Viral Vector (AAV)
The GTVF is set to begin servicing clients with AAV vector in early 2024 with a large, dedicated team and state-of-the-art facilities. 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, though with wide-ranging expertise across a range of AAV serotypes, the team will expand into other serotypes over time.
End-to-End Service
The GTVF offers a client-driven end-to-end service, and is on hand to support with some or all of the following activities:
- Project management
- Plasmid sourcing (as needed)
- Assay development
- Up-front pilot studies
- Small-scale pre-run testing
- Engineering test-runs
- Full-scale GMP manufacture
- QC testing and batch release
- Regulatory support
Facility staff
Professor of Human Molecular Genetics
Head of Business Development
Operations Director
Head of Production
Head of Quality
Head of Process Development
Head of AAV Delivery
Head of Projects
Business Manager
Director of Research Platforms
Operations Officer
GMP Cleanrooms:
The GTVF holds a growing number of state-of-the-art, MHRA accredited GMP facilities over multiple sites, which available for lentiviral vector (LV), retroviral vector (RV) and soon adeno-associated viral vector (AAV) production.
Specifically, the GTVF has four active, fully equipped production cleanrooms offer 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 three brand new, fully-equipped, independent cleanrooms are set to be opened which will further enhance available capacity for client projects.
MHRA manufacturing licenses:
- Investigational Medicinal Products (IMPs) (for use in clinical trials)
- “Specials” (manufacture & import of unlicensed medicines)
Both commercial and academic clients choose to work with the GTVF for a number of reasons:
-
A large, highly skilled team with extensive expertise to support all vector manufacture needs, including production, QA/QC, process development and regulatory support
-
Multiple fully equipped production cleanrooms and the flexibility to use them concurrently to deliver vector quickly
-
An alignment with early phase development with extensive knowledge of complex clinical development
-
The strategic backing and alignment with Kings – an internationally renowned University
-
Experience culminated over the manufacture of >100 batches of viral vector for clinical trials across Europe
Production
The production team currently makes use of a transient production/transfection system, using adherent cells with multi-layer cell factories. The system has been validated over the production of >100 batches of lentiviral vector and retroviral vector. The AAV facility will also initially make use of an adherent cell line system.
With ongoing process development work, the teams will look to move to suspension lines and adherent/suspension bioreactor systems over time.
Process Development and Process Innovation
This team are dedicated to the continuous development of process and assays. The team is on hand to support requested client analytical work, and is focused on developing our own internal processes, with a particular focus on:
- Advanced bioprocessing methods
- Scale-up
Quality Control (QC) and Quality Assurance (QA)
The GTVF has a dedicated in-house quality team who are able to carry out assay development in conjunction with the process development team, and also titrations (flow-based/ PCR/ ELISA). The GTVF has established, long-term relationships with external third parties for carrying out all required characterisation, safety, or purity assays.
The quality team also ensure regulatory compliance is maintained across all GMP and GLP facilities. A major component of the end-to-end service provided by the GTVF is the support around regulatory submissions (CTA and IND). This makes the GTVF very much a one-stop shop for supporting its clients on anything they may need all the way to batch release, and the clinic.
Partners
The KCL is part of the London Innovation Hub for Gene Therapies (London IHfGT). This is a new UK initiative designed to advance the clinical development of new genetic treatments through the production of GMP (Good Manufacturing Practice) viral vectors. Our funders are detailed below alongside the IHfGT website.
Medical Research Council
Biotechnology & Biological Sciences Research Council
LifeArc
Contact us
Get in touch to discuss your lentiviral vector, retroviral vector, and adeno-associated viral vector GMP manufacturing needs: