The King’s College London Gene Therapy Vector Facility (GTVF) hosts four MHRA accredited, fully equipped production cleanrooms for GMP vector production, with plans to open more in the coming 12-24 months. Our capabilities include Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-associated Viral Vector (AAV) production for early phase clinical trials. The GTVF also offers expertise in process innovation, knowledge transfer, and training to address critical skill shortages.
GMP facilities, available for the production and development of:
The production team currently makes use of a transient production/transfection system, using adherent cells with multi-layer cell factories. The system is validated and has been used in the production of >100 GMP batches of lentiviral vector and retroviral vector. The AAV platform will also initially make use of an adherent cell line system.
With ongoing process development, the teams will look to scale up our processes by incorporating suspension lines and adherent/suspension bioreactor technology as production options, with a view to enable clients to be even more productive in early-stage clinical trials, getting more valuable data.
Production Process
The GTVF adopts a highly flexible model, enabling us to adapt to client requirements with:
The GTVF takes ownership of all aspects of your viral vector manufacture, including some or all of the following activities:
Plasmid sourcing (as needed)
Assay validation and development
Small-scale R&D grade engineering batches
Large-scale R&D grade engineering batches
Large-scale GMP batches
QC release testing and batch release
Regulatory support
Project Management
Plasmid Supply
The GTVF can provide plasmids, including supplying helper plasmids as needed and having all plasmid manufactured to the correct grade. Alternatively, clients can provide their own plasmids if preferred.
Cleanrooms and Licenses
GMP Cleanrooms
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 soon Adeno-associated Viral Vector (AAV) production.
Specifically, the GTVF has four active, fully equipped production cleanrooms which 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, and work to their timelines. Over the next 12-24 months, further brand new, fully-equipped independent cleanrooms are to be opened which will further enhance available capacity for client projects, and bring down lead times.
MHRA Manufacturing Licenses:
Investigational Medicinal Products (IMPs) - for use in clinical trials
Specials (manufacture & import of unlicensed medicines)
Client-base
The GTVF works with pharmaceutical companies, biotechs and academic groups, all with a focus on early-stage clinical trials. Being an academic based vector manufacturer, with the backing of the large and renowned King’s College London, and a small-scale focus, we are able to offer highly competitive pricing compared to larger scale suppliers. In addition, with 4 of our own GMP cleanrooms, and more coming in 12-24 months, we have fast timelines, backed up by a huge 50+ person team with >100 GMP batches worth of experience. We work with the UK, Europe and USA routinely.
Tech Transfer
The GTVF can help mediate tech transfer both in and out of the facility at the beginning and end of projects. For later stage clinical trials, the GTVF routinely tech transfers processes out, so that later, larger scale production can be carried out by alternative suppliers or clients in-house facilities.
Get In Touch
Contact us to discuss your lentiviral vector, retroviral vector, and adeno-associated viral vector GMP manufacturing needs:
