Overview
The King’s College London Gene Therapy Vector Facility (GTVF) provides cutting-edge solutions in manufacturing, process development, and quality control to support your cell and gene therapy programs.
- Manufacturing – Scalable GMP-grade manufacturing of LV, RV, and AAV as either drug substance or drug product.
- Process Development – Custom solutions from engineering batch manufacturing to plasmid optimization, bespoke assay development, and tailored process innovations.
- Quality Control – Comprehensive in-house and outsourced QC testing, along with shelf life, and in-use stability studies.
- QP Release available
We understand the financial challenges of early-stage clinical trials, which is why our competitive pricing enables both grant funded and commercial groups to bring their therapies to the clinic without being hindered by commercial price tags.
GMP facilities, available for the manufacture of:
Lentiviral Vector
Retroviral Vector
Adeno-Associated Viral Vector
Infrastructure
GMP Cleanrooms
The GTVF holds four 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.
Our significant GMP lab space enables concurrent manufacture of GMP viral vector. Combining extensive cleanroom space with a large team of ~60, 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.
Manufacturing Science and Technology (MSAT), Process Development (PD) and Quality Control (QC)
The GTVF has established MSAT, PD and QC labs to enable end-to-end project support to be provided.
MHRA Manufacturing Licenses:
- Investigational Medicinal Products (IMPs) - for use in clinical trials
- Specials (manufacture & import of unlicensed medicines)
Quality Assurance
The GTVF has a large in-house QA team made up of 9 experts. This team collaborates with all other teams to ensure that facilities, processes and projects remain compliant under our MHRA license. In particular, our QA team will be on hand throughout the project lifecycle to ensure that a project is manufactured in a way that enables eventual batch release, for example helping the client in identifying a suitable QC testing regime based on where their trial will take place. The GTVF has its own QP who is on hand to support with batch release. At the end of a project, the QA team will provide data to the client for completing relevant sections of the IMPD for drug substance/drug product.
Get In Touch
Contact us to discuss your lentiviral vector, retroviral vector, and adeno-associated viral vector GMP manufacturing needs: