Retroviral Vector Manufacturing
The King’s College London Gene Therapy Vector Facility (GTVF) hosts four MHRA accredited, fully equipped production cleanrooms for GMP viral vector production. Two additional cleanrooms are currently under construction to further boost capacity. The GTVF has established quality control, MSAT and process development labs to enable the provision of end-to-end project support.
End-to-End Project Support
The GTVF takes ownership of all aspects of client viral vector manufacture.
Plasmid Supply
The GTVF has packaging plasmids available for use as needed and has qualified suppliers to manufacture plasmids to the required grade. Alternatively, clients can provide their own plasmids if preferred.
Manufacturing Science and Technology (MSAT) & Process Development (PD)
Our dedicated PD and MSAT teams provide up-front development work to set client projects up for success.
- Establishment of qualified platform manufacturing process
- Manufacture of engineering batches at scale requested
- Provision of GMP-identical material for pre-clinical work
- Plasmid assessment, procurement and ratio optimisation
- New assay development, e.g. bespoke titre assays
- Ability to develop new manufacturing process for bespoke projects
GMP Production
- Platform manufacturing process available - adherent, transient transfection, cell factory system
- Manufacture of drug substance or drug product
- Titre capabilities sufficient for the most ambitious early-stage clinical trials
Quality Control (QC)
- Validation and execution of selected in-house QC testing
- Management of any outsourced QC testing
- Management of shelf-life and in-use stability studies
Quality Assurance (QA)
- Maintenance of regulatory compliance across all GMP and R&D activities
- Management of all required documentation to enable QP release
- Support with regulatory submissions
QP Release
The GTVF has its own QP's to provide QP release certification for GMP viral vector.
Get in touch for more information using the link below
Production and development services also available:
Get In Touch
Contact us to discuss your lentiviral vector, retroviral vector, and adeno-associated viral vector GMP manufacturing needs: