Adeno-Associated Viral Vector Manufacturing
The King’s College London Gene Therapy Vector Facility (GTVF) hosts four MHRA accredited, fully equipped production cleanrooms for GMP vector production. The GTVF is opening brand new GMP production cleanrooms dedicated to AAV manufacture and expects to be GMP operational in the next 12 months.
Although AAV is a new capability within the GTVF, it has been active in LV and RV manufacture for nearly 20 years, and the team is building on the extensive AAV knowledge and experience of our Centre Director Professor Robin Ali, who has been involved in academic and commercial AAV supply for many years.
End-to-End Project Support
The GTVF takes ownership of all aspects of client viral vector manufacture.
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
The AAV team has developed a single use, low bioburden, low endotoxin manufacturing platform in adherent bioreactors. The manufacturing process can be adapted to the client's serotype of interest. Please enquire for more information.
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 to provide QP release certification for GMP viral vector.
Get In Touch
Contact us to discuss your lentiviral vector, retroviral vector, and adeno-associated viral vector GMP manufacturing needs: