The Cell and Gene Therapy Catapult’s UK cell and gene therapy GMP manufacturing survey has been carried out every year since 2014 to identify the national capability (technology and expertise) and available capacity (GMP facilities and associated quality requirements) for manufacturing cell and gene therapies
CGTC GMP Manufacturing Report 2023
Chief Manufacturing Officer, Stephen Ward, reflects on the launch of the 2023 GMP Manufacturing Report and discusses some of its key insights.
About the GMP Manufacturing survey
The first manufacturing survey was conducted following the House of Lords Committee’s recommendation of an annual stocktake into Regenerative Medicine manufacturing. A yearly review of the national capability and spare manufacturing capacity for these advanced therapies is essential for the prospective growth and investment within the sector.
The Manufacturing Survey aims to provide an overall picture of the capability and capacity of MHRA licensed cell and gene therapy manufacturing sites in the UK. Amongst other elements, the report highlights:
- Total manufacturing cleanroom footprint (including MALs and PALs)
- Total in-house QC footprint
- CRO capabilities
- Total number of full-time employees (including production, QA, QC, warehouse, and engineering staff only)
- Track record of experience (types of cells and/or viral vector/plasmid DNA and manufacturing processes)
- The distribution of the capabilities, footprint, and staff based on the geographical location of the facilities (London, Southern England (non-London), Midlands and Northern England and Scotland) and the product type (cell therapy, gene therapy or multifunctional)
- Predictions of the available manufacturing capacity at the facilities in 2023 and 2024