The cell and gene therapy catapult review of MHRA licensed GMP manufacturing facilities in the UK provides an insightful picture of the capability and capacity of cell and gene therapy manufacturing facilities that are open for collaboration. Initially a one-off review in 2013, this review is now an important annual undertaking
It is important to provide some background and context to the methodology behind the report and its data. The aim is to collect and summarise information on each of the MHRA-licensed manufacturing sites in the UK with GMP capacity accessible to the market and in particular, the technical and quality capabilities at each of the facilities, alongside predictions of their available operational capacity. All facilities were contacted for updates with regards to their capability and capacity.
The report covers 23 facilities in the UK which have a total cleanroom footprint of ~5,100m2. This network of facilities, supported by a strong workforce, is expected to continue to grow year on year, indicating that the UK is perfectly placed to service cell and gene therapy pipelines and provide a platform for continued sector growth.
Summary of results
The report contains detailed results, as well as an in-depth profile of each of the 23 sites individually. A summary of the findings is discussed below.
In 2017, the number of facilities increased by one – the addition of the NHSBT facility at Filton – giving a total of 23, which can be further categorised into 13 dedicated cell therapy sites, six dedicated gene therapy sites and four multifunctional sites.
There are also some geographical and regional observations. London has an equal number of cleanrooms compared to the remainder of South England. However, the total footprint in the South of England is significantly higher – more than twice the size. This feature demonstrates the dominance of early translational facilities in London compared to commercial facilities located outside of the Capital. The cleanroom footprint for the Midland and Northern regions are comparable to London.
The addition of the Filton site and expansion of pre-existing facilities of King’s College, Oxford Biomedica and Roslin Cells has driven growth in both total building footprints and cleanroom footprints by around 6% and 19% respectively.
So, how does this fare between cell therapy and gene therapy specialist sites? Over 50% of the total cleanroom operational space is dedicated to gene therapy (~2,951m2) whilst the dedicated cell therapy footprint is ~1,300 m2. Multi-functional facilities manufacturing both cell and gene therapies have a footprint of ~895 m2. Over 90% of the gene therapy capacity is commercially owned space with the remainder distributed between UK academia and the NHS.
The table below summarises the cleanroom footprint in the UK for cell and gene therapies.
Capacity and expansion
The UK cell and gene therapy industry continues to expand at a rapid rate and the cell and gene therapy manufacturing sector provides an important opportunity for economic growth. Spare manufacturing capacity is essential for this prospective growth within the sector, therefore predictions of available operational capacity in UK manufacturing centers is also compiled.
National booked capacity is running at 71% for cell therapy and 77% for gene therapy (including multifunctional facilities), compared to 76% and 84% for 2016. This reduction in booked capacity is likely indicative of projects at these sites coming to completion, freeing up capacity for new project cycles.
There are several planned expansions and new facilities identified across the UK. The opening of the Cell and Gene Therapy Catapult manufacturing centre will further enhance the existing manufacturing network and facilitate the largescale manufacture and initial commercial supply of cell and gene therapies.
Thoughts from Cell and Gene Therapy Catapult CEO, Keith Thompson
To support this burgeoning research and development, manufacturing and infrastructure continue to keep pace, with the size of the UK’s GMP licensed manufacturing space increasing year on year by nearly 20%, and further expansions on the horizon for 2019. By providing these facilities, the UK is well placed to service this exciting cell and gene therapy pipeline, and provide a platform for continued UK growth into these complex and technically challenging therapies.