The report from CGT Catapult, a center of excellence set up to support the expansion of the UK cell and gene therapy industry, shows growth across several developmental indicators including facilities, manufacturing space, and personnel.
The report is the seventh in the CGT Catapult’s series of annual survey reports on the status of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) MIA and MIA (IMP) licensed ATMP manufacturing facilities. It provides up-to-date metrics on the capability and capacity of MHRA-licensed cell and gene therapy manufacturing facilities in the UK, covering the growth in both industrial centres, including CDMOs and facilities for in-house product manufacture as well as early-stage translational centres in the academic and public sectors.
This year’s growth is particularly noteworthy given the effect the COVID-19 pandemic has had across the entire UK economy, said the authors of the report.
The numbers indicate that the industry is maturing at a promising rate, reflected in company expansions such as that of Oxford BioMedica and Cobra Biologics, finds the review.
Commercially-owned spaces are making significant increases across the country, with 10 companies now delivering their own GMP pipelines. 96% of the gene therapy space is commercially-owned, signalling that the industry is maturing and developing a healthy economy, said the authors.
Manufacturing space
Since November 2019, the manufacturing space in the UK sector has increased by 48% (from 7,970 m2 in 2019 to 11,756 m2 in 2020) through the addition of Oxford BioMedica’s third facility in Oxford – Oxbox - for commercial manufacturing of viral vectors, the expansion at Cobra Biologic’s pre-existing facility in Keele to enable the company to expand its clinical and commercial viral vector services as a CDMO, and the enhancement of CGT Catapult’s facility in Stevenage, creating six additional cleanrooms for companies to manufacture their own products.
The growth is occurring chiefly in the expansion of existing sites. The report shows that the total number of UK licenced facilities has remained at 26, despite the addition of the Oxbox manufacturing centre, as the University of Manchester's cleanroom facility recently closed and that resulted in the loss of cleanroom space for the manufacture of pluripotent stem cells.
The network of 26 facilities in the UK, operated by 21 organisations, comprises 11 dedicated cell therapy sites, eight dedicated gene therapy sites, and seven multifunctional sites. Of those 26 facilities, 11 are commercially-owned – including two with commercial production (MIA) licences – Oxford BioMedica and CGT Catapult Stevenage; 15 facilities are distributed between early-stage translational centres in the academic and public sectors.
The cleanroom footprint of industrial facilities has grown significantly - at over 164% the last three years, as per the new data.
There has also been an increase in product-pipeline manufacturing space, operated by 10 cell and gene therapy companies, according to the publication.
At CGT Catapult Stevenage – Achilles, Adaptimmune, Autolus, Freeline, and TCR2 are producing their own products whilst Allergan, Oxford BioMedica, Meira GTx, Instil Bio UK (formerly Immetacyte), and TC Biopharm operate their own stand-alone facilities for their pipelines.
Some 57% of the total cleanroom operational space in 2020 was dedicated to gene therapy, whilst the dedicated cell therapy footprint was 13%, shows the review. Multi-functional facilities manufacturing both cell and gene therapies comprise 30% of that total footprint.
The regional split of the total cleanroom facilities shows that the majority of the cell and gene therapy manufacturing activities are still located in Southern England (non-London) (51%), followed by Scotland (20%), Midlands and Northern England (16%) and London (13%), said the authors.
Finally, demand is outstripping supply with both cell and gene therapy facilities operating at a national average of 86% utilization, yet further capacity is being developed with over 700 m2 of additional total footprints expected to be licensed during the next 12 months, they added.
Growth but boost needed in skilled staff numbers
In terms of skilled staff availability, the data illustrates that there are 1,310 full time personnel reported this year, demonstrating a 15% increase compared to 2019.
However, as major investments in facilities and manufacturing capacity in the UK continue, the review stresses the need for a significant increase in the number of highly skilled jobs required to service the industry in the coming years.
And, in that context, CGT Catapult also announced last week the launch of the Advanced Therapies Skills Training Network (ATSTN), an initiative designed to encourage the take-up of roles in the advanced therapy and vaccine manufacturing industry by assessing candidate's transferrable skills and providing access to training.
The ATSTN initiative is funded to the tune of £4.7m (US$6.2m), which was awarded by the UK Department for Business, Energy & Industrial Strategy (BEIS) through UK Research and Innovation (UKRI), as part of its commitment to expanding the UK expertise in advanced therapies.