A new course launched by the Cell and Gene Therapy Catapult (CGT Catapult) and University of Hertfordshire is set to address skills gaps in the manufacture of cell and gene therapies as the industry progresses towards manufacturing at scale.

Developed jointly by the two organisations, the three-day course will provide theoretical and practical training on the aseptic manufacturing of cell and gene therapies, in line with European regulatory guidance for good manufacturing practice (GMP).

The cell and gene therapy industry in the UK currently supports over 3,000 jobs, a six-fold increase since 2012, and employment in the sector is set to more than double by 2024 as more therapies progress towards commercialisation.

The rapid growth of the industry is thanks, in part, to the Cell and Gene Therapy Catapult Manufacturing Centre, located in the Life Sciences Opportunity Zone in Stevenage and which provides the facilities needed for large scale clinical studies and commercialisation. In 2018, Hertfordshire LEP helped the Catapult secure £3.36m funding from the European Regional Development Fund (ERDF) to support further expansion of the manufacturing centre and provide additional support to growing cell and gene therapy companies. A further £2.9m Local Growth Fund (LGF) investment from the LEP in 2019 enabled the delivery of new analytical technologies for quality control to accelerate the development of their manufacturing processes.

Growth has also been accelerated by the Hertfordshire Science Partnership (HSP), which allows small businesses to set up knowledge exchange partnerships and access unique services including a research hotel and science concierge. HSP was set up by the University of Hertfordshire to boost the dynamic life sciences, pharmaceutical, and agri-tech sectors in the East of England, and supported by a £2.5 LGF investment from the LEP as well as help to secure an additional £1.45m from ERDF.

Keith Thompson, Chief Executive Officer, Cell and Gene Therapy Catapult said: “There is an accelerating demand for skills in the UK cell and gene therapy industry as employment, manufacturing space and the number of ongoing clinical trials increases year on year. We are delighted to collaborate with the University of Hertfordshire in developing this new initiative which will support professionals and apprentices working in the manufacturing of advanced therapies. By providing training on GMP quality standards which are vital to the manufacture of cell and gene therapies, we are furthering our mission to fuel the continuing growth of the industry.”

With cell and gene therapies being transformative and potentially curative living medicines, it is vital that manufacturing processes are safe, efficient and able to preserve their effectiveness. The new training programme is designed for staff working in cell and gene therapy manufacturing, with demand for manufacturing and bioprocessing roles tripling in the past two years alone. Participants will be trained to use state-of-the-art facilities and will be awarded a University of Hertfordshire accredited certificate upon successful completion of the training, contingent on assessments of their knowledge, understanding and practical skills.

Dr Salman Rahman, Commercial Lead in the School of Life & Medical Sciences, University of Hertfordshire said: "Through our partnership with The Cell and Gene Therapy Catapult including consultation with leading biotech companies developing new cell and gene therapies, together we have created this bespoke course that provides comprehensive training for practitioners working in Advanced Therapy Medicinal Product manufacturing. Students on the course will be taught theoretical knowledge including principles and operational aspects necessary for aseptic manufacturing of cell and gene therapy products in line with European regulatory guidance, complemented by practical learning experiences in state-of-the-art clean room facilities."

To learn more, please visit ct.catapult.org.uk and herts.ac.uk