Cell and gene therapy: manufacturing and talent trends 2023

To find out about the current trends in cell and gene therapy manufacturing, EPR spoke to Cell and Gene Therapy Catapult (CGT Catapult)’s Chief Manufacturing Officer, Stephen Ward, and Chief Business Officer, Jeanette Evans. They highlighted key data from the organisations recently published good manufacturing practice (GMP) Manufacturing Survey and Skills Demand reports, which focus particularly on the UK’s landscape.

Cell and gene therapy industry in 2023

According to data from the GMP Manufacturing Survey, in the past year: “There is an increase in the number of manufacturing organisations and the number of licensed facilities has remained stable. The size of the workforce continues to grow; a consistent trend over the last five years, while cleanroom footprint remains stable compared to 2022.”

In terms of talent within the sector, the report highlighted that compared to 2022, there has been “a 20 percent increase in the number of full-time employees, with the largest percentage increase being in the East of England. Continued growth in the workforce is crucial to ensure that the industry has access to skilled talent with the experience and knowledge needed to manufacture complex advanced therapies safely, efficiently and at scale.”

Looking ahead to the next twelve months, several significant manufacturing projects in the UK are planning to become GMP operational. For example, the GMP report stated that the contract development and manufacturing organisation (CDMO) eXmoor pharma, will be launching a cell and gene therapy process development and clinical manufacturing facility in Bristol. Licensing of the manufacturing suites is expected in early 2024.

The cell and gene therapy CDMO bottleneck isn’t capacity – it’s capability

Advanced therapies landscape – past and present

Reflecting on the past several years, Ward shared how the advanced therapy manufacturing sector has evolved. It has had good steady growth in terms of manufacturing capacity and capability, he remarked. “We have seen a growth out of more academic science establishment phases into more commercial phasing organisations. So now we have a really nice blend.”

Currently, there are 28 facilities which are licensed for advanced therapy manufacturing in the UK, Ward elaborated. “There is a 50/50 split, with 14 of which are academic and NHS, and there are 33 individual licensed sites… 11 licenses are dedicated to gene therapy, 15 are licenses dedicated to cell therapy, and seven of them are multifunctional.”

“But what you will see is the number of people employed and the size of the cleanrooms and the facilities that are utilised in the commercial space obviously outstrip what is in the academic space, which is what you would expect.”

For therapeutic modalities, there has been a huge explosion globally on viral vector capacity of the last several years, according to Ward. “What we are now seeing is that companies who were able to do multimodal facilities… some of them are now specialising in cell therapies because they can see there is a need for more focus [in] cell therapy manufacturing because there is a large capability globally now as well as in the UK for viral vector production.”

Challenges and solutions in cell and gene therapy manufacturing

On the major challenges in the field, Ward shared that over the past decade, there has been “an ever increasing conversion to automated processes.”

The reason he explained, is that while “inevitably, people have to do some manipulative work on cell processing… we need to be making manufacturing more efficient, more cost effective and be able to make it more productive… I think that is the challenge for the immediate years ahead.”

He stated that one solution is flexible platforms and flexible facilities. “These can allow companies to access higher density production environments and systems”, as well as pushing GMP clinical trials forward.

Workforce: cell and gene therapy industry

Recruitment

Evans shared that one of the key findings of the Skills report was that there has been a “significant increase” in the workforce within the advanced therapeutic medicinal product (ATMP) sector.

The report identified that “while the size of the workforce has approximately doubled from 2019 to 2023, this rate of growth is predicted to slow, but companies are still forecasting overall employment to grow by 63 percent over the next five years.”

Evans added: “We are recognising, particularly from a UK perspective and the report demonstrates this, is the level of investment in the cell and gene therapy space. In the development pipeline, there are over 114 clinical studies ongoing at the moment… and means there will be a future demand within the skills space.”

Skills

Particularly, “expansion of the current skills offering and the investment of the skills to make sure people are ATMP manufacturing ready, is something that is seen as a key need and identified within the Skills report.”

Evans also noted: “one thing that we recognise from the skills perspective is the offering and the diversity of the skills. ”Programmes available to industries are a little bit diverse and convoluted, and Catapult is [hoping] to look at ways [to] simplify the process and provide easy access to various skills trainings programmes.”

For example, these are apprenticeship and graduate schemes as well as career converters, Evans explained.

“Ultimately, this would support the growth of the ATMP sector and make sure that the industry has the appropriate skills across the whole of the infrastructure, whether it is academic research, all the way through from R&D, clinical trials and also well into medicines manufacturing.”

Future growth of the ATMP sector

Ward highlighted a key change in the recruitment space. Based on the survey, he stated that the Skills report found that people have qualitative responses around where they feel it is a problem to hire and where they see that as a growing problem. Specifically: “digital skills are coming through as a growing concern for businesses”.

Looking onward to 2028, the Skills report predicted that, out of a total 81 percent within the cell and gene therapy industry, roles will span support services, R&D and discovery, and bioprocessing. Within this, fifty four percent will fall into the latter category. The 2023 data found that the split for bioprocessing roles was 57 percent.

“This is the first time we have seen this, people starting to flag commercial experience. So, it shows how the industry is developing into a more commercially astute sector, not led by the science, perhaps where it was ten years ago, but ever growing into a more ‘how do we become successful businesses and sustainable businesses?’”

However, for the near-term, Evans reflected that the recent Autumn statements from the UK Government were “fairly promising for manufacturers”. She highlighted several examples: the discussion of fully expensing of capital investments for manufacturers as well looking at some enhancements of R&D tax credits.”

Overall, as summarised in CGT’s GMP Manufacturing report, among a challenging global economic landscape, intense global competition and technology innovation persisting at the forefront of change in the cell and gene therapy industry, immediate action is needed to support the future of the sector.