Cell and gene therapy (CGT) is an experimental space that has grown exponentially in recent years; the sector received nearly $20bn in funding last year, a 50% increase on the record $13.5bn it saw in 2018.

The clinical potential of these advanced therapies is clear, and has already been demonstrated in several cases. Removing cells, proteins or DNA from patients or donors allows this material to be re-engineered and reinfused into patients, providing highly personalised, often single-dose treatments that have long-lasting therapeutic effects, offering the prospect of disease-modifying or even curative impacts in tricky indications.

In the last few years the first crop of CGTs has begun to emerge, often with eye-watering price tags attached. Novartis’s gene therapy Zolgensma – the most expensive drug in the world – targets the genetic basis of spinal muscular atrophy, while Luxturna, which Novartis licensed from Spark Therapeutics in January 2018 for markets outside the US, delivers the functional copy of the RPE65 gene to improve vision and block progressive sight loss, and has been FDA-approved since December 2017.

CAR-T cell therapies such as Novartis’s Kymriah and Gilead’s Yescarta, meanwhile, have emerged as premium one-dose options for the precision treatment of aggressive forms of leukaemia and lymphomas.

Help wanted: the CGT skills gap

While the impressive investments of the last few years have allowed the CGT space to evolve, its rapid growth has led to a skills gap that’s hindering the delivery of much-needed therapies to patients.

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Less than a decade ago, the number of workers recorded in the advanced therapy field in the UK was a mere 500. According to a report by the country’s Cell and Gene Therapy Catapult (CGT Catapult), the UK’s workforce headcount in the field is now predicted to double from over 3,000 in 2019 to more than 6,000 in 2024. Despite this, the increased demand for skilled personnel in such a quickly evolving industry has become a significant obstacle for cell and gene therapy companies, with manufacturing reported as the skill area of greatest concern.

Project Farma is a consulting firm that provides biomanufacturing strategy and execution for the life sciences industry. The company’s director Phil Massey says “demand is outstripping supply in every sort of functional area” in the CGT field, which has seen a “paradigm shift” in recent years.

“In other disciplines like biologics or small molecules, the manufacturing is now a known commodity,” Massey explains. “We have facilities utilising established technologies such as large stainless-steel bioreactors and there is a great deal of automation already established.

“Switch to cell and gene therapy, where it’s personalised, or there are a lot of manual manipulations. The field just started to become industrialised about five years ago, and the manufacturing process is slower and less automated than the aforementioned other disciplines.”

The manufacture of cell and gene therapies – which can be highly personalised to patients and often target rare, hard-to-treat diseases – is a largely manual process that requires numerous skilled workers. The complexity of CGT manufacturing operations means that if companies are to scale up production and deliver therapies on a commercial level, a sizeable labour pool and extensive facilities are a must.

“Many of these therapies are personalised in nature,” Project Farma’s senior manager Daniel Foody says. “The batch sizes are so small that sometimes it doesn’t make sense to build a facility and do your own manufacturing.

“The manufacturing process is also more manual and labour-intensive. Therefore, different aspects of the manufacturing process become more challenging and require an enhanced level of monitoring and control.”

Scaling up UK skills capacity in CGT

In addition to the industry’s growing need for skilled professionals and capable facilities, the CGT Catapult’s report also revealed that advanced therapy medicinal products (ATMP) clinical trials across the UK rose by 20% last year, constituting an impressive 12% of all cell and gene therapy trials worldwide. The US has seen similar growth in the space; of the more than 1,000 cell and gene therapy developers worldwide, half are located in the US.

With the UK and US currently leading global CGT innovation, these regions are seeing the greatest demand for skilled workers – and, as a result, have launched a number of initiatives designed to tackle the issue.

The UK government’s continued investment in cell and gene therapy is a clear indication of its commitment to making Britain a world leader in the space. The Advanced Therapies Apprenticeship Community, launched in 2018, is the first apprenticeship programme designed specifically to train individuals in developing, manufacturing and delivering cell and gene therapies. Established by the CGT Catapult using £1.5m of funding from the government-backed Industrial Strategy Challenge Fund, the programme has so far seen 137 apprentices enrolled in courses across the UK.

In December, the CGT Catapult also launched the Advanced Therapy Skills Training Network (ATSTN). The network aims to expand the UK’s expertise in ATMP and vaccine manufacturing by both upskilling those already in the industry, and helping individuals enter the sector by assessing their transferrable skills and providing access to training. The ATSTN consists of an online training platform, national training centres and a career converter, which allow users from both inside and outside the industry to curate job matches based on their current skillset, and identify the training needed to progress in that field.

Developing the US CGT playbook

Across the pond, Project Farma is dedicated to advancing ATMP manufacturing capabilities in the US. The company created an Advanced Therapy Manufacturing Playbook, encompassing its experience and expertise in cell and gene therapies, to help companies successfully take ATMPs from production to commercialisation.

Massey adds that an initiative known internally as ‘PF University’ offers training and upskilling to existing Project Farma staff and external partners.

“We have put a significant investment into the training and development of our team,” he says. “We even have our own equipment. This allows our staff to get hands-on training and it comes in handy if we need to train our external partners on something like process validation, for example.

“We’re always learning and staying current on industry trends in such a rapidly changing environment – we have developed playbooks, templates, libraries through our years of experience. These have been critical for our teams and partners to springboard from, where speed to market is so critical for these life-saving therapies.”

Project Farma is also part of Precision ADVANCE, a collective formed by parent company Precision Medicine Group to provide cell and gene therapy companies with clinical, manufacturing and commercialisation solutions. Foody says Precision ADVANCE is a collection of teams and individuals with extensive CGT experience for “an industry that is talent-constrained”.

“Our goal is that ADVANCE will help provide therapeutic developers the resources they need in all major development areas, including clinical, manufacturing and commercialisation,” he says. “ADVANCE will accelerate development of these critical medicines from academia to the patient.”

The fact that many CGT companies form out of academia provides a valuable opportunity for the industry to partner with academics, and combine commercial know-how with scientific expertise, Massey says.

US academic institutions nurturing talent in the CGT sector include North Carolina State University, whose Biomanufacturing Training and Education Center offers opportunities to those seeking a career in the biomanufacturing industry, and the California Institute for Regenerative Medicine, which provides expertise and operational services to both academics and companies through its Cell and Gene Therapy Center.

A bright future ahead?

While the CGT sector has significant hurdles to overcome, growing investment in the space suggests it’s on track to revolutionise personalised and rare disease medicine. As the sector develops, new innovations are streamlining the advanced therapy manufacturing process in tandem with efforts to grow the workforce.

“There has been innovation in cell and gene therapy manufacturing like single-use, disposable, flexible, cleanroom and bioreactor technologies,” Massey says. “These have impacted the design and layout of facilities, whether it is retrofitting an existing facility or scaling up a greenfield facility.”

Both Massey and Foody are optimistic about the future of the sector, and the ground-breaking therapies it could bring to patients.

“Right now, there have only been a handful of treatments for rare diseases that have been commercialised, and many more will be in the upcoming years,” Foody says. “I think these are going to catapult a shift from not only rare or ultra-rare diseases, to diseases with larger patient populations. I’m confident we’re building a strong foundation today with these revolutionary medicines, so I think the future’s quite bright.”

Massey is equally positive. “I’m really optimistic, moving forward, that we’re going to get some of these life-saving and life-changing therapies to the patient more efficiently and quickly,” he says. “I think we have a lot of challenges ahead of us as an industry, but we have proven that even during a pandemic the life science industry can overcome any obstacles. I’m looking forward to an exciting next few years and beyond.”

Cell & Gene Therapy Coverage on Pharmaceutical Technology supported by Cytiva.

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