A recent report by the American Society of Gene & Cell Therapies stated that it is likely that 75 new therapies will be approved sooner than 2030.

Yet, the sector is facing a dearth of experienced biomanufacturing staff for advanced cell and gene therapies (CGTs) that has led to an increase in outsourcing.

BioPlan Associates’ 20th Annual Report and Survey of Biopharmaceutical Manufacturing found that 51.3% of the industry is experiencing critical manufacturing staff shortages—a figure that has more than doubled in three years, from 21.2%. 

Professor Ivan Wall, Head of the Center for Advanced Therapies Manufacturing Training at the University of Birmingham in the UK, provides further context and commentary on the skills shortage, how the industry needs to take more action to ensure future patient delivery, and how advances in technology will provide training solutions to save the gains in the CGT sector.

Contract Pharma: How severe is the skills shortage in CGT manufacturing facilities?

Ivan Wall: There have been a number of independent reports from across international governments and across the biopharma and cell and gene therapy industries over the last 7-8 years that describe the skills shortages across a variety of roles. These have increased in magnitude over time, correlating with increased clinical trials progress and market approvals of new CGT drugs. The CGT Catapult reports provide up-to-date information from survey participants but I think even these numbers don’t reflect the full extent of the shortage, because we are seeing competition from new sectors, such as cultivated meat, for the skills in cell culture scale up, analytics and quality that are front and center in manufacturing. The last estimate from CGT Catapult was ~8000 new manufacturing/quality roles by 2026.

Contract Pharma: What are some of the causes of the shortage?

Ivan Wall: In the UK, there are a relatively small proportion of science and specifically biology graduates attracted to manufacturing careers, even though a significant proportion from across the higher education continuum would be a good fit. Competition for these graduates from emerging sectors such as cultivated meat is only going to further increase pressure, as graduates seek alignment to socially and environmentally conscious careers. In addition, in the UK, there has been reduced mobility in EU talent in recent years and new hires from EU are now subject to UK Government Home Office license rules and visa requirements. Salary levels are also higher in places like the U.S., which also diverts talent to the North American continent. Finally, there is the issue of staff turnover. I’ve spoken in the past with companies where staff turnover can be 30-40% in some roles. Some of these losses will move to other companies in the sector so the sector overall benefits even if the individual company doesn’t. However, there is a significant group of people that will be leaving the sector and moving onto other careers for good.

Contract Pharma: What are some of the challenges the industry faces as a direct result of the skills shortage?

Ivan Wall: One of the biggest issues is workforce resilience. CGT manufacturing teams are still relatively small compared with other industries. Not being able to grow teams fast enough is going to affect productivity, and this is hampering the delivery of therapies to patients now, never mind when therapeutic approvals are moving into wider indications. In addition, there is huge time and cost in training someone in GMP. In the UK this can take up to 12 months and cost £100,000 per person. Losing that member of staff cannot just waste that time and cost, but also result in a loss of momentum, which if repeated can spread out across the sector. 

Contract Pharma: What are countries, governments, and organizations doing to address the CGT skills gap?

Ivan Wall: A number of countries have now recognized and started to discuss interventions to the CGT and CGT manufacturing skill shortages. In the UK, there has been a drive to establish new training programs, apprenticeships, reskilling of people from other sectors and outreach to schools to inspire the new generation in STEM. We are also working hard to address equality, diversity, and inclusion in the sector because there is huge opportunity to build resilience by increasing accessibility to careers by people who do not usually enter the sector. At the Center for Advanced Therapies Manufacturing Training, University of Birmingham, we are trying to increase career awareness and access by people from different social, ethnic, and educational groups. For example, we undertake outreach to further education colleges where students on vocational courses such as T-levels will bring the technical/hands on skills needed in manufacturing operations. In addition, the University of Birmingham is using virtual reality technology from FourPlus Immersive to teach some of the core skills needed for GMP cleanroom operators make new career entrants ‘workplace-ready’ and to reduce the training time and costs.

Contract Pharma: How will virtual reality and other technologies help address the skills shortage problem?

Ivan Wall: The University of Birmingham’s Center for Advanced Therapies Manufacturing Training is using virtual reality technology from FourPlus Immersive to teach some of the core skills needed for GMP cleanroom operators to make new career entrants ‘workplace-ready’ and to reduce the training time and costs. We are also using FourPlus VR to show what ‘a day in the life’ looks like for manufacturing operators with a free software called Proteus, available for Meta Quest (www.fourplus.co.uk).