For years we’ve talked ad nauseam about the shortage of qualified Science, Technology,
skills gap
Engineering and Mathematics (STEM) graduates and seen numerous – often extremely expensive – programmes initiated to encourage young people into STEM education. However, a recent study from the University of Leicester and the University of Warwick, funded by the Nuffield Foundation, suggests we might be focusing our efforts on the wrong problem: that it’s not a lack of STEM graduates that’s the problem for most industries, rather it’s that STEM graduates choose not to, or are unable to, find work in scientific industries like life sciences.
Is this because there are more attractive careers in an increasingly competitive job market? Or is it a more serious, structural problem, where the STEM education provided by universities and colleges is not adequately preparing students for a career in life sciences?
In this interview, professor Ian Marison, founder and CEO of the Biofactory Competence Center (BCC), and Dr Peter Levison, executive director business development at Pall Corporation, spoke to European Pharmaceutical Manufacturer about the most pressing challenges facing industry, how changes have caused a skills shortage and the steps both higher education and industry need to take to resolve this growing problem.
How has pharmaceutical manufacturing changed and what trends are you seeing emerge?
PETER: The most recent and significant transformation in pharmaceutical manufacturing has been the shift from batch processing to continuous manufacturing, whereby a batch of product no longer needs to go through each sequence stepwise. Instead, it flows through the process until complete. While continuous manufacturing has been used by the pharmaceutical industry for some time, tableting being one example, we are starting to see more applications in biopharmaceuticals, including in gene therapy manufacture.
IAN: Gene therapy is definitely one of, if not the biggest trend in biopharmaceuticals. Increased demand for these breakthrough treatments will require a seismic shift in production to meet rising demand and, ultimately, make treatments more cost-effective. The Food and Drug Administration (FDA) predicts that in 2020, it will see more than 200 applications a year for cell and gene therapy trials; by 2025, they will approve up to 20 therapies a year.
How will gene therapy production differ from traditional manufacturing and how will this impact manufacturing processes and demand for skills?
IAN: Currently, manufacturing methods for gene therapy vectors are designed and able to meet the demands of a relatively small number of patients. However, as gene therapy treatments for more common diseases become available, we will need to produce gene therapy vectors on a much larger scale. This means moving away from academic settings and embracing the use of industrial-scale bioreactors, which in turn requires people to have in-depth knowledge of this highly specialised equipment and how to use it.
PETER: Part of the problem is a lack of opportunity to work with the highly specialised equipment used in gene therapy manufacture. Graduates who have produced viral vectors at a very small scale in academic settings are likely to have no experience handling the large-scale bioreactors used to manufacture gene therapies on an industrial scale. Pall’s iCELLis bioreactor system, for example, which manufactures up to 500 m2 of adherent cells in a single piece of equipment, is an entirely different prospect from the traditional cell factories you would find in a university laboratory.
It is for this reason that Pall formed a partnership with the BCC in November 2017 to train new graduates and retrain unemployed workers on industrial-scale biopharma manufacturing technologies. We placed state-of-the-art equipment in the BCC facility in Switzerland for both single-use and continuous manufacturing processes, which students at the center can use to build their skills in biopharma manufacturing.
What are the main challenges facing biopharma around the skills shortage?
PETER: The problem is not the quality of students graduating from life science programmes or the standard of their education, but their lack of practical industry experience and understanding they possess. Biopharmaceutical manufacturing roles have evolved: in addition to traditional bioengineering skills, there is now more focus on data analytics, process analytical technologies (PAT) and automation than ever before. Part of the issue is the rapid pace of change within the industry.
IAN: The BCC is also seeing a trend in demand for industry training: from former pharmaceutical employees who have lost their jobs and who want to retrain into higher-skilled biopharmaceutical roles. The institution recently launched a dozen courses aimed at unemployed pharmaceutical workers, whereby they train for six weeks in the facility, then take a three-month placement in a biopharmaceutical company. Graduates of the course have an 80% chance of securing a full-time job on completion. The programme is also now available for people unemployed from a variety of scientific and non-scientific backgrounds, particularly those coming from the food and agriculture industries.
The pace of change in the industry is simply staggering. It’s unrealistic to believe that academic institutions will update their programmes at a pace to match, which is why we need to find other solutions. This is precisely why BCC formed our partnership with Pall back in 2017.
Tell us more about the BCC and the partnership with Pall.
IAN: The BCC was established back in 2016 to create a bridge between academia and industry. Since it was founded, we have trained nearly 1,500 people and are seeing an increase in demand for courses from around the world, especially in the last 12 months.
The goal of the partnership with Pall was to build on this strong foundation and create new ways to train graduates and retrain unemployed pharmaceutical workers to build their real-world skills in biopharma manufacturing. Course participants have access to state-of-the-art equipment, including bioreactors used for gene therapy manufacture, so that they gain firsthand experience with cutting-edge technologies.
PETER: We provided the BCC with some of our state-of-the-art equipment, including Pall’s iCELLis bioreactor system. This piece of equipment enables full-scale manufacture of adherent cells, but is very different from the traditional cell factories a student might find in a university laboratory. According to BCC and its participants, the training is well received. It’s not a silver bullet to the industry’s entire skills problem, but it’s a start.
What is at stake if the industry doesn’t find ways to overcome the skills challenge?
PETER: We are on the cusp of new treatments and technologies that have the potential to revolutionise modern medicine. The question is no longer what can be done, but whether it can be done with today’s workforce and their skillset. If the answer to that question is no, industry needs to act and quickly find longlasting ways to address the skills gap.
IAN: What the BCC is doing in partnership with companies like Pall has a positive impact, but it is just one of many solutions required. To truly overcome the skills challenge, we need to find a range of different ways to help the next generation of workers adapt to an ever-changing industry. The benefits cannot be understated, and neither can the risk if we fail to act.