By Prof. Ian Marison (Biofactory Competence Center) and Dr. Peter Levison (Pall Corporation)
Biopharmaceuticals are made by genetically modifying living organisms and are one of the most impactful advances of modern science. They already represent the industry’s fastest growing sub-sector and, with large investments and R&D in this space, biopharmaceuticals’ growth is only going to accelerate.
The biopharmaceutical sector, however, is not without its challenges, particularly around the manufacture of these ever-more complex drugs. It is extremely challenging for biopharma companies to find people who have the skills required to manage biopharmaceutical manufacturing processes, which increasingly focus on data analytics, process development and other computer science-related disciplines, rather than more traditional bioengineering skills.
New technologies, new skills challenges
A survey last year by the Coalition of State Bioscience Institutes found that companies generally have little difficulty filling traditional pharmaceutical manufacture roles. However, there is a global shortage of people who have the right technical expertise to navigate the complex biopharma internal and external challenges—from evolving regulatory environments to fast-emerging trends in areas such as continuous bioprocessing or the industrialization of gene therapy manufacture.
This last point is one of the reasons why our two companies – Pall Corporation and the Biofactory Competence Center (BCC) – formed a partnership in 2017 to provide people with the training they need to effectively operate at the cutting edge of biopharmaceutical production. In gene therapy manufacturing, for example, we’ve seen a skills issue where graduates, and those with traditional pharmaceutical manufacturing experience, have had little access to large-scale bioreactors that will be crucial to industrialized production of viral vectors, which to-date have traditionally been produced at small scale in academic settings. Pall’s scalable iCELLis® bioreactor systems, for example, which enable full-scale manufacture of adherent cells in a single piece of equipment, is an entirely different prospect to the traditional cell factories you would find in a university laboratory. In order for the current skills pool to be able to meet the needs of modern gene therapy production, this will have to change.
The same is true when it comes to continuous bioprocessing, a direction in which many biopharmaceutical manufacturers are now heading. People with traditional manufacturing experience often understand the principles, but they have little or no experience with the relevant continuous technologies or systems used, let alone the process analytical technologies (PAT) or automated systems that enable continuous manufacture. It was this that led Pall teams to deploy state-of-the-art continuous equipment in the BCC facility in Switzerland, so that participants in hands-on training courses could build their practical skills in biopharmaceutical manufacturing and gain first-hand experience of the technologies that are used in a truly continuous process.
Plugging the academia gap
In terms of centers of excellence in education, the life sciences sector is one of the most well-served. From established hubs in Boston in the USA and Cambridge in the UK, to emerging centers in the APAC region, there are many incredible institutions serving the sector. Therefore, the problem is not with the quality of students graduating from these programs or the standard of education but the lack of practical industry understanding when it comes to applying scientific knowledge in industry settings. Pace of change is the main issue. The industry is transforming so rapidly that university programs simply can’t adapt quickly enough to provide students with adequate practical knowledge.
The BCC was established in Switzerland in January 2016 to create a suitable bridge between academia and industry. It provides courses to hundreds of highly skilled academics and researchers to help them build the practical skills required to work in biopharmaceutical manufacturing, around new and emerging aspects of the industry, such as automation.
Since it was founded, the BCC has trained nearly 1,500 people, but in the past 12 months there has been a significant increase in demand from around the world. This reflects the industry transition we are experiencing and the fact that the current skills pool is no longer suited for modern biopharmaceutical manufacturing.
Maintaining our momentum
While the pace of discovery of breakthrough medicines is rapid and the potential of automation, personalized medicine and gene therapies are starting to be realized, there remain challenges. The main obstacle is not what can be done, but whether there is a workforce with the right skills in place to achieve it on an industrial scale. While Pall and the BCC formed a partnership to build the required skills, this represents just one solution of many that are needed. To realize the full potential that new treatments and technologies hold, the industry needs to recognize the challenges and do everything it can to put skills at the top of the collective agenda.
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Prof. Ian Marison
Ian is founder and CEO of the Biofactory Competence Center SA, Fribourg, Switzerland and part-time professor of bioprocess engineering at the HEAI-FR. Prior to this he was a professor for many years in Dublin and formerly CEO of NIBRT, Ireland.
Dr. Peter Levison
Peter is Executive Director Business Development for Pall Biotech and is responsible for developing strategic partnerships within the Biotech community through the management of a network of global thought leaders, working with key industrialists and academics around the world.