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Industry needs to realize the potential that new treatments and technologies hold and put skills at the top of its collective agenda, write Ian Marison and Peter Levison.
The pharmaceutical industry is in the middle of a period of intense transformation. Biopharmaceuticals represent the industry’s fastest-growing sub-sector and has brought about a major change to standard manufacturing processes with the shift from traditional chemical synthesis to the genetic manipulation of living organisms. There is a growing trend towards the use of artificial intelligence (AI) and process analytical technology (PAT) in drug production, and we have finally seen continuous manufacturing processes become more mainstream as they have in almost every other manufacturing industry around the world.
This sector-wide transformation has had a significant impact on the pharmaceutical industry’s skills needs. There is no shortage of people trained to handle traditional pharmaceutical manufacture. A survey last year by the Coalition of State Bioscience Institutes found that traditional manufacturing positions were the easiest functional roles to fill; the layoffs experienced towards the end of last year do indeed suggest an oversupply of such employees. But when you look at the skill sets required to manage biopharmaceutical manufacturing processes – in particular around engineering, data analytics and process development – the skill set shortage challenge persists.
There is a global shortage of people who are suitably trained for the complex and rapidly-changing world of biopharmaceutical manufacturing. With drug shortages fast becoming a major global crisis, it’s a problem that needs to be addressed immediately. But the question remains, how can our industry bring in new talent when every sector globally is crying out for the same skilled manufacturing workforce?
In terms of true centers of excellence in education, the life sciences sector is one of the most well-served in the world. From established innovation hubs in Boston in the USA and Cambridge in the UK, to emerging centers of excellence in the APAC region, there are some incredible educational institutions serving our sector that we should be very proud of.
The problem is not with the quality of the students coming through these programs, or with the standard of education they are getting. Rather it is the practical industry understanding – or lack of it – that these students have when it comes to applying scientific knowledge in an industry setting. At Pall Biotech, for example, we invest a great deal of time and resources giving graduates the practical training they need to be able to work effectively for our biopharmaceutical manufacturing customers.
Pace of change is the biggest issue. The industry is transforming so rapidly that university programs simply can’t adapt quickly enough to be able to provide students with adequate practical knowledge. Take, for example, advances in biopharmaceutical manufacturing automation. It’s taken roughly ten years to see parts of the biopharma manufacturing process become automated, but within the next five years, machine learning and PATs will have transformed the process many times over. By the time an educational institution has adjusted its programs to reflect an emerging trend, the industry has moved on again. Universities simply can’t respond this quickly, nor should we expect them to – a different solution is needed if we’re going to tackle the shorter-term skills gap in biopharma.
The Biofactory Competence Center (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, in particular around new and emerging aspects of the industry, such as automation.
Now, the BCC is seeing another significant trend in demands 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 and placement have an 80% chance of securing a full-time job on completion. The program is also now available for unemployed people from a variety of scientific and non-scientific backgrounds, particularly those from the food and agriculture industries.
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 all around the world. This reflects the industry transition we are experiencing and the fact that the current skills pool is no longer well-suited for modern biopharmaceutical manufacturing.
The industrialization of gene therapies is perhaps the single biggest challenge that’s faced the pharmaceutical industry in a generation. Demand is skyrocketing for the pre-clinical and clinical-grade viral vectors that make modifying a patient’s genome possible, but the industry hasn’t yet found a way of meeting the demand.
There are myriad reasons why scale-up has proved challenging, including the complexities associated with their manufacture. Growing commercial product pipelines require products to be characterized and consistently manufactured to scrupulous tolerances of purity, potency and safety. This requires an in-depth knowledge, and one of the fundamental barriers to progress has been the relative scarcity of people with the necessary skills and practical experience to manage such a complex and inherently challenging process.
Part of the problem is a lack of opportunity to work with the highly specialized 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 using 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 to the traditional cell factories you would find in a university laboratory.
It is for this reason that the BCC formed a partnership with Pall in November 2017 to train new graduates and retrain unemployed workers on industrial-scale biopharma manufacturing technologies. Pall has 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.
The healthcare industry worldwide is on a journey towards true precision medicine, with new advances in everything from genetic and non-genetic biomarkers, to personalized health data which brings new opportunities and innovations each day. The main obstacle at the moment is not what we can do, but whether we can do it on an industrial scale. We must be diligent in our efforts to ensure that the growing skills shortage does not become an obstacle to achieving this goal.
If we’re going to create systems that are flexible and scalable enough to achieve industrial levels production, we need people who have the skills to support the effort. This means thinking beyond traditional pharmaceutical manufacturing requirements, and instead finding and developing talent in automation, PAT, artificial intelligence, and the myriad other disciplines that will form the cornerstone of modern biopharmaceutical production. Pall and the Biofactory Competence Center formed a partnership to create a means by which to build the required skills, but it is just one part of the solution. To realize the potential that new treatments and technologies hold, the industry needs to recognize this challenge and do everything it can to put skills at the top of our collective agenda.
Professor Ian Marison is founder and CEO of the Biofactory Competence Center SA, Fribourg, Switzerland and part-time professor of bioprocess engineering at the HEAI-FR. Dr. Peter Levison is Executive Director, Business Development for Pall Biotech.