The biopharmaceutical sector is the fastest-growing part of the pharma industry, representing global revenues of $163 billion—about 20 percent of the total pharma market—and growing fast. Biopharma’s current annual growth rate of more than eight percent is double that of conventional pharma, and growth is expected to continue at that rate for the foreseeable future.i
This doesn’t mean, however, that the sector is without its challenges. To safely and effectively manufacture complex biologic drugs like cell and gene therapies and meet volume requirements significant transformation will be needed among biopharma manufacturing companies. This is not just in manufacturing suites and the laboratory, but in strategy, technology, operations, and processes.
Furthermore, there is a growing talent gap as the skills of the pharma workforce have not yet aligned with this new world of biopharma manufacturing. Biopharma companies are struggling to find the talent they need in advanced areas such as automation, computer science, and process modeling—not historically core skills in traditional pharmaceutical production, but now crucial to modern biopharma manufacturing. If left unchecked and untreated, this skills gap could hinder innovation.
Transforming skills needs
The shift to biopharma has required a wholesale transformation of standard manufacturing processes: moving from traditional chemical synthesis to the genetic manipulation of living organisms. The rise of automation and artificial intelligence (AI), and in particular process analytical technology (PAT), in drug production has brought new opportunities. But it also brings new challenges from a skills perspective. Biopharma companies struggle to find these skills within the current workforce and are now battling with every other industry sector in the world for ultra-high demand talent.
Great progress has been made, as the move toward continuous bioprocessing over the past four to five years demonstrates. However, biopharma has been slow to embrace the efficiencies and only now are manufacturers adopting continuous processes, if not wholly, then for at least some aspects of their production. But as continuous processing has become more commonplace, more and more companies struggle to get the skills they need to create and maintain these processes.
A survey conducted by the Coalition of State Bioscience Institutes last year indicates that while ‘traditional’ manufacturing positions were the easiest functional roles to fill (only nine percent of survey respondents found these difficult to fill), there is a lack of the skill sets needed to manage biopharmaceutical manufacturing processes—specifically in the areas of engineering, data analytics, and process development. The question is, what can the industry do to plug these gaps?
The life sciences sector is one of the best-resourced for education, with centers of excellence all around 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. The challenge isn’t with the quality of education or the graduates of these programs, but with the practical industry knowledge—or lack of it—that the graduates possess.
It’s also worth noting that a recent study from the United Kingdom’s University of Leicester and University of Warwick, funded by the Nuffield Foundation, implies that as an industry, our efforts may be misdirected. It’s not a dearth of Science, Technology, Engineering and Mathematics (STEM) graduates that’s the problem, rather it’s that STEM graduates choose not to, or are unable to, find work in scientific industries like ours.
The industry is also changing so quickly that educational programs cannot acclimatize quickly enough to equip students with the required practical skills and knowledge. Automation is a key area where this pressure is being felt. Although it’s taken about 10 years for sections of the biopharma manufacturing process to automate, in the next 10 years machine learning and advanced PAT will change the industry again many times over. By the time an educational program has adapted to address this, industry will have moved on again.
The rapid rise of gene therapies
The industrialization of gene therapy manufacture has added yet another skills challenge to the industry. The need for the pre-clinical and clinical-grade viral vectors that make modifying a patient’s genome possible has rocketed in the past 12 months. Several gene therapies have now received approvals, but scaling up production to commercial levels remains a challenge.
The nature of gene therapies made of living materials means quality assurance roles are more important, and more challenging, than in chemical-based pharmaceuticals.
The industry’s growing commercial product pipelines require products to be categorized and dependably manufactured to scrupulous tolerances of purity, potency, and safety. This needs in-depth and specialist expertise. One of the key barriers to advancement has been a shortage of people with the necessary skills and practical experience to manage such a complex and fundamentally challenging process.
It’s extremely unlikely students would even have access to the types of technologies used to manufacture cell and gene therapies. Graduates who have produced viral vectors at a small scale in academic settings are likely to have no experience using the large-scale bioreactors. What’s more, the skills learned using small academic laboratory equipment are not immediately transferrable since you need experience with that particular piece of equipment, and lots of it.
Overcoming the gap
It was these myriad skills issues that led to the Biofactory Competence Center (BCC) being established in Switzerland in January 2016. The BCC runs courses for academics, researchers, current pharmaceutical employees, and anyone who wishes to build their skills in industrial biopharma manufacturing.
Since its establishment, the BCC has trained almost 1,500 people, and over the last 12 months there has been a surge in demand from around the world mirroring the rapid industry evolution and underlining the fact that the present skills pool is no longer fully relevant for today’s biopharmaceutical manufacturing.
In particular, the BCC received a huge increase in requests for industry training from previous pharmaceutical employees who want to retrain into higher-skilled biopharmaceutical roles. The organization recently launched a set of courses designed specifically for unemployed pharmaceutical workers. These consist of six weeks of training in the facility, followed by a three-month placement in a biopharmaceutical company. Graduates of these courses have an 80 percent chance of securing a full-time job on completion.
In November 2017, the BCC formed a partnership with Pall to equip new graduates with the required skillset and retrain unemployed workers on industrial-scale biopharma manufacturing technologies. Pall has installed state-of-the-art equipment at 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.
A promising future
The global healthcare industry is on a path to a new age of precision medicine. There are remarkable advances in all fields, from genetic and non-genetic biomarkers, to personalized health data, to gene therapies that can treat once incurable conditions. The biggest issue we face now is not what we can do, but whether we can achieve it on an industrial scale and skills is a fundamental part of this industrialization challenge.
If we are embracing systems that are flexible and scalable enough to achieve industrial levels of production, we need to equip more people with the skills needed to succeed in this brave and challenging new world. We need to think beyond traditional pharmaceutical manufacturing requirements and nurture talent in key areas like automation, PAT, and AI, essentially combining traditional pharma skills with computer science capabilities. To fulfil the promise that novel treatments and technologies offer and unlock the true potential of our industry, we must all do more to ensure skills development becomes and remains a key focus otherwise the promise of this new age of healthcare will wither on the vine.
[i] McKinsey and Company. December 2014. Rapid growth in biopharma: Challenges and opportunities
Professor Ian Marison is the founder and CEO of the Biofactory Competence Center SA, Fribourg, Switzerland and a 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 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.