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Feliza Mirasol is the science editor for BioPharm International.
A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.
The need for skilled bioprocessing professionals remains a major concern in the biopharmaceutical industry, even as automation plays an increasing role on the manufacturing floor. Although the role of automated systems in bioprocessing is to reduce human interaction, and therefore the risk of contamination or user errors, in the manufacturing cycle, a certain level of operator oversight is still required.
This need is coupled with the pressure the biopharmaceutical industry is facing as the older generation of bioproduction staff begins to retire, amid a rapid increase of biomanufacturing facilities coming online. In addition, newer manufacturing technologies for gene therapies and cell therapies are added to the mix as these therapeutic products ramp up in the commercial space (1).
Important to keep in mind is that training needs can be highly variable from company to company, thus making a one-size-fits-all approach impractical. It is therefore recommended that all aspects of training-including design, development, and delivery-be customized to meet specific company needs (2). Because of the variety in practices and technologies, however, training cannot be readily standardized, which is a concern for biomanufacturing companies. The industry would have to be adaptive to customized training, which has been a significant obstacle in the current biomanufacturing climate where the overall attitude is conservative to changes (3).
Biopharmaceutical industry consultants recommend that training programs be accredited by a nationally recognized educational body to ensure high-quality standards and effectiveness of the training, but there is a general lack of interest in the industry for such formalized training. Instead, companies have been content to rely on existing courses that comply with certain standards. The lack of accreditation or certification, however, is especially an issue for advanced-level, specialized training (2, 3).
There is a general belief that, since the industry has never been credentialed, to do so now would pose a challenge, especially concerning the transferability of skills and competencies. Biotech facilities typically differ in equipment, pro cesses, and other factors, which would still require someone with knowledge to receive on-site training to reach competence (3).
Yet, the bioprocessing industry continues to invest in training, which it sees as a major requirement for avoiding problems and capacity constraints. New practices, such as online components, use of customized training, and the development of accredited/certified training have not yet been adopted, but new methods may be needed as bioprocessing grows globally and the added nuance of automation implementation is increasingly adopted.
In an interview with BioPharm International, Loe Cameron, director of Analytics & Controls at Pall Corporation, offered some insights into the need for developing a sufficiently trained bioprocessing workforce capable of operating in an increasingly automated world.
BioPharm: How do manufacturers find sufficient qualified personnel?
Cameron: This is a challenge as the required skills are evolving with the technologies, and demand has increased for highly skilled workers versus technicians and operators. If we look at recruitment trends, the industry has long been preparing for a gap in qualified personnel as the market expands beyond the number of newly available candidates and competition increases for existing talent. Because of this, we think it is important to not just focus on recruiting new talent, but also on retaining the existing workforce and making them part of the future. A strategy of both recruitment to supplement teams with new skill sets and continuing education (training) of existing personnel to stay relevant provides the best chance at business continuity and sustainable growth.
To bring in new recruits, it is becoming increasingly necessary to search outside both our industry and manufacturing as a whole, which creates challenges and opportunities. Automation talent from other industries, which are less closely regulated, may have experience with new approaches with great benefits to bioprocessing; however, they will need training in how to apply that knowledge in our regulated environment. Additionally, the drive to Pharma 4.0 and greater network security introduces implementation challenges more familiar to information technology (IT) professionals than the operational technology (OT) professionals who manage manufacturing today. This IT/OT convergence opens up a much larger skilled workforce to our recruiting efforts but could create risks if teams aren’t able to build a collaborative environment around their various strengths and weaknesses.
Retention of existing resources and the associated tacit knowledge, reaching into other industries to broaden the talent pool, and building consensus between IT/OT are all needed to ensure we have the right teams to take us into the future.
BioPharm: How do employee skill sets fit into the design and operation of new equipment and systems? Or, vice versa?
Cameron: In the manufacturing suite, we are starting to see a philosophical shift from training the employee to operate the equipment to designing the equipment around the employee. Greater importance is being placed on the human factors of equipment and system design, and vendors are taking more time to evaluate and research how the equipment and systems are used, and what that user experience is like.
Approaches such as usability trials and human machine interface (HMI) optimization provide value by reducing risk across the entire lifecycle of the equipment. This approach lowers skill and training requirements on the manufacturing floor but requires new skills in equipment design. Industrial designers, user experience specialists, and ergonomics engineers are getting more involved in the development of manufacturing equipment and making significant changes in how these products are realized.
BioPharm: What levels of automation should be expected in bioprocessing facilities in the future?
Cameron: The level of automation should be based on business goals, with a focus on making progress and de-risking wherever possible. We see automation as a tool rather than a goal. Since the advent of automation, there has been a drive to automate as many actions as possible to lower cost and risk while increasing quality, but there is also risk in automating too quickly.
In our industry, the best approach is to apply major technology changes incrementally so that we can understand the impact on the process and product. We also pay close attention to what other industries have experienced as we look to mitigate risks.
Overall, this industry has a very low tolerance for risk, so companies must ensure that automation efforts reflect that and gather as much insight as possible. Gathering information can also be part of the automation solution through process modeling and the eventual creation of processes that are self-optimizing. As a deeper understanding of the process is gained, we can make better use of data and apply automation where it will have the greatest impact.
BioPharm: Looking to the future, what impact will automated bioprocessing facilities have on the way staff are hired and the quality of staff that will be required?
Cameron: Humans still have to be involved in the process, no matter how far automation is implemented. At Pall, we are not looking to remove personnel, but rather provide positions that are more satisfying and offer a greater trajectory through automation. We want to minimize mindless work and allow our personnel the freedom to pursue continued education and grow with our team. It is no secret that turnover is a huge problem for this industry, so we feel that by providing more engaging and meaningful work, we can all grow together.
BioPharm: How much time and investment are typically needed to train personnel in automation systems, especially with newer systems and/or integrated systems?
Cameron: This depends on the level of automation. With thoughtful automation, training requirements can potentially be lowered by building standard operating procedures and sequences into the systems themselves. The manufacturing personnel and automation become a team when the control systems continuously reinforce taking the next step, the right way.
For redundant or repetitive functions that can be fully dedicated to the control system, automation removes not only the training requirement but the risk of mistakes and a less engaged workforce.
Ultimately, we find that by investing in the right automation and personnel, employees come up to speed rather quickly, which helps to streamline investment.
BioPharm: Are there sufficient monitoring, control, and data collection technologies available? Is the know-how to use these available?
Cameron: Lack of automation technologies is not a major concern, but technology selection and applications are very important. Planning and projecting is critical. Long-term automation goals should be considered up front so technology selections can be made in a way that does not cause delay or increase costs. Licensing models in the space are incredibly complicated and often have long-term impacts on operating expenses, and foundational systems like historians or automation platforms can have impacts on the implementation of future capabilities. Early development of a roadmap is critical.
While there isn’t a lack of technologies, we are often not the core market for the vendors that supply them. As a result, we often have to educate and take a bigger role in deployment than we would if we were in other industries. The specifics for data integrity must be considered and openly discussed from the start, which ultimately helps vendors to better adapt to what our industry requires.
And because know-how can be limited and installation requires investment, we are seeing the vendors (Pall included) making larger investments in simplifying solutions for customers so that they are more cost-effective, reliable, and faster to implement.
1. D. Stanton, “Bioproduction Bottlenecks Increasing Due to Staff Shortages, Says Report,” BioPharma-reporter.com, Aug. 15, 2017.
2. K. O’Driscoll, BioPharm International 25 (9) 2012.
3. E.S. Langer et al., 15th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (BioPlan Associates, Inc., Rockville, MD, April 2018).
Vol. 32, No. 4
When referring to this article, please cite it as F. Mirasol, “Where Automation Meets Skill Set," BioPharm International 32 (4) 2019.