: In your opinion what is the current level of adoption of continuous pharmaceutical processing technologies in the industry?
PL: Continuous processing is still in early adoption phases across the drug manufacturing industry, but there is already a great deal of progress for such early phases. Regulatory bodies, such as the US FDA, have been supportive, and even encouraging of, the advancement of continuous processes to enable further innovation in the drug treatments and therapies being developed for end users. In fact, small molecule drug manufacturers, such as Janssen (Prezista) have already successfully implemented commercial-scale continuous production processes.
As demand grows for safer, higher-quality and more efficacious drugs that are also more affordable, industry has been forced to find new ways to improve the production process. Even just ten to fifteen years ago, manufacturers were hesitant to accept/apply single-use technologies. But market demand helped make single-use technologies an innovation enabler, and while they are not yet fully standardized, adoption is increasing. We expect a similar trajectory for continuous processes across the drug manufacturing market but predict that industry will adopt it more quickly.
: What are some barriers that need to be overcome in order to advance the uptake of this technology? On the part of pharmaceutical companies, is it a lack of confidence, a lack of successful examples, or just an unwillingness to change?
PL: It’s a risk adverse industry to some extent because of the regulated nature of drug production. However, due to market changes, the time frame for accepting new, enabling technologies has become shorter. The industry is facing demand to produce more complicated molecules more efficiently and at a lower cost, so acceptance of more efficient approaches is not just nice to have – in some cases it is critical.
: Globally, do you see differences in the adoption of continuous processing techniques/technologies? What has your experience been with the various global regulatory agencies? Have they been supportive? Non-committal?
PL: Continuous bioprocessing is being discussed globally. To our knowledge there is no region in the world that is not including continuous bioprocessing as integral themes for conferences and webinars etc. Particularly in Asia, we see great interest in rapid adoption and workforce training to evolve towards continuous processes. Similarly, the regulatory agencies have been supportive of moving towards continuous processes for the future.
: As a supplier of techniques, technologies and expertise – what do you see as your role in promoting continuous processing technologies?
PL: It sounds cliché, but Pall Corporation was built on innovation. Our team takes pride in advancing the markets in which we serve with mission-critical equipment, systems and consumables, complemented by exceptional customer service and support.
From the beginning, Pall Biotech was a leader in stainless steel equipment. As the industry evolved, we became an early pioneer in the development of integrated single-use technologies. Now, our team is focused on leading the industry in bringing full-cycle, scalable continuous bioprocessing solutions to fruition. We are also fully committed to working with industry associations, educators, partners and clients to get there.
: In your opinion, will continuous processing become the preferred method for manufacturing pharmaceuticals? Or, will it become one of several technologies available in a manufacturer’s toolkit?
PL: We see it as an evolution of technologies. A lot of the fundamental building blocks of the process and theories of application remain the same. Generally, a continuous process will use the same buffers, chromatography media, membranes etc., that are used in a current batch process only they are used in a slightly different way. It is a misperception that the transition from batch to continuous processing is challenging—that is not actually the case.
As an industry, we must look to innovate across the board, and introduce technologies that can help change the direction of processes for the better. There is no point in seeking to implement continuous processes for drug production if they can only be used in the lab—scalability is critical.
: Finally, can you tell us what you see as the future for continuous processing?
PL: This is a data-driven industry, and right now, a lot of exploration and resulting data is being published about continuous processes, with a promising outlook. Just as single-use technologies transitioned from undesirable to completely acceptable, continuous processes will continue to gain traction—the efficiencies in time, footprint, operations, and process resources are just too hard to ignore.
We expect that just as we have seen with single-use technologies, the industry will realize the need for continuous process automation and standardization as these approaches become more feasible and scalable. And just as Pall has been active in the continued adoption and maturation of the single-use sector, we are working hard to align as a key contributor to the continuous standardization process.
Unlike single-use technologies, however, we expect continuous adoption to happen much quicker--perhaps even within the next decade!