Roundtable Part 6: The Future of Continuous Processing

The pharma/Bio industry is aware of the benefits of continuous bioprocessing, and process intensification. But there is likely a long learning and adoption curve for new devices being introduced into a GMP environment, and many regulatory questions are still unanswered, or are evolving slowly.  As with single-use devices, which have taken decades to become mainstream, continuous process evolution, and the benefits they will offer, are likely to come slowly.

We think the future of continuous manufacturing is bright based on the progress made to date, especially in small molecule/drug product and applicability of the concepts to other types of processing.

Each company is at different phases and may have its own challenges to work out, but we believe these can be addressed by not only sharing within given technology platforms and therapeutic areas but across those boundaries as well. Ultimately, we think this will result in a win not only for Industry, but, even more importantly, for the patients we serve.

As noted in FDA’s 2018 Strategic Policy Roadmap, continuous manufacturing remains a priority for the agency. We’re encouraged by the progress we have seen in the development and implementation of continuous manufacturing processes. Some of the continuous processes that were first approved by FDA are now approved by several other global health authorities. We see some contract manufacturing organizations (CMO) getting involved in continuous manufacturing. We hope these types of positive movements will facilitate the adoption of continuous manufacturing by a broader array of pharmaceutical companies.

We see this as an evolution that will happen over the next five to ten years, starting with process intensification technologies. As we have an extensive knowledge of our customers’ processes, we can strategically evolve their manufacturing process to fit their growth plans. Flexible, modular and automated facility design, integrated plug-and-play end-to-end solutions, digital tools, and single-use will continue to play a critical role in the future of continuous processing. Broadening up the holistic view of bioprocessing beyond integrated upstream and downstream solutions to include the supply management aspect will also be indispensable in the future to alleviate demand uncertainty.

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!

Investment in disruptive innovation is today’s mantra. Continuous processing will play a significant role in reducing cost of bio-manufacturing. This is driving investment and innovation in robust process analytics and associated automation. I see a sensible portion of the molecules on the market adopting continuous processing in the next five to ten years in both upstream and downstream processing. Thermo Fisher will remain steadfast in our collaborative approach with customers and suppliers with the implementation of continuous bioprocessing.