Roundtable Part 3: Adoption and Support of Continuous Processing by Global Regulatory Agencies

Different markets are at different points with regards to their experience and the number of approved drug applications using continuous manufacturing. Both the U.S. Food and Drug Administration and European Medicines Agency have been very supportive and collaborative in encouraging and expecting the use of the technology to realize the potential advantages of the technology, which is consistent with similar approaches in the food and chemical industries. For example, the U.S. now has multiple drug products on the market made by this technology. We believe that trend will continue, and that we will see increased adoption of this process over time through global marketing of already approved products as well as new drugs as more manufacturers and regulators become experienced with continuous manufacturing.

I do not see anyone adopting continuous manufacturing for API and formulations. Everyone dances to the FDA tune.

The FDA has discussed continuous manufacturing with the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency. All three agencies have given presentations at continuous manufacturing workshops. The three agencies recognize the potential benefits of continuous manufacturing and support its adoption.

There is no “one size fits all” solution and no established industry standard for what Next Generation Manufacturing looks like, resulting in substantial diversity. Every organization has their own approach and implementation strategy based on their most critical needs and process bottlenecks. As industry adoption evolves over time, there will likely be an industry accepted template. Regulatory bodies are advocating in favor of Next Generation Processing as they see the high potential of reducing the manual handling of products, as well as for better process control. Finally, we see collaborations between pharma manufacturers, regulatory agencies, industry associations and suppliers as key. A concrete example is the collaboration realized with one of our customers and the FDA on “inline virus spiking for linked polishing steps.” To familiarize the FDA with this novel approach, we presented this Next Generation Processing method to them, in order to prepare for their review when filing the drug. This collaborative model is what is needed to advance the industry.

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.

Emerging markets are catching up with developed markets in terms of investments. I don’t think access to continuous technologies is a concern irrespective of where one is in the world. From a regulatory perspective, efficacy and safety of the drug are the primary focus. Continuous processing is only an operational strategy. Regulatory is transforming and is supportive as along as a manufacturer provides satisfactory documentation. Regulatory process is non-negotiable and significant efforts made from the regulatory side to support the industry and save the diseased.