The FDA Recently Validated a Continuous Manufacturing Pharma Process Line—What Do You Think This Means for the Future?

Robert Dream, Technology & Regulatory Consultant, Comecer Group
A: Process design, measurement and control for enabling continuous processing adoption in the biotech and pharmaceutical industries — the shift from batch to continuous production methods is transforming the future of pharmaceutical manufacturing. The potential economic gains from increasing capacity utilization and reducing the length of process development, product release times and capital costs are driving the paradigm shift. Spurred by potential improvements to quality, patient safety and the time required for breakthrough medicines to reach patients, even the U.S. Food and Drug Administration (FDA) has advocated a move to continuous manufacturing (CM). However, with new methods come new challenges — particularly for process design, measurement, material traceability and control. Manufacturers, suppliers and research institutions are collaborating to solve these challenges at projects across the globe. The status of continuous processing in the pharmaceutical industry and considerations is based in part on research on how manufacturers can overcome the challenges related to quality, compliance, material traceability and process design and control.

Ed Godek, Manager, Process Technology, Glatt Air Techniques Inc.
A: The fact that FDA approved two products utilizing continuous manufacturing tells me that they are onboard with this new concept. It should allay the fears of the industry that FDA will not be willing to make this leap. From what I’ve heard, the review process went quickly and smoothly for both products. Of course, all solid dosage products cannot be processed utilizing continuous systems. Business risk and market demands will dictate some of this. The key for the future of continuous processing is going to be the capability and flexibility of the systems utilized. The system should be able to handle different forms of granulation, as well as direct compression. Another key aspect will be the ability for full integration of the unit operations within the system and the ability to control them to adequately produce quality product with little waste. The key for the future of continuous processing is going to be the capability and flexibility of the systems utilized.

Pär Almhem, President, Modwave
A: The fact that there are now two pharmaceutical products approved for continuous manufacturing, including one mainstream product, is very significant for continuous manufacturing as it goes from an idea towards widespread implementation in the pharmaceutical industry. One of the main reasons why continuous manufacturing has been so much slower to enter the pharmaceutical industry than other industries, which have used continuous manufacturing for decades, has been concern over the regulatory impact of such a transition. Now we have a pipeline of products that are either planned to be transitioned to continuous manufacturing, or are being developed directly for continuous manufacturing. The recent approvals help in establishing the regulatory framework needed and, together with continued progress on the processing side, support the path towards continuous manufacturing becoming the preferred concept for pharmaceutical manufacturing over time. This is a major step towards lower cost and better quality control in pharmaceutical manufacturing.

John Wass, CPIP, Consultant, Commissioning Agents, Inc.
Having regulatory precedence is only a minimum requirement. Having the process understanding and a robust risk management program to have the confidence to assume the risks associated with continuous manufacturing is the key to successful implementation. The benefits are immense and competitors with mature process capabilities will differentiate themselves significantly in the market; initially, however, this will most likely be an iterative, case-by-case approach to migrate from batch to continuous processing. From a business driver perspective, it may not even be cost-effective to transition a product in its life cycle from a batch process to continuous manufacturing due to market saturation or achieving returns on capital investment. Instead, moving forward, the industry will have to look at continuous manufacturing as a platform for process development for product types that have chemistries receptive to or enhanced by continuous processes. And having a renewed attention to automated process controls, on-line instrumentation and successful appli­cations of PAT will become enablers.

Christian Treitel, Pharma Business Development Head, Bosch Packaging Technology
A: Bosch Packaging Technology sees an enormous potential in continuous manufacturing, especially for the processing and production of solid dosage forms. The main reasons are a growing demand for faster time-to-market of new drugs, even higher safety, a higher degree of automation, as well as significant cost savings. This is why we are currently working on research and development in the area of continuous manufacturing, and have initiated cooperation with an experienced partner, the RCPE (Research Center Pharmaceutical Engineering) in Graz, Austria. We want to thoroughly evaluate and understand the mechanisms of continuous manufacturing before introducing technologies to the market, as our goal is always to offer our customers proven added value. To get continuous manufacturing processes approved is a very complex procedure. Our goal is to facilitate this procedure by developing technical solutions that are more easily approved.

Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.