FDA urges move from stop-start to continuous manufacturing
- The Food and Drug Administration is backing early adopters of continuous manufacturing and other advanced manufacturing technologies through its Emerging Technology Team, and by requesting funding as part of the president's 2019 budget.
- The FDA has also issued draft guidance on the development and implementation of continuous manufacturing for brand, generic and over-the-counter drugs, which furthers a global effort among regulatory authorities to encourage implementation of the practice.
- Less than four years ago, only one drug made with continuous manufacturing had been approved. Now there are five products from four drugmakers — and more than 20 companies engaging with the FDA.
Traditional manufacturing is a stop-start process, beginning with quantities of bulk ingredients that move step-by-step through production. Each batch has to be complete before the next batch begins, making the process disjointed.
As the name suggests, continuous manufacturing offers another approach by constantly moving drugs through the production line, without the need to complete a batch before the next one starts.
Continuous manufacturing often uses closed, automated modular systems that reduce human interaction. This can cut down on potential contamination and on human error, reducing the number of batches that have to be discarded or the number of times that the process has to be stopped and restarted.
The modularity and smaller footprint of a continuous manufacturing production line also allows for flexibility in scaling up or scaling down as required. Proponents argue that continuous manufacturing is more efficient and cost-effective than batch processing and therefore can improve return on investment for drugmakers and, in turn, patients.
Despite the potential advantages and the prevalence of continuous manufacturing in other industries, pharma has been slow on the uptake. Just a few companies use it for marketed products. Vertex Pharmaceuticals uses the technology to manufacture two of its cystic fibrosis drugs, Orkambi (lumacaftor/ivacaftor) and Symdeko (tezacaftor/ivacaftor), as does Eli Lilly for its breast cancer drug, Verzenio (abemaciclib).
Johnson & Johnson has also switched its production of Prezista (darunavir), an HIV treatment, to continuous manufacturing.
"We’ve seen early adopters find innovative solutions to overcoming challenges in developing their [continuous manufacturing] facilities," FDA Commissioner Scott Gottlieb and Janet Woodcock, director of the Center for Drug Evaluation and Research, said in a joint statement.
They noted too that the process lends itself to being transferable to different sites, which can help companies quickly establish continuous manufacturing at various locations.
- BioPharma Dive What you need to know about continuous manufacturing
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