FDA calls for industry input on continuous manufacturing guidelines
- The Food and Drug Administration plans to develop clearer guidelines around the adoption of continuous manufacturing and has asked industry stakeholders for input on how best to design a regulatory framework.
- The regulator has advocated companies make the switch from traditional batch production to continuous manufacturing, which to a large extent hasn't been widely adopted by drugmakers despite the potential benefits to speed and reliability.
- In the FDA's view, continuous manufacturing can reduce the risk of manufacturing failures and potentially help prevent drug shortages from developing — areas that have been in focus as the agency steps up its oversight of pharmaceutical production facilities.
Pharma has been loath to change over from batch production, which has served the industry for decades.
Continuous manufacturing (CM) techniques — already adopted in many other industries — promise to shorten production times significantly, while reducing the amount of human intervention needed throughout.
Two companies, Vertex Pharmaceuticals Inc. and Johnson & Johnson's subsidiary Janssen Pharmaceutical, have already made the switch to CM for two of their respective drugs. Vertex has been making its cystic fibrosis treatment Okrambi (lumacaftor/ivacaftor) using CM since the drug's approval in July 2015, while Janssen recently won FDA approval to switch from batch to CM for its HIV med Prezista (darunavir).
But the FDA clearly wants more companies to transition to CM, highlighting the approach's benefits in a blog post published Monday.
"CM can shorten production times and improve the efficiency of the manufacturing process," wrote Michael Kopcha, director of the FDA's Office of Pharmaceutical Quality. "CM also allows for more nimble testing and control that can help reduce the likelihood of manufacturing failures."
Oversight of Good Manufacturing Production standards has been high on the regulator's agenda in recent years, leading to a sharp uptick in the number of warning letters issued to companies in the U.S. and abroad.
Recent shortages of sodium bicarbonate, a much-needed drug commonly used by hospitals, have also highlighted vulnerabilities in supply. CM approaches could theoretically help suppliers spin up new manufacturing lines more quickly to meet spiking demand.
Implementing CM costs time and money, however, particularly for large companies upgrading several facilities. The FDA's Kopcha, though, emphasized that drugmakers can choose to switch over specific operations within a process as well as entire production chains.
The FDA hopes providing a "framework of principles" will help drugmakers navigate CM adoption and implementation. To this end, it has opened up a docket for public comment through September 21 to gather input from stakeholders.
- Food and Drug Administration Blog post
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