The US Food and Drug Administration (FDA) is inviting input through a public docket, open until September 21, 2017, on issues related to the adoption of continuous manufacturing in the pharmaceutical industry.
The FDA said it is interested in getting public feedback on published documents on this topic, including an industry-coordinated best practices document issued by the public-private consortium, the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), and white papers from a 2014 symposium published in the Journal of Pharmaceutical Sciences.
C-SOPs is a National Science Foundation-funded body with Rutgers University, Purdue University, the New Jersey Institute of Technology, and the University of Puerto Rico at Mayaguez, which is involved in developing methods for designing, scaling, optimizing, and controlling dosage form design and relevant manufacturing processes. The group is focused on developing a scientific foundation for the optimal design of structured organic particulate systems (i.e., active pharmaceutical ingredients dispersed in an organic matrix). In May 2015, at a workshop, Future of Pharmaceutical Manufacturing, the FDA invited interested parties to submit for agency consideration draft guidance or other materials discussing the science, technology, and best practices related to continuous manufacturing. In June 2016, C-SOPS submitted to the FDA an industry- coordinated best practices document on continuous manufacturing. FDA is interested in public comments about the science, technology, and practices discussed in the C-SOPS document.
In addition, FDA is seeking comments on other recommendations regarding continuous manufacturing that have already been published, including the proceedings, ”Regulatory and Quality Considerations for Continuous Manufacturing,” from the May 20-21, 2014 Continuous Manufacturing Symposium and published in the Journal of Pharmaceutical Sciences (DOI: 10.1002/jps.24324). FDA is inviting comment on control strategy, facility, and process validation considerations for continuous manufacturing of solid oral dosage forms.
In a blog posted on September 11, 2017, at FDA Voice, the blog of the FDA, Michael Kopcha, FDA’s Director, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, outlined the interest by the FDA in advancing continuous manufacturing and the efforts the agency is making. He points to The 21st Century Cures Act, enacted in December 2016, which authorized grants to support studying continuous manufacturing and recommending improvements to the process of continuous manufacturing of drugs and biological products. He also notes that the FDA is encouraging adoption of continuous manufacturing through FDA’s Emerging Technology Team (ETT), which assists companies that want to implement innovative technology, including continuous manufacturing, for manufacturing both new and existing drugs.
He points to two companies, Vertex Pharmaceuticals and Janssen Pharmaceuticals, which benefitted from early engagement with the ETT and which subsequently had two drugs approved using continuous manufacturing: He noted that Vertex Pharmaceuticals has been using a continuous manufacturing process for its cystic fibrosis drug, Orkambi (lumacaftor/ivacaftor) since its approval in July 2015. In 2016, the FDA approved a change in production from batch to continuous manufacturing for Janssen’s medication to treat HIV-1 infection, Prezista (darunavir).