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Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.
Progress is being made in continuous manufacturing. A regulatory working group for continuous manufacturing from the Center for Structured Organic Particulate Systems (C-SOPS), which involved volunteers from 16 companies, submitted a best practices guide for continuous solid-dosage drug manufacturing (1) to FDA in June 2016, which was subsequently posted for public comment on June 23, 2017. The document was developed in response to an FDA invitation, and it describes methodologies for “selecting, specifying, implementing, controlling, and optimizing” continuous systems for oral solid-dosage drug manufacturing (1). The document explains fundamental engineering concepts, describes key differences between batch and continuous systems, and reviews process monitoring and control and sampling plans, as well as addresses some common concerns, such as how to define a batch for a continuous process. The document looks at continuous manufacturing throughout the product lifecycle: for new products and post-approval changes.
In an FDAVoice blog post on Sept. 11, 2017, FDA announced that it is seeking industry input on continuous manufacturing practices, including the C-SOPS best practices guide (2). Industry members have been developing continuous manufacturing technologies for their own processes, and FDA wants to develop common guiding principles building on this progress. “Given these emerging variations, FDA’s goal is to provide a framework of principles that clarify our expectations, while still encouraging companies to innovate and implement continuous manufacturing. We are talking with industry and are also helping lead this conversation on a global level by engaging our foreign regulatory counterparts regarding the development of clear regulatory standards,” said Michael Kopcha, PhD, RPh, FDA’s director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER), in the blog post (2). The public docket is open for comment until Sept. 21, 2017.
An example of recent industry installations of continuous manufacturing equipment is at Pfizer’s Freiburg, Germany manufacturing site; the company broke ground for a PCMM (Portable, Continuous, Miniature and Modular) facility (a technology from the Pfizer, GEA, G-CON Manufacturing collaboration) and opened a continuous solid-dosage manufacturing facility in May 2017 (3, 4). In this continuous system, the three production steps of supplying, feeding, and mixing are linked together; two feeding systems from Coperion K-Tron use gravimetric twin-screw feeders with automated control, noted the supplier (4).
In October, 2017, C-SOPS will host an industry conference on continuous manufacturing that is open to the public. On Oct. 16, a “mini course” designed to introduce continuous manufacturing will provide a general introduction to product and process design, implementation, process control, and regulatory considerations. The C-SOPS team will also present some of the research they have been doing in continuous solid-dose manufacturing. On Oct. 17, the C-SOPS team will run workshops on various topics and will introduce the soon-to-be-launched New Jersey Continuous Manufacturing Institute (NJCMI), a collaboration between Rutgers University and The New Jersey Innovation Institute. NJCMI will help companies implement continuous manufacturing for both solid dose and biological systems.
1. C-SOPS Regulatory Working Group for Continuous Manufacturing, “Current Recommendations for Implementing and Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing,”(June 2016) http://docs.wixstatic.com/ugd/0da418_e51f1cf51ee248e09eead3166a554a72.pdf, accessed Sept. 14, 2017.
2. M. Kopcha, “Continuous Manufacturing” – Common Guiding Principles Can Help Ensure Progress,”(Sept. 11, 2017), https://blogs.fda.gov/fdavoice/index.php/2017/09/continuous-manufacturing-common-guiding-principles-can-help-ensure-progress/, accessed Sept. 14, 2017.
3. A. Shanley, “PCMM, The Next Generation,” www.pharmtech.com/pcmm-next-generation (Sept. 7, 2017), accessed Sept. 14, 2017.
4. Coperion K-Tron, “Feeding systems for continuous production at Pfizer Manufacturing Deutschland GmbH,” www.coperion.com/en/news-media/newsletter/2017/pharma-in-focus-edition-012017/feeding-systems-for-continuous-production-at-pfizer-manufacturing-deutschland-gmbh/, accessed Sept. 14, 2017.