Organizations Seek to Advance Industry Knowledge of Continuous Manufacturing

At an industry meeting of the Center for Structured Particulate Systems (C-SOPS) held at Rutgers University on Oct. 16, 2017, presenters detailed work that had been done and future plans to educate regulators and industry members about advances in and best practices for practical implementation of continuous manufacturing for solid-dosage drug products. Presenters from Rutgers University and the New Jersey Institute of Technology (NJIT), which are two of C-SOPS academic member institutions (along with Purdue University and the University of Puerto Rico at Mayaguez), shared recent research project results, and a speaker from FDA shared some of the work his group is doing in continuous manufacturing. In related news, on the second day of the conference, the New Jersey Innovation Institute (an NJIT Corporation) and Rutgers announced plans to form the New Jersey Continuous Manufacturing Institute, which will be a center of excellence to advance continuous manufacturing for both solid-dosage drugs and for biopharmaceuticals.

This year’s annual meeting was the first to be open to the industry and community (in addition to the consortium’s members), with the goal of reaching a broader audience. In addition to research activities, C-SOPS had convened a working group to submit a document to FDA that could potentially form the basis of a guidance on continuous manufacturing. The group submitted their document in June 2016, and in June 2017 it was posted in an FDA docket. The public comment period closed Sept. 21, 2017. The working group hopes to be able to reconvene and update the document with advances in technology that have occurred in the past two years. Another highlight from 2017 was the first meeting of an expert panel on continuous manufacturing established by the US Pharmacopoeial Convention (USP), which was launched following the 2016 partnership of USP and C-SOPS to bring together experts to begin addressing the development of standards in continuous pharmaceutical manufacturing.

Another key role for C-SOPS is education in continuous manufacturing. Since 2007, the group has trained nearly 100 doctoral and post-doctoral students who have moved on to positions in industry and FDA. The International Institute for Advanced Pharmaceutical Manufacturing (I2APM)-a partnership between C-SOPS, the EPSRC Future Continuous Manufacturing and Advanced Crystallisation (CMAC) Hub in the UK, and the Research Center Pharmaceutical Engineering in Austria-is also focusing on education efforts, noted presenters at the conference. The group is working on organizing existing educational material in order to make it more accessible and hopes to develop online training. I2APM plans to expand its educational efforts to Asia, including reaching regulators from India, China, and Japan.   

Industry has been making progress in the implementation of continuous manufacturing. Several research projects presented at the conference described advances in modeling and control for solid-dosage continuous manufacturing processes. Xiaochuan “Ben” Yang, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, noted in a conference presentation that companies who want to implement continuous manufacturing can apply to the Emerging Technology Team as described in the FDA guidance involving the submission of chemistry, manufacturing, and controls information containing emerging technology that was finalized in September 2017. In addition, FDA is supporting continuous manufacturing through grants for science activities outside of FDA and internal FDA projects, which are looking at issues such as how to use process analytical technology (PAT) to monitor continuous manufacturing for either identifying a state of control or for real-time release testing.