The deployment of continuous manufacturing (CM) is prompting the pharmaceutical industry to understand better the characteristics of the excipients they are using and work more closely with suppliers to assure that the materials are fit for purpose. CM is also prompting a harder look at how to open up the clearance pathway for new/modified excipients that would better serve the advanced processing needs and objectives.
The intensifying focus on excipients, as industry and regulators explore together how to take pharmaceutical manufacturing and control to the next level, was evident throughout the third FDA/Product Quality Research Institute Conference on “advancing product quality,” held in Rockville, Maryland in late March.
However, excipient issues received particular attention during the two-day track on “enhancing product quality though continuous manufacturing.” [For more on the FDA/PQRI conference and its scope, see IPQ April 12, 2017.]
Presenting during the track were experts from CDER’s Office of Pharmaceutical Quality (OPQ), EMA, and Japan’s PMDA. A plenary session presentation was also given by USP on the opportunities for standardization in CM.
Updates were provided during the track on the progress being made down the CM pathway by Vertex, which was the first company to have a new product approval from FDA incorporating a CM process, and by Janssen, which followed with the first clearance of a prior-approval supplement (PAS) to switch from batch to CM for an existing product (ibid.).
CM progress reports were also given by Merck, Novartis, Lilly, and Pfizer. MIT and Rutgers discussed their collaboration with pharma to advance CM and other technologies. [Editor’s Note: IPQ will be exploring the industry and academia CM initiatives in upcoming stories.]
Colorcon’s Schoneker Hones in on Excipient CM Issues
Placing the focus squarely on the excipient issues in implementing CM at the FDA/PQRI conference was Colorcon Global Regulatory Affairs Director Dave Schoneker.
Schoneker provided an overview of the relationship between excipient properties and the unique needs of CM processes. His remarks encompassed: ● excipient properties critical for CM ● excipient variability and CM ● excipient property characteristics ● ‘designed for purpose’ excipients ● novel excipient evaluation, and ● the workshop PQRI is planning on CM material attributes in 2018.