Seth Clark, Sr. Prin. Scientist, Biostatistics, Merck & Co., Inc., Kenilworth, New Jersey, U.S.A.
Melissa Matzke, Principal Scientist, Merck & Co., Inc.
Andrew Karl, Senior Management Consultant, Adsurgo LLC
Rosemary Lucas, Principal Consultant, Adsurgo LLC
Process characterization (PC) is the evaluation of process parameter effects on quality attributes for a pharmaceutical manufacturing process that follows a Quality by Design (QbD) framework. It is a critical activity in the product development life cycle for the development of the control strategy. We have developed a fully integrated JMP add-in (BPC-Stat) designed to automate the long and tedious JMP implementation of tasks regularly seen in PC modeling, including automated set up of mixed models, model selection, automated workflows, and automated report generation. The development of BPC-Stat followed an agile approach by first introducing an impressive prototype PC classification dashboard that convinced sponsors of further investment. BPC-Stat modules were introduced and applied to actual project work to both improve and modify as needed for real world use. BPC-Stat puts statistically defensible, flexible, and standardized practices in the hands of engineers with statistical oversight. It dramatically reduces the time to design, analyze, and report PC results, and the subsequent development of in-process limits, impact ratios, and acceptable ranges, thus delivering accelerated PC results.
