Integrated Platform at ICES Kilo-Lab for Process Quality by Design

摘要

The paradigm shift that is attempting to change the way pharmaceutical manufacturing is undertaken in the 21st century has raised practical challenges for the adoption and implementation of the Process Analytical Technology (PAT) framework initiated by the U.S. Food and Drug Administration (FDA). The motive is to engender a science-oriented pharmaceutical manufacturing that is along FDA's pharmaceutical product quality by design (QbD) ideology. One such challenge revolves around the integration of PAT technologies such as varied process analytics (e.g. sensors, spectrometry, chromatography, etc.), multivariate analyses, knowledge management, and process control under a common information exchange and data-logging platform. Such an integrated platform was recently installed and commissioned at the Kilo-Lab in the Institute of Chemical and Engineering Sciences (ICES). Its efficacy was demonstrated through synthesizing 4-D-erythronolactone at kilo-scale using a four-phase hybrid process.