ABSTRACT
The use of standardized lean manufacturing principles to improve drug discovery productivity is often thought to be at odds with fostering innovation. This manuscript describes how selective implementation of a lean optimized process, in this case centralized purification for medicinal chemistry, can improve operational productivity and increase scientist time available for innovation. A description of the centralized purification process is provided along with both operational and impact (productivity) metrics, which indicate lower cost, higher output, and presumably more free time for innovation as a result of the process changes described.
Subject(s)
Drug Discovery/economics , Pharmaceutical Preparations/economics , Pharmaceutical Preparations/isolation & purification , Chemistry, Pharmaceutical/economics , Chemistry, Pharmaceutical/methods , Chemistry, Pharmaceutical/organization & administration , Drug Discovery/methods , Drug Discovery/organization & administration , Efficiency, Organizational , Humans , Pharmaceutical Preparations/chemistryABSTRACT
Preparative HPLC and HPLC-MS are well established as the methods of choice for purification of pharmaceutical library compounds. Recent advances in supercritical fluid chromatography (SFC) have now made SFC a viable alternative to HPLC for this application. One of the potential arguments for using SFC in place of, or in addition to, HPLC is that it may offer different selectivity and thus has the potential for improved separation success rates. In this paper, we examine relative success rates for SFC and HPLC in obtaining adequate selectivity for successful separation. Our results suggest that use of SFC in addition to HPLC may result in a slight (1-2%) improvement in success rate compared to use of HPLC alone.
