Process chemistry in API development

Abstract

The timely supply of high-quality active pharmaceutical ingredients (APIs) depends on efficient process chemistry run under Good Manufacturing Practice (cGMP) guidelines. The enterprise requires the harmonization of technical, logistic, economic, and regulatory factors to result in a market viable production. This special of CHIMIA focuses on the technical and chemical aspects of API production known as Process Chemistry. Eighteen submissions outline a broad spectrum of topics in Process Chemistry: 1) company strategies in planning operations; 2) API target and chemical route evaluation; 3) chemical solutions to specific API targets; 4) technological methods for improving synthetic efficiency; 5) analytical methods for assessing safety in chemical operations; 6) educational opportunities at the academic/industry interface. Few of these topics arise in the normal course of chemical studies at university, but all of them become frontline concerns to the chemist entering the job market. It is our hope to highlight Process Chemistry and its challenges here in a way that brings home the excitement of this important pursuit.