The Development of API Manufacturing Processes – Targets and Strategies

Abstract

This article gives an overview on the questions to be asked and the activities to be planned during the development of an API manufacturing process. First of all the API properties required for formulation such as purity, polymorphism and solvate formation, residual solvents, particle morphology and particle size distribution have to be defined. Then process parameters have to be evaluated that ensure that the drug substance with these properties can be produced on lab scale. The transfer to large-scale production is discussed with emphasis on scale-up effects, appropriate equipment, potential bottlenecks, and cost aspects. Finally practical hints are given as how to design an API crystallization and work-up process in a way that all given requirements for the APi are fulfilled and the process can be run reproducibly and cost-effective in production.