Route Development: Designing Synthesis for GMP Production

Case study
Drug substance

The successful transition from initial synthesis of an API to a kilogram-scale route requires expert analysis and design. In addition to optimizing each intermediate reaction, chemists must balance economic, regulatory and time constraints. Furthermore, designing the best synthesis route for GLP and GMP production cannot begin without adequate knowledge of the compound, and it may require high-purity intermediates. Each API presents a unique set of challenges.

In this case study, our experts developed a robust, high-yield process to enable GMP production under tight time pressure for a first-in-human clinical trial. Read the full case study to learn how.