Optimizing API Manufacturing: Lessons from the Industry

API manufacturing is crucial in maintaining a consistent production of high-quality APIs. Its optimization involves de-risking – minimizing uncertainties; using FMEA to identify and prioritize product risks; raw material scalability; process optimization; continuous manufacturing; quality by design; automation and data integration; collaboration and knowledge sharing; and embracing sustainability. These have been informed by lessons learned from industry strategies and technologies, and experts underscore the need to consider raw material supply chain, process safety, and future manufacturing costs.