Evaluation of fast LC for in-process testing during drug substance scale-up and manufacture

摘要

Today, pharmaceutical companies are facing big challenges to reduce drug discovery and development timelines [1, 2]. The Analytical Science Department plays a significant and positive role in reducing the timelines by utilizing more efficient and faster technologies. In-process testing for the drug substances scale-up and manufacture is one of the critical steps to reduce the timelines. The quick delivery of results for in-process testing is even more important. It can not only speed up the process, but also ensure the quality of the active pharmaceutical ingredient (API) by carefully control of the reaction time (extra reaction time may produce more impurities by side reactions).