In this technical webinar our hosts explore and discuss the importance of developing a good crystallisation process for Active Pharmaceutical Ingredients (API). Crystallisation can pose a significant risk to the success of a drug; however, the risks can be mitigated with an comprehensive understanding of the process, using process analytical technologies (PAT).
Dr Scott shows case studies of two different compounds and the design of their crystallisation processes. For Compound 1, the scientists used a seeded crystallisation process based on solubility measurements, which resulted in a corrected yield close to the predicted yield. For Compound 2, they conducted form screening in a range of solvents and used different crystallisation techniques to determine the most stable form for further process development.
Dr Callahan explains the importance of process understanding in mitigating risks during process development and the availability of advanced technologies, such as the Blaze probe, which can monitor particle size and nucleation in real-time, alongside many other parameters, to help design and optimise crystallisation processes.