Our customer’s API was formulated as a cyclodextrin complex to address thermal and oxidative instability. However, filtration at pilot scale was very slow.
CatSci’s fully integrated chemistry, material science, formulation and analytical science teams gathered a thorough package of solubility and solution stability data. The process was thoroughly baselined using the Crystal16, the Blaze probe and a lab scale filtration rig. The process was redesigned to improve filtration.
The CatSci team was set the task of developing a robust scalable manufacturing process suitable for transferring to plant. Discover how they used Lumi, an AI computer vision tool, to monitor and record the reaction, which enabled us to make critical decisions more efficiently and effectively.
The client's Phase 1 process was struggling to deliver API in low kg qualities. In particular, Intermediate B was of variable quality, and residual metals were known to negatively affect the onward chemistry.