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.

Production batches of an API, which was a variable hydrate, revealed traces of an anhydrous polymorph. Elucidating the anhydrate formation mechanism and establishing a reproducible method for its preparation and quantification were imperative.

Our customer had a complex API forming step including 4 isolations, a reverse anti-solvent addition and micronisation. In addition, the polymorph in development was metastable. That's why, a thorough gap analysis and risk assessment were conducted, evaluating the four distinct API steps using the Blazemetrics probe alongside XRPD, TGA, DSC, and PLM. Solubility measurement and Dynochem process modelling were employed to optimise the process.

Our customer’s API was challenging; prior knowledge was fragmented, the API was poorly crystalline and there were limited solvent options due to solubility challenges, gelling, and solvation. The CatSci team repeated previous work and thoroughly characterised the known forms. An augmented polymorph screen was performed employing slurrying, evaporation, and recrystallisation methods. All screen hits were characterised using XPRD, DSC, TGA, and microscopy techniques.

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.

CatSci's material science team was tasked with developing a crystallization for a disaccharide that was produced from an enzymatic reaction.

CatSci's analytical team facilitated the development and deployment of an efficient and fast UHPLC method screening protocol.

CatSci’s analytical team employed Knime, a data analytics open source software to automate the transformation, visualisation and reporting of analytical data retrieved from the high throughput process development of a chiral synthetic step.

CatSci was tasked with catalyst screening for an asymmetrical hydrogenation of a target.

CatSci was tasked with designing a new bromination method for a key reaction intermediate. Use of bromine rendered the previous process unsuitable for a larger campaign and would require expensive and time-consuming alterations to the plant.

The route supplied by the client involved the use of phenyl cyanate for functionalising a heterocyclic intermediate with a nitrile group. Its ongoing use would require cyanide monitoring, a dedicated waste stream treatment step, and there were concerns over the sourcing of material of appropriate quality over the long term.

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.

CatSci was tasked with designing a new bromination method for a key reaction intermediate. Use of bromine rendered the previous process unsuitable for a larger campaign and would require expensive and time-consuming alterations to the plant.

CatSci was tasked with performing route-scouting, route selection and early-phase process development over a 6-month period to meet a pilot plant manufacturing slot.

CatSci was tasked with the development of a regioselective Buchwald-Hartwig amination for the final bond forming step of an API. The inherited conditions were not robust with respect to reaction conversion leading to stability concerns.