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.

Our Director of Material Sciences, Dr Robert Dennehy, gives his expert opinion on what makes a good crystallisation process.

CatSci hosted a free Material Science symposium entitled “A Medicine is More Than a Molecule.” This webinar explored the crucial role of material science in product design and how solid-sate properties play a key role in the success of pharmaceutical materials.  

Whilst good solubility is a target property in many drug discovery programs, a balance is often struck between solubility and potential efficacy which means that a poorly soluble molecule may need to be progressed.

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

Access the recordings of our third virtual symposium now. The event consisted of seasoned industry experts who delivered succinct 25-minute presentations on particle design, formulation development, and structural informatics.

Our Director of Material Sciences, Dr Robert Dennehy, explores the ways salt screening can be made more productive, including looking at degradation, pKa values and pHmax.

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.

Access the recordings of our first virtual symposium now. The event featured an impressive itinerary of four eminent speakers spanning industry and academia, who delivered digestible 30-minute presentations, covering topics from green technologies to material science, such as crystallisation.