The Process Development Blog

With 68% of 2022 FDA small molecule approvals containing chiral centres, structured enantioselective crystallisation strategies are essential for modern drug development.

On-demand webinar on continuous crystallization for API development, covering kinetics modelling, PAT deployment, and additive manufacturing tools for process control.

In this case study, scientists determine drying conditions that preserve the API physicochemical properties, while minimizing the drying time.

Ternary phase diagrams and PAT kinetic profiling raised enantiomeric excess from 92% to over 99% and yield from 87% to 98% for an oncology Phase I programme.

Thermal cycling controls API crystal morphology and size distribution, converting needles or plates into robust polycrystalline particles that filter and flow more easily.

[WEBINAR] Scale-up of crystallization processes is rarely trivial & often necessitates careful consideration and in-depth understanding of process parameters.

Computational solvent screening narrows 70 candidates to under 10 in 2–3 days, with solubility predictions within 20% of experiment—applied to API crystal morphology design.

Combining laser light scattering and microscopy for pharmaceutical particle size analysis eliminates common measurement artefacts and provides verifiable, morphology-aware results.

On-demand webinar on drug substance development bottlenecks-solubility, particle size, and morphology-featuring computational screening strategies, presented by APC's Dr Jacek Zeglinski.

Subtle changes in particle size, shape, & distribution can have a major impact on pharma solubility and stability and cause flow and formulation issues.