The Process Development Blog

Small molecules still dominate FDA approvals, but rising stereochemical and solid-state complexity demands stronger CMC strategies for 2026 readiness.

This on-demand webinar from APC explores how Crystallization-Induced Diastereomeric Transformation, or CIDT, can improve diastereomeric salt crystallization for chiral resolution. The session covers solubility behavior, phase relationships, counterion selection, solvent choice, solid-state control, and analytical strategies for improving enantiomer separation. It is relevant for pharmaceutical development teams working on chiral molecules, double salts, crystallization process design, yield improvement, purity optimization, scale-up, and enantiopure compound production.

We’ve curated a list of key crystallization publications from the past 25 years, showcasing the research and breakthroughs that have defined our approach and expertise. These publications represent the culmination of decades of innovative work by APC’s crystallization experts, illustrating our ongoing impact in this field.

This study introduces a hybrid method combining the COSMO-RS model with machine learning to predict aqueous solubility at room temperature.

APC's webinar covers novel HPAPI development strategies using digital twins, PAT, and continuous processing to cut development time and cost for highly potent APIs.

A scale-down and CFD modelling approach delivered a 10% crystallisation yield improvement within existing regulatory filing parameters in 12 weeks.

[Webinar] Learn more about the use of Continuous Processing for Crystallization.

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.

[WEBINAR] Industry bottlenecks in drug substance development: solubility, particle size, and morphology.