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.

See how CrysAI™ applies deep learning to crystallization and cell imaging—automating segmentation, improving reproducibility, and scaling insight.

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.

Explore peptide crystallization techniques including solvent screening, co-crystallization, and in-silico modelling to overcome scale-up challenges in peptide manufacturing.

Strong CMC outcomes depend on deep process development. Learn how a science-first approach ensures reproducibility, scalability, and successful tech transfer.

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.

For the synthesis & crystallization of APIs, Mixed Suspension Mixed Product Removal Crystallizers (MSMPRCs) can help address common issues in batch production.