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.

In this webinar, Guangyang Hou, a Senior Process Development Engineer at APC, explores how model-supported approaches in conjunction with the implementation of Process Analytical Technologies (PAT) and continuous processing, can minimize human intervention whilst drastically reducing development times.

Using data-rich experimentation and mixing models, which leverage CFD, a right-first scale up of the new process was achieved within the yield improvements translating directly back to the plant.

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

Our expert, Dr. Jacek Zeglinski talks about the various challenges which drug substance developers face when seeking to develop material suitable for tabletting

Particle sizing is hugely important. However, it is laden with complexities and there is a general misunderstanding of the techniques used.

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