The Process Development Blog

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

APC scientists developed an approach to enantiomeric crystallization process development that combines building a ternary phase diagram with PAT enabled kinetic profiling to unlock the thermodynamic and kinetics insights needed to support ultra-fast process development for these challenging crystallization processes.

Two case studies are presented herein illustrating how thermal cycling can be employed in a batch cooling crystallisation process to transform the undesired plate-like and needle-like morphology into thicker multi-layered plates or rod-like crystalline particles with a narrower size distribution.

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

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.

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

[WEBINAR] Good crystallization process design, can save months of development time. But, crystallization of stereoisomers can be particularly challenging.

[WEBINAR] Traditional solvent screening takes too long to fix issues for fast-moving clinical candidates. But modeling & smart experiments speed things up.