The Process Development Blog

Particle sizing is hugely important, with FDA mandating control of particle size for New Drug Applications. However, it is laden with complexities and there is a general misunderstanding of the techniques used.

Subtle changes in particle size, shape, and distribution can have a major impact on pharmaceutical solubility and stability. Moreover, low bulk densities can cause flow and formulation challenges during processing.

Good crystallization process design, for intermediates or final APIs, can save you months of time during development. However, crystallization of stereoisomers can be particularly challenging.

Traditional solvent screening takes too long to fix crystallization problems for fast-moving clinical candidates. However molecular modeling and smart experimentation to screen can help speed things up.