The Process Development Blog

Faster development despite rising stereochemical complexity! In this webinar, Brendan Roche, PhD reviews engineering strategies which can be applied to key unit operations (e.g. crystallization, isolation etc.) of enantiomers and diastereomers of varying stereochemical complexity.

Before the term “influencer” became synonymous with celebrity endorsements on social media, it could most assuredly have been a moniker to be applied to K. Barry Sharpless within the chemistry community.

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.