Rethinking Industrial Chiral Manufacturing: Why Chromatography Deserves a Second Look

Overview:

The manufacture of chiral active pharmaceutical ingredients (APIs) remains one of the most important challenges in modern pharmaceutical process development, estimations suggest that at least 60% of new APIs are single enantiomer drugs for the last 10 years. While asymmetric synthesis, biocatalysis and diastereoselective crystallisation are well accepted procedures for producing chiral APIs, preparative chromatography is considered as the last resort. Nevertheless, advances in stationary phase technology, solvent recycling procedures and continuous chromatographic operation have established industrial chromatography as a viable and economically competitive manufacturing platform for chiral separations, particularly when the development of an efficient asymmetric synthetic route is impractical, time-consuming, or associated with low selectivity. 

 Key learnings:

This webinar recording reviews the different options in the selection of an optimal manufacturing strategy for chiral APIs based on an assessment of technical feasibility, cost of goods, sustainability, process robustness, and time-to-market away from the assumption that chromatography is the last option. This perspective highlights the evolving role of industrial chromatography as an enabling technology within the broader toolbox of chiral manufacturing and discusses the potential of chromatography to improve process economics and environmental performance.

This webinar is presented by Laurence PEGON, Head of R&D – Axplora Pompey site, and Jean-Baptiste GUILLERMIN, Proposal Strategy Director.