Companies aim to deliver guaranteed scale-up, optimum performance, and best economics.
Daicel Chemical Industries and Groupe Novasep are partnering to streamline the use of chiral chromatography to manufacture late-stage clinical and commercial chiral intermediates and APIs.
Daicel plans to identify the best chiral stationary phase (CSP) from their library of commercial and developmental CSPs. Novasep Process will provide process optimization services, using its computer simulation software and full process development.
The intended result of this combined approach is to deliver guaranteed scale-up, optimum performance, and best economics for large-scale separations, explains Jean Blehaut, president of Novasep Process’ parma business unit.
“Today, several chiral drugs are commercially produced with chromatographic technologies. Such drugs include Pfizer’s Zoloft, UCB Pharma’s Keppra, Lundbeck’s/Forest Laboratories’ Cipralex/Lexapro, and Cephalon’s Nuvigil,” he points out.
“But the pharmaceutical industry is just discovering the potential of chiral chromatography to bring NCEs to the market faster. The existing commercial projects have demonstrated that it is often cheaper to produce single enantiomeric drugs with chromatography than use traditional technologies such as crystallization and/or asymmetric synthesis.”