Evaluation of simulated moving bed chromatography pharmaceutical process development

Simulated moving bed chromatography is a new technology to the pharmaceutical industry and its usefulness has yet to be established. To properly determine its potential, we arranged an evaluation using the enantioseparation of a drug candidate as the example. A laboratory-scale system was set up and operating within two days and was able to separate 125 g of the racemic mixture per day. At this throughput, each enantiomer was isolated in high purity (greater than 97.5% enantiomeric excess) and in greater than 98% (w/w) recovery.