
The main message coming from the conference was that large scale chromatography and in particular chiral separations using Simulated Moving Bed are now becoming common in manufacturing. There are already two drugs being made on 10-50 tonne scale using a last step resolution, presumably with racemisation and recycle, and FDA have no problems with the use of chromatography on large scale (e.g. re validation). Of course SMB is a continuous process, usually sandwiched between a batch racemic synthesis and a batch crystallisation, but despite this is an efficient manufacturing method. The expensive chiral stationary phase has been proved to be very robust, with no replacement required after 3 years. This helps to keep the costs down to an acceptable level.
This is a technique which all process chemists should consider as a viable manufacturing option.














