SubscribeCarboGen and AMCIS' Center of Excellence in Chromatography Services offers flexible and customized solutions for the separation and purification of lead compounds and intermediates.
As part of CarboGen and AMCIS' businesses our dedicated group of chromatographic specialists has cultivated expertise in method development, feasibility studies and scaling up chromatographic separations.
CarboGen and AMCIS' Chromatography Services specialize in Medium Pressure and High Pressure Liquid Chromatography (MPLC/HPLC) and Simulated Moving Bed Chromatography (SMB) and operate according to the highest standards of good manufacturing practice (cGMP). Depending on the method used, our typical scale ranges from 1 mg to 100 kg.
Manufacture
A true Center of Excellence within CarboGen and AMCIS' chemistry practice, our Chromatography Services also offer the added flexibility of integrating the separation step into a synthetic process for the manufacture of active pharmaceutical ingredients (APIs) for clinical and commercial use.
Case Study SMB
In the course of a recent project, a 11 step synthesis involved a late stage racemic intermediate, that required resolution into its enantiomers. The functional groups of the molecule did not allow for classical resolution and the development of an asymmetric synthesis was inconceivable within the given time frame.
At that stage, as a result of not being able to recycle the undesired isomer, a 50% loss of this late stage intermediate had a dramatic impact on the cost of goods for the product and the potential economic success of the program.
Through a joint development program with our customer, the synthesis was developed into a highly effective and efficient process. Simulated Moving Bed (SMB) chromatography was successfully employed for the resolution of the late stage intermediate, with the inclusion of a new process for recycling of the unwanted isomer through in-process racemization.
This process resulted in the desired enantiomer in high-optical purity and an overall yield of 85% from the racemate. In less than 1 week, the process throughput was optimized to 1.4 kg of racemate per day. To date more than one metric ton of the intermediate has been produced using this process.