Our client, a leading US major pharmaceutical company, was in a close race with a competitor to bring one of their lead products to the market. The process provided by the client was not viable from the point of view of safety, cost or robustness. At this time, development of a back-up compound by the client was giving disappointing results. The client turned to CarboGen and AMCIS requesting development and validation of an alternative process that would yield material of comparable impurity profile to that which had been used in the program to that point, along with delivery of primary stability batches - all within a timeframe of four to six months.

Within the given timeframe, AMCIS developed an alternative process in a program that included the optimization of an asymmetric reduction, elimination of expensive starting material and reagents and improvement in overall yield from 5 % to 25 %. The now robust process was successfully transferred to a third party manufacturer acting as second supplier.

AMCIS submitted the DMF for the process and successfully underwent the resulting FDA inspection three months later with no 483 being issued. As a result, our client successfully launched their product ahead of their competitor.