The Way Forward Options and Development Strategies

The first step in this direction was to do the following two things  

The first item was really to find out if new chemistry was available that we did not have access to when developing the commercial omeprazole process in the 1980s. As it turned out no matter how unprejudiced our approach to the problem, really tackling it from all possible angles, we could not identify any other route that would be better suited for the synthesis of the molecule than the current one for omeprazole (see Fig. 5). In one sense this was pleasing as it showed that a good job had been done in the first place  

Focusing now on strategic options, again some intensive discussions led to the identification of three principally different approaches that needed to be carefully evaluated and compared on their respective merits and weaknesses  

As the third option was one where considerable hands-on experience was available, our chromatography-based procedure definitely had to be kept alive in the sense that development resources were justified for improving the performance. However, a forecast of 5 kg production simply by linearly extrapolating data from the A kg batch, resulted in a really frightening scenario where considerable manpower (peak values of 20-30 people during certain stages) had to be allocated over 

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