Project challenge: Synthesis of a phase II NCE involved an intermediate that had high propensity to racemize. Also at isolation there was very low yield which contributed to product cost. Other major challenges included use of pyrophoric reagents, hydrogenation in specialized reactors and purication involved multiple column chromatographic steps. Solution design: Identication of critical process parameters and redesigning of the process with a commercia objective was achieved. Highlights of the approach: Racemization of chiral intermediate was prevented by reactant redesign whereby yield was improved three-fold which had signicant impact on the overall RMC
Exploiting dierence in chemical reactivity of functional groups, safer alternative reagents were selected to replace pyrophoric reagentsReplacement of corrosive additives resolved the use of specialized reactors for hydrogenation Efficient crystallization methods to bypass column chromatography and nally arrive at the desired polymorph Conclusion: This case study showcases the holistic approach adopted by our scientists in designing a commercially viable process and the cost impact of a technically strong product design.
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