Mitigating technical challenges and cost impacts by improved process design

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