Reducing Cycle Time By 88% Through Strategic Solvent Replacement In Pharmaceutical Development

Replacing a restricted solvent is usually treated as a compliance exercise. Here, a New England biotech needed to move away from methylene chloride, and the process it relied on had other problems: a 16-hour reaction and a work-up that involved pH adjustment, carbon treatment, and several distillations for solvent exchange. Starting with more than a dozen candidates, a process R&D team narrowed the field through solubility studies and small-scale trial reactions, then ran its new development work alongside the original baseline experiment. The study also covers how early analytical work surfaced a starting material purity issue that affected yield data, and what happened when the revised process moved to the pilot plant.

Read the case study to see how the team approached the screening and what the results looked like.