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In this case study, discover how Neuland partnered with a European mid-sized biotechnology company to scale an aryl sulfonamide NCE process from 5 grams to 500 grams for preclinical studies. By redesigning solvent, catalyst, isolation, and hydrogenation conditions across the three-stage route, Neuland established a safer and more economical non-GMP process while keeping future clinical and commercial scale-up requirements in view.
Improved the overall three-stage process yield by 80%.
Increased total yield from approximately 34% to more than 61%.
Reduced raw material cost contribution by 50%.
Delivered 500 g of product two weeks ahead of schedule.
Reduced impurities to below 0.35% for preclinical use.
Reduced key starting material consumption from 2.0 equivalents to 1.1 equivalents.
Replaced DMF and dioxane to reduce nitrosamine and peroxide-related process risks.
Replaced column chromatography with anti-solvent crystallization to improve scale-up efficiency.
Process Optimization Journey
Medicinal Chemistry Route Assessment → Phase-Appropriate Risk Review → Solvent and Reagent Optimization → Catalyst Reduction → Isolation Process Redesign → Hydrogenation DoE → 500 g Non-GMP Scale-Up → Future GMP Readiness
