Process Development Implications of Biotin Production Scale-Up

Abstract

Careful planning and construction of suitable in-process tests and isolation of new impurities observed led to quick, mechanistic-based assessments of problems seen in two steps of Biotin production scale-up and allowed for rapid changes to be made to resolve the issues. The quench of Grignard reaction mixtures with deuterium-based materials led to increased understanding of one of the main pathways for yield loss in a Grignard reaction contained with the Biotin process.