Case Study: IND-Enabling Studies And Chemical Synthesis Completed — Nine Months From Lead Selection

By Ricerca Biosciences, LLC

A client asked Ricerca to develop a robust chemical process, complete GLP toxicology to support a major program, and file an IND — all on a very aggressive timeline.

Benchmarking, process development, and scale-up work were completed in parallel with an extensive salt screening program. This resulted in 1.6 kg non-GMP preparation for preliminary toxicology studies and bioanalytical development.