Abstract

Fully Continuous Mulit-Step GMP Synthesis of Drug Substance in a Fume Hood Facility

Joel Calvin, Research Scientist, Eli Lilly

Development and implementation of flow process to make drug substance that include a Buchi operation for solvent exchange, Grignard formation using magnesium in a CSTR, a Negishi reaction in a solids handling PFR and a continuous anti-solvent/cooling crystallization of API. The process was run at our manufacturing small volume continuous facility.