by Howard Levine (hlevine
bptc
com) and Susan Dana Jones (sjonesbptccom)
Recently one of our clients asked whether it would be acceptable to use bulk drug produced during a scale-up or engineering run in a Phase 1 clinical trial. In the past, non-GMP engineering runs were used to confirm a manufacturing process and material produced during these runs could not be used in human clinical trials but could be used for preclinical GLP studies to support an IND.
