John Kavouris

Company: AbbVie

Job title: Scientist II, Process Development

Seminars:

Overcoming DAR Variability From an Unspecified Raw Material Impurity 11:30 am

Case-study on out-of-specification DAR result during clinical manufacturing of ADC: Investigation uncovered an unspecified impurity within raw materials, capable of reacting with the drug-linker an impacting DAR. A mismatch between raw materials used in development and manufacturing accounted for the OOS, but subsequent batches yielded in-spec DAR but lower than expected. Follow up investigative work…Read more

day: Day Two