Karthik Narsimhan

Company: AbbVie

Job title: Senior Development Engineer

Seminars:

Accelerated Process Development & Establishment of Analytical Comparability of a Vial Size Change of a Lyophilized ADC Drug Product 1:30 pm

Discovering how vial size was reduced pre-validation to meet overfill compliance following an administration change Sharing how a new lyophilization cycle for the smaller vial was developed rapidly using process modeling and lean experimental design Outlining how elevated moisture in the smaller vial posed comparability risks and reviewing the mechanistic studies and analytical bridging enabled…Read more

day: Day Two