Accelerated Process Development & Establishment of Analytical Comparability of a Vial Size Change of a Lyophilized ADC Drug Product
Time: 1:30 pm
day: Day Two
Details:
- 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 validation and regulatory alignment
