Seb Caille

Company: Amgen Inc.

Job title: Scientific Director of Process Development

Seminars:

1:30pm Shaping Best Practices for ADC Process Validation & Comparability 1:30 pm

Exploring industry approaches to process validation and comparability for ADCs, including key attributes for drug-linker and drug substance release specifications Discussing challenges in demonstrating comparability for ADCs with drug-linkers from different sources and strategies to meet regulatory expectations Sharing experiences from global ADC programs to identify best practices for ensuring process consistency and regulatory alignmentRead more

day: Day One CMC Track