Seb Caille

Company: Avidity Biosciences, Inc.

Job title: Senior Director

Seminars:

1:30pm Presentation on IQ ADC Working Group Activities 1:30 pm

Control strategy elements Treatment of conjugatable vs non-conjugatable impurities Process validation and comparability approachesRead more

day: Day One CMC Track

2:00pm Roundtable Discussion: Discussing Best Practices for ADC Process Validation & Comparability 2:00 pm

Exploring industry approaches to process validation and comparability for ADCs, including key attributes for drug-linker and drug substance release specifications Discussing comparability requirements for ADCs with druglinkers from different sources to meet regulatory expectations Discussing strategies for evaluating small molecule impurity clearance and establishing robust purge factor calculationsRead more

day: Day One CMC Track