Analytical Strategies to Accelerate Development & Enhance Process and Product Knowledge

Time: 3:00 pm
day: day 1 track 4 pm

Details:

• Understanding the mechanism
of action (MOA), structure–
function relationship, CQAs, and
degradation pathways early
in development will enhance
product and process knowledge
and enable acceleration.
• Strategies for CQA elucidation
and a holistic approach to
mAb, DS, and DP comparability
throughout development will be
discussed.
• Lessons learned from an
accelerated timeline will be
shared.