Srinath Thirumalairajan
Director, Process Engineering Pfizer
Seminars
Thursday 6th November 2025
Workshop highlights include:
- Breaking down the end-to-end playbook for drug-linker CMC development including: specifications and impurity control strategy, comparability, process development and validation, stability, and post-approval changesÂ
- Delving into framework for purge factor calculations and experimental evaluation of clearance of small molecule impurities in the ADC drug substance manufacturing process
- Exploring ADC IND and BLA filing strategies and recommendations per the ICH M4Q (R2) framework
Wednesday 5th November 2025
Chair:
Download the Full Event Guide for full details
