Andrey Sarafanov
Principal Investigator, Head of Research Laboratory FDA
Seminars
Wednesday 8th October 2025
Regulatory Insights into the Evaluation of Extractables in Biologic Therapies: FDA Perspectives & Case Studies
9:10 am
- Overview of FDA methodologies for identifying and assessing extractable substances in biologic drug packaging and delivery systems
- Common challenges and considerations when interpreting analytical data during regulatory review
- Case examples highlighting FDA’s decision-making process and expectations for supporting data
