Tony Bou Kheir

Company: Purespring Therapeutics

Job title: Head of Analytical Development & Quality Control

Seminars:

Evaluating Best Practice for Analytical Technology Transfer Process to Ensure Smooth Transitions During Upscaling 3:30 pm

Understanding the GMP requirements during the technical transfer of analytical methods to enable effective upscaling Establishing robust methodologies for sharing protocols, custom reagents, and assay standards during tech transfer Discussing analytical methods to develop confidence in CQA preservation throughout manufacturing, storage, and shipmentRead more

day: Day Two

PANEL DISCUSSION: Discussing Strategies to Correlate the Outputs of a Potency Matrix Approach to Manage Regulatory Expectations 1:00 pm

Exploring the potency matrix and understanding the relevance of the constituent assays Aligning measures of infectivity, mRNA, protein, and biological activity to generate robust potency assay data Understanding correction factors and correlation coalitions in potency assay read-outs Upper and lower limits: discussing regulatory perspectives on infectivity titresRead more

day: Pre-Conference Focus Day