Endotoxin Testing of Pharmaceutical Products using Synthetic Reagents

Endotoxin Testing of Pharmaceutical Products using Synthetic Reagents describes AstraZeneca’s approach to evaluating and adopting synthetic reagents for product endotoxin testing. As industry interest in alternative methods continues to grow, this presentation will explore the scientific, regulatory, and practical considerations involved in implementing synthetic reagents within a pharmaceutical development environment. The session will outline AstraZeneca’s journey toward adoption, including the drivers for evaluating synthetic reagent technologies and the steps taken to assess their suitability for pharmaceutical product testing. It will discuss current regulatory perspectives relating to the use of synthetic reagents and how these considerations influence validation strategies and implementation plans. The presentation will also describe the validation approach used to demonstrate method suitability, with attention to product-specific considerations, comparability, and data generation.

Presented by Poppy Cliffe, Senior Scientist in Microbiology, Global Product Development at AstraZeneca

Poppy is a Senior Scientist in Microbiology within Global Product Development at AstraZeneca, where she supports the development and assurance of microbiological control strategies for pharmaceutical products. Her current work focuses on the validation and implementation of product endotoxin testing using synthetic reagents across AstraZeneca’s product portfolio, contributing to the adoption of innovative and sustainable approaches in microbiological testing. She has also contributed to the scientific field through her previous published work on the assessment of synthetic reagents for pharmaceutical water testing, reflecting her ongoing interest in advancing alternative methods in microbiology. Poppy holds a BSc in Biomedical Science from the University of Birmingham and is currently completing a Master’s degree in Drug Discovery and Development. She also has previous experience working in infectious disease drug discovery prior to joining AstraZeneca.

Followed by a live questions and answers session