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.

From Reagent Science to Adoption Strategy

Regulatory acceptance of recombinant bacterial endotoxin testing (BET) continues to build alongside established LAL testing, and this session provides the foundational context that adoption planning often skips.

The presentation explains how recombinant reagents are manufactured, why protein composition and final formulation can differ between reagents, and what those differences may mean for method selection.

It then widens the view to the industry itself, drawing on survey insight from quality control teams to show where adoption currently stands, which pressures appear to drive change, and where readiness and timelines tend to diverge.

The session closes with an overview of the regulatory signals shaping recombinant BET globally, giving QC and QA teams a clearer reference point for planning their own path forward.

Presented by Nicola Reid, Director, Portfolio Product Manager, Pyrogen & Endotoxin Detection, Charles River

Nicola has over 25 years of experience with bacterial endotoxin testing and pharmaceutical microbiology. She has been involved in all aspects of the endotoxin assay, including the design and development of BET-specific reagents, instrumentation, and software. Her work has led her to directing workshops and training courses, as well as lecturing internationally on a variety of BET-related topics, including LAL and Recombinant methodologies, product validations and alternate method validations, 21 CFR Part 11, and BET regulatory affairs.

Followed by a live questions and answers session

Sponsored by Charles River Laboratories

For over 30 years, Charles River’s Microbial Solutions has led the way in optimizing microbiological quality control testing and minimizing contamination risks across industries. Our comprehensive portfolio includes Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing, all designed to enhance lab efficiency, support critical decision-making, and protect patients.

Our Endosafe® system offers rapid and traditional bacterial endotoxin testing with sustainable, animal-free recombinant reagents, allowing confident decisions on product safety. Celsis® accelerates product release, delivering sterility results in under seven days and bioburden results in less than two. Accugenix® provides unmatched accuracy in microbial identification services, leveraging the industry’s most extensive reference libraries.

Charles River is committed to advancing industrial microbiology, driving the adoption of modern technologies that enhance quality control, reduce costs, and ensure patient safety. Serving the pharmaceutical, consumer care, and cosmetics sectors, our solutions ensure smooth operations, lower manufacturing costs, and uphold your reputation in a competitive market.