Conference: Endotoxin and Pyrogen Testing - Pharmacopoeial and Scientific Developments

25/26 November 2025

Background & Objectives

Testing for endotoxins and pyrogens is a critical in-process and final release test for parenteral products. Over the past decades, various approaches have been developed to provide solutions for the wide range of products tested for endotoxins and pyrogens: RPT, LAL, MAT. With the LAL test method as an established, compendial methodology for bacterial endotoxins, including the harmonisation of EP, USP and JP, there is a solid basis for such testing. But the range of products to be tested is becoming broader and more complex as biotechnological and molecular biological techniques advance. Because of the importance of these tests, they are therefore under constant scrutiny by industry and regulators to ensure the effectiveness of the tests and the safe manufacture and release of products onto the market. Novel medicines such as cell and gene therapies and combinations with medical devices, as well as complex biopharmaceutical formulations, pose challenges for testing and require in-depth knowledge and expertise in the field of endotoxins and pyrogens. Furthermore, as the range of solutions offered by endotoxin testing vendors increases (e.g. recombinant factor C, ELISA-based test kits, automated LAL cartridge technology), it is important to gain a data-driven understanding of the benefits and limitations of each approach. Therefore, it is not only the discussions on low endotoxin recovery and endotoxin masking that are important. We should also focus on the need for future innovations within BET that provide solutions to current challenges with modern pharmaceutical and biopharmaceutical products for daily testing. In addition, automated solutions will play an important role, making issues of computer validation and data integrity important.

This conference will inform you about current developments in Endotoxin and Pyrogen testing, implementation of new methods as well as the practical use of established test methods like LAL for Endotoxin testing.

You become informed about

International regulatory developments
Feasibility of new and innovative products and methods
Special issues like masking/LER
Testing of critical substances
Application of alternative testing methods – MAT, RFC and more

Target Audience

Representatives of the regulatory and authorisation authorities
Specialists in laboratories for Endotoxin and Pyrogen Testing
QA/QC personnel in the biopharmaceutical environment
Scientist in research and development of testing systems
Project managers and outsourcing personnel
Biologists, analytical chemists and biochemists interested in Endotoxins and Pyrogens products

Congress Registration

Moderation

Dr Ulrich Herber, Charles River Laboratories
Dr Johannes Reich, Member of the ECA Pharmaceutical Microbiology Group, GM at Microcoat Biotechnologie

Tuesday, 25 November 2025

KEYNOTE on 25 November 2025: Artificial Intelligence in Pharmaceutical Industries
Dr Marcel Franke, Senior Scientist Predictive Formulation, Process Solutions/Upstream & Process Materials R&D Merck Life Science

Forty Years of Endotoxin Standardisation
Trusha Desai, National Institute for Biological Standards and Control, MHRA

A brief overview of Biological Standardisation
A history of Endotoxin Reference Standards
Collaborative studies and potency assignment
Changes in Endotoxin and Pyrogenicity testing over time, and their impact on potency assignment
What the material is and how it should be used correctly
Tracing of compendial Endotoxin reference materials to the International Standard
Upcoming project for the replacement of the 3rd WHO International Standard for Endotoxin

Procedure for BET Sample Hold Time Discrepancies at Boehringer Ingelheim
Dr Gertrud Lüllinger-Kube, Boehringer Ingelheim

Sample hold time studies are a GMP requirement
Diverse study outcomes of commercial products complicated the processing of deviations and batch release
Harmonized strategy process management (event vs deviation, CAPAs)
Risk-based approach to assess potential underestimation of endotoxin level, retrospectively and prospectively
Can be cross-linked with NBE guideline topic

Investigating Low Endotoxin Recovery (LER) and Pyrogenicity in Diverse Pharmaceutical Products
Dr Parysatis Sachs, Sanofi

Are masked endotoxins still pyrogenic?
LER in different products with different matrices and formats – extent and type of masking
Formulation components, active ingredient – what causes LER
Kinetics of masking and pyrogenicity – evaluation with MAT and rabbits

Limit Test Validation – Balancing Business Risk and Patient Safety
Dr Anthea Darius, Microcoat and Claudia König, Sanofi

Understanding the challenges during method development for endotoxin testing
Case studies showing limit test validations
Risk assessment of limit test validations
New strategy of data evaluation
Acceptance by Authorities

Advancements in Endotoxin Testing from the PSCI Report and Member Survey
Dr Shahjahan Shaid, GSK

Current practices in endotoxin testing, the environmental and ethical implications of using horseshoe crab blood, and the advancements in alternative testing methods
Data and insights are drawn from the Pharmaceutical Supply Chain Initiative (PSCI) reports and member surveys, highlighting industry trends and regulatory developments

Endotoxin Testing of Pharmaceutical Products Using Synthetic Reagents
Poppy Cliffe, AstraZeneca

Introduction/background/previous work
AZ approach to product endotoxin testing with synthetic reagents
Case studies with examples of product endotoxin testing using synthetic reagents
Conclusions, future and next steps

Product Validation with rCR at Bayer
Sandra Wieger, Bayer

Procedure and results of the validation of a contrast agent with rCR

Streamlined Validation of Recombinant Cascade Reagents: A Novel Approach Using Advanced Microfluidic Technology
Meg Provenzano, Veolia

Focus on key parameters for validating the rCR such as robustness, linearity, accuracy, and precision with real world data
Demonstrate how to easy adopt an rCR and microfluidic technology, especially due to updates from the pharmacopeia
Data showing a comparison of rCR data and LAL data on real pharmaceutical samples such as raw materials and finished products

Update on the Pyrogenicity in the Ph. Eur.
Dr Solène Le Maux, EDQM - Council of Europe

RSE, CSE or Crude LPS Preparations? A Closer Look at Detection Variability
Luisa Burgmaier, Microcoat

RSE, CSE or Crude LPS Preparations? A Closer Look at Detection Variability
Endotoxin detection systems show variable performance depending on the Control Standard Endotoxin (CSE) used, despite manufacturer assurances of comparability with Reference Standard Endotoxins (RSE)
Assay outcomes are influenced by both the assay type (e.g., chromogenic, turbidimetric, rFC) and the sample matrix, especially in biologics and pharmaceutical formulations
Structural differences among lipopolysaccharides (LPS), including those in crude preparations, significantly affect detection, particularly in complex matrices compared to water. Matrix–endotoxin interactions appear to drive inconsistent recovery, challenging the assumption that any CSE is universally applicable
RSEs yield more consistent results, highlighting the need for careful selection and characterization of endotoxin standards in testing, especially in studies involving Low Endotoxin Recovery (LER)

Wednesday, 26 November 2025

MAT: Thoughts on Test Sensitivity, Pyrogen Limits, MVD and Readout System
Dr Ingo Spreitzer, Paul-Ehrlich Institut, German Federal Institute for Vaccines and Biomedicines

What was / is the sensitivity of the RPT?
How was this translated to limits?
How to translate this to MAT sensitivity and MVD for your product?
Surprise: your product is contaminated with the chosen readout

Evaluating Synthetic Reagents for Endotoxin Testing
Poppy Cliffe, AstraZeneca

Introduction and background
Why AZ are exploring synthetic endotoxin testing reagents
Our evaluation of synthetic reagents for endotoxin testing
Future plans and next steps

Shaping the Future of Pyrogen Testing: Regulatory Updates and the Role of MAT
Case Study: Qualification of a Reporter Gene-Based Monocyte Activation Test (MAT)
Dr Nicole Rieth and Dr Luca Benedan, Eurofins

Regulatory Changes and their effects
Practical insights into the implementation of the Monocyte Activation Test
Qualification data for a reporter gene-based MAT method and compare its performance to that of a “classical” PBMC-based MAT kit
Method qualification followed the ICH Q2(R2) guideline, evaluating the parameters accuracy, intermediate precision, repeatability, linearity, limit of detection (LOD) and specificity
The reporter gene-based MAT assay demonstrated consistent dose-response curves, low assay variability, and agreement with the reference cell-based MAT kit
The reporter gene-based MAT is a reliable, ethical, and scalable option for pyrogen testing in pharmaceutical quality control

Implementing a New Type of Monocyte Activation Test Method to Detect and Quantify Pyrogens in GMP Environment
Dr Katarzyna Marciniak-Darmochwal, Charles River Laboratories

Monocyte Activation Test method to detect and quantify pyrogens
Endotoxin and non-exotoxin detection in MAT
Development and qualification of new type of MAT methods
Pros and cons of MAT method(s)

MHRA – Results of Survey and Discussions/Podium Discussion
Dr Elliot Lilley, UK National Centre for the Replacement, Refinement & Reduction of animals in research

Next Generation MAT – Analytical Precision Meets Regulatory Confidence
Dr Eva Kritikou, MAT Research

Higher Precision in endotoxin interpolation: Enhanced reproducibility and accuracy across different operators, laboratories and reagent batches, ensuring reliability in the MAT performance and accuracy in product testing, while accounting for the inherent donor-to-donor variability
Tailoring of NEP selection: Bridging regulatory requirements with the most suitable NEP by aligning product specific characteristics with monocyte activation biology
“Fit-for-purpose” MAT designs: Customized MAT formats that support a range of product requirements, from routine testing to complex product-specific validation and cross-validation studies following the Eu. Pharmacopoeia (2.6.30) guidelines
Advanced MAT detection methodologies: Transitioning from conventional ELISA to a state-of-the-art detection platform that can detect multiple pyrogenic cytokines in a single product sample with higher sensitivity and reproducibility while ensuring faster result turnaround and reduced hands-on time

Addressing the Major Flaw of Applying MAT Method 2 to Products with Low Endotoxin Recovery Effects, and Presenting a New Generation of Rapid, Simplified and Sensitive PBMC-based MAT with FBS-free Medium
Dr Shabnam Solati, CTL-MAT

Semi-quantitative’ MAT method 1, detected masking effects and the requirement of Ph. Eur. 2.6.30. for the use of the ‘reference batch comparison method’ 2
Method 2 and masking effects, reference batches and related issues
A method to detect masked endotoxins and overcome this problem
Introduction of a new generation of PBMC-based MAT with high sensitivity, an FBS-free medium, simplified evaluation and a test duration reduced to just one working day

HyPerMAT – Discover the Future of in Vitro Pyrogen Testing
Dr Johannes Lichti, HyQuality Dx

All-in-one kit – Same-day answers, minimal effort
Push the boundaries – Extended dynamic range for comprehensive testing
Cutting-edge – Usage of stable cell line
Enhance patient safety – Detection of endotoxins and non-endotoxin pyrogens with unique sensitivity and accuracy
Case study – Prove of assay reliability and robustness

Exhibition

Pre-Conference Tracks

Conference Tracks