Conference: Endotoxin and Pyrogen Testing - Pharmacopoeial and Scientific Developments

24/25 November 2026

Objectives

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

Highlights

  • Novel Technologies
  • Equivalence and Comparability Studies
  • Rapid MAT Testing
  • LER Experiences
  • Regulatory Developments and Regulators Experiences and Expectations

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 datadriven 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.

Featured Presentations

These presentations offer a first glimpse of the conference programme. Further presentations will be added soon.

Choosing MAT or BET: Risk Assessment
Dr Ingo Spreitzer, PEI

Validation and Implementation of rFC Assay for Clean Media Monitoring
Dr Juliane Bessert, Bayer

Comparability in Measurements by RPT, MAT and BET using LAL and Recombinant Reagents
Prof Yutaka Kikuchi, Tokyo Kasei University

Target Audience

The track is aimed at people working in the following areas:

  • 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

Moderators

Dr Johannes Reich, Microcoat
Dr Sven M. Deutschmann, Roche – Members of the ECA Microbiology Working Group

Congress Registration

Early Bird Rebate: Register until 31 August 2026 and save 100 EUR per congress day.

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