Current Trends in Endotoxin and Pyrogen Testing

04 May 2022

Objectives

For several years now, the field of endotoxin and pyrogen testing has been subject to a high pressure of change. Especially in Europe, also as a consequence of the 3R strategy of the European Union, alternative test methods have found their way into pharmacopoeias. The comparison of existing methods and alternative test methods, the experiences with pitfalls and possibilities but also limitations still leads to a lively discussion.

Learn about the latest trends and developments in this conference. International experts from industry and laboratories as well as representatives from EDQM will report on current requirements, implementation in practice, establishment of new methods and where these can also be a challenge.

Target Audience

This track provides information for all industry, authority or laboratory personnel involved in Endotoxin and Pyrogen testing and implementation of detection methods.

Moderators

Dr Johannes Reich
Managing Director, Microcoat, Member of The ECA Pharmaceutical Microbiology Working Group Advisory Board

Axel Schroeder
Concept Heidelberg

Programme

Welcome and and Organisationals
Axel H. Schroeder

European Pharmacopoeial Requirements and Perspectives
Dr Emmanuelle Charton, EDQM, Council of Europe

  • Bacterial Endotoxin test using recombinant Factor C: latest news
  • Recent revision of general chapter 2.6.30 Monocyte Activation Test
  • Towards an Animal-free Pyrogenicity testing strategy

The impact of endotoxin masking on the removal of endotoxin during manufacturing of a biopharmaceutical drug product
Jessica Stolzenberger, Boehringer Ingelheim

  • Low endotoxin recovery
  • Endotoxin removal
  • Downstream processing
  • Endotoxin, Lipopolysaccharide

Challenges of endotoxin detection during development of a novel VLP
Callum Scott, Allergy Therapeutics

  • Issues associated with the introduction of a MAT during the pre-clinical phase of development
  • Use of a MAT to release batches of Drug Substance & Drug Product

Validation of the Monocyte Activation Test for GMP Release Testing
Jonas van den Berg, Roche

  • Considerations for method development MAT validation strategy
  • Results for generic validation and product-specific validation of the MAT

Examples for a Potential Global Endotoxin and Pyrogen Test Strategy
Christoph Hansy, Takeda

  • Main Challenges related to BET and Pyrogen Testing
  • Benefits from a Global Testing Strategy
  • Examples

Experience with the shelf life/stability of the control standard endotoxin (KSE)
Patrick Koch, ThermoFisher

  • What are control standards
  • Stability study
  • Results and conclusion

Analyzing endotoxin in complex samples
Luisa Burgmaier, University of Tübingen

  • Blood plasma as a challenging sample matrix
  • Complex contamination of samples
  • Comparison of methods for analyzing samples

Nanoparticles and test interference in BET [complex sample matrix]
Speaker to be announced

Importance of formulation when assessing performance with real contamination
Alan Hoffmeister, Charles River Laboratories

  • How formulation effects recovery
  • Factors to consider
  • Critical elements or convenience?

rFC implementation strategy and Endotoxin technology roadmap in Sanofi Pasteur
Thierry Bonnevay, Sanofi Pasteur

  • Evolution of pharmacopoeias and regulation around endotoxins testing and rFC assays
  • Presentation of different solutions and data comparing different LAL based assays and rFC assays on different matrices
  • Strategy for middle and long term implementation of rFC inside Sanofi
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