Conference: Endotoxin and Pyrogen Testing

26/27 November 2024

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 or RFC

Background

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.

Enough reasons to attend this Endotoxin and Pyrogen Session at PharmaLab 2024.

Target Audience

This conference is addressed to all persons from

  • Pharmaceutical manufacturers
  • Biopharmaceutical companies
  • Contract laboratories
  • Tissue establishments
  • Authorities

who are involved in Endotoxin- and Pyrogen Testing.


Registration

 

Programme

Key Note on 26 November: The Promise and Challenges of In Vitro and In Silico Models in Drug Development
Dr Julia Schüler, Charles River Laboratories
The presentation will highlight important developments in the drug development technology landscape influenced by the concept of 3R and the evolving legal landscape. General characteristics of the different applications, their translational relevance as well as adoption drivers will be discussed. Case studies from oncology drug development will help to elucidate these trends and their impact on future processes.

Key Note on 27 November: Trends & Challenges for the Development & Testing of Biotech Drug Products
Prof. Dr. Hanns-Christian Mahler, Chief Enablement Officer (CEO), ten23 health

Current Pharmacopoeial Developments in the Field of Endotoxin and Pyrogen Detection
Dr Ingo Spreitzer, PEI, German Federal Agency for Vaccines and Biomedicines

Approval of a Monocyte Activation Test as a Replacement of the Rabbit Pyrogen Test
Dr Sven M. Deutschmann, Roche

A Comparison of Recombinant Factor C and LAL Based Methods for Bacterial Endotoxin Testing
Hiram Huzeyfe Yakut, Turkish Medicines and Medical Devices Agency

Good Practice in LER Hold Time Study: the Choice of the Endotoxin
Alessandro Pauletto, bioMérieux

Addressing Low Endotoxin Recovery During Biological Development - from Early Stage to Submission
Melanie Jänsch und Jessica Stolzenberger, Boehringer

The Mitigation Concept - Understanding the Masking Impact on Drug Product Manufacturing of Biologicals
Martina Wespel, Boehringer Ingelheim and Dr Anthea Darius, Microcoat

Supramolecular Assembly of Micellar Aggregates is the Basis of Low Endotoxin Recovery (LER) in a Drug Formulation that Can be Resolved by a Whole Blood Assay
Prof Klaus Brandenburg, Brandenburg Antiinfektiva c/o Forschungszentrum Borstel

Developing Endotoxin Assays Based on a Novel LPS-binding Peptide
Prof Dirk Linke, University of Oslo

On the Detection and Quantification of the Endotoxic, or not Endotoxic, Lipopolysaccharides
Dr Flavien Dardelle, LPS-Bioscience

Update on the Status of the USP proposed General Chapter <86> Endotoxin Testing using Recombinant Reagents
Mark Schweitzer, Chair of the USP General Chapters Microbiology Expert Committee

Lobster Hemocyte Lysate (LHL), a New Alternative for Pyrogen Test
Perdomo Morales, Center for Pharmaceuticals Research and Development, Cuba

Endotoxin Testing of mRNA Vaccines: Ensuring Product Safety and Effectiveness
Dr Mohamad Toutounji, Molgenium

Validation of a Complex Drug Product Using Recombinant Cascade Reagent
Veronika Wills, Associates of Cape Cod

Evaluating Synthetic Reagents for Endotoxin Testing
Poppy Cliffe, AstraZeneca

Recombinant Cascade Reagent and Limulus Amebocyte Lysate: A Detailed Analysis of Endotoxin Testing Methods
Dr Shady Kamal, Galderma

Out of the Endotoxin Box: Rethinking Pyrogens and Pyrogenicity
Dr Djikolngar Maouyo, Pyrodex

Automation of the Monocyte Activation Test Method 2 with the Opentron OT-2 robot
Delphine Trélat, Sanofi

LumiMAT™ : Rapid and easy MAT Using the Luciferase Reporter Assay
Tomohisa Nanao, Fujifilm Wako

Development of a Rapid MAT Test Using Immortalized Monocyte Cells (aMylc)
Kazuo Miyazaki, Mican

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