Conference: Endotoxin and Pyrogen Testing

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 2023.

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.

Programme

Key Note on 21 November: The Impact on the Revised Annex 1 for Rapid Microbiological Methods Implementation
Dr Michael Miller

Key Note on 22 November: Preparedness in pandemic vaccine manufacturing and deployment
Prof Dr Isabelle Bekeredjian-Ding

Towards Animal Free Pyrogen Tests in the Ph. Eur: Latest Progress
Dr Gwenaël Ciréfice, EDQM

If it’s not broken, why fix it?
Jelena Novakovic Jovanovic, Galenika

Suitability of rFC-based Endotoxin Tests: a Comparison Study including Different Pharmaceutically Relevant Grades of Water and Product
Dr Ana Gonzalez Hernandez, GSK

Establishment of a rFC Assay for the Detection of Bacterial Endotoxins
Dr Holger Kühn, BioChem

Novel Recombinant Cascade Reagent (rCR) as Equivalent of LAL for Sustainable BET
Dr Hiroki Fukuchi, Fujifilm

A Validation Approach for Implementing a Sustainable, Scientifically Sound Recombinant Cascade Reagent
Jordi Igelsias, Charles River Laboratories

Seamless Software Integration Allows for Complete Automation of the entire Endotoxin Testing Workflow
Sinéad Cowman, Lonza

Transformative Developments in Endotoxin Testing
Dr Veronika Wills, ACC

A Trimeric coiled-coil Motif Binds Bacterial Lipopolysaccharides with Picomolar Affinity
Prof. Dirk Linke, University Oslo

All endotoxins are Lipopolysaccharides, but all Lipopolysaccharides are not Endotoxins!
Dr Martine Caroff, LPS -Biosciences

Endotoxin Masking – Dependency on LPS Mutant and Matrix Formulation
Luisa Burgmeier, Microcoat

Preselection of NEP-reference Materials in different MAT-setups
Dr Josephine Hubloher, Paul Ehrlich Institut, German Federal Institiute for Vaccines and Biomedicines

Implementing New Type of Monocyte Activation Test Method to detect and quantify Pyrogens.
Dr Kasia Marciniak-Darmochwal, Charles River Laboratories

Advancing Pyrogen Testing with Automated MAT
Ruben Huis in 't Veld, MAT Research

Development of a Novel MAT Test Product (MylcMAT) using Immortalized Monocyte Cells (aMylc cell) derived from Peripheral Blood Mononuclear Cells
Kazuo Miyazaki, MiCAN Technologies Inc

MAT Investigation on two Non-endotoxin Pyrogens
Dr Peter Brügger, Lonza/MAT Research