Conference: Endotoxin and Pyrogen Testing

Objectives

This conference will inform you about current developments in Endotoxin and Pyrogen testing 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. Different approaches have been developed over the last few decades to provide solutions for the breadth of product range that is tested for endotoxins and pyrogens: RPT, LAL, MAT. With the LAL test method as the established, compendial methodology for bacterial endotoxins with harmonization of the EP, USP and JP. Due to the importance of these tests, they are under ongoing scrutiny by industry and regulators to ensure testing efficacy and safe manufacturing and release of products into the market. Novel medicinal products such as cellular and gene therapies and combinations with medical devices as well as complex biopharma formulations pose testing challenges and require in-depth knowledge and expertise in the field of Endotoxins and Pyrogens. In addition, as the choice of solutions offered by suppliers for endotoxin testing becomes wider (e.g. recombinant factor C, ELISA-based test kits, automated LAL cartridge technology) it is important to get a data driven understanding of the advantages and limitations of each approach. So not only the discussions on low endotoxin recovery and endotoxin masking are important. Additionally the need for future innovations within BET that provide solutions to current challenges with modern pharmaceutical and biopharmaceutical products for the day-to-day testing should be in our focus.

Enough reasons to attend this Endotoxin and Pyrogen Session at PharmaLab 2022.

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.

09.15 - 10.00 h
Congress Keynote: Biological Manufacturing – Demanding Quality and Compliance Requirements
Dr Tilman Rock, SVP, Site Head Vienna (Austria), Boehringer Ingelheim Biopharma

Pyrogenicity: The Transition from RPT to MAT
Dr Ingo Spreitzer, Paul-Ehrlich Institut, German Federal Agency for Vaccines and Biomedicines

Advantages of the Monocyte Activation Test in Quality Control Testing of Lifecycle Products
Dr Liliana Alleri, GSK

Optimization of the Monocyte Activation Test to assess Reactogenicity of Outer Membrane Vesicle Vaccines
Dr Marijke Molenaar-de Backer, Sanquin

Generic Method and Specific Product Validation of the Monocyte Activation Test
Dr Jonas van den Berg, Roche
Maria Gajewi, Microcoat

Development and Validation of the Monocyte Activation Test (MAT) for Parenteral Preparations that still require RPT Testing for Regulatory Compliance
Dr Koen Marijt, MAT Research

Monocyte Activation Test as the Sole Tool to identify Synergistic Effects when Parenteral Drugs are contaminated with Multiple Pyrogens
Shabnam Solati, CTL-MAT

Monocyte Activation Test: A Pyrogen Detection Solution for Gene Therapy Products?
Anne Claire Erba, Merck

Alternative Pyrogen Methods: FDA Case Studies
Dr Reyes Candau-Chacon, FDA, USA

Alternative Approaches to Medical Device Testing with the MAT
Dr Sandra Stoppelkamp, University Tübingen

Interleukin Interference during MAT Testing
René Ørving, Novo Nordisk

Validation of the Monocyte Activation Test with three Therapeutic Monoclonal Antibodies
Dr Ruth Daniels, Janssen

09.15 - 10.00 h
Congress Keynote: Impurities - USP Draft Chapter <477> User-Determined Reporting Thresholds (UDRT), and Other Relevant Chapters
Dr Christian Zeine, Senior Manager Scientific Affairs EMEA, USP

LER Challenges and Their Solutions – A Case Study
Dr Harald Meissner, Morphosys

Validation of a Dedicated Sample Preparation Method
Dr Gertrud Lallinger-Kube, Boehringer Ingelheim
Dr Michael Kracklauer, Microcoat

Reducing the Environmental Impact on LAL Testing and Improving Employee Sustainability Utilizing Microfluidic Technology for BET
Hayden Skalski, Veolia Water Technologies and Solutions

Custom Made iPSC-Derived Macrophages as an Efficient Tool for Next Generation Pyrogen Testing
Shifaa Abdin, Hannover Medical School

Depyrogenation by Moist Heat: How Removing Endotoxins in an Autoclave; Time/Temperature Results on different Endotoxins located in/on Different Substrates
Maria Luisa Bernuzzi, Fedegari
Alessandro Pauletto, Charles River Laboratories

How to increase Sustainability in QC Testing? Future Proofing Pyrogen Detection
Allen Burgenson, Lonza

Implementing Annex 1 Revisions: Improving Biofilm Detection in WFI Systems Using Rapid LAL Methods
Jordi Iglesias, Charles River Laboratories

Recombinant Reagents for BET – Regulatory Landscape, Comparability Studies and Their Future Routine Use including Automation
David Guy, ACC

The rFC Journey: Validation for Water Testing Completed – What’s Next?
Carmen Marín Delgado de Robles, F. Hoffmann-La Roche

Endotoxin Testing: LAL, rFC and Semi-Automation
Marine Marius, Sanofi

Diversity, Complexity, and Originality of Lipopolysaccharides Structures
Dr Martine Caroff, LPS Biosciences

Moderation

Dr Sven M. Deutschmann, Roche