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 2019

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.