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.

New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)
Dr Joachim Ermer, Sanofi-Aventis Deutschland
Head of QC Lifecycle Management Frankfurt Chemistry

MAT Task Force
Dr Oleg Krut, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines

Validation of MAT – Regulatory Experiences
Dr Ingo Spreitzer, PEI, German Federal Agency for Vaccines and Biomedicines

Development of the Monocyte Activation Test on vaccines containing inherently pyrogenic components
Stéphanie Richard, Sanofi Pasteur

Comparison of a Monocyte Activation Test based on fetal bovine serum and on human AB serum
Dr Eelo Gitz, Sanquin Reagents

Pyrogenicity associated with heat-inactivated microorganisms isolated in our laboratory from actual samples
Dr Anja Fritsch, Confarma

Proficiency Test Program for MAT
Dr Ruth Röder, Microcoat Biotechnologie

MAT implementation: from validation to use in routine in a GMP QC Lab
Chiara Celli, Merck

MAT - Ready for GMP Routine?
Stefan Gärtner, Labor LS

The Monocyte Activation Test: Validation & Analysis
Katrin Pauls, Lonza

Endotoxin, ten misconceptions around detection and control
Kevin Williams, bioMérieux

Laboratory Services - from Outsourcing to a strategic partnership (Key Note Presentation at the Plenum)
Dr Jürgen Balles, Dr Thomas Meindl and Ingo Grimm, Labor LS

Current development in Endotoxin and Pyrogen Testing – FDA Point of View
Dr Jessica Hankins, U.S. Food and Drug Administration

Putting Patient Safety First, View from the other side
Milanka Setina, Medicines and Medical Devices Agency of Serbia

LER Hold-Time studies
Anders Thorn, Novo Nordisk

Endotoxin and Pyrogen detection of LER Samples
Paul Negwer, PEI, German Federal Agency for Vaccines and Biomedicines

Endotoxins – Requirements of CP
Dr Qing He, Chinese National Institutes for Food and Drug Control

Practical Insights in BET
Dr Jelena Novakovic, Galenika

A Global Perspective for Quantifying All Endotoxins within Pharmaceutical Water Systems
Nicola Reid, CRL

4 Factors affecting the recovery of endotoxin
Peter Kitschmann, Bausch & Stroebel
Dr Michael Kracklauer, Microcoat

Application of a recombinant three-factor chromogenic reagent, PyroSmart, for bacterial endotoxins test
Dr Hikaru Mizumura, Seikagaku
Veronika Wills, ACC

Evaluation of rFC for product testing
Marine Marius, Sanofi Pasteur