Endotoxin and Pyrogen Testing - Part of PharmaLab 2015
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 advanced medicinal products 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.
Current discussions on low endotoxin recovery and endotoxin masking and the need for
future innovations within BET that provide solutions to current challenges will be presented.
These examples show the need for staying abreast of scientific developments.
Target Group
This Conference is addressed to all persons of
..pharmaceutical manufacturers
..biopharmaceutical companies
.. contract laboratories
.. tissue establishments
who are involved in Endotoxin- and Pyrogen Testing or must evaluate the risks for release.
Programme
The Limulus Amebocyte Lysate (LAL) Test for Bacterial Endotoxins Discovery, Development and Applications
Jack Levin, M.D., University of California School of Medicine
Current Developments in Endotoxin / Pyrogen testing in the European and other Pharmacopeias
Dr. Ingo Spreitzer, Paul-Ehrlich-Institut, German Agency for Vaccines and Biomedicines
Kinetic Bacterial Endotoxin Assay Challenges for Biologics
Dr. Fatma Gökin Bahar, Arven Pharmaceuticals
Increasing LAL Testing Efficiency with Endosafe® Nexus™ Robotic Endotoxin Testing System
Matthew Paquette, Pfizer Biotech
An Improved Monocyte Activation Test Using Cryopreserved Pooled Human Mononuclear Cells
Shabnam Solati, Sanquin Plasma Products
Challenges on Performing LAL in Oil Products
Dr. Jelena Novakovi Jovanovi, Galenika
Pyrogen and Endotoxin Analysis: Concepts and Considerations As We Move Forward
Robert Mello, Ph.D., Mello PharmAssociates
LPS Aggregation Changes in Low Endotoxin Recovery –Seeing is believing
Dr. Masakazu Tsuchiya, Charles River Laboratories
FDAs Current Thinking on LER
Dr Patricia Hughes, CDER, FDA
Case Study: Overcoming Endotoxin Masking in a Drug Product
Johannes Reich, University Regensburg
Endotoxin Masking – Origin, Natural Occuring Endotoxins and Demasking
Peter Cornelis, Toxikon Europe
Development of a LAL-based method to overcome LER in a Biologics product
Dr. Friedrich v. Wintzingerode, Roche Diagnostics
Recombinant Factor C : Sustainable Alternative for Endotoxin Detection
Elena Gustchina, Lonza
Reduction of Test-Interferences by Using a Recombinant Limulus Factor c ELISA
Stefan Gärtner, Labor L+S
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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