Düsseldorf/Neuss, Germany
Course No 200034
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Current US Regulation and FDAs Thinking
Jessica Hankins, US FDA
PDA LER Technical Report Scope, Overview, Impact on Industry
Dr Friedrich von Wintzingerode, Roche
The Evolution of Endotoxin Test
Kevin Williams, bioMerieux
LER - An alternative Explanation
John Dubczak, CRL
Pyrogenicity of Food Supplements: Comperative Study of MAT, BET and rFC
Stefan Gärtner, Labor L+S
From First Evaluation to a Representative Endotoxin Test: a Story about Masking
Dr Jan Erik Rau, Lonza
An approach to LER (Low Endotoxin Recovery) & Update of EP chapter 5.1.10
Hans Noordergraaf, Abbott Biologicals
Evaluation of new solutions for endotoxin testing for water samples
Marine Marius, Sanofi Pasteur
(1->3)-ß-D-Glucan: A biological response modifier found as a contaminant in pharmaceuticals
Veronika Wills, Associates of Cape Cod
Requirements of JP
Yutaka Kikuchi, National Institute of Health Sciences
LPS Structure
Martine Caroff, LPS Bioscience
Biophysical interpretation of a systematic comparison of MAT and BET for LER understanding
Wilmar Correa, Research Center Borstel
Pyrogen and Endotoxin Testing – Where do we go?
Dr Ingo Spreitzer, PEI, German Federal Agency for Vaccines and Biomedicines
Monocyte Activation Test for predicting pyrogenic content in vaccines without animal models
Dr Barabara Capecchi, GSK
Challenges in applying the Monocyte Activation Test for routine testing in the QC environment
Dr Ruth Röder, Microcoat
Pyrogen detection with the cryopreserved PBMC-based MAT Cell Set: performance, study examples and challenges
Dr Eelo Gitz, Sanquin
Pyrogen detection with the MM6 cell-line: implementation as a routine test
Mathilde Arnault/Dr Anja Fritsch, Merck/Confarma
Healthy human immune cells as pyrogen detection source and advancement of drug release testing
Shabnam Solati, MAT Biotech