Endotoxin and Pyrogen Testing - This conference is part of PharmaLab 2018

21 November 2018, Düsseldorf/Neuss, Germany

Course No. 200034



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

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