Endotoxin and Pyrogen Testing - This conference is part of PharmaLab 2019

13 November 2019, Düsseldorf/Neuss, Germany

Course No. 200034



MAT Task Force
Dr Sven Deutschmann, Roche Diagnostics

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
Programme - 13 November 2019
Congress Keynote 13.11.2019: Laboratory Services - from Outsourcing to a strategic partnership (Key Note Presentation at the Plenum)

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
Dr Johannes Reich, Microcoat

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

Evaluation of rFC for product testing
Marine Marius, Sanofi Pasteur

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