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1st Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

October 7th — 9th 2008

Hamburg, Germany

Programme

The mosaic of autoimmunity: Novel aspects
Yehuda Shoenfeld
Immunogenicity of therapeutic proteins
Melody Sauerborn, Vera Brinks
Gyrolab® is a versatile and powerful bioanalytical platform for evaluating immunogenicity of recombinant therapeutic proteins
Mats Inganäs
Increase of sample throughput on Biacore®, Example for anti-mAb-antibodies
Kerstin Kröger (Novartis Biologics)
Detection of Anti-Drug Antibodies (ADA) in the Presence of Drug
Denise Sickert (Novartis Biologics)
Clinical Experience in the Treatment of Fabry Disease Identifies the Need for Immunogenicity Assay Standardization
Joan Keutzer, Daniel Gruskin, Susan Richards, John Yee (Genzyme Corporation)
Immunogenicity: The US Perspective
Bonnie Rup (AAPS)
Clinical aspects of Immunogenicity
Petersen (Novonordisk)
Risk analysis & risk management of immunogenicity
Paul Chamberlain (bioLOGICA Consulting & NDA Advisory Board)
EMEA guidance on unwanted immunogenicity for biotherapeutics
Robin Thorpe (NIBSC)
Protein Aggregation and Immunogenicity
Mary Cromwell (Genentech)
Characterization and stability of heat-stressed insulin upon storage at 80 °C
Ruedeeporn Tantipolphan
Controlled degradation and characterization of a Monoclonal Antibody for immunogenicity testing
Vasco Filipe (LACDR)
The Need for Standardization of Immunogenicity Assays for Gaucher Disease Enzyme Replacement Therapy
Joan Keutzer, Michael Yeh, Susan Richards, John Yee (Genzyme Corporation)
Detection of Anti-Idiotype Antibodies to Rituximab in Patients with Severe Pemphigus
Enno Schmidt (University of Lübeck)
Workshop: Biosimilars and Comparability
Paul Chamberlain (bioLOGICA Consulting & NDA Advisory Board)
Monoclonal Antibody Workshop
Sue Stephens, Andy Popplewell (UCB)
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