Biotek Salon#16: Immunogenicity Testing in a Regulated Environment
starts:19/06/2018ends:19/06/2018from:13:30to:17:00address:COBIS, Ole Maaløes Vej 3, 2200 Copenhagen Nprice:Free of charge for the members, Non members: 500 DKK Import to calendar
adresse:
COBIS, Ole Maaløes Vej 3, 2200 Copenhagen N
Welcome by DANISH BIO – DANSK BIOTEK and Anders Beltoft of Celerion
14:00
Challenges in Bioanalytical Anti-Drug Antibody (ADA) and PK Assay Development presented by Patrick Brennecke, Manager Method Development LBS & CBA at Celerion Switzerland AG
14:30
Stability of Anti-Drug Antibodies in Human Samples presented by Lone Hummelshøj Landsy, Senior Scientist at Novo Nordisk A/S
15:00
Pre-Existing Antibodies and the Multi-Tiered Assay Approach – Experience with the FDA presented by Madeleine Dahlbäck, Senior Scientist at Novo Nordisk A/S
15:30
Case Study: Successfully Navigating an FDA Immunogenicity Audit presented by Raymond Farmen, VP of Global Bioanalytical Sciences at Celerion
16:00
Networking, food and refreshments
Biotek Salon #16
Venue: COBIS, Ole Maaløes Vej 3, 2200 Copenhagen N
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