Biotek Salon#16: Immunogenicity Testing in a Regulated Environment

starter:19/06/2018 slutter:19/06/2018 fra:13:30 til:17:00 adresse:COBIS, Ole Maaløes Vej 3, 2200 Copenhagen N price:Free of charge for the members, Non members: 500 DKK Import to calendar
adresse:
COBIS, Ole Maaløes Vej 3, 2200 Copenhagen N
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Programme

  • 13:30
    Registration and networking
  • 13:50
    Welcome by 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

Date: 19/06/2018

Time: 13:30 - 17:00

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