A key method of evaluating immunogenicity involves detection and analysis of anti-drug antibodies (ADAs) and an understanding of antibody behavior. Validated methods of assessing immunogenicity and bioassays for PK/TK are a key part of the drug development process and also an expectation of regulatory bodies.
Celerion and One Nucleus are hosting an Innovation Seminar which will look at the challenges faced in the biotech industry in regard to bioassay development and immunogenicity testing. Leaders working in bioanalytical and bioassay development will come together to provide case studies and best practices for handling the most common issues in biological assay development, validation, transfer, and regulatory considerations.
Programme:
12:30 Registration and lunch
13:00 Welcome by One Nucleus and Celerion
13:10 Introduction
13:30 Challenges in Bioanalytical Anti-Drug Antibody (ADA) and PK Assay Development
14:00 Stability of Anti-Drug Antibodies in Human Samples
14:30 Break coffee/tea/networking
15:00 Pre-Existing Antibodies and the Multi-Tiered Assay Approach – Experience with the FDA
15:30 Case Study: Successfully Navigating an FDA Immunogenicity Audit
16:00 Q&A with speaker panel
16:30 End of session, Networking / Drinks
17:30 Close
