Bioassay Development and Immunogenicity Testing in a Regulated Environment
Attendance at this event is complimentary
This event is mainly targeting protein and antibody researchers, bioanalysis research scientists and research groups with an interest in precision medicine, translational oncology and biomarkers.
Please note, all registrations are subject to the approval of the sponsor and registrations cancelled if they are not considered to meet the above criteria. You will be informed if your registration has been cancelled within 2 working days of registering online for this event.
Email Alicia for further information.
Bioassay development and Immunogenicity testing for biologics are important considerations for drug development companies when it comes to ensuring the efficacy and safety of a therapeutic proteins.
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
Keynote: Dr Scott Summerfield, Senior Director and WW Head of Bioanalysis, GSK
13:30 Challenges in Bioanalytical Assay Development
Dr Patrick Brennecke, Technical Director Bioanalytical Translational Science, Celerion
14:00 A few surprising things about immunogenicity
Dr Geoff Hale, Company Director, The Native Antigen Company, Absolute Antibody, BioArchitech
14:30 Break coffee/tea/networking
15:00 An Integrated Approach to Managing Immunogenicity Risk and Optimum Protein Design
Dr Jeremy Fry, Director, ProImmune
15:30 Case Study: Successfully Navigating an FDA Immunogenicity Audit
Rafiq Islam, Executive Director, Celerion
16:00 Q&A with speaker panel
16:30 End of session, Networking / Drinks
17:30 Close
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Babraham Research Campus
Cambridge, Cambridgeshire CB22 3AT
United Kingdom