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 behaviour. 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.
(+44) 1223 496 000
Babraham Bioscience Technologies Ltd
Babraham Research Campus
CB22 3AT, United Kingdom
01223 813 557