Advances in Immunogenicity Evaluation | Paving the Way for Safer Biologic Therapies Application Note
Authors: Stuart Knowling, Ph.D, Sartorius | Last updated: January 2024
Overview
Assessing the immunogenicity of a potential therapeutic protein product is a regulatory requirement prior to approval. Recent guidelines from the FDA and EMA have both included recommendations that novel in vitro technologies, such as Octet® Bio-Layer Interferometry (BLI), be adopted. Choosing a sensitive and reliable assay method that enables rapid anti-drug antibody (ADA) evaluation is crucial for success. And BLI offers multiple advantages when used in isolation or combination with existing techniques.
With automated immunoassays, this high-throughput, label-free approach delivers unparalleled sensitivity and flexibility, adeptly handling a range of media and drug tolerances. It streamlines ADA detection by identifying both high and low affinity antibodies without requiring cumbersome plate washing. Resulting in significant time and regent savings. This technique is applicable to a wide range of therapeutics, including antibodies, proteins, and peptides, and is compatible with human and animal samples.
- Document type: Application Note
- Page count: 10
- Read time: 17 minutes
Key Takeaways
- The impact of immunogenicity on the pharmacokinetics (PK) and pharmacodynamics (PD) of therapeutic proteins, and the clinical consequences of anti-drug antibodies (ADAs).
- Comparison of the various analytical platforms used for measuring ADAs, including their strengths and weaknesses, and the importance of assay sensitivity and drug tolerance in immunogenicity evaluation.
- Antibody aggregation as a critical quality attribute (CQA) in immunogenicity and how BLI can be used to assess aggregation and binding properties of antibodies.
- The process of humanization of therapeutic antibodies to reduce immunogenicity, and the use of BLI in evaluating the biophysical properties and immunogenic potential of humanized antibodies.
- Future directions in immunogenicity testing, including the use of BLI for real-time, label-free analysis of polyclonal antibody responses, and the importance of avidity in addition to affinity in evaluating immunological responses to vaccines and therapeutics.
Figure 1. Cover of Application Note.
