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BPI Contributor

March 22, 2024

1 Min Read
Sartorius T cells releasing antibodies
getty images Sartorius

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® Biolayer Interferometry (BLI), be adopted. Choosing a sensitive and reliable assay method that enables rapid anti-drug antibody (ADA) evaluation is crucial for success. 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 range of therapeutics, including antibodies, proteins, and peptides, and is compatible with human and animal samples.

Key Takeaways

  • Impact of immunogenicity on pharmacokinetics and pharmacodynamics of therapeutic proteins, and the consequences of ADAs

  • Comparison of the various analytical platforms used for measuring ADAs

  • Antibody aggregation and use of  BLI to assess aggregation and binding

  • Humanization antibodies and use of BLI in evaluating biophysical properties and immunogenic potential

  • Future directions in immunogenicity testing

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