Bioanalysis Zone

Pre-existing antibodies within clinical samples: How does this affect immunogenicity outcomes?


Pre-existing antibodies in treatment-naïve subjects have been often detected during clinical ADA assessments. However, limited information on prevalence, physiological effect, and impact on post-treatment ADA induction is available. This presentation will address pre-existing antibody characterization and implications for immunogenicity management and strategies during clinical studies.

What will you learn?

  • Gain insight into assessing early immunogenicity risks
  • Assess implications for therapeutic design
  • Gain understanding on immunogenicity assay design and validation
  • Enhance understanding on how best to evaluate readouts on dose-dependent immune response.

Who may this interest?

  • Bioanalytical and Biomarker industry leaders developing and validating immunogenicity assays in support of Preclinical and Clinical Drug Development.


Thomas Lee 80x95



Thomas Lee
Associate Director, Biologics and Biomarkers
Frontage Laboratories, Inc.

Dr. Thomas N. Lee is associate director for biologics at Frontage laboratories. He is responsible for design and implementation of immunogenicity and biomarker analysis across multiple disease platforms and study phases.


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