Immunogenicity risk assessment has grown as a significant part of Protein therapeutics for Pre-Clinical and Clinical testing for regulatory submissions. Based on this, it is the requirement of CROs, who provide clients with Immunogenicity assays and data, to keep abreast of any changes or interpretations of the FDA Guidance’s as well as regulatory observations as the number of protein based therapeutics increases significantly.


The recent white paper that came out of the European Bioanalysis Forum, shows us that immunogenicity of nonclinical animal assessments can change1 and be adopted by CROs like KCAS. Likewise, slide presentations at the recent WRIB by representatives of the FDA: Recent FDA Observations of Immunogenicity Assays2, can also provide insight into what type of immunogenicity data is expected from clients. The FDA slide presentation at WRIB made clear that the determination of the Cut point, Assay positive controls, Assay Sensitivity and other validation parameters are very important and presented examples of what they were observing which they were concerned about.


At the October Immunogenicity and Bioassay Summit held in Washington DC, KCAS made it a point to discuss these interpretations of the Immunogenicity guidance with other industry thought leaders and learn how the FDA is interpreting the industry regulations.  The interpretations are specifically, with regards to the Cut point, Sensitivity curves and analysis of the LPC used in the immunogenicity assays. John Pirro represented KCAS at this important meeting where he shared his expertise and was a major contributor to the evolution of this critical drug development area. “I was delighted to discuss our interpretation with industry leaders and representatives from the FDA/CDER. These discussions led to the assessment that our interpretation of the guidance was acceptable with industry leaders and to representatives of the FDA/CDER.”


Based on this, KCAS is confident we are providing our clients with an acceptable process for generating Immunogenicity data that Is In line with regulatory agencies.


Please contact us to further discuss our immunogenicity validation processes and how they can help you with pre-clinical and clinical studies.


  1. Ann Lauren, Joanne Goodman, Jonas Blaes, John Cook, Kyra Ja Cowan, Madeleine Dahlback, Joanna Grudzinska-Goeble, Deborah McManus, Robert Nelson, Susanne Pihl and Philip Timmerman; “A Strategic approach to nonclinical immunogenicity assessment: a recommendation from European Bioanalysis Forum”; White Paper Bioanalyisis (2021) 13(7), 537-549
  2. Mohsen Rajabi, Ph.D.; Division of new Drug Study integrity (DNDSI), Office of Study Integrity and Suveillance (OSIS), U.S. Food and Drug Administration (FDA) “Recent FDA Observations of Immunogenicity Assays”; Slides Presented at WRIB 2021


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