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Abstract

European Bioanalysis Forum Workshop, Lisbon, Portugal, September 2016: At the recent European Bioanalysis Forum Focus Workshop, ‘current analysis of immunogenicity: best practices and regulatory hurdles’, several important challenges facing the bioanalytical community in relation to immunogenicity assays were discussed through a mixture of presentations and panel sessions. The main areas of focus were the evolving regulatory landscape, challenges of assay interferences from either drug or target, cut-point setting and whether alternative assays can be used to replace neutralizing antibody assays. This workshop report captures discussions and potential solutions and/or recommendations made by the speakers and delegates.

Keywords:

  • antidrug antibody (ADA)
  • cut-point
  • drug tolerance
  • immunogenicity
  • neutralizing antibodies
  • regulatory guidance
  • target interference
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