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Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices
Joanne Goodman1, Simon Cowen2, Viswanath Devanarayan3
1MedImmune, Aaron Klug Building, Granta Park, Cambridge, Cambridgeshire, CB21 6GH, UK, +44 (0) 203 749 6244, +44 (0) 1223 471472.
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.
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