Conference Report: Immunogenicity: prediction, detection and effective assay development

The Immunogenicity: Prediction, Detection and Effective Assay Development conference, organized by the Pharma iQ, a division of IQPC, was held in Munich, Germany, 21–23 June of 2010. The meeting covered a broad range of topics related to the unwanted immunogenicity of biotherapeutics. Perspectives from the US FDA and EMA were presented along with discussions focusing on analytical method development and validation, methodologies allowing for prediction of potential immunogenicity, risk-based assessment and mitigation of immunogenic potential of biologics, and other topics. The conference consisted of a preconference workshop and 2 days of plenary sessions, which included presentations as well as group discussions. Particular attention was drawn to the review of the FDA guidance and Committee for Medicinal Products for Human Use guidelines on immunogenicity evaluation. Presenters and meeting participants engaged in an active and productive discussion around scientific aspects involved in immunogenicity evaluation and methodologies involved during routine sample testing. Discussions also centered around challenges and opportunities related to detection and characterization of immunogenicity, as well as analysis of the latest technologies to enable accurate and meaningful interpretation of the results. The meeting attracted a broad range of participants from various sized companies, backgrounds and interests.