EMA Guideline On Immunogenicity Assay Of Therapeutic Protein Products

The EMA’s (European Medicines Agency) issued its latest guidelines in 2017. It revises the guidelines published in 2006. Both documents refer to the immunogenicity testing of therapeutic protein products (TPPs). The document offers specific guidance on immunogenicity assays and on integrated analysis of the clinical significance of these assays. General Pointers There are significant differences […]