– EMA PLOTS NEW GUIDANCE ON IMMUNOGENICITY ASSESSMENT OF BIOTECHNOLOGY-DERIVED THERAPEUTIC PROTEINS
April 14th, 2014
THE EUROPEAN Medicines Agency (EMA) is to develop new expanded guidance on the immunogenicity assessment of biotechnology-derived therapeutic proteins.In a note, EMA said more specific guidance for presenting immunogenicity data was needed, along with advice on data requirements for antibody assays; the role of in vitro and in vivo non-clinical studies; the risk-based approach to immunogenicity; using clinical data to study correlations of induced antibodies to allergic and anaphylactic/anaphylactoid reactions; delayed immunological reactions; ...
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