Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals.
作者： M Wadhwa , C Bird , P Dilger , R Gaines-Das , R Thorpe
DOI: 10.1016/S0022-1759(03)00206-0
关键词:
摘要: An important aspect of evaluating the safety therapeutic biologicals is assessment unwanted immunogenicity such in recipients. Properly planned studies with appropriately devised strategies are critical if valid conclusions concerning to be derived. Such need conducted using carefully selected and validated procedures. Several techniques available for detection measurement including immunoassays, radioimmunoprecipitation assays (RIPAs), surface plasmon resonance (SPR) bioassays. A combination methods characterization induced antibodies usually necessary a detailed understanding type(s) generated against product. This review considers benefits limitations various antibody outlines strategy products.
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