| Literature DB >> 12957392 |
M Wadhwa1, C Bird, P Dilger, R Gaines-Das, R Thorpe.
Abstract
An important aspect of evaluating the safety of therapeutic biologicals is the assessment of the unwanted immunogenicity of such biologicals in recipients. Properly planned immunogenicity studies with appropriately devised strategies are critical if valid conclusions concerning the unwanted immunogenicity are to be derived. Such studies need to be conducted using carefully selected and validated procedures. Several techniques are available for detection and measurement of immunogenicity including immunoassays, radioimmunoprecipitation assays (RIPAs), surface plasmon resonance (SPR) and bioassays. A combination of methods for characterization of the induced antibodies is usually necessary for a detailed understanding of the type(s) of antibodies generated against a therapeutic product. This review considers the benefits and limitations of the various techniques available for antibody detection and outlines a strategy for the assessment of unwanted immunogenicity of therapeutic products.Mesh：
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Year: 2003 PMID： 12957392 DOI： 10.1016/s0022-1759(03)00206-0
Source DB: PubMed Journal: J Immunol Methods ISSN： 0022-1759 Impact factor: 2.303