%0 Journal Article %1 Geng.2005 %A Geng, D. %A Shankar, G. %A Schantz, A. %A Rajadhyaksha, M. %A Davis, H. %A Wagner, C. %D 2005 %J J.Pharm.Biomed.Anal. %K Animals Antibodies Assay Chemistry Drug Enzyme-Linked Humans Immunoassay Immunoenzyme Immunosorbent Industry Monoclonal Pharmaceutical Preparations Reproducibility Research Results Sensitivity Specificity Techniques analysis and methods of pharmacology protein %N 3-4 %P 364-375 %T Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies %U PM:15963677 %V 39 %X Immunogenicity has always been an important consideration in the evaluation of pharmaceutical protein biologics. In this article, method validation parameters relevant to enzyme immunoassays are described for assays applied to the analysis of anti-drug antibodies, with special considerations for immunogenicity to therapeutic monoclonal antibodies. Common strategies for experimental investigation of various validation parameters are proposed. In addition, a novel, yet simple, approach is proposed to categorize the validation effort into two mutually interdependent phases, based on the characterization of validation parameters as "system descriptive" or "system controlled". System descriptive parameters are those that must be characterized but need not have pre-specified acceptance criteria for assay validation. In contrast, system-controlled parameters should be understood early in assay development, and optimized and confirmed using a priori acceptance criteria in validation to assure

@article{Geng.2005, abstract = {Immunogenicity has always been an important consideration in the evaluation of pharmaceutical protein biologics. In this article, method validation parameters relevant to enzyme immunoassays are described for assays applied to the analysis of anti-drug antibodies, with special considerations for immunogenicity to therapeutic monoclonal antibodies. Common strategies for experimental investigation of various validation parameters are proposed. In addition, a novel, yet simple, approach is proposed to categorize the validation effort into two mutually interdependent phases, based on the characterization of validation parameters as "system descriptive" or "system controlled". System descriptive parameters are those that must be characterized but need not have pre-specified acceptance criteria for assay validation. In contrast, system-controlled parameters should be understood early in assay development, and optimized and confirmed using a priori acceptance criteria in validation to assure }, added-at = {2010-02-05T11:28:39.000+0100}, author = {Geng, D. and Shankar, G. and Schantz, A. and Rajadhyaksha, M. and Davis, H. and Wagner, C.}, biburl = {https://www.bibsonomy.org/bibtex/2d01e109a7372dcf73eb15fe67f6faa60/kanefendt}, interhash = {14afe034303741b605b3a6cf291efeeb}, intrahash = {d01e109a7372dcf73eb15fe67f6faa60}, journal = {J.Pharm.Biomed.Anal.}, keywords = {Animals Antibodies Assay Chemistry Drug Enzyme-Linked Humans Immunoassay Immunoenzyme Immunosorbent Industry Monoclonal Pharmaceutical Preparations Reproducibility Research Results Sensitivity Specificity Techniques analysis and methods of pharmacology protein}, number = {3-4}, pages = {364-375}, timestamp = {2010-02-05T11:28:42.000+0100}, title = {Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies}, url = {PM:15963677}, volume = 39, year = 2005 }