Normal 0 false false false EN-US ZH-CN TH MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin-top:0in; mso-para-margin-right:0in; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0in; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; mso-bidi-font-size:14.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Cordia New"; mso-bidi-theme-font:minor-bidi;} As more therapeutics based on recombinant proteins come into clinical use, the need to assess and evaluate the appearance of neutralizing antibodies (NAbs) becomes more important. The availability of a single volume covering all the principal aspects of the detection and quantification of antibodies, including a review of the expectations of regulatory authorities, greatly facilitates a more uniform approach across industry. This book serves as a resource for biopharmaceutical drug development as a comprehensive review of best practices for conducting these analyses. It provides a rational basis for the design of appropriate detection strategies and assays for antibodies to biopharmaceuticals. It covers American, European, and Japanese regulatory perspective on assessment of immunogenicity of therapeutic proteins. It discusses a variety of factors like the importance of using the appropriate assays to detect ADAs, the use pharmacodynamic parameters in drug-induced biological markers, and the technical challenges and regulatory considerations involved in standardization, optimization, and validation of cell-based assays for detection of anti-drug antibodies. This book also describes novel ideas for detecting anti-drug neutralization antibodies, including a two-stage approach that quantifies the bioactivity of circulating drugs in an immunoassay and a one-step method based on the use of engineered reporter cells.
