Immunogenicity Assay Development, Validation and Implementation
Part of the Analytical Chemistry eBook Collection
Edited by Robert Dodge & Renuka C Pillutla
In recent years there have been significant improvements and standardization in immunogenicity testing and the reporting of results. Technology developments and responses to increasing regulatory expectations have enabled the development of superior bioanalytical methods. In nine chapters from international experts, this book provides an excellent overview, with detailed summaries of advances in testing schemes. Critical topics include reagents used in assays, a summary of techniques used in overcoming assay interferences and considerations in statistical evaluation. Overviews of neutralizing antibody assays are presented together with an overview of regulatory guidance and recommended procedures.