The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations offers a comprehensive and in-depth look at all the principal aspects of the detection and quantification of antibodies that are essential to understanding and responding to the challenges they present. Bringing together a large-scale review of neutralization and biopharmaceuticals and the ability to measure, detect, and apply antibodies to modern science and medicine with international regulatory perspectives, the expectations of regulatory authorities, and the strengths and weaknesses of various assays, the book describes several novel ideas for detecting ADAs. Designed to serve as a resource for biopharmaceutical drug development, the book provides biotechnology companies and pharmaceutical drug development specialists, as well as non-experts, with key insights into the design, optimization, and qualification of assays, the establishment of sampling strategies, the choice of appropriate assay end-points, and data analysis for the detection and quantification of neutralizing antibodies.

Detection and Quantification of Antibodies to Biopharmaceuticals. Practical and Applied Considerations