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

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

Editor(s): Michael G. Tovey

Published Online: 20 JUN 2011 08:23AM EST

Print ISBN: 9780470566664

Online ISBN: 9781118075685

DOI: 10.1002/9781118075685

About this Book

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.

Table of contents

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    1. You have free access to this content
  1. Part I: Risk-Based Strategies

  2. Part II: Regulatory Requirements

  3. Part III: Principal Technologies Employed for the Quantification of Anti-Drug Antibodies

  4. Part IV: Assay Standardization and Validation

  5. Part V: Statistical Considerations

  6. Part VI: Adaptation of Anti-Drug Antibody Assays to Challenging Conditions

    1. Chapter 19

      Antibody Assays in Animal Research (pages 331–341)

      Vera Brinks, Francesca Gilli, Melody Sauerborn and Huub Schellekens

  7. Part VII: Novel Technologies for the Quantification of Neutralizing Antibodies

    1. You have free access to this content

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