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

The definitive book on the neutralization of recombinantbiopharmaceuticals


Recombinant biopharmaceuticals are an important tool fortreating a range of illnesses; however, their efficacy can beseverely impaired by their immunogenicity. When introduced into thebody, these pharmaceuticals can cause the immune system to produceanti–drug antibodies (ADAs) that neutralize their effects.


The first and only book to cover neutralization in connectionwith biopharmaceuticals and the measurement and application ofneutralizing antibodies in modern medicine at any real length,Detection and Quantification of Antibodies to Biopharmaceuticals:Practical and Applied Considerations offers a comprehensive andin–depth look at all the principal aspects of the detection andquantification of antibodies that are essential to understandingand responding to the challenges they present.


Bringing together a large–scale review of neutralization andbiopharmaceuticals and the ability to measure, detect, and applyantibodies to modern science and medicine with internationalregulatory perspectives, the expectations of regulatoryauthorities, 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 drugdevelopment, the book provides biotechnology companies andpharmaceutical drug development specialists, as well asnon–experts, with key insights into the design, optimization, andqualification of assays, the establishment of sampling strategies,the choice of appropriate assay end–points, and data analysis forthe detection and quantification of neutralizing antibodies.


Back cover:

The definitive book on the neutralization of recombinantbiopharmaceuticals


Recombinant biopharmaceuticals are an important tool fortreating a range of illnesses; however, their efficacy can beseverely impaired by their immunogenicity. When introduced into thebody, these pharmaceuticals can cause the immune system to produceanti–drug antibodies (ADAs) that neutralize their effects.


The first and only book to cover neutralization in connectionwith biopharmaceuticals and the measurement and application ofneutralizing antibodies in modern medicine at any real length,Detection and Quantification of Antibodies to Biopharmaceuticals:Practical and Applied Considerations offers a comprehensive andin–depth look at all the principal aspects of the detection andquantification of antibodies that are essential to understandingand responding to the challenges they present.


Bringing together a large–scale review of neutralization andbiopharmaceuticals and the ability to measure, detect, and applyantibodies to modern science and medicine with internationalregulatory perspectives, the expectations of regulatoryauthorities, 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 drugdevelopment, the book provides biotechnology companies andpharmaceutical drug development specialists, as well asnon–experts, with key insights into the design, optimization, andqualification of assays, the establishment of sampling strategies,the choice of appropriate assay end–points, and data analysis forthe detection and quantification of neutralizing antibodies.


Contents:

INTRODUCTION: A PERSPECTIVE ix

Michael G. Tovey

CONTRIBUTORS xxi


PART I RISK–BASED STRATEGIES 1


1 Principles of Risk Assessment and Monitoring of AntibodyResponses to Biopharmaceuticals 3
Eugen Koren, Erik Foehr, and Charles A.O Neill


PART II REGULATORY REQUIREMENTS 13


2 Immunogenicity of Therapeutic Proteins: A RegulatoryPerspective 15
Susan Kirshner


3 Guidance on Immunogenicity Assessment of BiologicallyDerived Therapeutic Proteins: A European Perspective 37
Meenu Wadhwa and Robin Thorpe


4 Japanese Regulatory Perspective on Immunogenicity 57
Takao Hayakawa and Akiko Ishii–Watabe


PART III PRINCIPAL TECHNOLOGIES EMPLOYED FOR THEQUANTIFICATION OF ANTI–DRUG ANTIBODIES 81


5 Enzyme Immunoassays and Radioimmunoassays forQuantification of Anti–TNF Biopharmaceuticals and Anti–DrugAntibodies 83
Klaus Bendtzen and Morten Svenson


6 Confirmatory Immunogenicity Assays 103
Eric Wakshull and Daniel Coleman


7 The Use of Pharmacodynamics as a Surrogate Marker for theDetection of Anti–Drug Neutralizing Antibodies 119
Florian Deisenhammer


8 Cell–Based Assays for the Detection of NeutralizingAntibodies to Interferon Beta (IFN– ) and Tumor NecrosisFactor Alpha (TNF– ) Inhibitors 133
Anthony Meager


9 Detection of Neutralizing Antibodies against InterferonBeta by Real–Time RT–PCR 157
Francesca Gilli and Antonio Bertolotto


10 Competitive Ligand–Binding Assays for the Detection ofNeutralizing Antibodies 175
Bonnie W. Wu, George R. Gunn III, and Gopi Shankar


11 The Use of Surface Plasmon Resonance for the Detection andCharacterization of Antibodies 193
Steven J. Swanson and Daniel Mytych


12 Hypersensitivity Reactions to Biopharmaceuticals:Detection and Quantification of Drug–Specific IgE Antibodies211
Jörgen Dahlström and Lennart Venemalm


PART IV ASSAY STANDARDIZATION AND VALIDATION 233


13 Standardization and Validation of Immunoassays 235
Daniel Kramer


14 Standardization and Validation of Cell–Based Assays forthe Detection of Neutralizing Anti–Drug Antibodies 243
Deborah Finco–Kent and Amy Grenham


15 Standardization of Neutralizing Antibody Unitage byBioassay Design: Constant Antigen and Constant Antibody Methodology269
Sidney E. Grossberg, Yoshimi Kawade, and Leslie D.Grossberg


PART V STATISTICAL CONSIDERATIONS 287


16 Cut Points and Performance Characteristics for Anti–DrugAntibody Assays 289
Viswanath Devanarayan and Michael G. Tovey


17 Dilutional Linearity for Neutralizing Antibody Assays309
David Lansky and Carrie Wager


PART VI ADAPTATION OF ANTI–DRUG ANTIBODY ASSAYS TOCHALLENGING CONDITIONS 319


18 Detection of Antibodies to Biopharmaceuticals in thePresence of High Levels of Circulating Drug 321
Arno Kromminga and Michael G. Tovey


19 Antibody Assays in Animal Research 331
Vera Brinks, Francesca Gilli, Melody Sauerborn, and HuubSchellekens


20 Immunogenicity of Microbial Digestive Enzymes for OralReplacement Therapy in Pancreatic Exocrine Insufficiency 343
Claudia Berger and Uwe Niesner


PART VII NOVEL TECHNOLOGIES FOR THE QUANTIFICATION OFNEUTRALIZING ANTIBODIES 369


21 Measurement of Biologically Active Drug as an Approach toDetection of Anti–Drug Neutralizing Antibodies 371
Yao Zhuang and Shalini Gupta


22 A Novel One–Step Cell–Based Assay for Quantification ofNeutralizing Antibodies to Biopharmaceuticals 383
Christophe Lallemand and Michael G. Tovey


INDEX 399


PRODUCT DETAILS

ISBN-13: 9781118075678
Publisher: John Wiley & Sons Ltd (Wiley–Blackwell)
Publication date: September, 2011
Pages: 432
Dimensions: 157.00 x 242.00 x 29.29

Subcategories: Diseases and Disorders, Immunology, Pharmacology

MEET THE AUTHOR

MICHAEL G. TOVEY, PhD, INSERM Director of Research in the Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan, France. He is an Associate Editor of the Journal of Interferon and Cytokine Research and author of more than two hundred articles on interferon, cytokines, and biotechnology.