Deepen Your Understanding of Bioanalytical Aspects in Biological Therapeutics

Renowned chemists, immunologists, and biologists have come together to provide a comprehensive exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. This book offers a practical understanding of the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field.

Overview and Basic Immunology for Testing of Biological Therapeutics

Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. This section provides a thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics.

Pharmacokinetic Aspects

This section explores platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies. It provides comprehensive insights into the importance of quality control for reagents and the role of pharmacokinetics in biotherapeutic development.

Clinical Immunogenicity Prediction and Testing

Readers will benefit from practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays. This section delves into the critical aspects of immunogenicity and its impact on biotherapeutic efficacy and safety.

Regulatory Expectations for Bioanalytical Method Development

This section examines the critical reagents in bioanalysis and the regulatory expectations for bioanalytical method development, validation, and sample testing. Pharmaceutical scientists in industry, pharmaceutical regulators, and other professionals working in pharmaceutical companies will find this information invaluable.

Perfect for Pharmaceutical Scientists and Regulators

Bioanalytical Aspects in Biological Therapeutics is a must-have resource for pharmaceutical scientists in industry, as well as for pharmaceutical regulators and other professionals working in pharmaceutical companies. Graduate students studying bioanalytical assays for biological therapeutics will also find this book to be an essential reference.

Published by Wiley, this book is available in English and offers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development.