Deepen Your Understanding of Bioanalytical Aspects in Biological Therapeutics

Renowned chemists, immunologists, and biologists have come together to provide a practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. This book, “Bioanalytical Aspects in Biological Therapeutics,” offers a timely and comprehensive guide to the challenges and considerations for bioanalytical support in drug development and analysis.

Overview and Basic Immunology for Testing of Biological Therapeutics

The book begins with an overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics. This section provides a solid foundation for understanding the critical data generated from bioanalysis and how proven tools and methods are applied to the development of biologics.

Pharmacokinetic Aspects and Clinical Immunogenicity Prediction and Testing

Drug development and analysis professionals will learn about the importance of pharmacokinetic aspects, including platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies. Additionally, the book covers comprehensive explorations of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays.

Regulatory Expectations and Critical Reagents in Bioanalysis

Pharmaceutical scientists in industry, as well as pharmaceutical regulators and other professionals working in pharmaceutical companies, will benefit from in-depth examinations of critical reagents in bioanalysis and regulatory expectations for bioanalytical method development, validation, and sample testing. This section ensures that readers are well-versed in the necessary protocols and standards for bioanalytical testing.

Perfect for Pharmaceutical Scientists and Graduate Students

“Bioanalytical Aspects in Biological Therapeutics” is an essential resource for pharmaceutical scientists in industry, pharmaceutical regulators, and graduate students studying bioanalytical assays for biological therapeutics. With its comprehensive coverage of central topics in the field, this book is a must-have for anyone looking to deepen their understanding of how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics.