Product Description

Published March 2016

ISBN: 978-1-910420-19-5

Ligand-binding assays are a key tool in the bioanalysis of biologics, and so are widely used throughout the development of biotherapeutics. The chapters of this book cover the most exciting and challenging areas of application with a focus on problem solving, particularly complex or advanced analyses, and areas of debate. Applications such as antibody–drug conjugates, biosimilars and blood genotying are discussed, as well as challenges relating to cross-validation with LC-MS/MS methods, calibration curves, cut-point determination, automation, immunogenicity and interference. The current regulatory status is described, as well as emerging novel technologies.

Chapters

• Regulatory considerations
  Philip Oldfield
• Automation strategies
  Jin Wang & Mark Ma
• Ligand binding assays: calibration curves
  Kyra J Cowan
• Interference and matrix effect
  Judy Y Shih
• Additional constraints during biomarker method development: case studies
  Gilda Shayan , Sreeja Gopal , Shobha Purushothama & Chase Shen
• Immunogenicity and its effect on pharmacokinetics of biotherapeutics
  Boris Gorovits
• Cut point computation in immunogenicity assays: a tutorial
  Proveen D Dass & Masood U Khan
• Ligand binding assay measurement of antibody–drug conjugates
  Lindsay King
• (Bio) analysis of biosimilars
  Melody Sauerborn
• Multiplex assays for blood group genotyping
  Stephanie Boccoz , Gaelle Le Goff & Christophe Marquette
• Considerations and rationale for the selection of LC-MS/MS or ligand binding assays for bioanalysis of therapeutic proteins
  Charles Scott Hottenstein , Eric Dobrzynski , Joshua Albert , Jonathan Kehler & Matthew Szapacs
• Emerging and alternative technologies
  Stephanie Fraser , Mark Dysinger , Rebecca M Crisino & Saloumeh Fischer