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Current Issues in Ligand Binding Assay Bioanalysis

£155

Current Issues in Ligand Binding Assay Bioanalysis

Edited by Lindsay King

Category: Analytical Chemistry
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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

 

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