Skip to main content
Taylor & Francis Group Logo
    Advanced Search

    Click here to search products using title name,author name and keywords.

    • Login
    • Hi, User  
      • Your Account
      • Logout
      Advanced Search

      Click here to search products using title name,author name and keywords.

      Breadcrumbs Section. Click here to navigate to respective pages.

      Chapter

      Testing for Off-target Binding
      loading

      Chapter

      Testing for Off-target Binding

      DOI link for Testing for Off-target Binding

      Testing for Off-target Binding book

      Testing for Off-target Binding

      DOI link for Testing for Off-target Binding

      Testing for Off-target Binding book

      ByDiana M. Norden, Benjamin J. Doranz
      BookTranslational Medicine

      Click here to navigate to parent product.

      Edition 1st Edition
      First Published 2021
      Imprint CRC Press
      Pages 14
      eBook ISBN 9781003124542
      Share
      Share

      ABSTRACT

      Detailed specificity analysis is critical for drug development, as even minimal off-target binding may cause serious adverse events. Off-target binding is the primary cause of preclinical and early-stage clinical trial failures. Recent clinical data and our own profiling indicate that biotherapeutics frequently (~25%) display polyspecificity, resulting in failed clinical trials and severe adverse events in patients. As a result, specificity profiling is an important regulatory requirement for biotherapeutic categories, such as monoclonal antibodies and CAR T cell therapy. The primary methods for profiling the specificity of biotherapeutics include tissue cross-reactivity studies and cell-based expression arrays of structurally intact membrane proteins (“cell expression arrays”). This chapter details the advantages of each approach and discusses how to interpret outcomes when off-target interactions are discovered. More thorough specificity profiling of lead therapeutics will improve off-target binding prediction and minimize risk in biotherapeutic discovery programs prior to clinical development.

      T&F logoTaylor & Francis Group logo
      • Policies
        • Privacy Policy
        • Terms & Conditions
        • Cookie Policy
        • Privacy Policy
        • Terms & Conditions
        • Cookie Policy
      • Journals
        • Taylor & Francis Online
        • CogentOA
        • Taylor & Francis Online
        • CogentOA
      • Corporate
        • Taylor & Francis Group
        • Taylor & Francis Group
        • Taylor & Francis Group
        • Taylor & Francis Group
      • Help & Contact
        • Students/Researchers
        • Librarians/Institutions
        • Students/Researchers
        • Librarians/Institutions
      • Connect with us

      Connect with us

      Registered in England & Wales No. 3099067
      5 Howick Place | London | SW1P 1WG © 2022 Informa UK Limited