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Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
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Half-life extended biotherapeutics.

Roland E Kontermann1

  • 1a Institute of Cell Biology and Immunology , University of Stuttgart , Stuttgart , Germany.

Expert Opinion on Biological Therapy
|March 12, 2016
PubMed
Summary

Biotherapeutics often have short half-lives, requiring frequent dosing. Half-life extension strategies create long-lasting therapeutics with improved properties, enhancing treatment efficacy and patient compliance.

Area of Science:

  • Biopharmaceutical development
  • Drug delivery and formulation
  • Pharmacokinetics and pharmacodynamics

Background:

  • Many biotherapeutics exhibit short in vivo half-lives, limiting their therapeutic efficacy and requiring frequent administration.
  • This necessitates the development of strategies to prolong drug exposure and maintain therapeutic concentrations over extended periods.

Purpose of the Study:

  • To provide a comprehensive review of established and emerging half-life extension strategies for biotherapeutics.
  • To highlight strategies currently employed in approved drugs and clinical development.

Main Methods:

  • Review of literature focusing on half-life extension techniques.
  • Analysis of strategies involving increased hydrodynamic radius and neonatal Fc receptor (FcRn) recycling.
Keywords:
AlbuminFc regionFcRnPEGylationfusion proteinglycosylationhalf-life extensionpolymer

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  • Examination of albumin binding/fusion, Fc fusion, and PEGylation.

    • Main Results:

    • Half-life extension strategies are crucial for next-generation biotherapeutics, offering improved pharmacokinetic and pharmacodynamic profiles.
    • Current dominant strategies include albumin fusion, Fc fusion, and PEGylation.
    • Alternative approaches, such as polypeptide chain fusion, are advancing and provide further options.

    Conclusions:

    • A diverse array of half-life extension strategies exists for tailoring biotherapeutics to specific diseases and treatment modalities.
    • These strategies are integral to modern biopharmaceutical development, leading to more effective and convenient therapies.