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Related Experiment Video

Updated: Aug 9, 2025

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Assessing developability early in the discovery process for novel biologics.

Monica L Fernández-Quintero1, Anne Ljungars2, Franz Waibl1

  • 1Center for Molecular Biosciences Innsbruck (CMBI), Department of General, Inorganic and Theoretical Chemistry, University of Innsbruck, Innsbruck, Austria.

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|February 23, 2023
PubMed
Summary

Selecting biologics with good developability early saves resources and prevents late-stage failures. This review covers key properties and methods for optimizing biologic drug leads.

Keywords:
Biologicsantibodiesbiotherapeuticsdevelopabilitydrug developmentdrug discoverydrug propertieshalf-lifeimmunogenicitymanufacturability

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Area of Science:

  • Biopharmaceutical development
  • Drug discovery and optimization

Background:

  • Developability is crucial for biological drugs, alongside potency.
  • Early screening of developability attributes minimizes resource waste and late-stage attrition.

Approach:

  • Review of key developability properties: source, biophysical, pharmacokinetic, and recombinant expression.
  • Presentation of in silico, in vitro, and in vivo methods for identifying liabilities.
  • Discussion of parameters for injectable vs. oral biologics and future trends.

Key Points:

  • Early assessment of biologic source, biophysical, and pharmacokinetic properties is vital.
  • Utilizing computational, laboratory, and animal models aids in selecting optimal drug leads.
  • Consideration of delivery route (injectable vs. oral) impacts relevant developability parameters.

Conclusions:

  • Integrating comprehensive developability assessments early streamlines biologic drug development.
  • Proactive identification and mitigation of liabilities enhance the probability of successful drug development.
  • Future trends point towards evolving developability considerations for diverse biologic delivery methods.