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Related Experiment Video

Updated: May 6, 2026

Laboratory Scale Production and Purification of a Therapeutic Antibody
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Challenges in realizing therapeutic antibody biosensing.

Madoka Nagata1, Ellie D Wilson1, Kazunori Ikebukuro2

  • 1Lampe Joint Department of Biomedical Engineering, The University of North Carolina at Chapel Hill and North Carolina State University, Chapel Hill, NC 27599, USA.

Trends in Biotechnology
|July 24, 2025
PubMed
Summary

New technologies offer rapid, on-site monitoring for therapeutic monoclonal antibodies (mAbs), addressing pharmacokinetic variability. This enables faster clinical decisions and personalized patient treatment through bedside testing.

Keywords:
anti-idiotype moleculesbiosensorson-site monitoringtherapeutic drug monitoringtherapeutic monoclonal antibodies

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Area of Science:

  • Biotechnology
  • Pharmacokinetics
  • Analytical Chemistry

Background:

  • Therapeutic monoclonal antibodies (mAbs) show significant interindividual pharmacokinetic (PK) variability.
  • Current therapeutic drug monitoring (TDM) methods are complex and time-consuming, hindering rapid dose adjustments.

Purpose of the Study:

  • To review emerging technologies for on-site mAb monitoring.
  • To discuss advances in recognition elements and detection strategies for rapid bedside testing.

Main Methods:

  • Focus on novel recognition elements like anti-idiotype molecules and meditopes.
  • Examination of direct detection methods eliminating washing steps.
  • Assessment of prospects for continuous mAb monitoring.

Main Results:

  • Novel recognition elements allow for specific mAb detection.
  • Direct detection methods facilitate rapid, bedside testing.
  • Emerging technologies show promise for real-time therapeutic monitoring.

Conclusions:

  • On-site mAb monitoring technologies are advancing rapidly.
  • Challenges in sensor regeneration and stability need further research.
  • These technologies may enable real-time therapeutic monitoring at the bedside.