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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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Related Experiment Video

Updated: Jan 28, 2026

Fast Inspection of Quality of Indigo Naturalis by Multiple Light Scattering
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Dynamic Light Scattering for Assessing Aggregation in [177Lu]Lu-DOTA-Trastuzumab: A Quality Control Approach for

Huu Bao Nguyen1, Aran Kim2, Muhammad Zeeshan1

  • 1Department of Molecular Medicine, Brain Korea 21 four KNU Convergence Educational Program of Biomedical Sciences for Creative Future Talents, School of Medicine, Kyungpook National University, Daegu 41944, Korea.

Bioconjugate Chemistry
|January 27, 2026
PubMed
Summary

Radioimmunotherapy using Lutetium-177 (Lu-177) can cause antibody aggregation, reducing effectiveness. Dynamic Light Scattering (DLS) monitoring and aggregate removal are crucial for successful radioimmunotherapy treatments.

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Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction
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Area of Science:

  • Radiochemistry
  • Bioconjugation
  • Therapeutic Antibody Engineering

Background:

  • Radioimmunotherapy (RIT) utilizes radiolabeled antibodies for targeted cancer treatment.
  • High-linear energy transfer (LET) isotopes like Lutetium-177 (Lu-177) can induce antibody aggregation, compromising stability and bioactivity.
  • Current quality control methods may not detect aggregation induced by therapeutic radioisotopes.

Purpose of the Study:

  • To investigate the impact of conjugation chemistry, radiolabeling conditions, and purification on the aggregation of [177Lu]Lu-DOTA-Trastuzumab.
  • To evaluate the efficacy of Dynamic Light Scattering (DLS) as a quality control method for detecting aggregation.
  • To assess the therapeutic performance of aggregate-free [177Lu]Lu-DOTA-Trastuzumab in HER2-positive tumors.

Main Methods:

  • Formulation and characterization of [177Lu]Lu-DOTA-Trastuzumab using varying chelator-to-antibody ratios and radioactivity levels.
  • Aggregation monitoring via Dynamic Light Scattering (DLS) and comparison with conventional methods (SEC-HPLC, radio-TLC).
  • In vivo evaluation of HER2-specific uptake, tumor accumulation, and therapeutic efficacy in HER2-positive mouse models.

Main Results:

  • Increased chelator-to-antibody ratios and radioactivity led to significant aggregation, undetected by SEC-HPLC or radio-TLC.
  • Lutetium-177 (Lu-177) induced greater aggregation than Copper-64 (Cu-64), correlating with higher radiolytic stress.
  • Aggregation inversely correlated with HER2-specific uptake and tumor accumulation; aggregate-free formulations showed superior tumor growth inhibition (~65%).

Conclusions:

  • Dynamic Light Scattering (DLS) is a sensitive and practical tool for monitoring aggregation in radioimmunoconjugates.
  • Aggregate formation is a critical issue in therapeutic radiolabeling, necessitating robust quality control.
  • Ensuring aggregate-free radioimmunotherapy agents is essential for consistent safety, quality, and therapeutic effectiveness.