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Singlicate Ligand Binding Assay Using an Automated Microfluidic System: a Clinical Case Study.

Hao Jiang1, Alex Kozhich2, Jennifer Cummings2

  • 1Analytical and Bioanalytical Operations, Bristol-Myers Squibb, Princeton, New Jersey, USA. hao.jiang@bms.com.

The AAPS Journal
|June 8, 2017
PubMed
Summary

A robust bioanalytical strategy using ligand binding assays was developed for measuring monoclonal antibody BMS-986207 in oncology. This validated method ensures accurate quantification from discovery through clinical development.

Keywords:
GyrolabSinglicate bioanalysisligand binding assaypharmacokineticstoxicokinetics

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Area of Science:

  • Pharmacology and Pharmaceutical Sciences
  • Bioanalytical Chemistry
  • Oncology Therapeutics Development

Background:

  • Monoclonal antibody (mAb) therapeutics are crucial in oncology, requiring precise bioanalytical methods for quantification.
  • Integrated bioanalytical strategies are essential for tracking drug levels from discovery to clinical development.
  • The Gyrolab microfluidic system offers a platform for sensitive and efficient mAb quantification.

Purpose of the Study:

  • To develop and validate a bioanalytical strategy for quantifying the free monoclonal antibody BMS-986207.
  • To establish fit-for-purpose and regulated bioanalytical methods for oncology indications.
  • To ensure accurate and precise measurement of BMS-986207 throughout its development lifecycle.

Main Methods:

  • Development and validation of three integrated ligand binding assays (LBAs).
  • Utilized the Gyrolab microfluidic system for assay execution.
  • Assessed assay performance including accuracy, precision, stability, selectivity, dilutional linearity, carryover, and specificity.

Main Results:

  • LBAs demonstrated high accuracy and precision, with low bias and coefficient of variation (%CV) in both nonclinical and clinical assays.
  • The clinical assay met validation criteria using singlicate wells, supported by early phase study data.
  • >97% of samples met incurred sample reanalysis (ISR) criteria, confirming assay reproducibility.
  • No interference was observed from co-administered monoclonal antibodies.

Conclusions:

  • The developed bioanalytical strategy provides a reliable method for quantifying BMS-986207 in oncology studies.
  • The validated assays are suitable for supporting regulatory submissions and clinical trial monitoring.
  • The use of singlicate wells in the clinical assay represents a cost-effective and efficient approach.