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Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay

Rong Liu1, Brian Hoffpauir2,3, Shannon D Chilewski4

  • 1Immunochemistry and Biomarkers, Analytical and Bioanalytical Operations, Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, New Jersey, 08543, USA. rong.liu@bms.com.

The AAPS Journal
|November 1, 2016
PubMed
Summary
This summary is machine-generated.

The Gyrolab™ xP platform offers efficient, automated ligand binding assays (LBAs) for regulated bioanalysis. This microfluidic technology delivers high-quality data, reduces testing timelines, and supports biotherapeutic development.

Keywords:
Gyrolab™ xPligand binding assayregulated bioanalysissample analysisstudy validation

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Area of Science:

  • Bioanalytical science
  • Microfluidic technology
  • Pharmacokinetics and toxicokinetics

Background:

  • The Gyrolab™ xP is a microfluidic platform for ligand binding assays (LBAs).
  • Its utility in discovery bioanalysis is established, but limited reports exist for regulated bioanalysis.
  • Advantages include low reagent consumption, minimal sample volume, and automated methods.

Purpose of the Study:

  • Evaluate the Gyrolab™ xP platform for regulated bioanalysis.
  • Assess its potential for high-quality data generation and reduced testing timelines.
  • Support the accelerated delivery of biotherapeutics to patients.

Main Methods:

  • Validated six LBA methods for Good Laboratory Practice (GLP) toxicokinetic and clinical pharmacokinetic studies.
  • Performed validation, sample analysis, and method transfer procedures.
  • Utilized the Gyrolab™ xP platform for automated LBAs.

Main Results:

  • Successfully tested ~4000 samples for 6 GLP toxicology studies and ~1000 samples for 2 clinical studies.
  • Achieved high run pass rates (≥83%) and incurred sample reanalysis (ISR) pass rates (>94%).
  • Demonstrated maximum total error <30% across all QC levels and high instrument precision (CV ≤5%).

Conclusions:

  • The Gyrolab™ xP platform enables high-quality data generation for regulated bioanalysis.
  • Reduced bioanalysis timelines compared to manual plate-based methods were achieved.
  • Successful method transfer and high assay performance indicate suitability for late-stage clinical development.