Blog: The Spin

An immunoassay platform fit for regulated bioanalysis

Gyrolab xP workstation generates high quality data faster

REGULATORY.pngAs the pace of drug development increases, so does the demand on rapid and efficient generation of bioanalytical data in a regulated setting. In testing six ligand-binding assays on Gyrolab™ xP workstation, Rong Liu and her colleagues at Bristol-Myers Squibb have found that the system delivers the performance they need. This included high run and incurred sample reanalysis (ISR) pass rates for 5000 samples in a fraction of the time required for non-automated plate-based methods.

Proven high performance in tests based on validation guidelines

Prompted by previous reports of the suitability of Gyrolab xP workstation for regulated bioanalysis, the team at Bristol-Myers Squibb tested the system’s performance using six sandwich ligand-binding methods to analyze Fc-fusion proteins in 4000 samples in GLP toxicokinetic and 1000 samples in two clinical pharmacokinetic studies. Assays were validated in rat, monkey, and human matrices in the range 5–20% matrix, depending on assay. The methods were validated using current guidelines that recommend determining accuracy, precision, selectivity, specificity, dilutional linearity, stability, and interference.

Run pass rates were better than 83% and ISR pass rates were better than 94%. One assay had such high precision (CV ≤5%) that they could rely on a single calibration curve on one CD to analyze samples on all five CDs in a run, supported by QCs on individual CDs.

Saving time and resources

Gyrolab xP workstation provided significant gains in terms of reagent usage, ten times lower than traditional plate-based methods, that would, for example, reduce costs and cross-validation needed when changing lots. Five of the six methods required only one analyst for sample analysis. The timesaving was also considerable – 400 samples could be analyzed per instrument and analyst per day compared with only 140 with plate-based methods.  This resulted in shortening the team’s sample testing by as much as two weeks.

A frontrunner for discovery through late stage clinical trials

The authors concluded that “Overall, the platform was reliable, had reduced data turnaround times, was transferable to another testing lab, and had the needed throughput to support toxicology and clinical studies. When combined with upfront automated sample dilution, this platform is a frontrunner for high sample analysis throughput, high quality data generation, and reduced bioanalysis timelines required from discovery through late stage clinical trials.”

Reference

Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform. Liu R et al. AAPS J. 2017 Jan;19(1):82-91. doi: 10.1208/s12248-016-0006-z. Epub 2016 Oct 27.  PMID: 27796911. 

Find out more about Gyrolab systems

Download our applications brochure: Maximizing productivity in biopharmaceutical research and clinical development.

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If you are an AAPS member, you can register for the webinar “Accelerating Bioanalysis for Biotherapeutics using Gyrolab™ xP”, April 20, 2017, 12:30 PM EDT. Speakers: Rong Liu, Bristol-Myers Squibb Company and Tracey Clark, Pfizer.

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POSTED March 28, 2017

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