Product Titer Quantification

The broad dynamic range covered by Gyrolab platforms ensure high-sensitivity quantification throughout the development process.

High Throughput Screening of Low Titers at Early Stage Cell Line. Data courtesy of Merck.Increasing efficiency and productivity for product titer is even more critical as a result of increasing workloads in supporting multiple programs with limited resources. Current methods such as enzyme-linked immunosorbent assay (ELISA) or high-performance liquid chromatography (HPLC) create bottlenecks in critical workflows because of throughput constraints, limited dynamic range, and longer assay times. Gyros’ automated immunoassay platforms generate high-quality analytical data at high throughput using nanoliter volumes for more rapid and efficient product titer determination.

Gyrolab benefits for product titer quantification:

  • Broad dynamic range:
    Sensitivity down to 1 ng/mL and broad ranges (3–4 logs) to support post-transfection clone selection
  • Rapid results:
    Rapid quantification of murine or human IgG in under an hour to optimize plating density and clone selection
  • Automation and throughput:
    Reduce manual hands-on time with up to 560 data points generated unattended in under 5 hours
  • Precision and robustness:
    Provides reproducibility for better consistency and easy assay transfer

Gyros’ platforms offer key advantages for applications such as protein expression, cell line development, and the detection of bioprocess impurities. They are robust, automated platforms providing high throughput, enabling data-driven decisions with minimal bench time and rapid time to results.

High-throughput IgG titer for clone screening

Selection of stable, high-producing clones during cell line development (CLD) is subject to aggressive timelines and produces hundreds of clones requiring rapid assessment for product titer. The figure above shows titer distribution of all clones in a screen of low titers at early stage CLD. Posttransfection samples from 96-well plates were measured for IgG titer using a Gyrolab xP workstation, which processed 332 samples in four hours. Clones with high titers were further expanded.

Comparison product titer quantitation between Pro HPLC vs. Gyrolab xP workstation

 

    ProA HPLC Gyrolab
  Sample volume (ul) 10-100 ul 4 ul (including dead volumens
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  Measurement range 0.02 – 5 mg/mL (usually 1 – 50 ug load); samle dilution can be avoided by adjustment of sample injection volumes 0.04 – 6ml/mL; single 5x dilution for all samples
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  Precision (%CV)
Intra (neat)
≤ 3%
Inter (neat)
≤ 3%
Intra (5x dilution) <4% Inter (5x dilution )<11%
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  Assay time including sample preparation
(e.g. 100 samples)
13 – 16 hours < 2 -3 hours
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  Accuracy 88 -119% 99 – 112%
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    Percentage different to ProA HPLC is 2 – 13%
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