Product Titer Quantification

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

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. Gyrolab 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

Gyrolab 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 Gyrolab xP workstation, which processed 332 samples in four hours. Clones with high titers were further expanded.

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

  ProA HPLC Gyrolab
Sample volume (ul) 10-100 ul 4 ul (including dead volumens
 
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 - 6mg/mL; single 5x dilution for all samples
 
Precision (%CV)
Intra (neat)
≤ 3%
Inter (neat)
≤ 3%
Intra (5x dilution) <4% Inter (5x dilution )<11%
 
Assay time including sample preparation
(e.g. 100 samples)
13 - 16 hours < 2 -3 hours
 
Accuracy 88 -119% 99 - 112%
 
  Percentage different to ProA HPLC is 2 - 13%
 

 

 

    Gyrolab Systems
    Gyrolab technology reduces manual labor, assay development time, time to result and material consumption -and it improves workflow efficiency. 
    [Brochure]

    Gyrolab Kits
    Gyrolab ready to use kits for CHO-HCP, Protein A and IgG titer analysis increase productivity in bioprocess development and QC. 
    [Brochure]

    Gyrolab huIgG Kit
    Use Gyrolab huIgG Kit to determine concentrations of intact human monoclonal antibodies of IgG1, IgG2 and IgG4 subtypes during cell line development. 
    [Product information sheet]

    Immunoassays to maximize productivity in bioprocess development
    Gyrolab systems meet the needs of many biopharmaceutical companies that apply immunoassays to bioanalysis throughout bioprocess development. Gyrolab immunoassay platform addresses bottlenecks and delays by providing rapid assay development time, automation, high throughput, and a broad dynamic range that minimizes dilutions and repeats.  
    [Application Note]

    Single-system solution for quantification of monoclonal IgG and host cell proteins (HCP) (AR 206)
    Application Report data courtesy of AstraZeneca and GE Healthcare. 
    [Application Report]

    Quantification of antigen-specific antibodies in serum (AR 205)
    Application Report data courtesy of National Veterinary Institute, Sweden. 
    [Application Report]

    Product quantification (IgG Titer) using an automated analytical platform–Gyrolab workstation
    Lin Wang, Ph.D., Li Zhang, Fang Li and Eike Zimmermann,Ph.D. Boehringer Ingelheim, Fremont CA, USA 
    [Poster]

    Streamlining product titer using automated nanoliter-scale immunoassays with throughput, dynamic range & reliable reproducibility
    Recorded Webinar. Presenters: Matt Traylor, Analytical Development, Shire Human Genetic Therapies, “Rapid Development of Gyrolab Titer ELISAs to Support Biopharmaceutical Process Development” and Jun Heo, Analytical Scientist, Bioprocess Technology and Expression (BTE), Merck & Co., Inc., “High Throughput Monoclonal Antibody Titer Assay for BioProcess Development”. 
    [Webinar]

    Automated nanoliter-scale immunoassays to maximize productivity in bioprocess development
    Recorded Webinar: Karolina Österlund, Manager Field Application Scientists EU and Asia, Gyros Protein Technologies AB, presents Gyrolab™ systems and a range of easy-to-use immunoassay kits as an automated, high-throughput platform for cell line and bioprocess development, illustrated by case studies from Shire, MedImmune and Merck. 
    [Webinar]