Impurity Testing

The high precision and reproducibility of Gyrolab® systems speed up the entire biotherapeutics workflow.

Process related impurity concentrations are regulated in the manufacture of biologic drugs because of their immunogenic potential. Methods to detect and measure process related impurities are complex either because of the heterogeneous mixture of host cell proteins (HCPs) present in samples or the co-elution of Protein A with the therapeutic. Failure to accurately measure impurities can potentially reduce therapeutic efficacy or cause adverse reactions which has significant cost implications in both bioprocess development and production.

Gyrolab feature/benefits for impurity testing and analysis:

  • Broad dynamic range
    Minimizes dilutions and the need for repeat analysis with 3-4 logs of dynamic range
  • Rapid time to results
    Data-driven decisions with results in under an hour
  • Automation and throughput
    Reduces manual hands-on time with higher throughput for unattended operation
  • Precision and reproducibility
    Provides robustness for better consistency and easy assay transfer

Fast and accurate quantification of process related impurities is critical for biotherapeutics throughout downstream purification development and optimization. Current technologies, such as ELISA have limitations in terms of labor intensive protocols, lower throughput and narrow dynamic range. As a result, repeat analysis is common, further delaying project decisions and lot approvals. Automating impurities immunoassays such as host cell proteins (HCPs) and Protein A (ProA) on Gyrolab systems provide fast turn-around time, broad dynamic ranges and reproducibility, making it an ideal technology to support all phases of bioprocess and production.


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

    Gyrolab Kits, CDs and Rexxip Buffers
    Gyrolab Kits, CDs and Rexxip Buffers - Designed for best results 

    Gyrolab Protein A Kit
    Gyrolab Protein A Kit Quantifies MabSelect SuRe™ ligands and native Protein A residuals in bioprocess samples. 
    [Product information sheet]

    Gyrolab CHO-HCP Kit 1
    Gyrolab CHO-HCP Kit 1 is designed to measure CHO Host Cell Proteins impurities with performance that addresses many of the limitations of ELISA. 
    [Product information sheet]

    Quantitation of Host Cell Protein Impurities
    Gyrolab HCP assays deliver high precision results over a broad dynamic range, minimizing repeat analysis in bioprocess development and production. 
    [Application Note]

    Comparative HCP Testing Using Traditional and Emerging Technologies
    Martha Jackson, David Cirelli, Phoebe Baldus, Ned Mozier. BioTherapeutics Pharmaceutical Sciences, Analytical Research and Development, Pfizer, Andover, MA 

    High Throughput Process-related Impurity Testing Using a Gyrolab™ Workstation
    Meletios Roussis, Eric Beard, Keshavamurthy Prakash, Robert Strouse and Michael Washabaugh. Analytical Biochemistry, MedImmune, Gaithersburg, MD 20878 USA 

    Development of residual host cell protein assays for recombinant microbial biopharmaceuticals
    Katja Peiris and Daniel Schiwek, LCMD Analytical Development, Lonza AG, Switzerland 

    Minimizing Repeats and Making Rapid Data Driven Decisions using Automated Nanoliter-scale Immunoassays for Impurity Testing in Bioprocess and Production
    This recorded webinar focuses on the use of automated, nanoliter-scale flow-through technology to address a critical need for improved speed, throughput and reduced repeats in process related impurity testing. Presenters: Martha L. Jackson, Senior Research Scientist, Pfizer Inc. and Jun Hyuk Heo, Biochemist, Biotechnology New and Enabling Technologies (BNET), Merck & Co. 

    Cobra Biologics on the versatility of Gyrolab™ immunoassay platform in bioprocess development
    Anna Lönnerbro is an Analytical Scientist at Cobra Biologics, a CMO and CRO of biologics and pharmaceuticals for pre-clinical, clinical and commercial supply. Cobra Biologics offers support from small scale-up to large-scale bioprocess. Presenting at Gyrolab User Seminar in Copenhagen, Denmark on June 2, 2014, Anna described how the Gyrolab platform enables Cobra Biologics to deliver premium services with improved immunoassays.  
    [Case Study]

    How to get more reliable results with less effort
    Analytical results that you can depend on are crucial to success, especially in a regulated environment. For example, immunoassays that consistently deliver reliable data with high accuracy and precision are worth their weight in gold. ELISA has been the standard for immunoassays, but this situation is changing. We present here two case studies that show how a move from ELISA to Gyrolab™ assays is helping your colleagues to improve their results and lab workflows. 
    [Case Study]

    Jun Heo on using Gyrolab xP to automate high throughput HCP analysis
    Recorded Seminar: Jun Heo, Analytical Biochemist, Biologics-New and Enabling Technologies (BNET), Merck & Co., Inc., presents 'The Automation of a High Throughput Residual Assay to Support In-Process Analysis of Monoclonal Antibodies'. 

    Daniel Schiwek on The value of Gyrolab xP workstation in HCP analysis and bioprocess
    Recorded Seminar: Daniel Schiwek, Project Evaluation Manager at Global Biological Operations, Lonza AG, Visp, Switzerland, presents ‘Biopharmaceutical manufacturing in microbial systems – Gyrolab as an analytical platform supporting process development'. 

    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. 

    Streamlined and automated immunoassays adapted for bioprocess workflows accelerate QbD strategy initiatives
    Recorded Webinar: Presenter Daniel Forsström, application scientist at Gyros Protein Technologies  

    Gyrolab CHO-HCP E3G Kit
    For detection of CHO Host Cell Proteins using the industry standard Cygnus CHO HCP 3G ELISA antibody. 
    [Product information sheet]

    Gyrolab E. coli HCP Kit
    For the detection of Host Cell Proteins from Escherichia coli expression systems 
    [Product information sheet]

    Gyrolab Bioaffy 1000 HC Assay Toolbox
    Please download the product information sheet Gyrolab Bioaffy 1000 HC Assay Toolbox 
    [Product information sheet]

    Host-Cell Protein Analysis to Support Downstream Process Development
    Sanofi scientists present the successful implementation of the Gyrolab immunoassay system as a reliable platform for high-throughput HCP analysis, in combination with a robotic liquid handling system. The results were comparable to their gold-standard ELISA method. 
    [Case Study]