Impurity Testing

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

Correlation of results for samples throughout the purification of a therapeutic protein are shown. The error bars indicate that the results from Gyrolab xP workstation are less variable. 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 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.