Evaluation of Rapid Quantitation Methods for Titer, HCP and ProA By Gyrolab Platform During In-Process Development

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Evaluation of Rapid Quantitation Methods for Titer, HCP and ProA By Gyrolab Platform During In-Process DevelopmentGetting biopharmaceuticals through development and into clinical proof-of-concept fast and efficiently is critical for success in our industry. Therefore, high-throughput upstream and downstream process development approaches are increasingly being implemented. Hence, innovative and high-throughput analytical technologies are needed to support rapid process development. A novel automated analytical platform-Gyrolab xP workstation was investigated for the analysis of IgG titer, Host Cell Protein (HCP) and leached ProA during in-process development. The assays are automated within a Gyrolab compact disc (CD) containing affinity-capture columns of streptavidin-coated beads for analysis. Sample and reagent transfer to the columns in each microstructures are achieved by spinning the CD and are processed in parallel. Quantification is achieved by the integration of the fluorescent signal. We have evaluated the capability of Gyrolab in linearity, precision, accuracy, and range, in comparison with the ProA-HPLC method (for titer) and ELISA (for HCP and ProA), respectively.

In summary:

  • Sample and reagent consumption was significantly reduced by a factor of 10 – 25
  • Gyrolab assays significantly improves turnaround time compared with ELISA or HPLC methods
  • Gyrolab provides higher throughput, however some variation to ELISA results could result in poor correlation to the final process
  • The ProA assay was not applicable to all evaluated Ab products

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