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November 01, 2012 (Vol. 32, No. 19)

Using MS to Assess Biotherapeutic Quality

Shotgun Mass Spectrometry Can Be Used to Improve Production QC

  • Quality-Assessment Software

    Genedata Expressionist for Mass Spectrometry enables scientists to implement an end-to-end data-analysis workflow from raw MS instrument readouts to auditable quality reports. With support for modern MS instruments from Thermo (LTQ Orbitrap®), Waters (Xevo® and Synapt®), and AB Sciex (QTRAP®), users can adapt data analysis to meet their specific reporting standards.

    Using Genedata, researchers can leverage capabilities such as:

    • Real-time monitoring: Real-time monitoring of results and live adjustments to processing rules enables users to quickly address quality issues identified using interactive data exploration and flexible analysis workflows.
    • Scalability: The number of biotherapeutics to be tested as well as the number of replicate measurements to be taken is rapidly increasing, and therefore the software must process, analyze, and visualize huge quantities of experimental results.
    • Instrument independence: Most MS laboratories operate multiple instruments from different vendors. The flexible workflow system enables users to setup processing rules addressing different instrument performance characteristics and provides a common interface to all MS instruments.
  • Case Study

    Click Image To Enlarge +
    Figure 2. Heat map comparing production batches to reference samples with very little change in peptide abundances.

    The following example illustrates the successful application of Genedata Expressionist for MS for the quality assessment of biotherapeutics production in a leading biopharmaceutical company.

    Production lot/batch samples are analyzed using a tryptic digestion followed by LC-MS and compared with the FDA-approved biotherapeutic batch. Before employing Genedata Expressionist, data analysis was done in spreadsheets, included multiple file conversion steps, and a variety of nonstandardized processing steps. This created a data-analysis bottleneck, which prevented the process to scale up and reach production-scale targets. In addition, the lack of technical replicates and inability to easily increase throughput resulted in many false positive calls, shipment delays, and significant loss of revenues.

    Genedata Expressionist for Mass Spectrometry was introduced to address these issues. It provides a workflow system supporting automation and repeatable data processing with a highly scalable architecture that enables real-time analysis of large experiments. Together with a customized data export, the built-in support for all major MS instrument vendors allowed the team to eliminate manual file conversions and implement an auditable end-to-end solution that supports in-house validation and regulatory filings (Figure 2).

  • Outlook

    Biotherapeutics will continue to play an increasingly important role in the treatment of a wide range of relevant diseases. This expansion is increasing the number of biotherapeutics companies and contract manufacturing organizations capitalizing on the advantages of an integrated MS data analysis platform for quality control. Comprehensive and automated software solutions such as Genedata Expressionist for Mass Spectrometry help to improve productivity and process scalability by enabling better experimental designs.

    Finally, with patents of the first group of biologics drugs about to expire, regulatory agencies are working on establishing policies governing the approval of biosimilars. While these policies are evolving, it is reasonable to assume that the MS methods described here are going to play in important role in future regulatory frameworks.

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