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).