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Enterprise Software Platform Providing Flexible Solutions for the Multi-Attribute Method (MAM): Robust and Accurate CQA Monitoring

November 5, 2021

This presentation focuses on an end-to-end data processing workflow that bridges the characterization and quality monitoring phases of MAM approaches to deliver fast, robust, and accurate critical quality attribute (CQA) monitoring while providing a simple and intuitive software platform ideally suited for manufacturing environments.

In the characterization phase, raw LC-MS/MS data from a tryptic digest of the target molecule was loaded into a dedicated peptide mapping data processing workflow. The results were reviewed and used to generate an extracted ion chromatogram (XIC) library that contains information—such as expected retention time and charge and isotope signals—that was used to create and verify extracted-ion chromatogram data in the subsequent monitoring phase. In the monitoring phase, XICs were extracted from raw LC-MS data and peaks corresponding to the CQAs targeted in the XIC library were identified and quantified. All data processing was performed using the Genedata Expressionist® enterprise software platform (Genedata AG, Basel, Switzerland).

The presented method offers several advantages: i) fast processing of raw data based on targeted signals; ii) facilitated operation by non-expert users or even full automation; and iii) standardized analyses and elimination of any potential effects of operator bias.


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