Alexander Julian Veach1, Aude Tartiere2, Maurizio Bronzetti2, Da Ren1
1Amgen Inc., Thousand Oaks, CA, United States, 2Genedata, Inc., San Francisco, California, United States
I recently presented this work entitled “A single software platform providing automated MS data processing for end-to-end MAM lifecycle management” at the California Separation Science Society Mass Spectrometry Conference in Chicago, Illinois. Please find the abstract below.
Physiochemical characterization of therapeutic proteins is crucial for product quality control in the biopharmaceutical industry. Robust software that adheres to QbD principles is needed to rapidly identify and quantify multi-attribute method (MAM) LC/MS-based spectra.
Genedata Expressionist provides a single software platform for end-to-end MAM lifecycle management that enables method transfer from early stage molecule assessment to in-process analytics and offers plugins developed for use in GMP release and QC testing environments. The flexibility of the platform enables novel processes to test system suitability, detect new and missing peaks, and overcome limitations in the number of monitored attributes.
Using Genedata Expressionist, we optimized data processing for post-translational modifications (PTMs) including oxidation, deamidation, glycosylation, and clips. We developed methods for calculating relative abundances of PTMs that improved data accuracy by including more peaks, charge states, ion adducts, and peptides with non-specific cleavage. The automated attribute identification and quantification process saved time by avoiding the need for laborious manual integration. Additional time-savings were provided by running Genedata Expressionist on a dedicated server, thereby significantly reducing analysis time for large data sets.