Monitoring Product Attributes in Biopharmaceutical Development and QC with LC-HRMS

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Scott J. Berger, Liuxi Chen, Henry Shion, Min Du, Ying Qing Yu
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LC-MS peptide mapping data acquisition workflows that are used for biotherapeutic characterization can be reapplied to the later development challenge of monitoring product attributes, and then again for QC/lot release. However, the informatics workflows associated with processing peptide mapping data will necessarily evolve between the characterization exercise and the execution of the more targeted monitoring assay. In this work, we detail the generation of peptide mapping characterization data to define product features and attributes, the process of building a library of key attributes targeted for product monitoring studies, and the execution of a targeted monitoring study across multiple batches of an innovator and candidate biosimilar monoclonal antibody.