Vendor-Neutral MS Bioinformatics: Enhancing Polyclonal IgG Product Characterization with Byosphere

with Myriam Demant & Sawyen Ow

As a global biotech company developing innovative medicines, CSL must handle complex analytical challenges efficiently and effectively. A key driver is leveraging the global nature of our R&D mass spectrometry (MS) teams to seamlessly utilize the best methods and data from key laboratories. Here, we introduce the implementation of a vendor-neutral MS bioinformatics platform, Byosphere, that integrates advanced workflows and centralizes data from all our labs globally. Through the lens of our plasma product development teams, we explore the utilization of this integrated platform for characterizing polyclonal IgG products.

Due to the polyclonal nature of these molecules, MS structural characterization is confined to the Fc region of the IgG molecules. The Fc and Hinge regions are divided into four subclasses with known, albeit not entirely conserved, sequences. To assess key immunomodulatory functions, we developed a multi-attribute method (MAM) to characterize attributes within the Fc region, specifically afucosylation status, oxidation, deamidation, and lysine clipping. Additionally, we aimed to identify plasma-derived impurities to further characterize our product. For this purpose, we modified Byosphere host cell protein (HCP) workflow and template to enable reproducible and reliable analysis of impurities in our samples.

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