As a global biotech company developing innovative medicines, CSL must tackle complex analytical challenges efficiently. They leverage our R&D mass spectrometry (MS) teams worldwide to share optimal methods and data across labs. Here, they introduce Byosphere, a vendor-neutral MS bioinformatics platform, integrating advanced workflows and centralizing data globally. Focusing on plasma product development, they explore its use in characterizing polyclonal IgG products.

Due to the polyclonal nature of these molecules, MS structural characterization focuses on the Fc region of IgG molecules. The Fc and Hinge regions include four subclasses with known but variable sequences. To assess key immunomodulatory functions, they developed a multi-attribute method (MAM) for attributes within the Fc region, such as afucosylation status, oxidation, deamidation, and lysine clipping. Additionally, they adapted Byosphere’s host cell protein (HCP) workflow to ensure reproducible, reliable impurity analysis in their samples.