Day One (13th May 2025)Tuesday, 13 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

Characterizing products and bioprocesses is critical for R&D and manufacturing of biologics, e.g., mAbs or viral vectors. Evolving product complexity and regulatory demands are dictating the use of advanced bioanalytics. This study outlines an MS-based Multiple Attribute Method (MAM) strategy for post-translational modifications (PTMs) assessment of mAbs and adeno-associated viruses (AAVs) and host cell protein (HCP) profiling. Bioprocess parameters impact on product attributes and process-related impurities was assessed.

MAM enabled the profiling of key PTMs like glycosylation, oxidation, and deamidation. Using DIA-SWATH we quantified targeted high-risk HCPs and other relevant ones. These results defined the best design space, maximizing product quality and purification performance of our polishing platform.
We applied a MAM workflow to several AAV serotypes achieving a MS/MS coverage >95% of capsid viral proteins. PTMs identified (oxidation, deamidation, phosphorylation) were aligned with literature reports. Ongoing HCP profiling aims to improve further bioprocess understanding.

High-sensitivity and high-resolution MS-based approaches, namely MAM, are emerging as leading tools for biologics R&D and QC. These analytical solutions are being applied to characterize established biotherapeutics, e.g., mAbs, but also hold promise for more complex biologics, like AAVs, currently a major focus in gene therapy clinical trials.