Advanced Analytical Techniques

The characterization of biologics and biosimilars demands a suite of advanced analytical methods that ensure molecular consistency, purity, and safety. This session highlights the latest developments in orthogonal and high-resolution techniques, including mass spectrometry, capillary electrophoresis, nuclear magnetic resonance (NMR), and chromatography. Experts will discuss how these tools are applied for structural analysis, impurity profiling, glycosylation mapping, and aggregation assessment across product lifecycles. Emphasis will be placed on comparability exercises, demonstrating biosimilarity at the molecular level, and how analytical data supports regulatory approval and batch-to-batch consistency. Attendees will also gain insights into method validation, quality control strategies, and the integration of automated, AI-powered analytics to streamline processes. This session is crucial for analytical scientists, quality assurance professionals, and regulatory personnel seeking to meet the increasing complexity of biologic and biosimilar characterization.

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