One of the major challenges to developing successful biopharmaceutical products is understanding and characterizing potential impurities. Finding the source and magnitude of these impurities allows us to minimize and remove them during the manufacturing process to create a safe and effective drug. Development also needs to include supporting stability and forced-degradation studies to ensure long-term safety and efficacy.
Some impurities, such as protein degradants, host cell proteins, and various small molecules and polymers, require detailed MS-based characterization. This webinar discusses approaches implemented to characterize impurities by mass spectrometry.
Key topics presented include:
- High resolution accurate-mass (HRMS) analysis using QTOF and Orbitrap platforms
- Application of MS/MS and isotope ratios to support structural assignments
- Supporting strategies, including forced degradation and purification/enrichment approaches
Andrew Hanneman, PhD
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