News|Articles|October 21, 2025
Applying Analytical Quality by Design Principles to Biopharma Method Development and Optimization
Author(s)Waters
Key Takeaways
Applying Analytical Quality by Design (AQbD) principles to impurity method development enables robust, science-based strategies for characterizing and controlling critical quality attributes in protein therapeutics. This webinar will present a case study on developing a fluorescence-based (FLR) method for quantifying Mannose-5 glycans, demonstrating how risk-based design and systematic evaluation of method parameters enhance reliability, reproducibility, and product understanding across the biopharmaceutical lifecycle.
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