PH1001: The Role of Multi-Angle Light Scattering in Biosimilar Characterization and Approval

This collection of publications highlights studies where the DAWN^™ MALS instrument was used as part of an analytical panel for biotherapeutic approval and biosimilar comparability studies. The first case involves a company seeking re-approval after transitioning to a higher-yielding cell line. The second focuses on demon-strating biosimilarity between a developed biosimilar and reference products released in the U.S. and EU markets. The final study compares two approved biosimilars and the reference product, exploring their stability profile through forced degradation.