Bringing a biotherapeutic from the laboratory to the market is a complex and highly regulated process. The approval pathway requires thorough analytical characterization, including verification of structural complexity and heterogeneity, assessment of repeatability, evaluation of aggregation and stability, detection of impurities and contaminants, measurement of bioactivity and potency, and immunogenicity assessments.

Download this report to explore how MALS supports biotherapeutic characterization, biosimilar comparability, and regulatory approval with accurate analysis of molar mass, aggregation, and size variants.