Mitigate 3rd Party Delays with All Biophysical and Mass Spectrometry Analysis In-House

Extended characterization for biologics encompasses a comprehensive, orthogonal analytical strategy to define critical quality attributes beyond standard release tests. It integrates high-resolution mass spectrometry, peptide mapping, and glycan profiling; assessments of higher-order structure via CD, Microfluidic Modulation Spectroscopy, and native MS; and biophysical analyses such as SEC-MALS, and DSC to quantify size variants, aggregation, and stability. Our in-house capabilities encompass impurity profiling for process- and product-related variants. Forced degradation and stability studies support comparability, lifecycle control, and biosimilar development under ICH Q6B/Q5E frameworks and QbD principles. This extended toolkit de-risks process development, ensures lot-to-lot consistency, and accelerates development by linking molecular attributes to safety, efficacy, and manufacturability. Download the poster to learn more.