Critical Quality Attributes Application Compendium
The complex heterogenous nature of biotherapeutics requires accurate and robust analytical testing methodologies with dependable chromatographic separations. Identifying critical quality attributes (CQA) is the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals. In this compendium, we have selected applications to illustrate the state of-the-art chromatographic separation for each CQA using either HPLC-UV or light scattering detectors.
► Titer Determination ► Glycan Analysis
► Intact and Subunit Purity ► Aggregate and Fragment Analysis
►Peptide Mapping ► Charge Variant Analysis
►Amino Acid and Cell Culture Analysis ► Best Practices