2019 PharmSci 360
Critical Quality Attribute (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs are generally associated with the drug substance, excipients, intermediates (in-process materials), and drug product. Fully characterize the biologics and monitor the CQAs are important to guarantee the quality of the biotherapeutics. Different CQAs may require different analytical tools and methods for best sensitivity, selectivity and robustness. In this presentation, we will discuss the analytical suite Agilent offers to help researchers from sample preparation all the way to data reporting for biopharmaceutical characterization.