Critical quality attributes (CQAs) are essential measurements that include product-specific attributes such as size, charge, and glycosylation patterns as well as process-related impurities including host cell proteins (HCPs) and residual Protein A from chromatographic purification. CQAs must be identified early in the discovery process, reflect the target product profile of the drug candidate, and continue to be refined through preclinical and clinical development phases.
The Octet® Bio-Layer Interferometry (BLI) platform offers an excellent alternative to assays using traditional time- and labor-intensive methods to measure CQAs. Label-free assays are fast, fully automated, require only limited user intervention, provide a simplified workflow, and are used throughout biotherapeutic discovery and development to simplify and streamline the measurement of CQAs.
This compendium summarises the use of this fluidic-free instrument approach for a variety of CQA applications across the drug discovery and development workflow.
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