Critical quality attributes (CQAs) are defined as a physical, chemical, biological, or microbiological property or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality. These essential measurements include product-specific attributes such as size, charge, and glycosylation patterns as well as process-related impurities including host cell proteins 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. Traditional analytical techniques used to measure CQAs include UV spectroscopy, ELISA, and HPLC.
The Octet® BLI platform offers an excellent alternative to assays performed using these traditional time- and labor-intensive methods. 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 measurement of CQAs.
This compendium summarizes the use this fluidic-free instrument approach for a variety of CQA applications across the drug discovery and development workflow:
- Elucidate the mechanisms of action of different therapeutic modalities
- Rapid selection of optimal clones
- Streamline post translational modification assessment
- Simplify EC50 and IC50 studies
- Accurate method for the detection of contaminants
- Rapid detection of pre-aggregate/aggregate formation in protein solutions