Measurement of Critical Quality Attributes Using Octet® BLI Systems
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:
Accurate measurement of affinity maturation of polyclonal serum antibody responses to particulate antigens such as virions is challenging. Tsuji, et al, used the Octet® platform to assess the avidity of dengue virus-specific antibodies elicited in response to a tetravalent dengue vaccine. After validation of the assay using anti-dengue monoclonal antibodies, the assay was used to assess avidity of antibody responses to a tetravalent dengue vaccine candidate in phase 2 clinical trials conducted in dengue-endemic regions.
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