Rapid And Efficient Measurement Of Critical Quality Attributes And Parameters Using Octet® Bio-Layer Interferometry (BLI) Systems

Critical quality attributes (CQAs) refer to the chemical, physical, biological, or microbiological properties or characteristics that need to be maintained within specific limits, ranges, or distributions to ensure the quality of the final product. These key measurements include product-specific attributes like size, charge, and patterns in glycosylation, along with process-related impurities such as host cell proteins (HCPs) and residual Protein A from chromatographic purification.

Identifying CQAs early in drug discovery is critical, as they should align with the target product profile of the drug candidate and be continually refined throughout preclinical and clinical development. Conventional analytical methods used to analyze CQAs include enzyme-linked immunosorbent assays (ELISAs), high-performance liquid chromatography (HPLC), and UV spectroscopy. A promising alternative to assays performed utilizing these traditional, labor-intensive, and time-consuming techniques is the Octet® Bio-Layer Interferometry (BLI) platform. Its label-free assays are rapid and automated, and they necessitate minimal user input, simplify workflows, and support biotherapeutic discovery and development by streamlining CQA measurements. Gain insight into the use of this fluidic-free instrument approach for various CQA applications throughout the drug discovery and development process.