Allow Better Characterized Hits To Lead You to Better Therapeutics
Featured Product ADVERTISEMENT Oct 26, 2020
The desire to minimize costs for the production of biopharmaceutical drugs while maintaining high standards of quality and safety means that companies are constantly in search of technologies that can simplify the drug development workflow and reduce the time to results.
Bio-Layer Interferometry (BLI) shows the practicality and effectiveness of monitoring biomolecular interactions, as binding events are monitored directly in real-time and label-free. The use of this microfluidic-free technology has been rapidly increasing over the past decade. High detection sensitivity, a wide dynamic range, and streamlined workflows that reduce hours or even days from standard processes make the Octet system a compelling alternative to conventional methods such as analytical HPLC or ELISA.
Octet systems have become indispensable tools in drug discovery. The high-throughput capability and flexibility of the platform has helped accelerate almost every stage of the development workflow enabling informed decisions to be made earlier. BLI analyzes samples in complex biological samples such as serum, hybridoma supernatant or cell lysate, providing a detailed profile of antibody isotype, specificity and affinity.
The FDA has suggested that “quality attributes such as antigen specificity, affinity and on- and off-rates, avidity, potency, process-related impurities, stability, and half-life may affect pharmacology and should be studied.” Octet platforms provide broad applications to support these requirements. Molecular interaction information, like kinetic rate constants, affinity binding constants, and specific molecule quantitation are some of the main characterization information that can be monitored with BLI.
Octet platforms can be used for developing forced degradation and stability-indicating methods. They are suitable for measuring and distinguishing between fully-functional drug products and those whose binding activities have been affected by degradation. Ease of use, fast assay times and the platform flexibility enables rapid completion of assay development through design of experiments (DOE) essential in identifying and controlling critical quality attributes (CQAs) that ensure consistent and reliable quality of biopharmaceutical products. A comprehensive GxP package supports downstream applications in regulated QC environments that have stringent assay precision requirements.
Octet BLI platforms are helping accelerate hit characterization by providing scientists:
- High-precision ligand binding and potency assays
- Sample screening during cell line development
- Titer monitoring from bioreactors during production
- Determination of dynamic binding capacity of affinity resins on packed chromatographic columns and characterization of the purified product
- Detection and monitoring of potential process generated contaminants
- High-throughput glycan screening of crude and purified samples
From upstream processes such as cell line development to downstream processes like assessment of the dynamic binding capacity of purification columns and product contaminant testing, the Octet system provides an excellent option for any development workflow of biopharmaceutical drugs and their manufacturing process. The system is optimized for enhancing efficiency, reducing costs and time to results, all while maintaining quality criteria.