Minimize Cost and Maintain Quality in Drug Discovery
Drug development is expensive, long, and associated with a high attrition rate. Adding to the complexity is the long list of quality attributes required by regulatory authorities. The desire to minimize costs to produce 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, the regulatory review process and reduce the time to result.
Octet® Bio-Layer Interferometry (BLI) from Sartorius 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 approach offers several advantages over traditional label-free techniques like Surface Plasmon Resonance (SPR) and 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 Octet® BLI a compelling alternative to conventional methods such as analytical HPLC or ELISA.
The Octet® BLI platform has become an indispensable tool 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.” The Octet® BLI platform provides 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 this label-free technique.
Octet® systems can be used for developing forced degradation and stability-indicating methods. They are also 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 (CQA) that ensure consistent and reliable quality of biopharmaceutical products. A comprehensive GxP package supports downstream applications and regulated QC environments that have stringent assay precision requirements.
Octet® BLI instruments 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 glycosylation profiling of crude and purified samples
Improvements in predicting the potential success or failure of a product in clinical trials is essential to aid in reducing the spiralling development costs. 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, Octet® systems provide 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 result, all while maintaining quality criteria.
Moreover, Sartorius is a leading international provider to the biopharmaceutical and research sectors, ensuring reliability in supply chain and global service. Our responsive and customized application support will ensure your drug discovery project becomes a success. So, more people will have access to better medicine.
