Simplifying Biotherapeutic Manufacturing and Quality Control with Label-Free Biosensor Technology

Bio-Layer Interferometry (BLI) systems are used throughout biotherapeutic discovery, development, manufacturing and quality control (QC) workflows to simplify and streamline measurement of process and product attributes. They offer an excellent alternative to assays performed using time- and labor-intensive methods such as ELISA and HPLC. These label-free assays can be run fully automated, require much less user intervention, and provide a simplified workflow. Following an introduction to the principles of BLI, we highlight how the Octet BLI platform has been used in a wide range of analytical methods to assess binding kinetics, titer, impurities, aggregation, and activity for in-process testing, stability and lot release applications.

Topics to be covered

• Determining Binding Kinetics
• Determining Concentration and Titer
• Impurity Testing
• Developing Validation Assays
• Aggregation and Protein Stability Testing
• Antibody Fragment (Fab) Activity Assay
• Fc Receptor Binding Assays
• Influenza Vaccine Potency Assay
• Lot Release Testing

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