Biologics GxP Applications

Fc Receptor Binding Assays
The safety and efficacy of a therapeutic monoclonal antibody can be greatly impacted by its binding to both the target and to the FcγR. Antibodies are often engineered to achieve desired properties, including binding to FcγRs. 
 
Octet^® BLI systems offer a high throughput and sensitive solution for Fc receptor binding analysis, with a variety of assay-ready biosensor surfaces available for rapid and flexible assay development.

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Reproducible and accurate relative ligand binding potency methods can be used to assess lot-to-lot variability by monitoring either the drug binding response or the kinetics of binding including affinity constants. An ideal method must be stability-indicating as well.
 
The Octet^® BLI platform is increasingly used for assessing the potency of drug candidates. Octet^® BLI systems: 

• Readily accommodate the use of Design of Experiment (DOE) to rapidly develop robust potency measurement methods
• Provide relative affinity constant or response signals for potency measurements and comparability studies

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The active protein concentration can be used to determine the potency of the drug molecule. Octet^® instruments can be used to develop methods that measure active protein levels. Traditional protein concentration determination techniques like HPLC are being supplanted by more robust Octet^® BLI assays in both upstream and downstream bioprocesses. These assays enable: 

• Measurement directly from crude and unpurified samples, like cell culture media 
• Obtain IgG titer for a full microplate of 96 samples of in as little as two minutes 
• Walk away with automation capable with Octet^® RH96 and RH16 systems

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