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High-throughput binding affinity measurement using BLI and Dip and Read assays. Accelerates kinetics analysis, quantification, and characterization.

**Application** ■ Kinetics Analysis: It is possible to measure not only affinity (binding affinity: KD) but also kinetics (association rate constant: Ka, dissociation rate constant: Kd). (Example: Screening and characterization of proteins, antibodies, nucleic acids, glycoproteins, peptides, small molecules, etc.) ■ Quantification: It is possible to quickly, easily, and at low running costs quantify protein concentrations. Complete automation of protocols significantly reduces manual tasks and achieves high-precision quantification. (Example: Screening of expression libraries, optimization of culture conditions, purification checks) ■ Characterization Analysis: Rapid examination of optimal parameters for selecting the best antibodies and constructing assay systems is possible. (Example: Epitope binning, antibody isotyping, screening of antibody pairs)

We support researchers worldwide in the study and development of treatments and vaccines for SARS-CoV-2 through the Octet platform.

**Application** ■ Insights into COVID-19 Binding Epitopes (Flyer) This showcases a case where the binding mechanism of the virus was elucidated using the Octet system. ■ Rapid and High-Precision Potency Assay for Influenza Vaccines (Application Note 20) The Octet platform measures the binding of vaccines/antigens to antibodies with high throughput, accuracy, and reproducibility, providing the process development group with a robust and user-friendly measurement method as an alternative to the SRID method.

By using tools compliant with GxP and simple operations, we enable productivity improvements in the analysis development and quality control of pharmaceuticals under regulatory environments.

■ Fc receptor binding assay (Application Note 17) The safety and efficacy of antibody drugs can be significantly influenced not only by the antigen but also by the binding characteristics to FcγR. We rapidly measure the binding affinity of antibodies to FcγR, which is considered essential in the biopharmaceutical development process, across a wide range of affinities. ■ Ligand binding potency assay (Application Note 26) The ligand binding potency assay requires high reproducibility and precision in technology. Octet meets the stability required for lot release testing and is adopted as a method for evaluating the potency of drug candidates due to its user-friendliness and rapid measurement. ■ Potency measurement (Application Note 12) The measurement of potency and protein concentration is a critical process in the development of biopharmaceuticals. Common methods such as ELISA and HPLC are used, but Octet can be applied in both upstream and downstream processes, providing a more robust method for cell culture and media.

We accelerate the entire process from development to manufacturing of biopharmaceuticals, including cell line development, determination of dynamic binding capacity, potency assays, and impurity confirmation tests.

■Quantification of Affinity and Proteins The Octet system serves as an alternative method to ELISA and HPLC for the quantification of antibodies and therapeutic recombinant proteins, thanks to its high throughput, accuracy, speed, and ease of use, facilitating the transition to development, QC, and manufacturing. ■Impurity Confirmation Test - Residual Protein A (RPA) Detection The Residual Protein A Detection Kit applies the principles of BLI to enable high-sensitivity and accurate quantification of residual Protein A in bioprocess samples while maintaining a simple workflow. ■Impurity Confirmation Test – Host Cell Protein (HCP) Detection (Technical Note 41) Developed in collaboration with Cygnus Technologies, the Anti-CHO HCP Detection Kit uses BLI technology to detect host cell proteins that pose a risk of reducing the efficacy of biopharmaceuticals and vaccines. By combining the high throughput of the Octet system with the industry-standard Cygnus 3G anti-CHO HCP antibody, HCP assays can be performed with high sensitivity, high precision, and in a short time.

Label-free assay with just a single drop of sample. Enables simple and rapid kinetics analysis, protein quantification and detection, and assay development.

**Application** ■ Kinetics Analysis: It is possible to measure not only affinity (binding affinity: KD) but also kinetics (association rate constant: Ka, dissociation rate constant: Kd). (Example: Interaction analysis of proteins, antibodies, nucleic acids, etc.) ■ Protein Quantification: Quantification of specific protein concentrations in solutions with many contaminants, which is difficult with absorbance measurements, is possible. (Example: Protein expression monitoring, bioprocess development) ■ Protein Detection: Detection of the presence of active proteins and specific proteins in unpurified samples from just a single drop of sample is possible. (Example: Detection of specific proteins in column fractions, relative ranking of protein expression) ■ Assay Development: Rapid examination of optimal parameters for selecting the best antibodies and constructing assay systems is possible. (Example: Optimization of binding pairs, immunoassay development) *For more details, please refer to the PDF materials or feel free to contact us.*