Octet application "Potency Measurement and Impurity Confirmation Test"

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.

To minimize the manufacturing costs of biopharmaceuticals while maintaining high standards of quality and safety, technologies are being pursued to streamline the drug development workflow and reduce time. Analytical techniques that enhance efficiency while maintaining quality are essential in the development of biopharmaceuticals, from upstream processes such as cell line development to downstream processes including the determination of dynamic binding capacity of purification columns, impurity confirmation tests, and potency assays. The Octet system for analyzing biomolecular interactions meets the required demands with high sensitivity, high precision, and rapid measurement. ■ Screening of samples during cell line development ■ Monitoring through titer measurement in bioreactors ■ Determination of dynamic binding capacity of chromatography columns and characterization of purified products ■ Rapid and highly accurate detection of impurities such as host cell proteins and residual Protein A *For more details, please refer to the PDF document or feel free to contact us.

basic information

■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.