Octet Potency Assay Development Qualification and Validation Strategies - Application Note

Introduction

Kinetic analysis of biomolecular interactions is critical during drug discovery and development.

The affinity of an interaction directly affects the dose required for a biopharmaceutical to be effective. Real-time data on affinity and the kinetics of binding can provide useful information at every stage of biopharmaceutical reagent development. Moreover, understanding the mechanism of binding can provide insights into the desirability of a drug candidate during development, including implications for the drug’s stability upon complex formation with its binding target.

Binding kinetics assays and specifically affinity constant (KD) analysis are increasingly being used for biological products lot release. Regulatory requirements necessitate that such products be QC tested using methods that are robust and have been appropriately developed, qualified and validated under GMP conditions.

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