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Octet Kinetics Assay Method Development Guideline

1. Purpose

1.1 The purpose of this document is to describe the procedure for developing a ligand binding kinetics assay on Octet® QKe, RED96, RED96e, RED384 and HTX instruments. The procedures described are for developing binding kinetics assays for release testing of product batches and related applications. The document is intended as a general guideline only. Actual method development procedures may be different as they may be product dependent.

1.2 The procedures are aimed at developing kinetics binding assays to establish specificity, accuracy, precision, linearity and range as stipulated by the USP 1032 requirements for ligand binding assays.

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