Design and development of biological assays that conform to USP <1032> requires parameters for accuracy, precision, linearity and limit of quantitation (LOQ) to be established. This document is intended as a general guideline for developing product-specific ligand binding quantitation assays on Octet® R series instruments.
Careful design, development and qualification of biological assays allows the user to subsequently evaluate CQA in factors such as a change in production process, reference material or critical reagents. Therefore, the time, effort and resources used in developing a USP <1032> compliant assay can yield many benefits in its future use.
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