Upon confirmed specificity of the antibodies, the study samples are submitted to a neutralizing cell based assay to assess whether the binding antibodies alter the biological-drug product mechanism of action thereby blocking its effectiveness. The assay is designed such that cultured cells are used to assess whether the binding antibodies present neutralizing effects. These assays may be direct (acting directly on the cells resulting in a biological response) or indirect (acting through a ligand binding to a receptor at the cell surface) depending on the mechanism of action of the biological-drug product.

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