Fully Traceable Absolute Protein Quantification of Somatropin That Allows Independent Comparison of Somatropin Standards

Abstract

An independent method that does not rely on a preexisting protein standard has been developed and validated for the traceable value-assignment of total somatropin. The methods reported here address the amount of substance (mass fraction) of the standard materials but address neither biological activity nor other characteristics that may be important in assessing suitability for use as a calibrator.