ABSTRACT
High-performance liquid chromatography (HPLC) is an important tool for the characterization and quality control of recombinant DNA-derived proteins in the biotechnology industry. Both reversed-phase HPLC (RPC) of the protein and HPLC peptide mapping of enzymatic digests by RPC have been used to confirm the identity of protein products and monitor for contaminants. RPC is a highly selective chromatographic method that can be used to establish the identity and purity of proteins. The retention of proteins is related to the hydrophobic contact area upon binding to the non-polar chromatographic surface. A RPC method using a trifluoroacetic acid (TFA) and acetonitrile solvent system was developed to monitor growth hormone product quality, combining both isocratic and gradient elution parameters within a single run. Recombinant DNA-derived human growth hormone and pituitary-derived human growth hormone have the same chemical structure, and exhibit identical RPC chromatographic behavior.
