Application of 2-D DIGE to survey the quality of biological medicines

Abstract

2-D DIGE was used to investigate 'fingerprint proteins' in biological medicines. A presumably non-originator human albumin was analysed, and the 2-D DIGE patterns of the non-genuine and the authentic product were compared. The products could be clearly distinguished based on the pattern of minor components, which represent plasma proteins and degradation products remaining in the final products after fractionation and purification. The approach demonstrated that 2-D DIGE is an excellent tool for the analysis of biologicals of different sources and for ensuring the identity and quality of blood products.