Human Plasma Derived Drugs Separation by Fractionation of Plasma with Polyethylene Glycol

Human blood as a unique tissue (1), contains many important proteins with therapeutic uses (2). As a biological drugs, virus inactivation is one of the crucial steps in their preparations of these plasma derived proteins (3-6). The most important proteins in human plasma are: albumin, immunoglobulin, fibrinogen, and coagulation factors VII, VIII and IX (7). There are varieties of purification techniques for separation of these proteins (8-11). One of the methods is salting out (12, 13). There are not many salts which can be used in this method and most of the researchers use ammonium sulphate for precipitation of plasma protein (14, 15). But the problem is fractionation of plasma by ammonium sulphate needs to be repeated several times. The other compound which can be implemented for protein precipitation is the lactate of 2-ethoxy-6, 9-diamino-acridine (Rivanol) (16). After plasma fractionation by this substance, it has to be removed from the plasma, which sometimes its complete removal could be difficult. The other method for protein separation is ion exchange chromatography (17, 18). So far many commercially available gels have been produced for ion exchange chromatography for which scaling up for industrial scale is not so easy. The quality of plasma play an important role in the quality of final product of plasma fractionation (19). Ethanol fractionation of plasma is a very suitable method for the preparation of albumin, and immunoglobulin in large scale (20, 21). However, for separation of protein from human plasma by ethanol fractionation, different equipments are needed that to be installed in a plasma fractionation factory. In our study we used polyIran J Biotech. 2014 November;12(3): e1018 DOI:10.15171/ijb.1018