IVIg separation from human cryo-poor plasma by precipitation using polyethylene glycol and pH

Abstract

Introduction: Blood, the vital fluid of the human body, is mainly composed of plasma which is a source of highly valuable proteins essential for the body's survival. The separation of plasma proteins through the process of plasma fractionation has been ongoing since the 1950s and continues to progress and expand. Immunoglobulins are among the plasma proteins that play a crucial role in the body's immune system. The most abundant plasma immunoglobulin is Immunoglobulin G (IgG). Intravenous immunoglobulin (IVIg) is a therapeutic preparation of IgG derived from pooled plasma of thousands of donors, which is used in the treatment of autoimmune diseases and immune deficiency disorders. Aim: Cryo-poor plasma (CPP) is one of the separated blood products that contains high levels of albumin and immunoglobulins but is often unused and discarded. Therefore, developing practical methods for separating valuable protein components from this blood source is of great importance. The process of plasma purification is essential for ensuring the safety and efficacy of IVIg. Material and method: In line with this objective, this study investigates the separation of IVIg from human cryoprecipitate-poor plasma using a combined method of precipitation through pH changes and polyethylene glycol (PEG) 8 kilodaltons. For analyzing the protein precipitation pattern, SDS-PAGE and Native-PAGE methods with silver nitrate staining were employed. Results: According to the results of this study, using a pH of 4.6 for albumin precipitation yielded the best outcome, and subsequently, the use of 8 kilodalton PEG at a concentration of 10% weight/volume showed the highest efficacy in separating IVIg from cryoprecipitate-poor plasma.Conclusion: The result indicated that this method can be very effective in the purification of albumin and IgG if the pH conditions and PEG percentage are optimized.