Process for preparing human serum albumin

Abstract

The invention discloses a process for preparing human serum albumin. According to the process, a low-temperature ethanol separation method is adopted, and the human serum albumin is prepared from human plasma. The process comprises the steps of dissolving plasma; preparing an ingredient I; preparing an ingredient II and an ingredient III; preparing an ingredient IV; preparing an ingredient V; refining the ingredient V; carrying out ultrafiltration; diluting; carrying out pasteurization; sterilizing and packaging albumen; incubating products; and packaging finished products. The process has the advantages that solid-liquid separation is carried out by adopting a pressure filtration technology, so that the albumin yield which is higher than 29 g / L plasma is increased remarkably, the purity is higher than 98%, and the stability of the products is improved remarkably; Zetaplus deep filter-core filtration is combined with the prolongation of pasteurization time, so that the PKA (Protein Kinase A) level of the products is effectively controlled to be lower than 20IU / ml, and the risks of excessive heat source and virus infection in the products are reduced; and during the process, sodium chloride solutions of two gradient concentrations are used for carrying out ultrafiltration, so that not only can the ethanol residual quantity of the products be controlled to be lower than 0.025%, but also the aluminum residual quantity can be effectively minimized to be lower than 50 micrograms / L.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and relates to a process for separating and purifying protein drugs, in particular to a process for preparing human serum albumin. Background technique [0002] Human albumin is the main product of blood preparations and the final product of the backbone of the plasma protein production process. Albumin is synthesized very quickly in liver cells, and has the characteristics of relatively small molecule (molecular weight 66250), relatively large surface area, relatively symmetrical molecular configuration, simple structure, firmness, and high toughness. Albumin plays an important role in hemorrhagic shock, severe burns, cerebral edema, and hyperemia in liver and kidney diseases. Since Cohn et al. founded the low-temperature ethanol human plasma protein separation technology in the 1940s, the industrialized production of plasma proteins has made great progress. [0003] At present, mos...