Improved human serum albumin production process

Abstract

The invention relates to an improved human serum albumin production process, which comprises the following steps: plasma melting, detection, preparation of a component I, preparation of components II+ III, preparation of a component IV, preparation of a component V, refining of the component V, ultrafiltration, diluting, pasteurization inactivation, degerming and sub-packaging of protein and product incubation, wherein whether the corresponding steps meet the production requirements or not is judged according to precipitates obtained by filter pressing in the steps of preparation of the component I, preparation of the components II + III, preparation of the component IV and preparation of the component V. The components and the content of the protein in raw material plasma are detected firstly, and in the subsequent production, the weight of a filter pressing precipitate of each component is weighed to judge whether the component meets the purification requirement or not, so that thedetection procedures in the production are reduced, and the production efficiency is improved.

Description

technical field [0001] The invention relates to the separation and purification process of protein medicine in the field of biopharmaceuticals, more specifically, it relates to an improved production process of human 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 in liver cells at an extremely fast rate, and has the characteristics of relatively small molecules (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. In the...

AI Technical Summary

Problems solved by technology

In the existing production process, since the composition and content of plasma as raw material are relatively stable, the amount of low-temperature ethanol input in each process is also stable, and there is no need to make too many adjustments. According to the sequence of production processes, according to the The components of the protein can be divided into the following categories: Component I, Component II+III, Component IV and Component V. Each component contains impurity protein, so it needs to be gradually purified by low-temperature ethanol. The former component The purification effect will directly affect the treatment of the latter component, but in the prior art, it can only be determined whether the purification of the former component meets the production requirements of the latter component through multiple tests, and there are many testing procedures, so that affect production efficiency

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