Fermentation post-treatment process for recombinant human interferon alpha2b

Abstract

The invention discloses a fermentation post-treatment process for recombinant human interferon alpha2b. The recombinant human interferon alpha2b is extracted from an engineering bacterium expressing the human interferon alpha2b. The process comprises the following steps of: 1) removing strains from yeast fermentation broth; 2) concentrating target protein in fermented supernatant fluid and replacing buffer solution; 3) primarily purifying a hydrophobic layer; and 4) purifying by using size-exclusion chromatography. The process reduces equipment cost, production cost, energy consumption and environmental pollution, improves clinical safety of the product. The process is stable and simple, is suitable for large-scale production, has the safe and controllable production process and high production efficiency, remarkably reduces the energy consumption without environmental pollution, and has remarkable economic benefit. The quality of produced products meets the standard of Chinese Pharmacopeia (2010).

Description

technical field [0001] The invention relates to a post-fermentation treatment process of recombinant human interferon alpha 2b. Background technique [0002] Interferon (IFN) is a broad-spectrum antiviral agent, which does not directly kill or inhibit the virus, but mainly through the action of cell surface receptors to make cells produce antiviral proteins, thereby inhibiting the replication of hepatitis B virus; at the same time, it can also enhance the natural The activity of killer cells (NK cells), macrophages and T lymphocytes plays an immune regulatory role and enhances antiviral ability. Interferon is a group of active proteins (mainly glycoproteins) with multiple functions and a cytokine produced by monocytes and lymphocytes. They have broad-spectrum anti-virus, affect cell growth, differentiation, regulation of immune function and other biological activities on the same kind of cells. According to different production methods, interferon can be divided into two c...

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Problems solved by technology

[0004] In the late 1970s, with the emergence and development of genetic engineering technology, human interferon α can be produced through genetic recombination. However, the production and purification of recombinant human interferon α are mostly used in affinity antibody columns or liquid phases. Column, purification cost is high, and the production process is difficult to be scaled up industrially and other disadvantages; such as U.S. Patents US5710027, US5661009U, US4765903, US5196323, and Chinese patents CN100390198C, CN1876811A, etc.

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