Method for preparing high-purity rhNGF

A high-purity, cell culture technology, applied in the preparation methods of peptides, chemical instruments and methods, growth factors/inducing factors, etc., can solve the problems of high equipment requirements, unfavorable large-scale industrial amplification, and unfavorable large-scale industrial production, etc. achieve the effect of improving efficiency
CN108239146AInactive Publication Date: 2018-07-03XINTRUM PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
XINTRUM PHARMA
Publication Date
2018-07-03
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides a method for preparing high purity rhNGF from CHO cell culture, which combines cation- exchange chromatography and hydrophobic interaction chromatography. The method is characterized in that a cleaning step is added before chromatography by the two methods. Experiments prove that by the purification method, rhNGF precursor molecular variants can be removed, the content of N-terminal truncated and abnormal variants in purified products can be greatly reduced. The product has high purity and can meet the requirement of clinical application.
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Description

Technical field:

[0001] The invention relates to a preparation method of high-purity rhNGF, in particular to a method for obtaining high-purity rhNGF from CHO cell culture. Background technique:

[0002] RhNGF expressed by genetic engineering and produced in host cells usually contains a variety of impurities, including host cell proteins, nucleic acids, and variants of the expression product rhNGF, such as precursors, N-terminal truncations, and abnormalities; Impurities of various organic and inorganic components such as endotoxins, viral contaminants, and cell culture media components will be present. Among them, N-terminal truncation and abnormal variants and precursors are the most critical impurities that affect the quality of recombinant human nerve growth factor and must be removed.

[0003] The physical and chemical properties of these impurities vary, and the most effective removal methods also vary.

[0004] Currently, reports on the purification of rhNGF includ...

Claims

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