Preparation method for protein fixed-point pegylation modification

A technology of PEGylation and polyethylene glycol, applied in the field of protein modification, to achieve high modification yield, simple termination process, and good stability
CN112110982AActive Publication Date: 2020-12-22科兴生物制药股份有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
科兴生物制药股份有限公司
Publication Date
2020-12-22

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Abstract

The invention relates to the technical field of protein modification, and particularly relates to a preparation method for protein fixed-point pegylation modification. The preparation method for protein fixed-point pegylation modification comprises the step that in the presence of vitamins and / or coenzymes, 5 kD-40kD polyethylene glycol derivatives with the mass 3-7 times that of protein react with the protein. According to the preparation method, a new modification method is adopted for conducting pegylation modification of rhG-CSF, the reaction condition is mild, NADP <+> is generated afterthe reaction, and no harmful substance is generated; meanwhile, the preparation method is high in polyethylene glycol modification yield, the yield reaches 80% or above, the uniformity is high, the modification site is the first amino acid methionine Met at the N terminal of the protein rhG-CSF, and the stability is good; in addition, the modification reaction can be terminated by directly adjusting the acid, the termination process is simple, and the commercialized production cost is greatly reduced.
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Description

technical field

[0001] The present invention relates to the technical field of protein modification, in particular to a preparation method for protein site-directed pegylation modification. Background technique

[0002] With the rapid development of biotechnology, more and more recombinant protein drugs have been successfully applied to the treatment of human diseases. Recombinant human granulocyte colony stimulating factor (rhG-CSF) is a very successful genetic engineering drug. Human granulocyte colony stimulating factor (G-CSF) is produced by monocytes and fibroblasts, can stimulate the formation of granulocyte colonies, has a stimulating effect on neutrophils, and is often used in cancers receiving radiotherapy / chemotherapy Adjuvant therapy for patients and leukemia patients after bone marrow transplantation, Amgen was approved by the FDA in 1991, but due to the short half-life of rhG-CSF in vivo and the tendency to produce immunogenic reactions, its clinical use has be...

Claims

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