Injection preparation of anti-CTLA-4 monoclonal antibody

Abstract

The invention relates to the field of biomedicine, in particular to an injection preparation of an anti-CTLA-4 monoclonal antibody. The injection preparation of the anti-CTLA-4 monoclonal antibody comprises a pharmacodynamic molecule and a buffer solution, wherein the pharmacodynamic molecule is an anti-CTLA-4 monoclonal antibody with the protein content of 2-50 mg / ml; the buffer solution comprises buffer salt, a protein protectant, an isoosmotic adjusting agent and a nonionic surfactant; and the pH value of the buffer solution is 6.5-7.5. A good storage environment is provided for the anti-CTLA-4 monoclonal antibody, the stability of the antibody drug structure can be ensured, the generation rate of antibody aggregates in the preparation can be effectively reduced, and the curative effectof biological drugs is ensured; and the pharmacodynamic molecule anti-CTLA-4 monoclonal antibody has strong affinity and good biological activity, can specifically bind to CTLA-4 antigen, enhances the reactivity of T cells to various antigens, and is further used for treating various cancer diseases.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to an injection preparation of anti-CTLA-4 monoclonal antibody. Background technique [0002] As we all know, melanoma is a relatively common tumor of the skin, mucous membrane and pigmented membrane in clinical practice. In the past 30 years, the incidence of melanoma has increased significantly, and the mortality rate has also continued to rise. According to the statistics of the World Health Organization (WHO), about 66,000 patients die from skin cancer every year, and 80% of them die from melanoma. At present, chemotherapy and immunotherapy are the main treatments for advanced melanoma. The effect of chemotherapy is usually not satisfactory, and non-specific immunotherapy can rarely produce sustained curative effect. [0003] Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) is a receptor on the surface of T lymphocytes and a co-stimulatory molecule that inhibits T cell...

AI Technical Summary

Problems solved by technology

[0004] In addition, like most protein molecules, anti-CTLA-4 monoclonal antibodies are unstable and will undergo various chemical and physical degradation. Compared with traditionally synthesized small molecule drugs, biomolecules have complex primary and secondary , tertiary and other high-level structures, and the high-level structure of proteins is very fragile, prone to structural changes, such as denaturation, aggregation and precipitation, these degradation products will have a great impact on the safety of biopharmaceuticals, especially some protein aggregates It will stimulate the body's immune response, in mild cases, it will reduce the efficacy of biological drugs, and in severe cases, it may even cause the death of the patient

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