Injection preparation of anti-IL-17RA monoclonal antibody

Abstract

The invention relates to the field of biological medicines, and particularly provides an injection preparation of an anti-IL-17RA monoclonal antibody. The preparation comprises pharmacodynamic molecules and a buffer solution, the pharmacodynamic molecules are the anti-IL-17RA monoclonal antibody, and the buffer solution comprises a buffer salt, a protein protective agent, an osmotic pressure regulator and a surfactant, wherein the pH value of the buffer solution is 5.5-6.5. According to the invention, all components in the buffer solution interact with each other for synergistic cooperation, astorage environment suitable for long-term storage is provided for the anti-IL-17RA monoclonal antibody, the degradation, aggregation or precipitation of the antibody caused in the long-term storageor transportation process of the preparation can be avoided, the antibody can be stored in the environment for 36 months or more, the activity and the purity of the antibody can be kept stable in thestorage period, and the drug effect of the biological drug is guaranteed; the injection preparation can be used for various autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis, ankylosing spondylitis or scleroderma and the like.

Description

technical field [0001] The invention relates to the technical field of biomedical preparations, in particular to an injection preparation of anti-IL-17RA monoclonal antibody. Background technique [0002] Autoimmune diseases refer to diseases caused by the body's immune response to self-antigens, resulting in damage to its own tissues. Many diseases have been listed as autoimmune diseases, such as psoriasis, rheumatoid arthritis, ankylosing spondylitis, scleroderma, etc. Among them, psoriasis (Psoriasis), also known as psoriasis, is characterized by erythematous and scaly plaques of different sizes and clear borders on the skin, covered with a large number of dry silvery white scales, hence the name psoriasis. The histological features of psoriatic skin are excessive proliferation of epidermal keratinocytes, vascular proliferation, and infiltration of dendritic cells, macrophages, neutrophils, and T cells. The pathogenesis of psoriasis involves complex inflammatory response...

AI Technical Summary

Problems solved by technology

[0005] At present, many problems are often encountered in the process of research and development of anti-IL-17RA monoclonal antibodies. Monoclonal antibody products are usually used in high doses, about 200mg / time, but the volume of subcutaneous injection is limited, 1.0- 1.5ml is already a limit, which will indicate that the concentration of anti-IL-17RA monoclonal antibody will be as high as 100-150mg / ml. Therefore, the exploration of its preparation components and process is a great challenge. How to avoid injection preparations The degradation and increase of charge variants in the long-term storage process, how to avoid molecular aggregation with the prolongation of storage time under many unclear effects will lead to the generation of polymers and even the formation of precipitation, etc. The above-mentioned series of problems will affect The stability of anti-IL-17RA monoclonal antibody during long-term storage, therefore, the development of high-concentration anti-IL-17RA monoclonal antibody preparations with good stability is an urgent need to ensure its clinical stability and safety

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