Injection preparation of anti-IL-17RA monoclonal antibody

A technology for monoclonal antibodies and injection preparations, which can be applied in the direction of antibodies, anti-inflammatory agents, and medical preparations with non-active ingredients, which can solve the problems of limited dosing volume and impact.

Active Publication Date: 2020-10-30
BEIJING DONGFANG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 degradat...

Method used

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  • Injection preparation of anti-IL-17RA monoclonal antibody
  • Injection preparation of anti-IL-17RA monoclonal antibody
  • Injection preparation of anti-IL-17RA monoclonal antibody

Examples

Experimental program
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Effect test

Embodiment 1-15

[0050] Examples 1-15 of the present invention all provide an injection preparation of an anti-IL-17RA monoclonal antibody, the preparation includes a pharmacodynamic molecule and a buffer solution, and the pharmacodynamic molecule is an anti-IL-17RA monoclonal antibody with a protein content of 120 mg / ml , wherein, in the preparation provided by the present invention, the anti-IL-17RA monoclonal antibody is screened from a fully synthesized phage library using phage library display technology, and the phage antibody library display technology is a kind of coding exogenous antibody firstly established by Smith. The gene of the source protein or polypeptide is inserted into the phage coat protein gene, and the foreign protein or polypeptide is fused with the phage coat protein and expressed on the surface of the phage. The phage antibody library uses the above principles to express antibodies with different specificities or their functional fragments (Fab, Fv, ScFv) on the surfac...

Embodiment 16-19

[0104] Embodiments 16-19 of the present invention respectively provide an injection preparation of an anti-IL-17RA monoclonal antibody, the preparation includes a pharmacodynamic molecule and a buffer solution, and the pharmacodynamic molecule is an anti-IL-17RA monoclonal antibody with a protein content of 100 mg / ml , the amino acid sequence of the anti-IL-17RA monoclonal antibody is the same as in Examples 1-15.

[0105] The monoclonal antibody also includes a heavy chain constant region and a light chain constant region. The heavy chain constant region is one of human IgG1, IgG2, IgG3, and IgG4, and the light chain constant region is human CK.

[0106] Preferably, the heavy chain constant region is human IgG1. The components and contents of the buffer solutions in the injection preparations provided in Examples 16-19 are shown in Table 2.

[0107] Each component content table in the buffer solution in table 2 embodiment 16-19

[0108]

[0109]

Embodiment 20-22

[0111] Embodiments 20-22 of the present invention respectively provide an injection preparation of an anti-IL-17RA monoclonal antibody, the preparation includes a pharmacodynamic molecule and a buffer solution, and the pharmacodynamic molecule is an anti-IL-17RA monoclonal antibody with a protein content of 150 mg / ml , the amino acid sequence of the anti-IL-17RA monoclonal antibody is the same as in Examples 1-15.

[0112] The monoclonal antibody also includes a heavy chain constant region and a light chain constant region. The heavy chain constant region is one of human IgG1, IgG2, IgG3, and IgG4, and the light chain constant region is human CK.

[0113] The components and contents of the buffer solutions in the injection preparations provided in Examples 20-22 are shown in Table 3.

[0114] Each component content table in the buffer solution in the embodiment 20-22 of table 3

[0115]

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/12A61K47/02A61K47/18A61K47/26A61K47/10A61K39/395A61P37/02A61P17/06A61P29/00A61P19/02A61P19/08A61P17/00
CPCA61K9/0019A61K47/02A61K47/10A61K47/12A61K47/18A61K47/183A61K47/22A61K47/26A61K2039/505A61P37/02C07K16/244
Inventor 白义张利萍田睿
Owner BEIJING DONGFANG BIOTECH
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