Liquid preparation containing anti-human CD117 monoclonal antibody and application thereof

By adding amino acid protectors and surfactants to the anti-human CD117 monoclonal antibody injection, the problem of increasing viscosity caused by high concentration was solved, and a low viscosity liquid preparation suitable for subcutaneous injection was prepared.

CN119424630APending Publication Date: 2025-02-14QYUNS THERAPEUTICS CO LTD
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Patent Information

Application Number
CN202410074975.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-01-17
Publication Date
2025-02-14

AI Technical Summary

Technical Problem

The high concentration of existing anti-human CD117 monoclonal antibody injections leads to an increase in viscosity, making it difficult to manually push the syringe push rod to inject the drug into the skin.

Method used

Low viscosity liquid preparations are prepared by adding amino acid protecting agents and surfactants to the liquid preparations, combined with high concentrations of anti-human CD117 monoclonal antibodies.

Benefits of technology

It is achieved while maintaining the low viscosity of the liquid preparation while maintaining the high concentration of anti-human CD117 monoclonal antibody, making it suitable for subcutaneous injection, ensuring that the drug can be injected smoothly.

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Abstract

The invention discloses a low-viscosity liquid preparation of an anti-human CD117 monoclonal antibody. The low-viscosity liquid preparation is suitable for being used as an injection, particularly a hypodermic injection. The liquid preparation comprises more than 120 mg / mL of the anti-human CD117 monoclonal antibody, 10-500 mM of the amino acid protective agent and 20 mM of the buffer salt, and by means of the liquid preparation, the subcutaneous injection administration concentration of the anti-human CD117 monoclonal antibody at least can reach 120-160 mg / mL.
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