Stable anti-IgE humanized single anti-agent

Abstract

The invention discloses a stable anti-Ige humanized monoclonal-antibody preparation, which is prepared by anti-Ige humanized monoclonal-antibody protective-agent, buffer, surfactant and isoosmotic adjustment. The preparation disclosed by the invention has the advantages of stability and convenient usage.

Description

technical field [0001] The invention belongs to the field of biotechnology, and more specifically, the invention discloses a biological preparation. Background technique [0002] Asthma is a common disease, with total direct and indirect costs of all types of asthma treatment totaling $14 billion in the United States alone. And according to the US Centers for Disease Control (CDC) and the National Center for the Prevention of Health Statistics (PNCHS), asthma causes at least 2 million emergency room visits and more than 5,000 deaths each year. [0003] IgE is the main cause of asthma allergic symptoms, anti-IgE humanized monoclonal antibody is the first humanized therapeutic antibody (Xolair) for the treatment of asthma, and the first approved treatment designed for IgE antibody method, it can be applied to adult and adolescent patients with moderate to severe persistent asthma, for subcutaneous use, it is suitable for adult and adolescent patients (12 years old or above) w...

AI Technical Summary

Problems solved by technology

[0004] The current preparation of anti-IgE humanized monoclonal antibody is made of anti-IgE humanized monoclonal antibody as the main drug, with sucrose, L-histidine, L-histidine hydrochloride and Tween-20 as auxiliary materials Freeze-dried preparation, the stability of this preparation is not high and the viscosity of the liquid after dissolution is high, it is inconvenient to inject and use, and many patients express a strong sense of pain during use

Relatively inconvenient for both storage and clinical use