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A kind of stable anti-tnf alpha antibody preparation and its application

A liquid preparation and preparation technology, applied in the field of anti-TNF-α antibody preparations, can solve problems such as easy chemical changes, increase in charge isomers, and impact on product quality consistency

Active Publication Date: 2018-01-02
INNOVENT BIOLOGICS (SUZHOU) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Most of the currently known anti-TNF-α antibody preparations are not stable, and chemical changes (such as deamidation and some oxidation) are prone to occur during storage, resulting in the increase of charge variants, which potentially affects the quality consistency of the product
In addition, the drug often causes side effects such as pain, itching, redness and swelling at the subcutaneous injection site of the patient.

Method used

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  • A kind of stable anti-tnf alpha antibody preparation and its application
  • A kind of stable anti-tnf alpha antibody preparation and its application
  • A kind of stable anti-tnf alpha antibody preparation and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Each component and content in the preparation are as shown in Table 1:

[0098] Table 1

[0099]

Embodiment 2

[0101] Each component and content in the preparation are as shown in Table 2:

[0102] Table 2

[0103]

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PUM

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Abstract

The present invention relates to a stable anti-TNF-α antibody preparation and its use, specifically the preparation comprises: (i) a therapeutically effective amount of anti-TNF-α antibody; (ii) containing 0.8-6.2mg / ml histidine (iii) an osmotic pressure regulator; and (iv) a surfactant, wherein the pH of the formulation is 5.5-6.5. The preparation of the present invention can not only effectively reduce the chemical degradation reaction rate of the anti-TNF-α monoclonal antibody, improve the chemical stability of the antibody, prolong the shelf life of the product, but also eliminate or reduce the side effects of the patient's injection site, and improve the patient's drug use. comfort. In addition, the invention also discloses a method for stabilizing the antibody and the application of the preparation.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a stable anti-TNF-α antibody preparation and its application. Background technique [0002] Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic erosive arthritis. It is also one of the main diseases causing disability in developed countries. [0003] In the past 10 years, the preparations for the treatment of RA have changed from a wide range of immune modulators to specific molecular targeting cytokines and cells involved in the pathogenesis of RA, blocking different stages in the pathogenesis of RA, and achieving the goal of treating RA. Purpose. A variety of inflammatory cells and factors are involved in the pathogenesis of RA, among which tumor necrosis factor (TNF-α) is in a dominant position. At present, the most in-depth research and the most successful development are TNF-α antagonists, such as adalimumab, the world's first fully human anti-...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K39/395A61K47/18A61K47/26A61K47/10A61K47/04A61P19/02A61P29/00
Inventor 汪音爵邱建亮黄小乐孙左宇
Owner INNOVENT BIOLOGICS (SUZHOU) CO LTD
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