Stable anti-TNF-alpha antibody preparation and uses thereof

Abstract

The present invention relates to a stable anti-TNF-alpha antibody preparation and uses thereof. Particularly the preparation comprises: (i) a therapeutically effective amount of an anti-TNF-alpha antibody, (ii) a buffer system containing 0.8-6.2 mg/ml histidine, (iii) an osmotic pressure adjusting agent, and (iv) a surfactant, wherein the pH value of the preparation is 5.5-6.5. According to the present invention, with the preparation, the chemical degradation reaction rate of the anti-TNF-alpha monoclonal antibody can be effectively reduced, the chemical stability of the antibody can be improved, the shelf life of the product can be prolonged, the side effect at the injection site of the patient can be eliminated or reduced, and the medication comfort of the patient can be improved. In addition, the present invention further discloses a method for stabilizing the antibody and the uses 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-...

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.

Images