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Antibody composition for TNF-alpha, and application thereof

An antibody composition and the technology of the composition are applied in the directions of antibodies, drug combinations, medical preparations of inactive ingredients, etc., can solve problems such as discomfort and pain, and achieve the effect of reducing pain and discomfort

Active Publication Date: 2017-12-19
BIO THERA SOLUTIONS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Based on this, it is necessary to provide an antibody composition against TNF-α for the problems of discomfort, pain and other problems caused by the ingredients, pH and other factors of the existing subcutaneous injection preparations

Method used

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  • Antibody composition for TNF-alpha, and application thereof
  • Antibody composition for TNF-alpha, and application thereof
  • Antibody composition for TNF-alpha, and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Embodiment 1: Preparation of antibody composition

[0075] This embodiment gives an example to the preparation of the preparation A of 20L:

[0076] (1) Weigh out the following ingredients: 840g mannitol (stabilizer), 20g polysorbate 80 (surfactant) and 20L water for injection.

[0077] Carbon dioxide is charged after the preparation of the formulation is completed.

[0078] (2) Dissolving the weighed mannitol (stabilizer) and polysorbate 80 (surfactant) in about 90% by weight of the water for injection to prepare a solvent system.

[0079] It has been proved that the order of adding mannitol (stabilizer) and polysorbate 80 (surfactant) does not affect the quality of the preparation and can be selected at will.

[0080] (3) Thaw the BAT1406 antibody concentrate containing 2.0 kg of total protein in a water bath, and then add the solvent system to the antibody concentrate under stirring until the final weight of the total solution is reached.

[0081] (4) Fill carbon ...

Embodiment 2

[0085] Embodiment 2: Stability study under room temperature condition

[0086] Prepare PBS sample A1 (20mg / mL) of BAT1406 antibody and low-concentration sample A2 (4mg / mL), medium-concentration sample A3 (20mg / mL), high-concentration sample A4 (100mg / mL) of preparation A, and place at room temperature Keep for 2 weeks. The formula composition of A1-A4 number sample is shown in Table 2A:

[0087] Table 2A

[0088]

[0089] The samples were tested by capillary electrophoresis (capillary electrophoresis, CE), size-exclusion chromatography (size-exclusion chromatography, SEC) and biological activity (TNF-α-induced L929 cytotoxicity neutralization experiment). The results of the determination are shown in Table 2B and figure 1 .

[0090] The results showed that: samples with three concentrations of BAT1406 antibody A preparation, low (A2 sample), medium (A3 sample), and high (A4 sample), were placed at room temperature for 2 weeks, and the degradation trend of the main peak...

Embodiment 3

[0094] Embodiment 3: Study on factors affecting pH of preparation

[0095] Prepare 10 L of samples of BAT1406 antibody A preparation (see Table 1A for the specific formula) with a concentration of 100 mg / mL, store in a pressure tank, fill with different amounts of carbon dioxide, and place it at 4 ° C. When detecting different carbon dioxide pressures, the pH of the preparation in the pressure tank . The results of the assay are listed in Table 3A.

[0096] The carbon dioxide gas pressure of table 3A.BAT1406 A preparation influences the experimental result on pH

[0097] Carbon dioxide pressure (mmHg)

Formulation pH

300

4.76

270

4.98

240

5.06

210

5.15

180

5.30

150

5.51

100

5.84

[0098] Prepare BAT1406 antibody A preparation (see Table 1A for specific formula) with a concentration of 100mg / mL sample 10L, store in vials and injection needles (see Table 3B for material information), fill carbon ...

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Abstract

The invention provides an antibody composition for TNF-alpha, and an application thereof. The solvent of the composition comprises water, and the solute of the composition comprises an anti-TNF-alpha antibody; and the pH value of the composition is 4.0-8.0, and the pH value is adjusted through introducing carbon dioxide to the solvent and solute mixture of the composition. Compared with antibody compositions in the prior art, the antibody composition contains no common buffer systems, adopts carbon dioxide introduction to substitute a buffer system and keep the pH value of a preparation stable, reduces the pains and discomfort during patient injection, and is of great significance to treating TNF-alpha-related diseases.

Description

technical field [0001] The present invention relates to the new pharmaceutical preparation, in particular to an antibody composition against TNF-α and its application. Background technique [0002] Rheumatoid arthritis (RA) is a common arthritis, which belongs to autoimmune disease, and the incidence rate in the population is 0.3-1%. If it is not treated in time, it can lead to bone destruction and joint damage. A variety of pro-inflammatory cytokines are involved in the pathogenesis of RA, such as tumor necrosis factor-α (TNF-α), interleukins such as IL-1, IL-6, IL-8, etc. (Marc Feldmann, RavinderN.Maini. Discovery of TNF-α as a therapeutic target in rheumatoid arthritis preclinical and clinical studies. Joint Bone Spine, 2009; 69:12-18.). Therefore, inhibiting the production of pro-inflammatory cytokines or blocking their physiological effects is a hot spot in the field of RA research. In recent years, many newly developed biological agents can control the progress of th...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K47/02A61K47/10A61K47/26A61P19/02A61P29/00
CPCA61K47/02A61K47/10A61K47/26A61K2039/505C07K16/241
Inventor 林键
Owner BIO THERA SOLUTIONS
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