Anti-human vascular endothelial growth factor monoclonal antibody drug preparation, and applications thereof

A monoclonal antibody, vascular endothelium technology, applied in the direction of antibodies, anti-inflammatory agents, anti-tumor drugs, etc., can solve problems affecting drug efficacy, toxic side effects, and unpublished pharmaceutical preparation components.

Pending Publication Date: 2018-01-05
JIANGSU T MAB BIOPHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] CN 101935349 B discloses the preparation method of a novel anti-human vascular endothelial growth factor (VEGF) monoclonal antibody stock solution, but it does not disclose the composition of pharmaceutical preparations
In addition, compared with conventional chemical drugs, the quality of antibody dru

Method used

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  • Anti-human vascular endothelial growth factor monoclonal antibody drug preparation, and applications thereof
  • Anti-human vascular endothelial growth factor monoclonal antibody drug preparation, and applications thereof
  • Anti-human vascular endothelial growth factor monoclonal antibody drug preparation, and applications thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0049] Example 1 Effects of different pH and buffer systems on the stability of 5 mg / ml (low concentration) anti-vascular endothelial growth factor monoclonal antibody preparations

[0050]Anti-VEGF single antigen solution was desalted into purified water. Add the prepared buffer mother liquor by final concentration 50 mmol / L (wherein pH 3.6, 4.0, 5.0 and 5.6 select sodium citrate / citric acid buffer, pH 6.0 and 7.0 select disodium hydrogen phosphate / sodium dihydrogen phosphate buffer for use , pH 8.0 using Tris hydrochloric acid buffer), and adjust the final concentration of anti-vascular endothelial growth factor monoclonal antibody to 5 mg / ml, sterile filter. The samples of each group were divided into 2 ml vials, sealed and placed in a constant temperature incubator at 37 °C. The samples were taken on the 30th day, and the purity was detected by reducing SDS-PAGE and SEC-HPLC.

[0051] Table 1 SEC-HPLC purity of pharmaceutical preparations under different pH and buffer sys...

Example Embodiment

[0054] Example 2 Screening effects of different pH and buffer systems on the stability of 200 mg / ml (high concentration) anti-vascular endothelial growth factor monoclonal antibody preparations.

[0055] In order to investigate the influence of pH and buffer system on preparation stability, prepare different pH buffer solution mother liquors respectively (wherein pH 5.0, 5.5 and 6.0 select histidine / histidine hydrochloride buffer, pH 6.0, 6.5 and 7.0 select phosphoric acid for use. disodium hydrogen phosphate / sodium dihydrogen phosphate buffer). The anti-vascular endothelial growth factor single-antigen solution was concentrated by ultrafiltration and then replaced with pure water, and each buffer stock solution was added to the final concentration of 30 mmol / L. At the same time, adjust the anti-vascular endothelial growth factor monoclonal antibody to a final concentration of 200 mg / ml, and sterile filter. The pharmaceutical preparations of each group were divided into 2 ml ...

Example Embodiment

[0059] Example 3 Selection of protective agent

[0060] Long-term storage will lead to increased aggregation of anti-vascular endothelial growth factor drug preparations, mainly because the slow change of protein conformation leads to the exposure of certain hydrophobic regions, so that protein molecules aggregate with each other to form aggregates. Trehalose, mannitol, sucrose, arginine and other protective agents can interact with protein molecules to improve protein stability and inhibit the formation of aggregates.

[0061] 3.1 The effect of protective agents on protein thermal stability

[0062] In this example, the effects of methionine, lysine, arginine, glycine, sucrose, sorbitol, mannitol, maltose, trehalose, sucrose, arginine and other single components on the thermal stability of proteins were investigated; blank The control group was the disodium hydrogen phosphate / sodium dihydrogen phosphate buffer group, and no protective agent was added. The anti-vascular endo...

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Abstract

The invention discloses a drug preparation containing anti-human vascular endothelial growth factor monoclonal antibody, and applications thereof. The drug preparation comprises 2 to 200mg/ml of anti-human vascular endothelial growth factor monoclonal antibody, 5 to 80<mu>mol/ml of a pH buffer, 2.5 to 120mg/ml of a protective agent, and 0.03 to 1.2mg/ml of a surfactant. The drug preparation can beused for treating a plurality of diseases, especially neovascular eye diseases such as age-related macular degeneration (AMD), diabetic macular edema (DME), pathologic myopia (PM), retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals, and relates to a pharmaceutical preparation containing anti-human vascular endothelial growth factor monoclonal antibody and its application. Background technique [0002] Vascular endothelial growth factor (VEGF) is a highly specific growth factor that can promote endothelial cell mitosis, promote angiogenesis, increase vascular endothelial permeability, and protect nerves. VEGF is widely distributed in the brain, kidney, liver, eyes and other tissues and organs of the human body, among which retinal pericytes, pigment epithelial cells, endothelial cells, ganglion cells, etc. in the eyes can express VEGF. [0003] Overexpression of VEGF can cause abnormal proliferation of new blood vessels, leading to a variety of diseases, such as tumors, ocular neovascular proliferative diseases, among which ocular neovascular proliferative diseases include age-related macular degeneration (age-related macula...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P35/00A61P35/02A61P29/00A61P19/02A61P17/06A61P9/10A61P3/10A61P27/02A61P7/10A61P27/10
Inventor 严守升陆游于东安顾迎迎谢宁
Owner JIANGSU T MAB BIOPHARMA
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