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Hydro-acupuncture preparation of monoclonal antibody

A technology of antibodies and preparations, which is applied in the field of aqueous injection preparations, can solve problems such as the inability to redissolve proteins, and achieve the effects of facilitating large-scale production, simple formulas, and strong buffering capacity

Inactive Publication Date: 2010-08-11
HARBIN PHARMA GROUP BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
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Problems solved by technology

The disadvantage is that the protein obtained by the precipitation reagent sometimes cannot be reconstituted

Method used

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  • Hydro-acupuncture preparation of monoclonal antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1: Water needle comparison solution

[0017] Element

Embodiment 2

[0018] Example 2: Solution A

[0019] Element

Embodiment 3

[0021] Stability investigation, the storage stability of the above three formulations was investigated by accelerated drug stability test at a temperature of 25°C.

[0022] The storage stability of the preparation is enhanced and can be used for the treatment of tumors by parenteral route. S. Mathers and H-C. Mahler also prepared a highly concentrated liquid of anti-EGFR antibody by ultrafiltration, and invented a method for liquid preparation of anti-EGFR antibody (application number / patent number: 200580004883). These two inventions have greatly alleviated the inconvenience caused by the low concentration of protein drugs in the past, but they also have shortcomings. First of all, their patents use salts such as phosphate or acetate as a buffer system, and the protein in the form of liquid preparations When the salt concentration is slightly high, it will produce opalescence or precipitation, which is prone to physical and chemical reactions, thus losing its activity. Second...

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Abstract

The invention provides a preparation method of a hydro-acupuncture preparation of an anti-EGFR-antibody. The hydro-acupuncture preparation of the anti-EGFR-antibody consists of anti-EGFR-antibody albumen, a buffer salt and a surface active agent, and has the advantages that the buffer salt not only has the effect of buffering pH, but also exists in solution as a protective agent of the albumen; and simultaneously, PEG replaces hemolytic Tween as the surface active agent, so that a formula is safe. The hydro-acupuncture preparation for the anti-EGFR-antibody albumen has the advantages of high stability, prolonged valid period and low cost.

Description

technical field [0001] The invention relates to an aqueous injection preparation of anti-EGFR monoclonal antibody. Background technique [0002] Epidermal growth factor receptor (EGFR) plays an important role in regulating tumor cell growth, repair and survival, angiogenesis, invasion and metastasis, and is expressed in a considerable part of human tumors. In addition, in many malignant tumors, the expression of EGFR is often associated with poorer prognosis and lower survival rate. Therefore, it can be speculated that if there is a drug that can block the activity of EGFR, it will inhibit its phosphorylation and signal transduction, so as to play multiple anti-tumor effects, and at the same time increase the anti-tumor efficacy of chemotherapy and radiotherapy. Compared with natural ligands, anti-epidermal growth factor receptor (EGFR) monoclonal antibodies have higher affinity when binding to EGFR, so blocking EGFR-mediated cellular pathways is a highly specific Mode of ...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K47/16A61P35/00
Inventor 李郑武刘高波赵华南李会成冷国庆陈玉军王莹王晴程广伟
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG
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