Liquid preparation of CD47 monoclonal antibody and preparation method of liquid preparation

A monoclonal antibody, liquid preparation technology, applied in the direction of antibodies, medical components of antibodies, medical preparations of non-active components, etc., can solve problems such as stability effects, and achieve the effect of good stability and low quantity

Pending Publication Date: 2021-03-19
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its stability is easily affected during the preparation of injections and storage
At present, there are few reports on CD47 monoclonal antibody preparations. Therefore, it is necessary to develop a stable CD47 monoclonal antibody preparation to meet the needs of clinical medication.

Method used

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  • Liquid preparation of CD47 monoclonal antibody and preparation method of liquid preparation
  • Liquid preparation of CD47 monoclonal antibody and preparation method of liquid preparation
  • Liquid preparation of CD47 monoclonal antibody and preparation method of liquid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (1) Formulation:

[0028]

[0029] (2) Preparation method

[0030] Weigh the prescribed amount of buffer, add water for injection to dissolve, adjust the pH to 5.5, use the buffer system obtained above to concentrate the CD47 antibody protein stock solution by ultrafiltration, replace the original buffer system of the CD47 antibody protein, and then add the prescribed amount of chitosan and Egg yolk lecithin, stirred evenly, then adjusted the CD47 protein concentration to 50 mg / ml with a buffer system, sterile filtered through a 0.22 μm filter membrane, and then filled.

Embodiment 2

[0032] (1) Formulation:

[0033]

[0034] (2) Preparation method

[0035] Weigh the prescribed amount of buffer, add water for injection to dissolve, adjust the pH to 6.0, use the buffer system obtained above to concentrate the CD47 antibody protein stock solution by ultrafiltration, replace the original buffer system of the CD47 antibody protein, and then add the prescribed amount of trehalose and egg yolk Lecithin, stir evenly, then adjust the CD47 protein concentration to 50 mg / ml with a buffer system, filter aseptically through a 0.22 μm filter membrane, and then fill it.

Embodiment 3

[0037] (1) Formulation:

[0038]

[0039] (2) Preparation method

[0040] Weigh the prescribed amount of buffer, add water for injection to dissolve, adjust the pH to 5.0, use the buffer system obtained above to concentrate the CD47 antibody protein stock solution by ultrafiltration, replace the original buffer system of the CD47 antibody protein, and then add the prescribed amount of sucrose and asparagus Amide, stir evenly, then adjust the CD47 protein concentration to 60mg / ml with a buffer system, perform sterile filtration through a 0.22μm filter membrane, and then fill it.

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PUM

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Abstract

The invention belongs to the technical field of protein and polypeptide drugs, and particularly relates to a liquid preparation of a CD47 monoclonal antibody. The liquid preparation comprises a CD47 monoclonal antibody, a stabilizer, a solubilizer and a buffer agent. According to the liquid preparation, after the stabilizer is added into a CD47 antibody solution, the CD47 antibody solution can surround antibody protein, so that the movement of macromolecular substances is blocked, the space structure of protein molecules is maintained, and precipitates of protein molecules are organized. Afterthe solubilizer is added into the CD47 antibody solution, the homogeneity of the protein in the solution is improved, antibody aggregation and CD47 antibody degradation in the preparation are furtherreduced, and the preparation has a simple formula and a stable protein system, is convenient to produce on a large scale, store and transport and is convenient in clinical administration.

Description

technical field [0001] The invention belongs to the technical field of protein and polypeptide drugs, and in particular relates to a CD47 monoclonal antibody liquid preparation and a preparation method thereof. Background technique [0002] CD47, also known as integrin-associated protein (IAP), ovarian cancer antigen OA3, Rh-associated antigen, and MER6, is a multispan transmembrane receptor belonging to the immunoglobulin superfamily. Its expression and activity have been linked to many diseases and disorders. It is a ubiquitously expressed transmembrane glycoprotein with an immunoglobulin-like domain and five transmembrane domains, which acts as a cellular ligand for SIRPα through the NH of signal regulatory protein α (SIRPα) 2 The terminal V-like domain binds SIRPα. SIRPα is mainly expressed in myeloid cells, including macrophages, granulocytes, dendritic cells (DC), mast cells, and their precursors, including hematopoietic stem cells. [0003] CD47 plays a crucial rol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/08A61K47/24A61K47/36A61K47/26A61K47/12A61P35/00
CPCA61K9/0019A61K9/08A61K39/39591A61K47/12A61K47/24A61K47/26A61K47/36A61P35/00
Inventor 张贵民赵丽丽刘增智刘忠
Owner LUNAN PHARMA GROUP CORPORATION
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