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Stable lyophilized preparation of recombinant human anti-CD20 monoclonal antibody

A monoclonal antibody, freeze-dried preparation technology, applied in the direction of antibody, freeze-dried delivery, drug combination, etc., to achieve the effect of reducing degradation and aggregation, improving stability, and rapid reconstitution

Inactive Publication Date: 2016-06-29
HAISCO PHARMA GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There is currently no lyophilized preparation of anti-CD20 monoclonal antibody on the market, so it is necessary to provide a stable, clinically available and suitable storage lyophilized preparation of recombinant human anti-CD20 monoclonal antibody

Method used

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  • Stable lyophilized preparation of recombinant human anti-CD20 monoclonal antibody
  • Stable lyophilized preparation of recombinant human anti-CD20 monoclonal antibody
  • Stable lyophilized preparation of recombinant human anti-CD20 monoclonal antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: Prepare the solution before freeze-drying with the concentration shown in Table 1, and freeze-dry it into a finished product.

[0025] Table 1

[0026] Element

concentration

Recombinant Human Anti-CD20 Monoclonal Antibody

20mg / mL

Histidine-Histidine Hydrochloride

20mM

sucrose

20mg / ml

Mannitol

25mg / ml

Polysorbate 80

0.05％

Edetate disodium

0.02mg / ml

Sodium chloride

2mg / ml

PH value

5.7

[0027] The purified recombinant human anti-CD20 monoclonal antibody stock solution (concentration 10-30 mg / mL, 20 mM citrate buffer, pH 6.6) was concentrated by ultrafiltration with an ultrafiltration membrane bag (molecular weight cut-off 30 kDa), and ultrafiltered to In 20mM, pH5.7 histidine-histidine hydrochloride buffer, the final concentration of ultrafiltration is (20-30mg / mL), and then mixed with a certain proportion of sucrose, mannitol, polysorbate 80, edetic...

Embodiment 2

[0033] Embodiment 2: Prepare the solution before freeze-drying with the concentration shown in Table 2, and freeze-dry it into a finished product.

[0034] Table 2

[0035] Element

concentration

Recombinant Human Anti-CD20 Monoclonal Antibody

20mg / mL

Histidine-Histidine Hydrochloride

20mM

Trehalose

20mg / ml

Mannitol

30mg / ml

Polysorbate 20

0.05％

Edetate Calcium Sodium

0.02mg / ml

Sodium chloride

1mg / ml

PH value

5.5

[0036] The purified recombinant human anti-CD20 monoclonal antibody stock solution (concentration 10-30 mg / mL, 20 mM citrate buffer, pH 6.6) was concentrated by ultrafiltration with an ultrafiltration membrane bag (molecular weight cut-off 30 kDa), and ultrafiltered to 20mM, pH5.5 histidine-histidine hydrochloride buffer solution, the final concentration of ultrafiltration is (20-30mg / mL), and then mixed with a certain proportion of trehalose, mannitol, polyso...

Embodiment 3

[0038] Embodiment 3: Stability investigation

[0039] The stability of the above freeze-dried preparation was investigated by experiment of influencing factors under high temperature and light conditions, and compared with the liquid preparation (ofatumumab injection) under the same conditions. The experimental conditions and methods are as follows: (1) Accelerated experiment at 25°C: place samples in a thermostat at 25°C, and take samples in October, January, February, March, and June; (2) Accelerated experiment at 40°C: Place samples in a 40°C incubator, and take samples in 0 months, January, February, and March; (3) 60°C accelerated experiment: place samples in a 60°C incubator, and take samples in 0 and 10 days; ( 4) Illumination experiment: Place samples in a room temperature light box at 5000±500 lx, and take samples on day 0, day 5, and day 10. The sampled freeze-dried preparation was reconstituted with 5ml of water for injection. After reconstitution, the test was pe...

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Abstract

The invention relates to a stable lyophilized preparation of a recombinant human anti-CD20 monoclonal antibody. The lyophilized preparation is composed of the recombinant human anti-CD20 monoclonal antibody, a buffer system, a protective agent, an excipient and the like. The lyophilized preparation provided by the invention has a loose, full and complete appearance, has stability significantly superior to that of liquid preparations, and is suitable for long-term storage.

Description

field of invention [0001] The invention belongs to the field of pharmaceutical preparations. Specifically relates to a freeze-dried preparation of a stable recombinant human anti-CD20 monoclonal antibody. Background technique [0002] CD20 is a specific marker molecule on the surface of B lymphocytes, expressed on the surface of more than 95% of normal or malignant B lymphocytes. Studies have shown that CD20 has the function of a calcium ion channel. By regulating the concentration of intracellular calcium ions, it affects the cell cycle, regulates cell proliferation and differentiation, and even leads to the occurrence of cell apoptosis. The mechanism of action mainly includes complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) (JohnsonP. Sensitivity and immunization also lead to apoptosis of B cells (Ghetie MA. Blood, 2001, 97(5): 1392-1398.). At the same time, CD20 is not expressed in hematopoietic stem cells, progenitor cells,...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K39/395A61P35/00
Inventor 彭飞钟娇懿张志超陈朝燕魏菁菁吴伟于鹏展范林萍
Owner HAISCO PHARMA GRP INC
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