Liquid preparation of immunosuppressant monoclonal antibody

A monoclonal antibody and immunosuppressant technology, applied in the direction of antibodies, immunoglobulins, antibody medical components, etc., can solve the problems of many excipients and complicated operations

Pending Publication Date: 2021-07-09
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Patents CN 102686216A and CN104399075A disclose anti-CD20 monoclonal antibody liquid preparations, which use many excipients and complicated operations

Method used

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  • Liquid preparation of immunosuppressant monoclonal antibody
  • Liquid preparation of immunosuppressant monoclonal antibody
  • Liquid preparation of immunosuppressant monoclonal antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1 investigates the influence of buffer system on the stability of liquid formulations

[0038] Combining the molecular characteristics of the anti-CD20 human-mouse chimeric monoclonal antibody, the buffer system commonly used in the protein preparation process, and the buffer range of the buffer system, after preliminary selection, citric acid / sodium citrate, acetic acid / sodium acetate, and disodium hydrogen phosphate were finally selected / sodium dihydrogen phosphate, histidine / histidine hydrochloride and disodium hydrogen phosphate / potassium dihydrogen phosphate buffer system were screened, and the preparation formula and test results are shown in Table 1 and Table 2, respectively.

[0039] Table 1 Liquid preparations of anti-CD20 human-mouse chimeric monoclonal antibody containing different buffer systems

[0040] serial number Element Formulation 1 Anti-CD20 Human Mouse Chimeric Monoclonal Antibody 20mg / mL 2 Polysorbate 80 0.003％...

Embodiment 2

[0045] Embodiment 2 investigates the influence of stabilizer on the stability of liquid preparation

[0046] The preparation formula and test results are shown in Table 3 and Table 4, respectively.

[0047] Table 3 contains anti-CD20 human-mouse chimeric monoclonal antibody liquid preparations with different stabilizers

[0048] serial number Element Formulation 1 Anti-CD20 Human Mouse Chimeric Monoclonal Antibody 20mg / mL 2 Histidine / Histidine Hydrochloride 15mM 3 stabilizer See Table 4 4 Polysorbate 80 0.03％ 5 Preparation pH 6.0

[0049] Table 4 SEC-HPLC aggregate results of anti-CD20 human-mouse chimeric monoclonal antibodies containing different stabilizers

[0050]

[0051]

[0052] Various liquid preparations added with different stabilizers were stored at 2-8°C, 25°C and 40°C respectively. The SEC-HPLC results showed that the increase of polymers and small molecules in the liquid preparations of 120mM and 240m...

Embodiment 3

[0053] Embodiment 3 investigates the influence of solubilizing agent on the stability of liquid preparation

[0054] The formulation formulations and stability test results are shown in Table 5 and Table 6, respectively. The liquid formulations of different formulations were subjected to 5 cycles of freezing and thawing and shaking for 3 days.

[0055] Table 5 Anti-CD20 human-mouse chimeric monoclonal antibody liquid preparations added with different concentrations of solubilizer

[0056] serial number Element Formulation 1 Anti-CD20 Human Mouse Chimeric Monoclonal Antibody 20mg / mL 2 Histidine / Histidine Hydrochloride 15mM 3 sucrose 120mM 4 Solubilizers See Table 6

[0057] Table 6 Freezing-thawing and shaking test results of anti-CD20 human-mouse chimeric monoclonal antibody liquid preparations added with different concentrations of solubilizer

[0058]

[0059]

[0060] Note: A-3D = shaking for 3 days, FT-5C = repeated f...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly discloses a liquid preparation of an immunosuppressor monoclonal antibody, the liquid preparation provided by the invention comprises an anti-CD20 human-mouse chimeric monoclonal antibody, a buffer solution system, a stabilizer, a solubilizer and the like, the anti-CD20 human-mouse chimeric monoclonal antibody provided by the invention is better in stability and lower in aggregate, and the protein storage time is effectively prolonged.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a liquid preparation of an immunosuppressant monoclonal antibody. Background technique [0002] CD20 is an immunosuppressive receptor that acts as a surface antigen on B cells and appears from pre-B cells to mature B cells. Monoclonal antibodies targeting CD20 are referred to as anti-CD20 monoclonal antibodies. It has been reported that anti-CD20 monoclonal antibodies mainly kill tumors derived from B cells through three mechanisms: antibody-dependent cytotoxicity (ADCC); complement-dependent cytotoxicity (CDC); cell growth inhibition caused by antibody binding to CD20 molecules , cell cycle changes and apoptosis and other direct effects. Rituximab (trade name: MabThera) is a human-mouse chimeric monoclonal antibody, which has mouse-derived variable regions and human-derived constant regions. Biogen) research and development, global sales in 2018 reached ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/08A61K47/26A61K47/18A61P35/00A61P35/02A61P29/00A61P19/02A61P37/02A61P9/14
CPCC07K16/2887A61K9/08A61K9/0019A61K47/26A61K47/183A61K39/39591A61P35/00A61P35/02A61P29/00A61P19/02A61P37/02A61P9/14C07K2317/24A61K2039/505
Inventor 张贵民赵丽丽刘金花刘忠
Owner LUNAN PHARMA GROUP CORPORATION
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