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Liquid composition comprising monoclonal antibody against thymic stromal lymphopoietin

A technology of liquid composition and monoclonal antibody, which is applied in the direction of anti-cytokine/lymphokine/interferon immunoglobulin, antibody, drug combination, etc. It can solve the problems of unstable preparation, antibody residue, high viscosity of antibody preparation, etc.

Active Publication Date: 2021-07-06
MABWELL (SHANGHAI) BIOSCIENCE CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, an increase in the antibody concentration is accompanied by many disadvantages, such as excessively high viscosity of the antibody preparation, resulting in difficulty in injection, pain at the injection site, antibody residue in the container, difficulty in production, etc.
In addition, high-concentration antibodies tend to aggregate and form particles, resulting in unstable preparations and increased immunogenicity, making storage and long-term storage difficult

Method used

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  • Liquid composition comprising monoclonal antibody against thymic stromal lymphopoietin
  • Liquid composition comprising monoclonal antibody against thymic stromal lymphopoietin
  • Liquid composition comprising monoclonal antibody against thymic stromal lymphopoietin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Example 1 Screening of murine monoclonal antibodies

[0092] 1.1 Preparation of monoclonal cells

[0093]Using human TSLP protein according to the conventional method described in the literature (Lonberg, N., et al., nature 368 (1994) 856-859; Fishwild, D.M., et al., Nat. Biotechnol. 14 (1996) 845-851 and WO98 / 24884) to immunize 10 Balb / c mice, and then determine the anti-TSLP titer in the serum of the immunized mice by antigen-specific ELISA.

[0094] TSLP solution (at pH 9.6, 0.1M NaHCO3) with a concentration of 1ug / ml was coated in a 96-well plate, 100ul per well, and incubated overnight at 4°C. Then wash off the coating solution, add blocking solution to each well, and incubate at room temperature for 2 hours. Mouse serum was pre-diluted 400-fold in PBSA (PBS containing 1% BSA) and serially diluted 1:2 to 204,800-fold in 10 dilution steps. After washing away the blocking solution, the diluted serum was added to the plate wells and incubated at room temperatur...

Embodiment 2

[0135] Example 2 Kinetic study of the affinity of anti-human TSLP murine antibody in vitro

[0136] Fortebio (BLITZ pro1.1.0.28) instrument was used to analyze the binding kinetic parameters of murine antibody and human TSLP protein.

[0137] Soak the AMC bioprobe in kinetic buffer (PBS, containing 0.01%BSA, 0.002%Tween20, pH7.4) for 10 minutes before measurement; then place the probe in kinetic buffer containing 100nM mouse antibody (PBS , containing 0.01% BSA, 0.002% Tween20, pH7.4) for 1000 seconds to capture the mouse antibody; further, the probe was mixed with 100nM antigen solution (PBS, containing 0.01%BSA, 0.002%Tween20, pH7.4) For the binding reaction, the binding time was 600 seconds; afterward, the probe was transferred to kinetic buffer (PBS, containing 0.01% BSA, 0.002% Tween20, pH7.4) for dissociation reaction, and the time was 600 seconds. After the experiment was completed, the response value of the blank control was deducted, and the 1:1 Langmuir binding m...

Embodiment 3

[0139] Example 3 Preparation of anti-human TSLP chimeric antibody

[0140] The molecule D01 with high affinity, high blocking ability and cell activity was selected, and the heavy and light chain variable region and its CDR domain sequence of the antibody are shown in Table 2.

[0141]

[0142] The heavy chain variable region sequence of the murine anti-human TSLP monoclonal antibody and the heavy chain constant region sequence of the published human monoclonal antibody IgG2 subclass were spliced ​​together and constructed into a mammalian cell expression vector; the murine anti The light chain variable region sequence of the human TSLP monoclonal antibody D01 and the light chain constant region sequence of the published human monoclonal antibody κ subclass are spliced ​​together and constructed into a mammalian cell expression vector. The heavy chain carrier and light chain carrier of the constructed anti-human TSLP chimeric antibody were paired and mixed, and HEK293 ce...

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Abstract

The present invention provides a liquid composition comprising a monoclonal antibody against thymic stromal lymphopoietin. The liquid composition contains the monoclonal antibody at a high concentration, the antibody can be kept stable for a long time, and a preparation has appropriate viscosity and osmotic pressure and can be used as a subcutaneous injection preparation. In addition, the invention further provides application of the liquid composition in preparation of drugs for treating diseases or symptoms related to TSLP signal transmission and / or TSLP high expression. The invention further provides a container comprising the liquid composition and a medicine box comprising the container.

Description

technical field [0001] The present invention relates to the field of biopharmaceutical preparations, in particular, the present invention relates to a liquid pharmaceutical preparation comprising a stable anti-thymic stromal lymphopoietin (TSLP) antibody. Background technique [0002] Thymic stromal lymphopoietin (TSLP) is a cytokine produced by epithelial cells in response to pro-inflammatory stimuli. It acts on dendritic cells (DC) and mast cells to drive the body's sensitized inflammatory response. TSLP-activated DC can express TARC and MDC, the chemical factors that aggregate Th2. In addition, DCs activated by TSLP (TSLP-DC) can also initiate the conversion of CD4 T cell precursors to Th2, and Th2 cells can produce allergic factors IL-4, IL-5, IL-13 and TNF-α, while reducing Production of IL-10 and IFN-γ. [0003] TSLP plays an important role in the development of allergic asthma, targeting TSLP can inhibit multiple asthma-related biological pathways, including IL-4, I...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P29/00A61P35/00A61P11/06A61P17/00A61P37/08A61P11/00A61P11/02C07K16/24
CPCA61K2039/505A61P11/00A61P11/02A61P11/06A61P17/00A61P29/00A61P35/00A61P37/08C07K16/24C07K2317/24C07K2317/56C07K2317/565C07K2317/76C07K2317/92C07K2317/94
Inventor 陈坤季荣钰梅菲孙小伟游猛方鹏吴伶俐谭小钉
Owner MABWELL (SHANGHAI) BIOSCIENCE CO LTD
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