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Anti-programmed cell death-ligand 1 (PD-L1) antibody preparation

A technology of PD-L1 and liquid preparations, which is applied in the direction of antibodies, antibody medical components, anti-tumor drugs, etc., and can solve problems such as easy turbidity, poor stability, and high viscosity

Active Publication Date: 2020-06-05
SICHUAN KELUN BIOTECH BIOPHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] After a lot of experiments and repeated explorations, the inventors of the present application unexpectedly found that the liquid preparation composed of anti-PD-L1 antibody and specific prescription has excellent physiological compatibility and stability, and further developed a high-concentration antibody preparation with high Concentration protein preparations overcome the problems of poor stability, high viscosity and easy turbidity, so the application discloses liquid preparations that are particularly beneficial to long-term storage and clinical use of medicines, thus completing the present invention

Method used

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  • Anti-programmed cell death-ligand 1 (PD-L1) antibody preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0123] Prescription 1: anti-PD-L1 humanized monoclonal antibody 20mg / ml, 100mM sodium chloride, 20mM citric acid-sodium citrate, pH5.2.

[0124] Prescription 2: anti-PD-L1 humanized monoclonal antibody 20mg / ml, 100mM sodium chloride, 20mM citric acid-sodium citrate, pH 5.6.

[0125] Prescription 3: Anti-PD-L1 humanized monoclonal antibody 20mg / ml, 100mM sodium chloride, 20mM citric acid-sodium citrate, pH 6.0.

[0126] Prescription 4: anti-PD-L1 humanized monoclonal antibody 20mg / ml, 100mM sodium chloride, 20mM citric acid-sodium citrate, pH 6.4.

[0127] Prescription 5: anti-PD-L1 humanized monoclonal antibody 20mg / ml, 100mM sodium chloride, 20mM citric acid-sodium citrate, pH 6.8.

[0128] The preparation method of the antibody preparation of prescription 1-5 is as follows:

[0129] 1. Prepare buffer: add 100mM sodium chloride and 20mM citric acid to the water for injection, and adjust to the pH value required in the above prescription with sodium hydroxide.

[0130] 2. T...

Embodiment 2

[0139] Prescription 6: Anti-PD-L1 humanized monoclonal antibody 20mg / ml, 140mM sodium chloride, 20mM histidine-histidine hydrochloride, polysorbate 80 with a mass volume ratio of 0.02%, pH 5.8.

[0140]Prepare 100ml of the antibody preparation of prescription 6, the preparation method is as follows:

[0141] 1. Prepare the buffer solution: add 140mM sodium chloride and 20mM histidine to the water for injection, and adjust the pH to 5.8 with hydrochloric acid.

[0142] 2. The antibody stock solution (batch number 1) was replaced by ultrafiltration, dialyzed to the above buffer solution, adjusted to 20 mg / ml antibody concentration, and an appropriate amount of polysorbate 80 stock solution was added.

[0143] 3. The prepared sample is sterilized and filtered through a filter with a pore size of 0.22 μm under laminar flow conditions, filled into a vial, and the sample is obtained by plugging and capping.

[0144] The sample stability of prescription 6 was investigated at 40°C fo...

Embodiment 3

[0146] Prescription 7: Anti-PD-L1 humanized monoclonal antibody 20mg / ml, 140mM sodium chloride, 20mM histidine-histidine hydrochloride, polysorbate 80 with a mass volume ratio of 0.02%, pH 5.0.

[0147] Adjust the pH of the buffer to 5.0, and the rest of the preparation method is the same as in Example 2.

[0148] The sample stability of prescription 7 was investigated at 40°C for 28 days, and the test results are shown in Tables 5-9.

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Abstract

The invention relates to the field of therapeutic antibodies, in particular relates to an anti-programmed cell death-ligand 1 (PD-L1) antibody preparation. The preparation comprises an anti-PD-L1 antibody, a buffer solution and sodium chloride, and added sugar and / or sugar alcohols are absent. The anti-PD-L1 antibody preparation of the invention can maintain antibody stability after long-term storage. In addition, the invention further relates to a use of the anti-PD-L1 antibody preparation in preparing drugs used for the prevention and / or treatment and / or adjuvant treatment and / or diagnosis of tumors or anemia

Description

technical field [0001] The present invention relates to the field of therapeutic antibodies, more specifically, the present invention relates to an anti-PD-L1 antibody preparation and its medical application. Background technique [0002] PD-1 (Programmed Death 1), the full name of programmed death receptor 1, is a type I transmembrane glycoprotein and belongs to the CD28 family member. PD-L1 (Programmed Cell Death-Ligand 1) is a type I transmembrane glycoprotein with a size of 40KDa. [0003] Under normal physiological conditions, after antigens enter the body, they are processed by antigen-presenting cells (APC) and linked to MHC. TCR molecules on the surface of T cells specifically recognize the antigenic peptide presented by APC, and at the same time recognize the MHC molecules that form a complex with the antigenic peptide. In addition, many immune regulatory molecules on the surface of T cells participate in the reaction, generating co-stimulatory signals, and promoti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/08A61P35/00A61P35/02A61P7/06
CPCC07K16/2827A61K9/08A61K47/12A61P35/00A61P35/02A61P7/06A61K2039/505A61K39/39591C07K2317/24C07K2317/94A61K9/0019A61K47/02A61K47/10A61K47/22A61K47/26A61K2039/545C07K2317/565
Inventor 肖亮邓莉萍黄海玉刘启刚刘立平郭大成薛彤彤王晶翼
Owner SICHUAN KELUN BIOTECH BIOPHARMACEUTICAL CO LTD
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