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

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...

Examples

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.

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...

Examples

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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