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A pharmaceutical composition of anti-PD-L1 humanized monoclonal antibody

A technology of PD-L1 and monoclonal antibody, which is applied in drug combination, antibody, drug delivery, etc., can solve the problems of physical instability of protein that is more difficult to control than chemical instability, physical instability and loss of potential biological activity

Active Publication Date: 2022-03-15
CHIA TAI TIANQING PHARMA GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the ability of proteins to integrate highly ordered structures, it is easy to undergo a large number of structural changes other than chemical modification.
The physical instability of proteins is more difficult to control than chemical instability, and the exposure of hydrophobic regions will promote aggregation or self-association, which may lead to physical instability and loss of potential biological activity

Method used

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  • A pharmaceutical composition of anti-PD-L1 humanized monoclonal antibody
  • A pharmaceutical composition of anti-PD-L1 humanized monoclonal antibody
  • A pharmaceutical composition of anti-PD-L1 humanized monoclonal antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-12

[0215] Example 1-12 Preparation of anti-PD-L1 humanized monoclonal antibody 5G11 injection

[0216] According to the preparation method of the preparation formula in Table 1: prepare the purpose buffer solution and adjust to the required pH value with an acid-base regulator. The eluate of the purified anti-PD-L1 humanized monoclonal antibody 5G11 was replaced by ultrafiltration with the prepared purpose buffer. After the replacement was complete, the corresponding isotonic agent / stabilizer and surfactant in Table 1 were added, and Control the final concentration of the antibody to the required target concentration, sterilize and filter, aseptically dispense into vials, add Seza caps, and pass the visual inspection to obtain the product.

[0217] Among them, the anti-PD-L1 humanized monoclonal antibody 5G11 comprises the heavy chain variable region sequence shown in SEQ ID NO: 13 and the light chain variable region sequence shown in SEQ ID NO: 15. The heavy chain amino acid se...

Embodiment 13

[0221] Example 13 Quality Research of Anti-PD-L1 Humanized Monoclonal Antibody 5G11 Injection

[0222] Twelve batches of anti-PD-L1 humanized monoclonal antibody 5G11 injection were prepared according to the methods in Examples 1-12. A comprehensive quality study was carried out on each batch of injection, and protein aggregates and degradation product fragments were analyzed by molecular sieve chromatography (Size-Exclusion chromatography, SEC) and sodium dodecyl sulfate capillary electrophoresis (CE-SDS). , CEX) to analyze charge heterogeneity, and enzyme-linked immunosorbent assay (ELISA) to analyze the biological binding activity of antibodies.

[0223] SEC determination method: TSKgel molecular sieve chromatographic column (manufacturer: TOSOH; model: TSKgel G3000 SWXL; specification: 5μm, 7.8*300) is used, and the pH is 7.0±0.1 NaCl containing 2 HPO 4 The buffer is used as the mobile phase for elution, and the detection wavelength is 280nm. Under the chromatographic c...

Embodiment 14

[0230] Example 14 Stability study of anti-PD-L1 humanized monoclonal antibody 5G11 injection at 2-8°C

[0231] According to the method of Examples 1-12, 12 batches of anti-PD-L1 humanized monoclonal antibody injection were prepared. Each batch of injections was placed in an environment of 2-8°C, and samples were taken for testing in 0, 1, 2, 3 and 6 months. Use molecular sieve chromatography (SEC) and ion exchange chromatography (CEX) to measure the purity, enzyme-linked immunosorbent assay (ELISA) to measure the biological binding activity of monoclonal antibody, and investigate the purity and activity of monoclonal antibody injection during storage at 2-8 °C Changes of the drug composition to evaluate the stability of the pharmaceutical composition of the present invention. The related index detection method is the same as that in Example 13. See Table 3 for the purity and activity stability of anti-PD-L1 humanized monoclonal antibody injection at 2-8°C.

[0232] Table 3 ...

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Abstract

The present invention belongs to the field of antibody preparations, and in particular relates to a pharmaceutical composition of anti-PD-L1 humanized monoclonal antibody, said pharmaceutical composition comprising 1-150mg / ml anti-PD-L1 humanized monoclonal antibody, 3- 50 mM buffer, 2-150 mg / ml isotonicity adjuster / stabilizer and 0.01-0.8 mg / ml surfactant at a pH of about 4.5-6.8. The preparation prevents the polymer growth of the antibody in it, and at the same time, can maintain the biological binding activity of the antibody well for a long time.

Description

technical field [0001] The invention belongs to the field of antibody preparations, in particular to a pharmaceutical composition of anti-PD-L1 humanized monoclonal antibody. Background technique [0002] PD-L1 (Programmed death-ligand 1), also known as CD247 and B7-H1, is a ligand of programmed death-1 (PD-1). PD-L1 is highly expressed on the surface of various tumor cells, and the malignancy and poor prognosis of tumors are closely related to the expression level of PD-L1. In the tumor microenvironment, PD-L1 on the surface of cancer cells binds to PD-1 or CD80 on the surface of T cells, inhibits the activation and proliferation of T cells, promotes effector T cells to enter a state of exhaustion or anergy, and induces the activation of T cells. Apoptosis stimulates helper T cells to differentiate into regulatory T cells, thereby preventing T cells from killing tumor cells. Anti-PD-L1 antibodies can block the interaction of PD-L1 with PD-1 and CD80, so that related negat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61P35/00
CPCC07K16/2827A61K47/02A61K47/12A61K47/22A61K47/26A61K9/0019A61K9/08A61P35/00A61K2039/545A61K2039/505C07K2317/22C07K2317/24C07K2317/94A61K39/39591A61K47/10A61K39/3955A61K47/14
Inventor 李建文程艳菊李盈淳赵伟张喜全
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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