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A stable anti-PD-1 antibody preparation and its use

A PD-1 and antibody technology, which is applied in the direction of antibodies, medical preparations with non-active ingredients, specific peptides, etc., can solve the problem of affecting the quality of anti-PD-1 antibody preparations, poor stability and protection of anti-PD-1 antibodies, and There are no obvious benefits to protect antibodies, etc., to achieve the effect of reducing the rate of chemical degradation reaction, improving chemical stability, and improving the comfort of medication

Active Publication Date: 2021-06-29
兴盟生物医药(苏州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Part of the inventors of this application found that the protective agent components in the currently marketed anti-PD-1 antibodies are relatively complex, contain components that have no obvious benefit to the protected antibody, and often cause side effects such as increased pain at the injection site of the patient.
In the accelerated stability study of preparations, the stability and protection effect of anti-PD-1 antibody is poor, which leads to the decrease of stability and protection effect of anti-PD-1 antibody products during storage and transportation (especially under high temperature conditions), which indirectly affects anti-PD -1 The quality of antibody preparation products

Method used

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  • A stable anti-PD-1 antibody preparation and its use
  • A stable anti-PD-1 antibody preparation and its use
  • A stable anti-PD-1 antibody preparation and its use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1 Antibody Preparation Formula 1

[0045] The content of each component in the preparation is as shown in Table 1:

[0046] Table 1 Antibody preparations

[0047] Element content Anti-PD-1 antibody SYN125 5mg / mL Citrate 20mM Sodium chloride 100mM Polysorbate-80 0.01% (w / v) pH 6.0

Embodiment 2

[0048] Embodiment 2 Antibody preparation formula 2

[0049] The content of each component in the preparation is as shown in Table 2:

[0050] Table 2 Antibody preparations

[0051]

[0052]

Embodiment 3

[0053] Example 3 Antibody preparation formula 3

[0054] The content of each component in the preparation is as shown in Table 1:

[0055] Table 3 Antibody Preparations

[0056] Element content Anti-PD-1 antibody SYN125 45mg / mL Citrate 20mM Sodium chloride 100mM Polysorbate-80 0.01% (w / v) pH 6.0

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PUM

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Abstract

The invention is the field of antibody preparations and especially involves a stable anti -PD‑1 antibody preparation and its purpose.Specifically, the preparations include citric acid, sodium chloride and polyshan pearl, and pH is 5.0‑8.0.Compared with the existing anti -PD‑1 antibody -protected anti -PD‑1 antibody preparations, which are available in the existing anti -PD‑1 antibody product or patented, can not only effectively reduce the chemical degradation response rate of anti -PD‑1 antibodies, but also improve the chemical stability of the antibody.Extend the shelf period of the product, and can eliminate or reduce the side effects of the injection site of the patient and improve the comfort of the patient's medication.

Description

technical field [0001] The invention belongs to the field of antibody preparations, in particular to a stable anti-PD-1 antibody preparation and its application. Background technique [0002] PD-1 (Programming death 1, programmed death receptor 1), is an important immunosuppressive factor in the human body, is an immunoglobulin, and is a membrane protein composed of 268 amino acids. It was first cloned from the apoptotic mouse T-cell hybridoma 2B4.11. Immunomodulators targeting anti-PD-1, including anti-PD-1 monoclonal antibody (Anti-PD-1 monoclonal antibody), can block the interaction between PD-1 and its ligands PD-L1 and PD-L2 It is of great significance for anti-tumor, anti-infection, anti-autoimmune diseases and organ transplantation survival. [0003] Antibody drugs for clinical treatment of diseases must be stored under suitable conditions before being used in patients to ensure stable and reliable product quality. Therefore, the research and development of protect...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/12A61K47/02A61K47/26A61K39/395A61P35/00A61P31/00A61P37/00A61P37/06
CPCA61K9/0019A61K9/08A61K47/02A61K47/12A61K47/26A61K2039/505A61P31/00A61P35/00A61P37/00A61P37/06C07K16/2818
Inventor 靳志刚谭莹
Owner 兴盟生物医药(苏州)有限公司
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