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Stable antibody preparation

A preparation and stable technology, applied in the direction of antibodies, anti-tumor drugs, non-active ingredients of polymer compounds, etc., can solve problems such as unsatisfactory effects, and achieve the effect of guaranteeing shelf life, good stability, and preventing aggregation.

Inactive Publication Date: 2017-05-10
SHANGHAI NAT ENG RES CENT OF ANTIBODY MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when these strategies are applied to high-concentration injection preparations requiring hundreds of mg / ml or more, the effect is not very satisfactory

Method used

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Experimental program
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Effect test

Embodiment 1

[0038] Embodiment 1 Hyaluronidase and Cyclodextrin Effects on Antibody Preparations

[0039] Stability study of anti-EGFR antibody formulations containing hyaluronidase and cyclodextrin at 25°C. The formulations may contain, in addition to hyaluronidase and cyclodextrin, further excipients as indicated in Table 1.

[0040] Table 1: Anti-EGFR antibody preparation formulation

[0041]

[0042] The above sample preparations were incubated at 35°C for 60 days, and then analyzed by SDS-PAGE at time points of 0, 20, 40, and 60 days, respectively. SDS-PAGE is used as an analytical technique to separate free and high molecular weight species from native proteins according to their molecular weight. Due to the high tendency of macromolecular antibodies to aggregate in high concentration antibody preparations, non-reducing SDS-PAGE was used to assess covalent aggregates.

[0043] Table 2: SDS-PAGE analysis results of aggregates of anti-EGFR antibody preparations with different formu...

Embodiment 2

[0046] The influence of embodiment 2 sugar on antibody preparation

[0047] The effect of different levels of sugar on the stability of anti-EGFR antibody formulations was evaluated. We placed the samples at -20°C, 8°C and 45°C under the conditions of 60% humidity and detected the aggregation of antibodies in anti-EGFR antibody preparations by SE-HPLC at different time points.

[0048] Table 3: Anti-EGFR antibody preparation formula table

[0049] serial number Element F9 F10 F11 F12 1 Anti-EGFR antibody (mg / ml) 200 200 200 200 2 Sucrose (mM) 20 100 200 400 3 Histidine buffer (mM) 150 150 150 150 4 Polysorbate 80(%) 0.02 0.02 0.02 0.02 5 rHuPH20 (unit U / ml) 50000 50000 50000 50000 6 HP-β cyclodextrin (%) 35 35 35 35

[0050] Table 4: Effects of sugars on the stability of anti-EGFR antibody preparations

[0051]

[0052] From the experimental results shown in Table 4, it can be seen that sugar h...

Embodiment 3

[0053] The impact of embodiment 3 surfactant on antibody preparation

[0054] The most suitable candidates in terms of stability were screened from the non-ionic surfactants polysorbates (eg polysorbate 20 or 80) and paloxamers (eg paloxamer 188 or 168). We mainly analyzed the aggregation of anti-EGFR antibody preparations with different contents of polysorbate 20 and paloxamer 188 during storage to analyze the influence of different surfactants on the stability of the preparation. We placed the samples under the conditions of 30°C and 60% humidity, and detected the aggregation of antibodies in the anti-EGFR antibody preparation by SE-HPLC method at different time points.

[0055] Table 5: Anti-EGFR antibody preparation formula table

[0056]

[0057] Table 6:: the impact of surfactant on the stability of anti-EGFR antibody preparations

[0058]

[0059] As can be seen from the above Table 6, compared with the preparation containing paloxamer 188 surfactant, polysorbat...

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Abstract

The present invention relates to the technical field of biology, discloses a stable antibody preparation, specifically a high-concentration anti-EGFR antibody preparation containing hyaluronidase and cyclodextrin, wherein the preparation has good stability, is particularly suitable for subcutaneous injection, and can be used for treating human head and neck squamous cell carcinoma, colorectal cancer, pancreatic cancer, non-small cell lung cancer, bladder cancer, and other diseases.

Description

technical field [0001] The invention relates to the technical field of biomedicine, and more specifically, the invention discloses a stable preparation. Background technique [0002] Epidermal growth factor receptor (EGFR) is an important receptor for cell proliferation and signal transduction of epidermal growth factor. EGFR produces effects by combining with its ligand. The specific ligands of EGFR are EGF and EGF-related polypeptides, including transforming growth factor alpha (TGF-α), amphiregulin, and heparin-binding EGF-like growth factor. In order to activate EGFR, the ligand EGF (monomer) binds and connects two adjacent receptor chains at the same time, so that the intracellular kinase domain of the receptor phosphorylates each other on multiple tyrosines, and the tyrosine kinase activity increases Thereby, several signaling pathways such as ras-MAPK pathway, PI3 kinase pathway and JAK / STAT pathway can be activated. Excessive EGFR function due to EGFR receptor over...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K47/42A61K47/40A61K47/26A61P35/00
Inventor 黎健荣张彦胡湘丽董玮婷顾云凯
Owner SHANGHAI NAT ENG RES CENT OF ANTIBODY MEDICINE
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