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Antibody composition preparation and application thereof

A technology of antibody composition and preparation, which is applied in the direction of antibodies, drug combinations, anti-tumor drugs, etc., to achieve the effects of long-term storage, good tumor treatment activity, and prevention of content increase

Active Publication Date: 2013-03-13
SUZHOU KANGJU BIOTECHNOLOGY CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, there is currently no antibody composition preparation related to the formation of Trastuzumab Trastuzumab and Pertuzumab

Method used

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  • Antibody composition preparation and application thereof
  • Antibody composition preparation and application thereof
  • Antibody composition preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Liquid and lyophilized pharmaceutical product formulations for parenteral administration according to the invention are as follows:

[0056] 1. Preparation of liquid preparations

[0057] The solutions of Trastuzumab and Pertuzumab were exchanged into the corresponding preparation buffer (such as 20mM L-histidine, pH 6.0 or 20mM L-histidine, 0.02 %w / v polysorbate 20, pH6.0), and concentrated to a certain protein concentration, such as 70mg / ml. It is then diluted to the desired protein concentration with the corresponding formulation buffer. Protein-stabilizing formulation components such as sucrose, amino acids such as L-arginine can be added in dissolved or solid form, and surfactants can be added in stock solution form. Finally, the Trastuzumab and Pertuzumab preparation solutions of the same volume were mixed evenly. All formulations were filter sterilized through a 0.22 μm filter, then aseptically dispensed into sterile glass vials and sealed with rubber stoppers...

Embodiment 2

[0072] Example 2: Formulation A

[0073] Formula: 25mg / ml Trastuzumab, 25mg / ml Pertuzumab, 20mM L-histidine, 120mM trehalose, 100mM L-arginine, 0.02%Tween20, pH6.0;

[0074] Table 3: Stability data for Formulation A

[0075]

Embodiment 3

[0076] Example 3: Formulation B

[0077] Formula: 25mg / ml Trastuzumab, 25mg / ml Pertuzumab, 20mM L-Histidine, 120mM Trehalose, 100mM L-Arginine, 0.04%Tween80, pH6.0;

[0078] Table 4: Stability data for Formulation B

[0079]

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PUM

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Abstract

Relating to the technical field of pharmaceutical preparations, the invention provides an antibody composition preparation composed of Trastuzumab and Pertuzumab. The antibody composition preparation has better tumor treatment activity. Compared with the independent treatment of Trastuzumab and Pertuzumab, the composition preparation shows a synergistic effect of the two antibodies, and can reach a tumor control rate of 92.43%. And the preparation provided in the invention has better stability, thus being in favor of long-term preservation of the antibody composition preparation. The antibody composition preparation provided in the invention is applicable to preparation of drugs treating diseases or symptoms suited to anti-HER2 antibody therapy. During application, the antibody composition preparation disclosed in the invention is used with a chemotherapeutic agent jointly or sequentially.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an antibody composition preparation formed by Trastuzumab Trastuzumab and Pertuzumab and an application thereof. Background technique [0002] Human epidermal growth factor receptor 2 (Her-2) is a transmembrane sugar with receptor tyrosine kinase (receptortyrosine kinase, RTK) activity encoded by the proto-oncogene CerbB2 (Her2 / neu) protein. It belongs to the epidermal growth factor receptor family, which includes HER1 (erbB1, EGFR), HER2 (erbB2, NEU), HER3 (erbB3) and HER4 (erbB4). Studies have shown that Her-2 has gene amplification and protein overexpression in 20% to 30% of primary breast invasive ductal carcinomas. Her-2 positive breast cancer has strong invasiveness, short disease-free survival and poor prognosis. Trastuzumab Trastuzumab (trade name: Herceptin, herceptin) produced by Genentech, a subsidiary of Roche, is a humanized monoclonal antibody...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P35/00
Inventor 谭靖伟王群唐瑶
Owner SUZHOU KANGJU BIOTECHNOLOGY CO LTD
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