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Injection preparation of anti-epidermal growth factor receptor monoclonal antibody

A technology of epidermal growth factor and monoclonal antibody, which is applied in the direction of antibodies, anti-inflammatory agents, skin diseases, etc., can solve the problems of no reports, etc., and achieve good stability, good solubility and stability, and good application prospects

Active Publication Date: 2021-06-22
SHANGHAI JMT BIO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there is no report on the pharmaceutical preparations of antibody BA03, especially the injection preparations.

Method used

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  • Injection preparation of anti-epidermal growth factor receptor monoclonal antibody
  • Injection preparation of anti-epidermal growth factor receptor monoclonal antibody
  • Injection preparation of anti-epidermal growth factor receptor monoclonal antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The preparation of embodiment 1 antibody

[0051] For the sequence information and preparation method of the antibody, please refer to the antibody BA03 disclosed in Chinese Patent Application Publication CN103772504A. details as follows:

[0052] The heavy chain variable region sequence of the antibody is:

[0053] QVQLQESGPGLVKPSETLSLTCTVSGFSLSNYDVHWVRQAPGKGLEWLGVIWSGGNTDYNTPFTSRLTISVDTSKNQFSLKLSSVTAADTAVYYCARALDYYDYEFAYWGQGTLVTVSS (SEQ ID NO: 1)

[0054] The light chain variable region sequence of the antibody is:

[0055] EIVLTQSPDFQSVTPKEKVTITCRASQSIGTNIHWYQQKPDQSPKLLIKYASESISGIPSRFSGSGSGTDFLTINSLEAEDAATYYCQQNNEWPTSFGQGTKLEIK (SEQ ID NO: 2)

[0056] (1) According to the heavy chain variable region sequence and the light chain variable region sequence of the antibody, respectively design and synthesize PCR primer oligonucleotide fragments encoding the heavy chain and light chain variable region sequences, and introduce the required restriction enzymes during synt...

Embodiment 2

[0067] Example 2 Screening of buffer and pH combination in antibody BA03 injection preparation

[0068] 1) The purpose of this example is to screen the pH and buffer system suitable for antibody BA03. To this end, we designed 7 buffer systems, respectively 20mM citric acid system (containing citric acid and sodium citrate with a total concentration of 20mM), pH 6.0; 20mM histidine system (containing a total concentration of 20mM histidine and histidine hydrochloride), pH 5.5, 6.0, 6.5; and 20mM phosphoric acid system (containing a total concentration of 20mM phosphoric acid, sodium dihydrogen phosphate and disodium hydrogen phosphate), pH 6.0, 6.5, 7.0. Since the 20mM pH6.5 histidine system and the 20mM pH6.5 phosphoric acid system precipitated during the ultrafiltration process, the protein precipitated out, so 0.05% PS80 and 0.87% sodium chloride solution were added to redissolve the protein. See Table 1 for details. In each buffer system, the antibody concentration was 10...

Embodiment 3

[0089] Example 3 Screening of other adjuvants in the antibody BA03 injection preparation

[0090] 1) Screening program for excipients

[0091] According to the buffer system screening results, we have selected 20mM histidine buffer system (total concentration is 20mM histidine and histidine hydrochloride, pH5.5) and 20mM citric acid buffer system (total concentration is 20mM citric acid and sodium citrate, pH6.0) as the buffer system designed for the prescription. In addition, in the previous buffer screening, we did not investigate the pH below 5.5. In the formulation screening, we added the 20mM histidine system with pH 4.5 and pH 5.0 respectively (total concentration of 20mM histidine and histidine Amino acid hydrochloride) to ensure that the final pH selected is the optimum pH. The selection and amount and range of auxiliary materials are 0-5% sucrose, 0-5% trehalose, 0-0.05% Tween 80, 0-0.87% sodium chloride and 0-2% glycine. The excipients and prescription screening s...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and relates to an injection preparation of a monoclonal antibody, in particular to an injection preparation of an anti-epithelial growth factor receptor (EGFR) monoclonal antibody. The present invention also relates to the use of the injection preparation for the preparation of drugs for the prevention and / or treatment of diseases related to EGFR activity disorders or disorders (such as tumors and / or tumor metastasis, diseases related to angiogenesis, non-specific inflammation) . The anti-EGFR monoclonal antibody injection preparation of the present invention exhibits good stability in tests such as shaking, 25°C and 40°C high-temperature accelerated tests, and 2-8°C long-term storage stability, and has good application prospects.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an injection preparation of a monoclonal antibody, in particular to an injection preparation of an anti-epithelial growth factor receptor (EGFR) monoclonal antibody. The present invention also relates to the use of the injection preparation for preparing medicines for preventing and / or treating tumors and / or tumor metastasis. Background technique [0002] Developments in the field of biotechnology have enabled the preparation of a series of proteins for pharmaceutical applications by recombinant DNA technology over the past two decades. Protein medicines such as monoclonal antibodies can be used eg in tumor therapy, eg for specific immunotherapy or tumor vaccination. Therapeutic proteins are structurally larger and more complex than conventional organic and inorganic active ingredients, with complex three-dimensional structures and many functional groups that can affect ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61K9/08A61P35/00A61P35/02A61P17/06A61P17/00A61P19/02A61P29/00A61P37/08A61P15/00A61P13/08A61P37/02
CPCA61K9/0019A61K9/08A61K2039/505C07K16/2863C07K2317/56
Inventor 张甘良徐红秦民民张哲如
Owner SHANGHAI JMT BIO INC
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