NOVEL PROINSULIN GLARGINE AND METHOD FOR PREPARING INSULIN GLARGINE THEREFROM
The present invention discloses novel proinsulin glargine and a method for preparing insulin glargine therefrom, and belongs to the technical field of recombinant protein preparation. According to the present invention, a sequence of the proinsulin glargine containing SOD fusion peptide subjected to site-directed mutagenesis and "0 C peptide" is designed; recombinant Escherichia coli engineering bacteria for expressing insulin glargine are constructed; insulin glargine fusion protein in a form of an inclusion body is expressed by inducing the engineering bacteria; and denaturation, renaturation, modification, enzyme digestion, separation and purification are carried out to obtain a mature insulin glargine active pharmaceutical ingredient. According to the present invention, the SOD fusion peptide sequence is mutated to enhance the fermentation yield of the insulin glargine by 75%; and a "0 C peptide" strategy is adopted to avoid remaining of C-peptide residues and reduce the quality loss and miscleavage impurities in the enzyme digestion transformation. The purity of the insulin glargine active pharmaceutical ingredient prepared in the present invention is up to 99.9%, and the maximum single impurity content is controlled at 0.05%..
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Patent| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Europäisches Patentamt - (2024) vom: 06. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
TANG CHUANGEN [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
Source: www.epo.org (no modifications made), First posted: 2024-03-06, Last update posted on www.tib.eu: 2024-03-19, Last updated: 2024-03-22 |
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| Patentnummer: |
EP4206220 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
EPA001009273 |
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| 245 | 1 | 0 | |a NOVEL PROINSULIN GLARGINE AND METHOD FOR PREPARING INSULIN GLARGINE THEREFROM |
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| 520 | |a The present invention discloses novel proinsulin glargine and a method for preparing insulin glargine therefrom, and belongs to the technical field of recombinant protein preparation. According to the present invention, a sequence of the proinsulin glargine containing SOD fusion peptide subjected to site-directed mutagenesis and "0 C peptide" is designed; recombinant Escherichia coli engineering bacteria for expressing insulin glargine are constructed; insulin glargine fusion protein in a form of an inclusion body is expressed by inducing the engineering bacteria; and denaturation, renaturation, modification, enzyme digestion, separation and purification are carried out to obtain a mature insulin glargine active pharmaceutical ingredient. According to the present invention, the SOD fusion peptide sequence is mutated to enhance the fermentation yield of the insulin glargine by 75%; and a "0 C peptide" strategy is adopted to avoid remaining of C-peptide residues and reduce the quality loss and miscleavage impurities in the enzyme digestion transformation. The purity of the insulin glargine active pharmaceutical ingredient prepared in the present invention is up to 99.9%, and the maximum single impurity content is controlled at 0.05%. | ||
| 650 | 4 | |a bio | |
| 650 | 4 | |a A61K: Preparations for medical, dental, or toilet purposes (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms a61j0003000000;chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles a61l; soap compositions c11d) | |
| 650 | 4 | |a C12N: Microorganisms or enzymes; compositions thereof; propagating, preserving, or maintaining microorganisms; mutation or genetic engineering; culture media (microbiological testing media c12q0001000000) | |
| 650 | 4 | |a C07K: Peptides (peptides containing β-lactam rings c07d;cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, c07d;ergot alkaloids of the cyclic peptide type c07d0519020000; single cell proteins, enzymes c12n;genetic engineering processes for obtaining peptides c12n0015000000) | |
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