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Universal pharmaceutical formulation for recombined human serum albumin fusion proteins for injection

A technology of human serum albumin and fusion protein, which is applied in the field of production and manufacture of fusion protein formed by recombinant human serum albumin and therapeutic protein, and clinical therapeutic drugs

Active Publication Date: 2010-04-14
BEIJING MEIFUYUAN BIO PHARM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, different human serum albumin fusion proteins have completely different characteristics of their therapeutic proteins. Therefore, when using aqueous preparations, the differences of each fusion protein must be taken into account. Long-term preparation screening and stability inspections will take at least a minimum of time. It takes two years to obtain a complete and reliable data link

Method used

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  • Universal pharmaceutical formulation for recombined human serum albumin fusion proteins for injection
  • Universal pharmaceutical formulation for recombined human serum albumin fusion proteins for injection
  • Universal pharmaceutical formulation for recombined human serum albumin fusion proteins for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1: Performance of recombinant human serum albumin fusion protein in aqueous injection formulation

[0036] The formulations of different recombinant protein drugs when made into water preparations are obviously different, and form their own patented formulations. For example, the formulations of recombinant interferon α2a and interferon α2b are different, and the recombinant granulocyte stimulating factor injection water The formulation formulation is also different from that of recombinant interferon. The recombinant human granulocyte-stimulating factor injection NEUPOGEN finished water injection formulation of Amgen Company of the United States was used as a reference for formulation screening and comparison. Specifications of NEUPOGEN injection of American Amgen Company 0.5ml: each tube contains rhGCSF: 0.3mg; acetic acid: 0.295mg; mannitol: 25.0mg; polysorbate 80: 0.02mg; sodium salt: 0.0175mg. Therefore, on this basis, taking human serum albumin / granulocyt...

Embodiment 2

[0045] Example 2: Freeze-dried dosage form-research on the type of sugar added in the formula (sucrose, glucose, lactose, trehalose):

[0046] Aiming at the specificity of the molecular structure of the human serum albumin fusion protein, the present invention adds different kinds of sugars on the basis of the selected mannitol selected in preliminary prescription screening to investigate whether the stability of the finished freeze-dried preparation can be increased.

[0047] Select qualified human serum albumin / interferon α2a stock solution, and make 10mM PB, 0.3mg fusion protein, 4% mannitol, 1% sucrose (or trehalose, glucose, lactose respectively), 0.004% Tween 80, The preparation of pH 6.5 has a filling volume of 0.5 ml; at the same time, 10 mM PB, 0.3 mg fusion protein, 5% mannitol, and 0.004% Tween 80 are prepared in a loading volume of 0.5 ml for comparison. After lyophilization, a purity analysis was performed. The results showed that, for the protein purity of the f...

Embodiment 3

[0050] Embodiment 3: research on polysorbate 80 content in freeze-dried dosage form-formulation

[0051] Aggregates are readily formed against recombinant human serum albumin fusion proteins. Taking recombinant human serum albumin / granulocyte stimulating factor fusion protein (rHSA / GCSF) as an example, a detailed prescription screening study was carried out. There is a free sulfhydryl group on the GCSF molecule. When two GCSF molecules meet, they can form a dimer, which cannot be separated by conventional methods, but can only be separated by complete denaturation. The formation of aggregates greatly reduces the biological activity of the prepared protein. During the production and preparation of rhGCSF, this kind of polymer is completely denatured and then refolded (of course, the yield will decrease). After the human serum albumin fusion protein is formed, it can no longer be resolved by denaturation-refolding. Recombinant human serum albumin fusion protein itself has 17 ...

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Abstract

The invention provides a pharmaceutical formulation for manufacturing a clinical medicament for recombined human serum albumin / therapeutic protein fusion proteins for injection, which is universal, simple and extremely effective. The pharmaceutical formulation and a freeze-drying process include that a clinical therapeutic injecting injection is formed by using single effective formulation to prepare, freeze and dry different recombined human serum albumin fusion proteins. Frozen and dried injection is capable of decreasing the possibility of forming fractured dissociative human serum albumins, dissociative therapeutic protein fragments and fusion protein polymers. Products can be stored in a long period of time and are not easy to be decomposed or degenerated; the products have accurate dose, fine appearance, good stability and high safety and can greatly improve the safety of pharmacy. The pharmaceutical formulation and production process steps are simple and unique, high in quality and easy in industrialization, and pharmaceutics has the greatest advantages that no allergy or toxic and side effects are produced to human bodies and the like.

Description

[0001] The present invention is US patents US7,244,833B2, US7,442,371B2 and US7,572,437B2, Chinese invention patent ZL02142881.6, Chinese invention patent ZL200410042814.8, Chinese invention patent ZL200410057313.7, Chinese invention patent application CN101260145A, Chinese invention patent Patent application CN1011121753A and Chinese invention patent application CN101172091A, and the continuation application of the international PCT invention patent application WO2009 / 043277A1. technical field [0002] The invention belongs to the technical field of manufacturing biological products for treatment and prevention, in particular to the production and manufacture of fusion proteins formed by recombinant human serum albumin and therapeutic proteins for clinical therapeutic drugs. The present invention uses specific preparation formulations and production process steps, especially the fusion protein is applied to the manufacture of clinical medicine with specific, simple and effecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/38A61K38/16A61K47/36A61K47/34A61K47/26A61P43/00A61K47/64
Inventor 于在林富岩韩国代月函韩旭邢静富俞淞杨小楠万园
Owner BEIJING MEIFUYUAN BIO PHARM TECH
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