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Protein medicinal preparation containing beta-glucan as auxiliary material

A pharmaceutical preparation, dextran technology, applied in the biological field, can solve the problems that sucrose is difficult to form a glass state and has no protective effect, and achieve the effects of preventing protein aggregation, enhancing stability, and good water holding capacity

Inactive Publication Date: 2016-07-13
SUZHOU KANGJU BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, sucrose is difficult to form a glass state at high temperature and cannot protect

Method used

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  • Protein medicinal preparation containing beta-glucan as auxiliary material
  • Protein medicinal preparation containing beta-glucan as auxiliary material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Preparation of soluble β-glucan

[0038] Saccharomyces cerevisiae (Saccharomycescerevisiae, ATCC7752) was used for fermentation and culture to obtain yeast cells.

[0039] Specifically, Saccharomyces cerevisiae is gradually expanded to 1000L-scale fermentation production through shake flask culture. Yeast grows in carbon sources, nitrogen sources, vitamins, inorganic salts and trace elements, and defoamers can also be added to control foam, such as defoamer Antifoam204.

[0040] It is produced in the culture mode of deep aeration combined with fed feeding, and the carbon source glucose or glycerol is selected as the limiting substrate to control fed feeding. During production and fermentation, samples are taken regularly to determine the optical density OD of the fermentation broth 600nm , when OD 600nm After reaching a stable value or a certain value, the fermentation production is terminated. After yeast fermentation and cultivation, use a plate and fra...

Embodiment 2

[0045] Example 2: Liquid and lyophilized pharmaceutical product formulations for parenteral administration according to the invention as follows;

[0046] 1. Preparation of liquid formulations

[0047] Exchange the trastuzumab solution into the corresponding formulation buffer (e.g. 20 mM L-histidine, pH 6.0 or 20 mM L-histidine, 0.02% w / v polysorbate) by ultrafiltration / diafiltration method 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. The stabilizer soluble beta-glucan can be added in dissolved form and the surfactant can be added in solution. Finally, the same volume of trastuzumab preparation solution was mixed evenly.

[0048] All formulations were sterilized by sterile filtration through a 0.22 μm filter and dispensed under aseptic conditions into sterile glass vials and sealed with rubber stoppers and aluminum caps. These formulations...

Embodiment 3

[0054] Example 3: Trastuzumab (Trastuzumab) and Pertuzumab (Pertuzumab) Antibody Combination Liquid Formulation

[0055] Formula: 25mg / ml trastuzumab, 25mg / ml pertuzumab, 20mML-histidine, 2% soluble β-glucan, 0.02% Tween20, pH6.5; specific steps are shown in Table 2 ,

[0056] Table 2: Stability Data for Trastuzumab and Pertuzumab Antibody Combination Liquid Formulations

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Abstract

The invention discloses a protein medicinal preparation containing beta-glucan as an auxiliary material. The preparation is prepared from at least one protein medicinal material having a concentration of 10-300mg / ml, a buffer agent having a salt concentration of 1-120mM and pH value of 6.5+ / -1.5, a stabilizing agent which is beta-glucan and has a concentration of 0.1-10 percent, and a nonionic surfactant having a concentration of 0.01-0.1 percent. The beta-glucan is a high-molecular polymer formed by connecting monomer beta-D-glucopyranose through beta-(1-3) and beta-(1-6). Soluble beta-glucan has a water-absorbing swelling capability, has an excellent water binding capacity in water, can form a high-viscosity solution after being dissolved in water, can be used for effectively preventing protein aggregation and enhancing the protein stability, and can be used as a protecting agent of protein medicines.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a protein drug which can be used in various liquids or freeze-dried preparations. The invention also relates to β-glucan as a stabilizer and optionally contains at least one protein drug , Other buffers, formulations of surfactants. Background technique [0002] With the development of modern bioengineering technology, more and more proteins are used in medicine, including peptides, enzymes, monoclonal antibodies, etc. But protein molecules are larger and more complex than traditional organic or inorganic molecules. Some proteins, such as polypeptides, have multiple functional groups in addition to their three-dimensional structure. Therefore, higher requirements are put forward for the preparation of such protein drugs. The preparation must at least maintain the integrity of the overall conformation of the protein core amino acid sequence and protect the functional gro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/36A61K9/08A61K9/19A61K38/00A61K39/395A61K38/43A61K38/47
CPCA61K47/36A61K9/08A61K9/19A61K38/00A61K38/43A61K38/47A61K39/395
Inventor 孙玉华王征谭靖伟
Owner SUZHOU KANGJU BIOTECHNOLOGY CO LTD
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