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Protein preparation and preparation method thereof

A protein preparation and protein technology, applied in the direction of peptide/protein components, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of protein preparation production process, complex components, affecting the quality and stability of protein preparations, etc. Achieve the effect of good stability, simple process and excellent properties

Pending Publication Date: 2021-01-12
BEIJING C & N INT SCI TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The presence of isomers may affect the quality and stability of protein preparations
The composition of current protein preparations is relatively complex and contains many types of auxiliary ingredients, such as buffers, surfactants, structural protection agents, etc., and a wide variety of auxiliary ingredients will have a significant impact on the production process of protein preparations

Method used

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  • Protein preparation and preparation method thereof
  • Protein preparation and preparation method thereof
  • Protein preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Embodiment 1: Preparation of GLP-1-Fc fusion protein liquid preparation

[0063] 1. Preparation of preparation preparation solution:

[0064] Dosing in the container in the following order: water for injection → disodium hydrogen phosphate-sodium dihydrogen phosphate → arginine → methionine → sucrose.

[0065] During the addition of materials, the liquid is in a stirring state.

[0066] After the material is added and completely dissolved, the pH value of the solution should be tested, and the solution should be adjusted to pH = 6.0±1.5 (according to the isoelectric point setting of the protein) with hydrochloric acid, then add water for injection to the predetermined volume in the container, and continue to stir until uniform , to obtain the formulation solution.

[0067] 2. Preparation of liquid preparations:

[0068] A certain volume of formulation formulation is added to the container. Add a stir bar to the vessel and place it on a magnetic stirrer for stirring....

Embodiment 2

[0069] Embodiment 2: Stability test of GLP-1-Fc fusion protein liquid preparation

[0070] This example tests the stability properties of the GLP-1-Fc fusion protein liquid preparation obtained in Example 1, including long-term storage conditions (2-8°C), repeated freeze-thaw conditions, and stability under other conditions. The specific results are as follows Table 1 to Table 3 are shown.

[0071] Table 1. Stability data for long-term storage conditions (2-8°C)

[0072]

[0073] Table 2. Repeated freeze-thaw stability data

[0074]

[0075] Table 3. Other Stability Test Data

[0076]

Embodiment 3

[0077] Example 3: Stability test of GLP-1-Fc fusion protein liquid preparation and similar preparations

[0078] This embodiment compares the GLP-1-Fc fusion protein liquid preparation obtained in Example 1 with similar commercial products (dulaglutide, its preparation formula is: 10mM citrate buffer solution, 4.6% mannitol and 0.02% Tween 80 ) stability properties, the specific results are shown in Table 4.

[0079] Table 4. Other Stability Test Data

[0080]

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Abstract

The application provides a protein preparation. The protein preparation comprises a pH regulator, a structural protective agent and an osmotic pressure regulator, and is free of a surfactant. The application further provides a method for preparing a protein preparation. The method comprises the following steps of: (a) providing an aqueous solution comprising the pH regulator, the structural protective agent, and the osmotic pressure regulator and free of the surfactant; and (b) adding a protein to the aqueous solution.

Description

[0001] field of invention [0002] The present application generally relates to the field of biological products, and specifically, the present application provides protein preparations and preparation methods thereof. [0003] Background of the invention [0004] Protein preparations have been widely used in research and process production. Recombinant proteins are used to manufacture various biological products, especially protein drugs, due to their strong operability and high yield. Fusion proteins usually require artificial structural design, so it is often necessary to use recombinant expression technology. The molecular structure and production process of recombinant fusion proteins are relatively complex, so their heterogeneity is ubiquitous, such as oxidation type, deamidation type, disulfide bond mismatch, disulfide bond break, lysine residue glycation isomers, etc. Even after the purification process, there may still be a variety of variants with different post-tra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/02A61K47/18A61K47/26A61K38/26A61K47/68A61P3/10
CPCA61K9/19A61K47/02A61K47/183A61K47/26A61K38/26A61K47/68A61P3/10
Inventor 宋海峰肖志华魏开华王伊付洁高柳村钱尼良冯红茹万徳有杨利崔新玲
Owner BEIJING C & N INT SCI TECH