Protein stabilization in solution

一种蛋白质、氧化硅涂层的技术，应用在溶液中蛋白质的稳定化领域，能够解决费事等问题

Inactive Publication Date: 2006-05-31
NOVO NORDISK HEALTH CARE AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, due to the greater propensity to form aggregates as protein concentration increases, maintaining the stability of protein-concentrated liquid formulations is generally more laborious than more dilute liquid formulations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0045] As already indicated above, the first aspect of the present invention relates to the use of a material selected from the group consisting of silica-coated glass, siloxane-coated glass, acyclic olefin polymers, cycloolefin polymers and cycloolefin polymers as the inner wall material of the container. Olefin / linear olefin copolymer; the container comprises (1) a wall portion and (2) one or more closed portions not forming part of the wall portion, and contains gamma-carboxyglutamine having 9-12 Gla residues Preparation of proteins with acid (Gla) domains.

[0046] Closely related to this latter aspect of the invention, a further aspect of the invention provides at least partially filled containers having as container inner wall material a material selected from those immediately above, said container comprising (1) a wall portion and (2) preparations of one or more occluded segments that do not form part of the wall segment and that contain a gamma-carboxyglutamic acid (G...

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PUM

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Abstract

Provided are storage containers for proteinaceous pharmaceutical compositions which are characterized in, among other things, comprising (i) a wall portion, wherein an inner wall material thereof is selected from silica-coated glass, silicone-coated glass, polymers of non-cyclic olefins, cycloolefin polymers and cycloolefin / linear olefin copolymers and (ii) one or more closure portions not constituting part of the wall portion, and which contains a formulation of a protein. Also provided are new methods of storing proteinaceous compositions. In one aspect, the stored protein is characterized as having an amino-terminal gamma-carboxyglutamic acid (Gla) domain with 9-12 Gla residues.

Description

field of invention [0001] In particular, the present invention relates to the use of an inner wall material for containing or storing, in particular, vitamin K-dependent coagulation proteins, such as Factor VIIa, of pharmaceutical formulations, which reduces the occurrence of dimerization, oligomerization and and / or the propensity or minimization of multimerization and / or other possible processes. In particular, the present invention relates to the containment and temporary storage of protein liquid formulations, especially aqueous liquid formulations. Background of the invention [0002] In the context of the present invention, groups of proteins known to be vitamin K-dependent prothrombin proteins are of particular interest, of which Factor VII (FVII) is an example. The proteins in question constitute an important class of coagulation factors involved in the naturally occurring physiological process known to be hemostasis, and they all have a similar protein domain struct...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48B65D1/02
CPCA61K38/4846A61P7/04C08F110/00B65D1/02A61K38/48
Inventor M·B·詹森B·L·汉森T·科恩费尔特K·K·雅克布森
Owner NOVO NORDISK HEALTH CARE AG
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