Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Solid forms of anti-EGFR-antibodies.

A form, antibody technology, applied in the direction of antibodies, antibody medical components, anti-animal/human immunoglobulin, etc., can solve problems such as errors and disadvantages

Inactive Publication Date: 2006-12-27
MERCK PATENT GMBH
View PDF14 Cites 3 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Freeze-drying methods for stabilizing protein formulations are disclosed, for example, in WO9300807 and WO9822136, however, a serious disadvantage of lyophilized formulations is that the user must reconstitute the lyophilizate before use, which represents a considerable source of error
This method is disadvantageous due to additional work in method development (ensuring stability during lyophilization), preparation (production cost duration) and e.g. validation due to the addition of an additional preparation method compared to liquid preparations

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0141] Example 1: Reagents and precipitation and / or crystallization conditions that can be used according to the invention

[0142] The following table contains in each case all possible hydrates, the relevant salts and derivatives of the compounds known to the person skilled in the art.

[0143] 1. Precipitation reagent

[0144] 1.1 Salt:

[0145] For example sodium acetate trihydrate, potassium chloride, sodium chloride, trisodium citrate dihydrate, dipotassium hydrogen phosphate, disodium hydrogen phosphate dihydrate, ammonium sulfate, ammonium acetate, ammonium bromide, ammonium chloride, trisodium citrate Ammonium, diammonium hydrogen citrate, ammonium dihydrogen phosphate, diammonium hydrogen phosphate, diammonium tartrate, citric acid monohydrate, imidazole, potassium acetate, potassium bromide, tripotassium citrate monohydrate, potassium dihydrogen phosphate, potassium sulfate , Magnesium acetate tetrahydrate, Magnesium bromide hexahydrate, Magnesium chloride hexahyd...

Embodiment 2

[0191] Example 2: Crystallization of Erbitux with Ammonium Sulfate TM

[0192] 500μl protein (20mg / ml)

[0193] 400 μl buffer (10 mM phosphate solution, pH 8.0)

[0194] 100 μl precipitant (saturated ammonium sulfate solution in 10 mM phosphate solution (pH 8.0))

[0195] The precipitation reagent was added in solution to the protein solution (batch method). After pipetting, the sample should be mixed by "hand shaking". This method can be performed at room temperature or at 4°C.

Embodiment 3

[0196] Example 3: Crystallization of Erbitux from ethanol TM

[0197] 500 μl protein (20 mg / ml in 10 mM citrate solution (pH 5.5))

[0198] 400 μl buffer (10 mM citrate, pH 5.5)

[0199] 100 μl precipitant (50% (v / v) ethanol in 10 mM citrate solution (pH 5.5)) or

[0200] 500 μl protein (20 mg / ml in 10 mM citrate solution (pH 5.5))

[0201] 500 μl precipitant (50% (v / v) ethanol in 10 mM citrate solution (pH 5.5))

[0202] The precipitation reagent was added in solution to the protein solution (batch method). After pipetting, the sample should be mixed by "hand shaking". This method can be performed at room temperature or at 4°C.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention relates to solid forms of antibodies against the EGF receptor, especially precipitates and crystals of monoclonal antibodies against the EGF receptor, especially preferably Mab C225 (Cetuximab) and Mab h425 (EMD 72000), that create biologically active antibody proteins by dissolution or suspension in an aqueous medium. Said proteins can be obtained by precipitation of the antibody dissolved or suspended in the aqueous medium and / or one of the variants or fragments thereof by means of a precipitation reagent. The invention also relates to pharmaceutical preparations containing at least one solid form of the cited antibody in a precipitated non-crystalline form, a precipitated crystalline form or a soluble or suspended form, and optionally carrier and / or auxiliary substances and / or other pharmaceutical active ingredients, and to a method for producing inventive solid forms of anti-EGFR-antibodies.

Description

Background of the invention [0001] The present invention relates to solid forms of antibodies against the EGF receptor (EGFR), in particular monoclonal antibodies against the EGF receptor, particularly preferably precipitates and crystals of Mab C225 (cetuximab) and Mabh425 (EMD72000), obtained by dissolving or suspending The biologically active antibody protein is produced in an aqueous or non-aqueous medium, and said solid form can be obtained by precipitating one of the antibody and / or its variants and / or fragments dissolved or suspended in an aqueous medium by a precipitating reagent. The present invention also relates to pharmaceutical formulations comprising at least one solid form of the above-mentioned antibodies in precipitated amorphous form, precipitated crystalline form or dissolved or suspended form, and optionally, excipients and / or adjuvants and / or or other pharmaceutically active ingredients, and relates to a method for preparing a solid form of an anti-EGFR an...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14C07K16/28A61P35/00A61K39/395
CPCC07K16/2863C07K2299/00A61K9/143A61K9/145A61K2039/505C30B7/00A61K39/39591C07K2317/24A61P35/00A61K9/14A61K39/395
Inventor S·马瑟斯H-C·马勒
Owner MERCK PATENT GMBH
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com