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Detection and quantitation of cyclodextrins

A technology of cyclodextrin and detection limit, which is applied in the field of detection and quantification of cyclodextrin, and can solve problems such as the inability to separate cyclodextrin

Inactive Publication Date: 2007-11-14
BIOGEN MA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These techniques are not effective in isolating cyclodextrins from protein compositions

Method used

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  • Detection and quantitation of cyclodextrins
  • Detection and quantitation of cyclodextrins
  • Detection and quantitation of cyclodextrins

Examples

Experimental program
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Embodiment 1

[0047] Natilizumab is recombinantly expressed in cholesterol auxotrophic cells cultured in the presence of approximately 720 mg / L MBCD. Antibodies are purified in three conventional chromatography steps. A method was developed for determining the amount of MBCD present after each purification step and in the final antibody preparation (suitable for pharmaceutical applications).

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Abstract

The invention relates to the detection and quantitation of cyclodextrins and cyclodextrin derivatives in solutions comprising a protein. The invention further relates to methods of evaluating pharmaceutical preparations for the presence of residual cyclodextrins.

Description

technical field [0001] The present invention relates to the detection and quantification of cyclodextrins and cyclodextrin derivatives in protein-containing solutions. The invention further relates to methods of assessing the presence of residual cyclodextrins in pharmaceutical formulations. Background technique [0002] Cyclodextrins are cyclic polysaccharides usually composed of six (α-cyclodextrin), seven (β-cyclodextrin) or eight (γ-cyclodextrin) glucose units composed of The α-1,4-glucosidic linkages form cyclic rings. These glucose units form a chair conformation with all secondary hydroxyl groups on one side of the ring and all primary hydroxyl groups on the other side. As a result, its outer surface is hydrophilic, making the cyclodextrin water soluble. In contrast, the cavities of cyclodextrins are hydrophobic because they are composed of C 3 and C 5 Atomic hydrogens and ether-like oxygens are linked. This structure allows cyclodextrins to form inclusion compl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53
CPCG01N2030/8836C08B37/0015Y10T436/143333G01N2030/8813G01N33/53
Inventor 佐兰·索希奇鲁林·奎兰詹姆斯·埃亨罗宾·姆哈特雷
Owner BIOGEN MA INC