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US 7,887,797 B2Granted
Immunoglobulin fractions
AssigneeCSL Behring GmbH
InventorsSylvia Miescher, Reinhard Franz Bolli
Life of this patent
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Abstract
The present invention relates to novel pharmaceutical compositions comprising fractions of human immunoglobulin preparations, novel applications of these compositions and a method for manufacturing the compositions.
Claims16
An isolated fraction of human antibodies from a heterogeneous human donor population, obtained by a method comprising the following steps:
- (a) subjecting a human antibody preparation from a heterogeneous donor population to a size fractionation,
- (b) recovering a fraction of dimeric antibodies, wherein purity of the dimeric antibody fraction is at least 75% and wherein purity analysis is carried out immediately after size fractionation,
- (c) monomerizing the dimeric antibodies having an apparent molecular weight of about 300 kDa to produce remonomerized antibodies, and
- (d) optionally admixing the remonomerized antibodies with a pharmaceutically acceptable carrier or excipient.
1 more element
A method for manufacturing a pharmaceutical composition comprising a fraction of human antibodies from a heterogeneous human donor population comprising:
- (a) subjecting a human antibody preparation from a heterogeneous donor population to a size fractionation;
- (b) recovering a fraction of dimeric antibodies, wherein purity of the dimeric antibody fraction is at least 75% and wherein purity analysis is carried out immediately after size fractionation,
- (c) monomerizing the dimeric antibodies having an apparent molecular weight of about 300 kDa to produce remonomerized antibodies, and
- (d) optionally admixing the remonomerized antibodies with a pharmaceutically acceptable carrier or excipient.
1 more element
Dependencies are inferred from the claim text.