公开(公告)号：EP2900262A1

公开(公告)日：2015-08-05

申请号：EP13770475.5

申请日：2013-09-26

申请人： Octapharma AG

发明人： HEGER, Andrea ,  SVAE, Tor-Einar ,  ROEMISCH, Juergen ,  ZOECHLING, Alfred

IPC分类号： A61K39/395 ,  A61K47/00 ,  A61K9/00 ,  G01N33/49

CPC分类号： A61K47/183 ,  A61K39/39591 ,  C07K16/00 ,  C07K16/18 ,  G01N33/49 ,  G01N33/80

摘要： A non-hemolytic acidic composition comprising an immunoglobulin selected from immunoglobulin A, immunoglobulin G or immunoglobulin M at a pH value in the range of 4.65 to 5.7 comprising one or more excipients selected from amino acids, sugars and sugar alcohols in a concentration range of 100-350 mmol/l, in particular 200-350 mmol/l, characterized in that it displays an optical density (OD) in the range of 0.14 to -0.1 when the OD is determined in a spectrophotometer at 414 nm at a film thickness of 0.825 mm; and its use in an assay for determination of the hemolytic potential of intravenously applied pharmaceuticals and compositions and preparations displaying a reduced potential of hemolysis when being applied intravenously.

公开(公告)号：EP2627348A1

公开(公告)日：2013-08-21

申请号：EP11770100.3

申请日：2011-10-13

申请人： Octapharma AG

发明人： BRANDSTAETTER, Hubert ,  SCHULZ, Petra ,  ROEMISCH, Juergen

IPC分类号： A61K38/17 ,  C07K1/18 ,  C07K14/435

CPC分类号： C07K14/472 ,  A61K38/1709 ,  C07K1/36 ,  C07K14/435 ,  C07K14/47

摘要： A method for purification of complement Factor H from a complement Factor H containing source such as blood or blood plasma, in particular a caprylate precipitate of a Factor H containing source, which is e.g. obtained by addition of caprylate ions to fractions of blood or plasma, comprising the steps of: a)providing a Factor H containing source, in particular reconstitution of caprylate precipitate to provide a complement Factor H containing solution; b)performing a cation exchange chromatography in particular as first chromatographic step; c)performing an anion exchange chromatography; d)performing a hydroxyl apatite chromatography; e)followed by ultra/diafiltration to obtain a complement Factor H concentrate.