摘要:
A process for manufacturing of a Factor VIII product having a ratio of FVIII:C/FVIII:Ag of at least 0.7 in the Factor VIII product by using chromatography wherein at least one chromatographic step is performed by means of employing; An affinity chromatography resin having an affinity for specifically binding of Factor VIII which is effected by an affinity ligand which is immobilised on the affinity chromatography resin, said affinity ligand is a 13 kD yeast derived Fab antibody fragment directed to the Factor VIII molecule. An anionic chromatography resin. A size exclusion resin. A Factor VIII product obtainable according to the process with a monomer content of >98% for treatment of haemophilia and avoiding formation of inhibitors.
摘要:
A process of purifying the Growth Factor Protein G-CSF (Granulocyte Colony Stimulating Factor) in a purification sequence employing chromatography, comprising binding the G-CSF to Capto MMC™, which is a multimodal resin that comprises a negatively charged 2-(benzoylamino) butanoic acid ligand, at a pH from 4 to 6.2; and eluting the G-CSF at a pH greater than 6.3.
摘要:
A method for stabilising a human blood protein or human blood plasma protein with a molecular weight of >10 KDa by adding melezitose to a solution comprising the human blood protein or human blood plasma protein with a molecular weight of >10 KDa.
摘要:
The present invention relates to a method or process for the manufacture of a virus and prion save native fibrinogen concentrate of high purity and low amounts of fibrinopeptide A and fibronectin.
摘要:
A process for isolation and purification of a target protein by chromatography wherein the chromatography removes or depletes prions (PrPSC), comprising the steps of contacting a potentially PrPSC contaminated sample comprising a target protein with a multimodal chromatographic material; setting buffer conditions so that the target protein is bound to the multimodal chromatographic material and whereas PrPSC is not binding to the multimodal chromatographic material; followed by elution of the target protein. a process for isolation and purification of a target protein free of prion protein (prpSC).
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.
摘要:
A method for inactivation or removal of coagulation factors FII, FVII, FVIIa, FIX, FIXa, FX, FXI and FXIa in or from protein containing solutions obtained from blood, blood plasma, plasma fractions or by recombinant means wherein the protein containing solution is contacted with an organic acid or its salt while being stirred.
摘要:
The present invention relates to a method or process for the manufacture of a virus and prion save native fibrinogen concentrate of high purity and low amounts of fibrinopeptide A and fibronectin.
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.
摘要:
A process of freeze drying of an essentially aqueous solution comprising at least one first step having a first temperature and pressure level (i.e. primary drying phase) and at least one second step having a second temperature and pressure level (i.e. secondary drying phase) following the first step, wherein in the secondary drying phase limited desorption energy input is applied.