Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Separation or purification
Patent
1994-08-29
1998-02-03
Degen, Nancy
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
Separation or purification
530383, 514 12, C07K 118, C07K 14755, A61K 3837
Patent
active
057145903
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a process for recovering a highly pure virus-inactivated factor VIII from blood plasma or cryoprecipitate by means of anion exchanger chromatography.
In EP-A-0 238 701 there has been described a process for the production of a high-purity non-infectious antihemophilia factor, wherein fibrinogen, globulins, albumins and other interfering components are removed from the cryoprecipitate by means of an ethanol precipitation. The accumulation from the cryoprecipitate is necessary because the factor VIII is contained in the material only in very low amounts. However, this accumulation step impairs the AHF content in the final product. The processes hitherto known for the production of factor VIII do only produce very low amounts of active substance. Thus, by the application of the factor VIII produced via the conventional route, the patient will be burdened with large amounts of antigenic substances. This procedure is not without risk. Therefore, there have been plenty of attempts for further accumulating the factor VIII by separation operations. Thus, it has been attempted to obtain products having a higher specific activity by means of affinity chromatography using animal antibodies directed against factor VIII. However, this technique is very expensive and cost-intensive. On the other hand, this technique is also not quite unobjectionable, because also a certain amount of animal protein is always eluted from the column in each chromatographic separation.
European Patent Application No. 88 108 458.6 describes a process for producing a highly pure virus-free antihemophilia factor wherein a cryoprecipitate comprising factor VIII is treated with aluminum hydroxide and with biologically compatible organic solvents/detergents, in a preferred embodiment followed by further gel permeation chromatography using ion exchanger material. European Patent Application No. 88 118 478.2 describes a chromatography material based on copolymers of oligoethyleneglycols, glycidyl methacrylates and pentaerythritol dimethacrylates as being particularly suitable for producing a highly pure virus-free factor VIII.
WO 90/14886 describes a medium for separating proteins. The material disclosed therein describes a water-insoluble matrix bearing a plurality of polyamine moieties, said polyamine moieties comprising at least 3 basic nitrogen atoms, and said nitrogen atoms being separated by a chain of at least two carbon atoms positioned therebetween, with at least 5 of such carbon atoms being present in the case that each polyamine group has a total of 3 nitrogen atoms. This separating medium is suitable for at least a partial purification of factor VIII.
EP 0 343 275 A1 relates to a process for producing a highly pure antihemophilia factor (AHF or factor VIII) which, in purifying a cryoprecipitate, has been rendered virus-free by a treatment with biologically compatible organic solvents/detergents. The process is characterized in that the cryoprecipitate, prior to the removal of viruses therefrom, is thawed, is extracted with water containing from 1 to 3 U/ml of heparin at pH 6.5-7.5, is then admixed with an aluminum hydroxide suspension and, after cooling to from 10.degree. C. to 18.degree. C. and adjusting the pH value to from 6 to 7, is subjected to centrifugation and filtration and then further processed in a per se known manner. It is particularly advantageous that the sample, after the removal of the virusses, is subjected to gel permation chromatography on ion exchanger materials.
It is true, the process described in European Patent Application No. 88 108 458.6 provides an increase in the yield of factor VIII; however, the yield of the biologically active factor VIII still is not optimal.
Therefore, the technical problem defining the object of the invention is to provide a process which is capable of improving the recovery of a biologically active factor VIII from the sources of cyroprecipitate or blood plasma and ensures a more economical procedure.
This problem surprisingly is solved by a process a
REFERENCES:
patent: 4876241 (1989-10-01), Feldman et al.
Schwinn Horst
Stadler Monika
Degen Nancy
Octapharma AG
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