Chemistry: molecular biology and microbiology – Maintaining blood or sperm in a physiologically active state...
Patent
1998-02-19
1999-12-28
Stucker, Jeffrey
Chemistry: molecular biology and microbiology
Maintaining blood or sperm in a physiologically active state...
4241761, 424529, 424530, 424531, A01N 102
Patent
active
060079797
DESCRIPTION:
BRIEF SUMMARY
The object of the present invention is a method for reduction of the viral infectiousness of potentially infectious material, such as human or animal body fluids or fractions derived therefrom from which biologically active substances can be isolated, wherein the infectiousness is due to non-lipid-coated viruses.
Potentially infectious materials, such as human or animal body fluids, are an important pool of biologically active and hence valuable substances. However, isolation of the biologically active substances from these sources is not unproblematic which has become apparent in the past especially in the case of HIV transmission by preparations recovered from blood plasma. Thus, an essential requirement for the administration of such preparations is their being virus-proof, i.e. no infectious particles must be transmitted with these preparations.
Viruses which are lipid-coated are effectively inactivated by treatment with non-ionic biocompatible solvents and detergents. Such methods are described in EP 0 131 740. Non-lipid-coated viruses are not adequately inactivated by such treatment. WO 94/17834 reports that an adequate inactivation of non-lipid-coated viruses, such as hepatitis A viruses, for instance, is achieved only by combined treatment of a solution by non-ionic detergents and heating thereof at 60 to 65.degree. C. However, the heat treatment period being as long as more than 5 to 30 hours represents a drawback since the valuable biologically active substances are predominantly proteins, the complex structure of which is altered or even destroyed by such heat treatment. This involves reduction of the activity of the corresponding fractions. Thus, the known methods result in a reduction of the potential recovery of these products.
DE 40 21 542 A1 discloses a combined process for the preparation of non-infectious blood plasma. The plasma is treated with non-ionic tensides and prior to removal of the lipid layer are added biologically compatible lipids. Thereafter, the lipid phase is separated and the non-ionic tenside is removed by solid phase extraction on hydrophobic materials.
EP-A 0 239 859 is concerned with a method of removing lipid soluble process chemicals from biological materials containing the lipid soluble process chemicals. The method comprises bringing the biological materials containing the lipid soluble process chemicals into contact with an effective amount of a naturally occurring oil extracted from a plant or an animal or a synthetic compound of similar chemical structure. Agitating the resulted mixture, separating out an upper-phase and a lower-phase by the sedimentation and decanting the upper-phase. The method is particularly useful for producing physiologically acceptable plasma relatively virus free.
European patent application EP-A 0 525 502 discloses a process for manufacturing of virus inactivated immunoglobulin solutions for intravenous application. The immunoglobulin is treated with non-ionic tensides which are removed subsequently by solid phase extraction on hydrophobic materials.
European patent application EP-A 0 112 563 discloses a solvent treatment of plasma protein products. Plasma protein products are slurried in a dry state with an organic solvent to remove virus infectivity.
WO-A 83/04371 discloses a method of inactivating a lipid virus in a protein carrier selected from the group consisting of hepatitis B virus (HBV) and non-A, non-B hepatitis (NANBH) by contacting said virus for an extended period of time and ambient temperature with a halohydrocarbon treating agent preferably chloroform in an amount of 5% v/v to 50/50% v/v.
The problem underlying the invention is to provide a method by which a reduction of the infectiousness of non-lipid-coated viruses contained in potentially infectious or actually infectious materials can be achieved.
Surprisingly, it has been shown that infectiousness due to non-lipid-coated viruses in potentially infectious materials can be reduced by treatment of such materials with a hydrophobic phase capable of forming a two-phase
REFERENCES:
patent: 4789545 (1988-12-01), Woods et al.
patent: 5648472 (1997-07-01), Gehringer et al.
Biesert Lothar
Marguerre Wolfgang
Schwinn Horst
Octapharma AG
Stucker Jeffrey
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