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US4640834A Expired / Lapsed US ⏱️ 0.0 years remaining

Method of inactivating reproducible filterable pathogens in blood products as well as a method of producing blood products

Assignee: Oesterreichisches Institut fuer Haemoderivate
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Filing: 1985-02-26
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Granted: 1987-02-03
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Expires: 2005-02-26
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Abstract

Abstract A method of inactivating viruses in blood products is described, wherein the blood products are heat-treated in a humid or in a solid state in the presence of inorganic or organic hydroxyl group-containing compounds having an H+-dissociation constant of <10-11 in a concentration of more than 0.05 (5% by weight) and less than 0.70 (70% by weight). The hydroxyl group-containing compounds may be water, methanol, ethanol or mannitol. The temperature may amount up to 121 DEG C., the heat treatment may last from 1 s to 100 h. The inactivation method may be applied for producing blood products selected from enzymes, proenzymes including coagulation factors, enzyme inhibitors, immunoglobulins, albumin, plasminogen, fibrinogen, fibronectin or plasma, the inactivation destroying any reproducible filterable pathogens that might be present.

Inventors

  • 👤 Johann Eibl
  • 👤 Otto Schwarz
  • 👤 Fritz Elsinger
  • 👤 Gunter Wober
  • 👤 Anton Philapitsch
  • 👤 Yendra Linnau
  • 👤 Friedrich Dorner
  • 👤 Karl Trambauer
  • 👤 Wolfgang Frechinger

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-03 10:48
CPC Classifications
A; A61; A61K; A61K35/00; A61K35/12; A61K35/14; A61K35/16; A61L; A61L2/00; A61L2/02; A61L2/04; A61L2103/00; A61L2103/05

Claims Analysis

Total Claims: 23
Claim 1
Independent Claim 129 words
A method of inactivating viable filterable pathogens in a blood product, which comprises: placing said blood product in a solid state in a closeable treating zone in the presence of a hydroxyl group-containing compound selected from the group consisting of water, methanol, ethanol, and mixtures thereof, and closing said treating zone; maintaining the content of said hydroxyl group-containing compound in said treating zone to provide said blood product with a content of hydroxyl group-containing compounds of more than 0.05 (5% by weight) and less than 0.70 (70% by weight); and heating said blood product in the solid state in the closed treating zone at a temperature of between 50° and 121° C. to increase the partial vapor pressure of said hydroxyl group-containing compound, to thereby inactivate viable filterable pathogens.
Claim 2
Independent Claim 129 words
A method of inactivating viable filterable pathogens in a blood product, which comprises: placing said blood product in a solid state in a closeable treating zone in the presence of a hydroxyl group-containing compound selected from the group consisting of water, methanol, ethanol, and mixtures thereof, and closing said treating zone; maintaining the content of said hydroxyl group-containing compound in said treating zone to provide said blood product with a content of hydroxyl group-containing compounds of more than 0.05 (5% by weight) and less than 0.70 (70% by weight); and heating said blood product in the solid state in the closed treating zone at a temperature of between 50° and 121° C. to increase the partial vapor pressure of said hydroxyl group-containing compound, to thereby inactivate viable filterable pathogens.
Claim 3
Dependent Claim 44 words
A method as set forth in claim 1, wherein the content of said hydroxyl group-containing compound is maintained to provide said blood product with a content of hydroxyl group-containing compound of more than 0.05 (5% by weight) and less than 0.40 (40% by weight).
Claim 4
Dependent Claim 49 words
A method as set forth in claim 2, wherein said hydroxyl group-containing compound is water, said water being present in the blood product at between about 0.06 (6% by weight) and about 0.30 (30% by weight), and said heating being at a temperature of from 50° to 90° C.
Claim 5
Dependent Claim 24 words
A method as set forth in claim 1, wherein said blood product is heated in the presence of an inert gas free of oxygen.
Claim 6
Dependent Claim 21 words
A method as set forth in claim 4, wherein said blood product is heated in the presence of an oxygen-binding substance.
Claim 7
Dependent Claim 15 words
A method as set forth in claim 4, wherein said inert protective gas is nitrogen.
Claim 8
Dependent Claim 29 words
A method as set forth in claim 1, wherein the content of said hydroxyl group-containing compound is maintained by the addition of a hydroxyl group-containing compound in gaseous form.
Claim 9
Dependent Claim 23 words
A method as set forth in claim 7, wherein said content of said hydroxyl group-containing compound is less than 0.40 (40% by weight).
Claim 10
Dependent Claim 16 words
A method as set forth in claim 7, wherein said hydroxyl group-containing compound is water vapor.
Claim 11
Dependent Claim 28 words
A method as set forth in claim 9, wherein the partial vapor pressure of said hydroxyl group-containing compound is increased to between about 0.1 and about 2 bars.
Claim 12
Dependent Claim 16 words
A method as set forth in claim 1, wherein said viable filterable pathogens are hepatitis viruses.
Claim 13
Dependent Claim 23 words
A method as set forth in claim 1, wherein said viable filterable pathogens are agents capable of transmitting AIDS (acquired immune deficiency syndrome).
Claim 14
Dependent Claim 24 words
A method as set forth in claim 1, wherein said blood product is heated for a period of from 1 s to 100 h.
Claim 15
Dependent Claim 49 words
A method of producing blood products selected from the group consisting of enzymes, proenzymes, enzyme inhibitors, immunoglobulins, albumin, plasminogen, fibrinogen, fibronectin and plasma and mixtures thereof by using a method as set forth in claim 1, wherein said inactivation is effected at any desired stage of said product method.
Claim 16
Dependent Claim 23 words
A method as set forth in claim 14, further comprising converting said blood products into a galenic or pharmaceutical preparation after said inactivation.
Claim 17
Dependent Claim 27 words
A method as set forth in claim 1, further comprising additional fractionation steps for liberating said heat-inactivated blood products from any neoproteins or neoantigens formed during heat-inactivation.
Claim 18
Dependent Claim 158 words
A blood product, selected from the group consisting of enzymes, proenzymes, enzyme inhibitors, immunoglobulins, albumin, plasminogen, fibrinogen, fibronectin and plasma, produced by fractionation, wherein the blood product has been treated, at any desired stage of the fractionation, by a method which comprises: placing said blood product in a solid state in a closeable treating zone in the presence of a hydroxyl group-containing compound selected from the group consisting of water, methanol, ethanol, and mixtures thereof, and closing said treating zone; maintaining the content of said hydroxyl group-containing compound in said treating zone to provide said blood product with a content of hydroxyl group-containing compound of more than 0.05 (5% by weight) and less than 0.70 (70% by weight); and heating said blood product in the solid state in the closed treating zone at a temperature of between 50° and 121° C. to increase the partial vapor pressure of said hydroxyl group-containing compound, to thereby inactivate viable filterable pathogens.
Claim 19
Dependent Claim 158 words
A blood product, selected from the group consisting of enzymes, proenzymes, enzyme inhibitors, immunoglobulins, albumin, plasminogen, fibrinogen, fibronectin and plasma, produced by fractionation, wherein the blood product has been treated, at any desired stage of the fractionation, by a method which comprises: placing said blood product in a solid state in a closeable treating zone in the presence of a hydroxyl group-containing compound selected from the group consisting of water, methanol, ethanol, and mixtures thereof, and closing said treating zone; maintaining the content of said hydroxyl group-containing compound in said treating zone to provide said blood product with a content of hydroxyl group-containing compound of more than 0.05 (5% by weight) and less than 0.70 (70% by weight); and heating said blood product in the solid state in the closed treating zone at a temperature of between 50° and 121° C. to increase the partial vapor pressure of said hydroxyl group-containing compound, to thereby inactivate viable filterable pathogens.
Claim 20
Dependent Claim 14 words
A composition comprising the blood product of claim 17 in a pharmaceutically acceptable carrier.
Claim 21
Dependent Claim 158 words
A blood product, selected from the group consisting of enzymes, proenzymes, enzyme inhibitors, immunoglobulins, albumin, plasminogen, fibrinogen, fibronectin and plasma, produced by fractionation, wherein the blood product has been treated, at any desired stage of the fractionation, by a method which comprises: placing said blood product in a solid state in a closeable treating zone in the presence of a hydroxyl group-containing compound selected from the group consisting of water, methanol, ethanol, and mixtures thereof, and closing said treating zone; maintaining the content of said hydroxyl group-containing compound in said treating zone to provide said blood product with a content of hydroxyl group-containing compound of more than 0.05 (5% by weight) and less than 0.40 (40% by weight); and heating said blood product in the solid state in the closed treating zone at a temperature of between 50° and 121° C. to increase the partial vapor pressure of said hydroxyl group-containing compound, to thereby inactivate viable filterable pathogens.
Claim 22
Dependent Claim 158 words
A blood product, selected from the group consisting of enzymes, proenzymes, enzyme inhibitors, immunoglobulins, albumin, plasminogen, fibrinogen, fibronectin and plasma, produced by fractionation, wherein the blood product has been treated, at any desired stage of the fractionation, by a method which comprises: placing said blood product in a solid state in a closeable treating zone in the presence of a hydroxyl group-containing compound selected from the group consisting of water, methanol, ethanol, and mixtures thereof, and closing said treating zone; maintaining the content of said hydroxyl group-containing compound in said treating zone to provide said blood product with a content of hydroxyl group-containing compound of more than 0.05 (5% by weight) and less than 0.40 (40% by weight); and heating said blood product in the solid state in the closed treating zone at a temperature of between 50° and 121° C. to increase the partial vapor pressure of said hydroxyl group-containing compound, to thereby inactivate viable filterable pathogens.
Claim 23
Dependent Claim 14 words
A composition comprising the blood product of claim 19 in a pharmaceutically acceptable carrier.

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Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1990-02-02 1990-08-04 1991-02-03 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1994-02-02 1994-08-04 1995-02-03 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1998-02-02 1998-08-04 1999-02-03 $7700.00 Window Closed / Lapsed

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