EP0094611A2
Expired / Lapsed
EP
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A method for the heat treatment of plasma of plasma fractions and compositions obtained thereby
Assignee: Cedars-Sinai Medical Center
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Filing: 1983-05-11
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Granted: —
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Expires: 2003-05-11
Abstract
Abstract Heat treatment of dry, for instance, lyophilized plasma compositions particularly fractions containing Factor VIII concentrates inactivates undesirable micro-organisms such as any hepatitis virus. Subsequent reconstitution is effected by adding sterile water until solubilization. Therapeutically and diagnostically useful products and procedures are achieved, for instance permitting transfusion of plasma to hemophiliacs without fear of conveying hepatitis.
Inventors
- 👤 Alan Rubinstein
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-03 23:09
CPC Classifications
C; C12; C12N; C12N9/00; C12N9/14; C12N9/48; C12N9/50; C12N9/64; C12N9/6421; C12N9/6424; C12N9/644; A; A61; A61K; A61K35/00; A61K35/12; A61K35/14; A61K35/16; A61K39/00; A61K39/12; A61K39/29; A61L; A61L2/00; A61L2/02; A61L2/04; A61L2/08; A61L2/12; C07; C07K; C07K14/00; C07K14/435; C07K14/745; C07K14/755; C12Y; C12Y304/00; C12Y304/21; C12Y304/21022; A61L2103/00; A61L2103/05; A61L2103/09
Claims Analysis
Total Claims: 79
Claim 1
Independent Claim
48 words
A method for treating a substantially dry composition including Factor VIII to reduce or eliminate the infectivity of the microorganisms present in the composition comprising heating the composition for a predetermined period of time at a predetermined temperature sufficient to reduce or eliminate the infectivity of the microorganisms.
Claim 2
Independent Claim
48 words
A method for treating a substantially dry composition including Factor VIII to reduce or eliminate the infectivity of the microorganisms present in the composition comprising heating the composition for a predetermined period of time at a predetermined temperature sufficient to reduce or eliminate the infectivity of the microorganisms.
Claim 3
Independent Claim
59 words
A method for treating a substantially dry composition including Factor VIII to reduce or eliminate the infectivity of the microorganisms present in the composition comprising heating the composition for a predetermined period of time at a predetermined temperature sufficient to reduce or eliminate the infectivity of the microorganims while retaining substantially all of the antigenicity of the infectious microorganisms.
Claim 4
Independent Claim
59 words
A method for treating a substantially dry composition including Factor VIII to reduce or eliminate the infectivity of the microorganisms present in the composition comprising heating the composition for a predetermined period of time at a predetermined temperature sufficient to reduce or eliminate the infectivity of the microorganims while retaining substantially all of the antigenicity of the infectious microorganisms.
Claim 5
Independent Claim
68 words
A method for treating a substantially dry composition including Factor VIII to reduce or eliminate the infectivity of the microorganisms present in the composition comprising heating the composition for a predetermined period of time at a predetermined temperature sufficient to inactivate the microorganisms present in the composition, and adding sterile water to the composition following completion of said heating step until solubilization of the composition is substantially achieved.
Claim 6
Independent Claim
68 words
A method for treating a substantially dry composition including Factor VIII to reduce or eliminate the infectivity of the microorganisms present in the composition comprising heating the composition for a predetermined period of time at a predetermined temperature sufficient to inactivate the microorganisms present in the composition, and adding sterile water to the composition following completion of said heating step until solubilization of the composition is substantially achieved.
Claim 7
Independent Claim
19 words
A method as claimed in any one of claims 1, 2, and 3 wherein the composition is a fraction.
Claim 8
Independent Claim
25 words
A method as claimed in any one of claims 1, 2 or 3 wherein the composition is heated by a method other than microwave irradiation.
Claim 9
Independent Claim
27 words
A method as claimed in any one of claims 1, 2 or 3 wherein the heating is by contact with a heated substance or by infrared irradiation.
Claim 10
Independent Claim
19 words
A method as claimed in any one of claims 1, 2, or 3 wherein the composition is a cryoprecipitate.
Claim 11
Independent Claim
20 words
A method as claimed in anyone of claims 1, 2 or 3 wherein the composition is a dry cryoprecipitate supernatant.
Claim 12
Independent Claim
38 words
A method as claimed in either claims 1 or 2, including reconstituting the composition until solubilization of the composition is substantially achieved following said heating of the composition for said predetermined period of time at said predetermined temperature.
Claim 13
Dependent Claim
25 words
A method as claimed in claim 1, 2 or 3, wherein said composition is Factor VIII concentrate and said predetermined temperature is at least 60°C.
Claim 14
Dependent Claim
19 words
A method as claimed in claim 10, wherein said predetermined temperature falls within a range between 60°C and 100°C.
Claim 15
Independent Claim
27 words
A method as claimed in any one of claims 1 to 3, wherein said composition includes Factor IX concentrate and said predetermined temperature is at least 100°C.
Claim 16
Dependent Claim
19 words
A method as claimed in claim 12 wherein said predetermined temperature falls within a range between 100°C. and 110°C.
Claim 17
Independent Claim
17 words
A method as claimed in any one of claims 1 to 13 wherein said composition includes fibrinogen.
Claim 18
Dependent Claim
19 words
A method as claimed in claim 14, wherein said predetermined temperature falls in a range between 60°C. and 125°C.
Claim 19
Independent Claim
23 words
A method as claimed in any one of claims 1 to 15 including lyophilizing the composition thereby to obtain the substantially dry composition.
Claim 20
Independent Claim
28 words
A method as claimed in any one of claims 1, 2 or 3 wherein the infectivity of the microorganism is reduced or eliminated solely by heating the composition.
Claim 21
Independent Claim
27 words
A method as claimed in any one of claims 1, 2 or 3 wherein the infectivity of the microorganism is reduced or eliminated by heating the composition.
Claim 22
Independent Claim
23 words
A method as claimed in any one of claims 1, 2 or 3 wherein the composition is essentially free of blood clotting enzymes.
Claim 23
Dependent Claim
26 words
A method as claimed in claim 19 wherein the composition is essentially free of Factors II, VII, IX, X, XII and XIII or their activated forms.
Claim 24
Independent Claim
34 words
A method as claimed in 20 wherein the composition contains less than about 15 units of any of the Factors II, VII, IX, X, XIII or.XIII or their activated forms per gram of protein.
Claim 25
Dependent Claim
25 words
A method as claimed in claim 18 wherein the infectivity of the microorganism is not reduced or eliminated by the action of any toxic gas.
Claim 26
Dependent Claim
22 words
A method as claimed in claim 18 wherein the composition is free of a therapeutically sufficient concentration of a blood clotting enzyme.
Claim 27
Dependent Claim
27 words
A method as claimed in claim 19 wherein the composition contains a ratio of antihemophilic units of any blood clotting enzyme of about from 10:1 to 500:1.
Claim 28
Independent Claim
17 words
A method as claimed in anyone of claims 1 to 24 wherein the microorganism is a virus.
Claim 29
Dependent Claim
14 words
A method as claimed in claim 25 wherein the virus is any hepatitis virus.
Claim 30
Dependent Claim
14 words
A method as claimed in claim 26 wherein the virus is human hepatitis virus.
Claim 31
Dependent Claim
17 words
A method as claimed in claim 26 wherein the virus is hepatitis B, or non-A, non-B hepatitis.
Claim 32
Independent Claim
58 words
A method for treating a plasma fraction containing Factor VIII to substantially inactivate any hepatitis virus present in the fraction comprising lyophilizing the plasma fraction to increase the heat stability thereof and heating the lyophilized plasma fraction for a predetermined period of time at a predetermined temperature sufficient to render hepatitis virus present in the plasma fraction inactive.
Claim 33
Independent Claim
58 words
A method for treating a plasma fraction containing Factor VIII to substantially inactivate any hepatitis virus present in the fraction comprising lyophilizing the plasma fraction to increase the heat stability thereof and heating the lyophilized plasma fraction for a predetermined period of time at a predetermined temperature sufficient to render hepatitis virus present in the plasma fraction inactive.
Claim 34
Independent Claim
79 words
A method for treating a plasma fraction to substantially inactivate any hepatitis virus present in the plasma fraction comprising lyophilizing the plasma fraction to increase the heat stability thereof, heating the lyophilized plasma fraction for a predetermined period of time at a predetermined temperature sufficient to inactivate hepatitis virus present in the plasma fraction, and adding sterile water to the lyophilized plasma fraction following completion of said heating step until solubilization of the lyophilized plasma fraction is substantially achieved.
Claim 35
Independent Claim
79 words
A method for treating a plasma fraction to substantially inactivate any hepatitis virus present in the plasma fraction comprising lyophilizing the plasma fraction to increase the heat stability thereof, heating the lyophilized plasma fraction for a predetermined period of time at a predetermined temperature sufficient to inactivate hepatitis virus present in the plasma fraction, and adding sterile water to the lyophilized plasma fraction following completion of said heating step until solubilization of the lyophilized plasma fraction is substantially achieved.
Claim 36
Dependent Claim
54 words
A composition containing inactivated microorganisms and at least Factor VIII, said microorganisms having been inactivated by a method consisting essentially of heating the composition in a substantially dry state to inactivate said microorganisms, said composition being substantially free of the activate, infectious form of the micro- organisms, and said Factor VIII being substantially active.
Claim 37
Dependent Claim
54 words
A composition containing inactivated microorganisms and at least Factor VIII, said microorganisms having been inactivated by a method consisting essentially of heating the composition in a substantially dry state to inactivate said microorganisms, said composition being substantially free of the activate, infectious form of the micro- organisms, and said Factor VIII being substantially active.
Claim 38
Dependent Claim
14 words
A composition as claimed in claim 31 wherein the inactivated microorganism is a virus.
Claim 39
Dependent Claim
14 words
A composition as claimed in claim 32 wherein the virus is any hepatitis virus.
Claim 40
Dependent Claim
17 words
A composition as claimed in 33 wherein the hepatitis virus is hepatitis B, or non-A, non-B hepatitis.
Claim 41
Dependent Claim
17 words
A composition as claimed in anyone of claims 31 to 34 wherein the composition is substantially dry.
Claim 42
Dependent Claim
12 words
A composition as claimed in claim 35 wherein the composition is lyophilized.
Claim 43
Dependent Claim
13 words
A composition as claimed in claim 35 wherein the composition is a cryoprecipitate.
Claim 44
Dependent Claim
15 words
A composition as claimed in claim 35 wherein the composition is a dry cryoprecipitate supernatant.
Claim 45
Dependent Claim
20 words
A composition as claimed in any one of claims 31 to 34 wherein the composition is solubilized in sterile water.
Claim 46
Dependent Claim
17 words
A composition as claimed in any one of claims 31 to 39 including a Factor VIII concentrate.
Claim 47
Dependent Claim
17 words
A composition as claimed in any one of claims 31 to 40 including a Factor IX concentrate.
Claim 48
Dependent Claim
13 words
A composition as claimed in anyone of claims 31 to 41 including fibrinogen.
Claim 49
Dependent Claim
32 words
A lyophilized composition containing non infectious hepatitis B virus and at least Factor VIII which composition is substantially free of said virus in the infectious form, said Factor VIII being substantially active.
Claim 50
Dependent Claim
32 words
A lyophilized composition containing non infectious hepatitis B virus and at least Factor VIII which composition is substantially free of said virus in the infectious form, said Factor VIII being substantially active.
Claim 51
Dependent Claim
52 words
A lyophilized composition containing non-infectious non-A, non-B hepatitis virus and at least Factor VIII, said virus having been made non-infectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form, said Factor VIII being substantially active.
Claim 52
Dependent Claim
52 words
A lyophilized composition containing non-infectious non-A, non-B hepatitis virus and at least Factor VIII, said virus having been made non-infectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form, said Factor VIII being substantially active.
Claim 53
Independent Claim
43 words
A method for inactivating virus in a composition which contains at least an antihemophilic factor and which is suspected to contain an infective virus, which method for inactivating consists essentially of heating the composition in the dry state until the virus is inactivated.
Claim 54
Independent Claim
43 words
A method for inactivating virus in a composition which contains at least an antihemophilic factor and which is suspected to contain an infective virus, which method for inactivating consists essentially of heating the composition in the dry state until the virus is inactivated.
Claim 55
Independent Claim
57 words
A method for treating a dry composition containing antihemophilic factor purified to at least a greater activity of antihemophilic factor per unit weight of protein than the concentration of such factor in normal human plasma, and suspected to contain an infective virus, which method comprises heating the composition in the dry state until the virus is inactivated.
Claim 56
Independent Claim
57 words
A method for treating a dry composition containing antihemophilic factor purified to at least a greater activity of antihemophilic factor per unit weight of protein than the concentration of such factor in normal human plasma, and suspected to contain an infective virus, which method comprises heating the composition in the dry state until the virus is inactivated.
Claim 57
Dependent Claim
12 words
The method of claim 46 wherein the virus is any hepatitis virus.
Claim 58
Dependent Claim
14 words
The method of claim 46 wherein the titer of infective virus is not predetermined.
Claim 59
Dependent Claim
13 words
The method of claim 46 wherein the composition is free of cellular microorganisms.
Claim 60
Dependent Claim
47 words
A composition containing non-infectious virus, and antihemophilic factor said virus having been made non-infectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form and anti-hemophilic factor in the denatured form.
Claim 61
Dependent Claim
47 words
A composition containing non-infectious virus, and antihemophilic factor said virus having been made non-infectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form and anti-hemophilic factor in the denatured form.
Claim 62
Dependent Claim
19 words
The composition of claim 50 wherein less than about 50% of the antihemophilic factor is in the denatured form.
Claim 63
Dependent Claim
20 words
The composition of claim 51 wherein about from 30% to 10% of the antihemophilic factor is in the denatured form.
Claim 64
Dependent Claim
57 words
A composition containing non-infectious virus and at least including Factor VIII in a purification to at least a greater activity of antihemophilic factor per unit weight of protein than the concentration of such factor in normal human plasma, which composition is substantially free of said virus in the infectious form and said factor in the denatured form.
Claim 65
Dependent Claim
57 words
A composition containing non-infectious virus and at least including Factor VIII in a purification to at least a greater activity of antihemophilic factor per unit weight of protein than the concentration of such factor in normal human plasma, which composition is substantially free of said virus in the infectious form and said factor in the denatured form.
Claim 66
Dependent Claim
58 words
In a method wherein a therapeutically effective amount of Factor VIII is infused into a patient, the improvement comprising infusing into said patient a composition containing non-infectious virus and a therapeutically effective amount of said factor, which composition is substantially free of said virus in the infectious form and substantially free of said factor in the denatured form.
Claim 67
Dependent Claim
58 words
In a method wherein a therapeutically effective amount of Factor VIII is infused into a patient, the improvement comprising infusing into said patient a composition containing non-infectious virus and a therapeutically effective amount of said factor, which composition is substantially free of said virus in the infectious form and substantially free of said factor in the denatured form.
Claim 68
Dependent Claim
19 words
The method of claim 54 wherein the patient has a congenital hemophilia and not an acquired Factor VIII inhibitor.
Claim 69
Dependent Claim
17 words
The method of claim 54 wherein the amount of Factor VIII is greater than about 15 units/ml.
Claim 70
Dependent Claim
33 words
A composition comprising non-infectious virus and a therapeutically effective amount of Factor VIII, said composition being substantially free of said virus in the infectious form and including Factor VIII in the denatured form.
Claim 71
Dependent Claim
33 words
A composition comprising non-infectious virus and a therapeutically effective amount of Factor VIII, said composition being substantially free of said virus in the infectious form and including Factor VIII in the denatured form.
Claim 72
Dependent Claim
25 words
The composition of claim 57 wherein the Factor VIII is present in an amount greater than about 20 units/ gram of protein in the composition.
Claim 73
Dependent Claim
27 words
The composition of claim 58 wherein the Factor VIII is present in an amount of about from 100 to 2000 units/gram of protein present in the composition.
Claim 74
Independent Claim
33 words
A method for inactivating virus in a composition comprising at least Factor VIII in a therapeutically effective amount, which method comprises heating the composition in the dry state until the virus is inactivated.
Claim 75
Independent Claim
33 words
A method for inactivating virus in a composition comprising at least Factor VIII in a therapeutically effective amount, which method comprises heating the composition in the dry state until the virus is inactivated.
Claim 76
Dependent Claim
26 words
A vaccine for hepatitis including the composition of an immunogenically effective amount of inactivated hepatitis virus in a blood plasma fraction together with a carrier therefor.
Claim 77
Dependent Claim
26 words
A vaccine for hepatitis including the composition of an immunogenically effective amount of inactivated hepatitis virus in a blood plasma fraction together with a carrier therefor.
Claim 78
Dependent Claim
27 words
A vaccine for an undesirable virus including the composition of an immunogenically effective amont of inactivated virus in a blood plasma fraction together with a carrier therefor.
Claim 79
Dependent Claim
27 words
A vaccine for an undesirable virus including the composition of an immunogenically effective amont of inactivated virus in a blood plasma fraction together with a carrier therefor.
References Cited (Backward Citations)
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