EP0099445A2
Expired / Lapsed
EP
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Sterilized plasma and plasma derivatives and process therefor
Assignee: New York Blood Center
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Filing: 1983-03-26
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Granted: —
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Expires: 2003-03-26
Abstract
Abstract A mammalian blood plasma or plasma derivative substantially free of active hepatitis B or non-A, non-B viruses is disclosed, the plasma being characterized by the presence of factor VIII, the percent by weight of denatured factor VIII to the sum of undenatured factor VIII and denatured factor VIII being less than 50%. The plasma is sterilized by contact with a detergent, alcohol or ether, preferably a mixture of detergent and ether, usually followed by removal of the viral sterilizing agent.
Inventors
- 👤 Alfred Mayer Prince
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-03 10:12
CPC Classifications
A; A61; A61L; A61L2/00; A61L2/02; A61L2/08; A61L2/081; A61K; A61K31/00; A61K31/13; A61K31/14; A61K35/00; A61K35/12; A61K35/14; A61K35/16; A61L2/16; A61L2/18; A61P; A61P7/00; A61P7/04; C; C07; C07K; C07K14/00; C07K14/435; C07K14/745; C07K14/755; A61L2103/00; A61L2103/05
Claims Analysis
Total Claims: 58
Claim 1
Independent Claim
54 words
A mammalian blood plasma substantially free of living hepatitis B and non-A, non-B viruses, said mammalian blood plasma being characterized by the presence of factor VIII .. the percent by weight of denaturated factor VIII to the sum of undenaturated factor VIII and denaturated factor VIII being less than 50% (i. e. ≥ 0.5).
Claim 2
Dependent Claim
54 words
A mammalian blood plasma substantially free of living hepatitis B and non-A, non-B viruses, said mammalian blood plasma being characterized by the presence of factor VIII .. the percent by weight of denaturated factor VIII to the sum of undenaturated factor VIII and denaturated factor VIII being less than 50% (i. e. ≥ 0.5).
Claim 3
Dependent Claim
15 words
A mammalian blood plasma according to claim 1, characterized by having no infective hepatitis viruses.
Claim 4
Dependent Claim
17 words
A mammalian plasma according to claim 1,characterized by having less than one infective virus particle per liter.
Claim 5
Dependent Claim
18 words
A mammalian plasma according to claim 1, characterized by having less than 10 infective virus particles per liter.
Claim 6
Dependent Claim
34 words
A mammalian blood plasma according to claims 2, characterized by being substantially free of viral inactivating agents which crosslink with the proteinaceous portion of a virus or interact with nucleic acid of a virus.
Claim 7
Dependent Claim
18 words
A mammalian blood plasma according to claim 5, characterized by being substantially free of an aldehyde or lactone.
Claim 8
Dependent Claim
29 words
A mammalian blood plasma according to claim 2, characterized by the presence of a nonionic detergent, said nonionic detergent being present in an amount less than 1% by weight.
Claim 9
Dependent Claim
30 words
A mammalian blood plasma according to claim 3, wherein the amount of denatured factor VIII is less than 20% based upon the combined amount of denatured and undenatured factor VIII.
Claim 10
Dependent Claim
30 words
A mammalian blood plasma according to claim 3, wherein the amount of denatured factor VIII is less than 10% based upon the combined amount of denatured and undenatured factor VIII.
Claim 11
Dependent Claim
20 words
A mammalian blood plasma according to claim 8, wherein said mammalian blood plasma is human blood plasma or plasma derivative.
Claim 12
Dependent Claim
24 words
A mammalian blood plasma according to claim 10, wherein said human blood plasma is pooled blood plasma or plasma derivative from such pooled plasma.
Claim 13
Dependent Claim
38 words
A process for inactivating the hepatitis B virus in mammalian blood plasma which comprises contacting said blood plasma with a viral inactivating agent selected from the group consisting of a nonionic detergent, alcohol, ether, or a mixture thereof.
Claim 14
Dependent Claim
38 words
A process for inactivating the hepatitis B virus in mammalian blood plasma which comprises contacting said blood plasma with a viral inactivating agent selected from the group consisting of a nonionic detergent, alcohol, ether, or a mixture thereof.
Claim 15
Dependent Claim
18 words
1 3 . A process according to claim 12, wherein said plasma is contacted with a nonionic detergent.
Claim 16
Dependent Claim
54 words
A process according to claim 12, wherein said plasma is contacted with an alcohol of the formula wherein. R 3 is C 1 to C 18 alkyl or an alkenyl group which . can contain an oxygen or an sulphur atom in the chain and can be substituted by one or more hydroxy groups.
Claim 17
Dependent Claim
47 words
A process according to claim 12, wherein said viral inactivating group is an ether of the formula wherein R 1 and R 2 are independently C 1 to C 18 alkyl or alkenyl which alkyl or alkenyl can contain an oxygen or sulphur atom in the chain.
Claim 18
Dependent Claim
19 words
. A process according to claim 12, wherein the plasma is contacted with a nonionic datergent and an ether.
Claim 19
Dependent Claim
18 words
A process according to claim 16, wherein said contact with nonionic detergent and ether is a successive contact.
Claim 20
Dependent Claim
40 words
A process according to claim 12, wherein said plasma remains in contact with said viral inactivating agent for a period of time of at least one minute and is maintained at a temperature of between -5° C and 50° C.
Claim 21
Dependent Claim
22 words
A process according to claim 18, wherein the viral inactivating agents are present in an amount of at least 0.1% by weight.
Claim 22
Dependent Claim
30 words
A process according to claim 19, wherein said viral inactivating agents are present in an amount of between 0.1 and 50% by weight based upon the weight of the plasma.
Claim 23
Dependent Claim
20 words
A process according to claim 20, wherein following said treatment said viral inactivating agent or agents is or are removed.
Claim 24
Dependent Claim
18 words
A process according to claim 12, wherein said mammalian blood plasma is human blood plasma or plasma derivative.
Claim 25
Dependent Claim
23 words
A process according to claim 23, wherein said human blood plasma is pooled blood plasma or plasma derivative from such human plasma pools.
Claim 26
Dependent Claim
19 words
A process according to claim 12, wherein the blood plasma subjected to said process contains Non-A, Non-B .Hepatitis virus.
Claim 27
Dependent Claim
47 words
A composition containing factor VIII wherein the percent by weight of denatured factor VIII to the sum of undenatured factor VIII and denatured factor VIII is less than 30%, said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 28
Dependent Claim
47 words
A composition containing factor VIII wherein the percent by weight of denatured factor VIII to the sum of undenatured factor VIII and denatured factor VIII is less than 30%, said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 29
Dependent Claim
30 words
A composition according to claim 25, wherein the percent by weight of denatured factor VIII to the sum of undenatured factor VIII and denatured factor VIII is less than 20%.
Claim 30
Dependent Claim
30 words
A composition according to claim 25, wherein the percent by weight of denatured factor VIII to the sum of undenatured factor VIII and denatured factor VIII is less than 10%
Claim 31
Dependent Claim
30 words
A composition according to claim 25, wherein the percent by weight of denatured factor VIII to the sum of undenatured factor VIII and denatured factor VIII is less than 5%.
Claim 32
Dependent Claim
47 words
A composition containing factor IX wherein the percent by weight of denatured factor IX to the sum of undenatured factor IX and denatured factor IX is less than 30%, said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 33
Dependent Claim
47 words
A composition containing factor IX wherein the percent by weight of denatured factor IX to the sum of undenatured factor IX and denatured factor IX is less than 30%, said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 34
Dependent Claim
30 words
A composition according to claim 29, wherein the percent by weight of denatured factor IX to the sum of undenatured factor IX and denatured factor IX is less than 20%.
Claim 35
Dependent Claim
30 words
A composition according to claim 29, wherein the percent by weight of denatured factor IX to the sum of undenatured factor IX and denatured factor IX is less than 10%.
Claim 36
Dependent Claim
30 words
A composition according to claim 29, wherein the percent by weight of denatured factor 1X to the sum of undenatured factor IX and denatured factor IX is less than 5%.
Claim 37
Dependent Claim
47 words
A composition containing factor X wherein the percent by weight of denatured factor X to the sum of undenatured factor X and denatured factor X is less than 30%, said composition having less than 10 infectious virus particles of hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 38
Dependent Claim
47 words
A composition containing factor X wherein the percent by weight of denatured factor X to the sum of undenatured factor X and denatured factor X is less than 30%, said composition having less than 10 infectious virus particles of hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 39
Dependent Claim
30 words
A composition according to claim 33, wherein the percent by weight of denatured factor X to the sum of undenatured factor X and denatured factor X is less than 20%.
Claim 40
Dependent Claim
48 words
A composition according to claim 33, wherein the percent by weight of denatured factor X to the sum of undenatured factor X and denatured factor X is less than 10%, said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 41
Dependent Claim
30 words
A composition according to claim 35, wherein the percent by weight of denatured factor X to the sum of undenatured factor X and denatured factor X is less than 5%.
Claim 42
Dependent Claim
47 words
A composition containing factor II wherein the percent by weight of denatured factor II to the sum of undenatured factor II and denatured factor II is less than 30%., said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 43
Dependent Claim
47 words
A composition containing factor II wherein the percent by weight of denatured factor II to the sum of undenatured factor II and denatured factor II is less than 30%., said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 44
Dependent Claim
47 words
A composition containing factor VII wherein the percent by weight of denatured. factor VII to the sum of undenatured factor VII and denatured factor VII is less than 30%, said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 45
Dependent Claim
47 words
A composition containing factor VII wherein the percent by weight of denatured. factor VII to the sum of undenatured factor VII and denatured factor VII is less than 30%, said composition having less than 10 infectious virus particles of Hepatitis B or Non-A, Non-B Hepatitis per liter.
Claim 46
Dependent Claim
12 words
A composition according to claim 25, substantially free of other plasma proteins.
Claim 47
Dependent Claim
12 words
A composition according to claim 29, substantially free of other plasma proteins.
Claim 48
Dependent Claim
12 words
A composition according to claim 33, substantially free of other plasma proteins.
Claim 49
Dependent Claim
24 words
A composition comprising fibrinogen wherein the percent by weight of denatured fibrinogen to the sum of undenatured and denatured fibrinogen is less than 30%.
Claim 50
Dependent Claim
24 words
A composition comprising fibrinogen wherein the percent by weight of denatured fibrinogen to the sum of undenatured and denatured fibrinogen is less than 30%.
Claim 51
Dependent Claim
16 words
A composition according to claim 42, wherein said composition is substantially free of other plasma proteins.
Claim 52
Dependent Claim
23 words
A composition according to claim 43, wherein said denatured fibrogen is present in an amount based on said sum of less than 20%
Claim 53
Dependent Claim
27 words
A gamma globulin wherein the weight percent of the sum of the denatured proteins to the sum of all denatured and undenatured proteins is less than 30%.
Claim 54
Dependent Claim
27 words
A gamma globulin wherein the weight percent of the sum of the denatured proteins to the sum of all denatured and undenatured proteins is less than 30%.
Claim 55
Dependent Claim
17 words
Mammalian blood plasma according to claim 1 which is clear and transparent when stored for one week.
Claim 56
Dependent Claim
14 words
Mammalian blood plasma according to claim 46, substantially free of microaggregates of precipitated lipoproteins.
Claim 57
Dependent Claim
62 words
A mammalian blood plasma substantially free of cytomegaloviruses, Epstein Barr viruses, lactic dehydrogenase viruses, herpes group viruses, rhabdoviruses, leukoviruses, myxoviruses, alphaviruses, Arboviruses (group B), paramyxoviruses, arenaviruses, coronaviruses, said mammalian blood plasma being characterized by the presence of factor VIII, the percent by weight of denatured factor VIII to the sum of undenatured factor VIII and denatured factor VIII being less than 50%.
Claim 58
Dependent Claim
62 words
A mammalian blood plasma substantially free of cytomegaloviruses, Epstein Barr viruses, lactic dehydrogenase viruses, herpes group viruses, rhabdoviruses, leukoviruses, myxoviruses, alphaviruses, Arboviruses (group B), paramyxoviruses, arenaviruses, coronaviruses, said mammalian blood plasma being characterized by the presence of factor VIII, the percent by weight of denatured factor VIII to the sum of undenatured factor VIII and denatured factor VIII being less than 50%.
References Cited (Backward Citations)
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