CA2225470A1 - Method and apparatus for inactivating contaminants in blood products - Google Patents

Method and apparatus for inactivating contaminants in blood products

Info

Publication number
CA2225470A1
CA2225470A1 CA002225470A CA2225470A CA2225470A1 CA 2225470 A1 CA2225470 A1 CA 2225470A1 CA 002225470 A CA002225470 A CA 002225470A CA 2225470 A CA2225470 A CA 2225470A CA 2225470 A1 CA2225470 A1 CA 2225470A1
Authority
CA
Canada
Prior art keywords
blood product
blood
type
group
protein compounds
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002225470A
Other languages
French (fr)
Other versions
CA2225470C (en
Inventor
Ruth Laub
Luc De Wael
Mario Di Giambattista
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sartorius Stedim Biotech GmbH
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/BE1995/000069 external-priority patent/WO1996002571A1/en
Application filed by Individual filed Critical Individual
Publication of CA2225470A1 publication Critical patent/CA2225470A1/en
Application granted granted Critical
Publication of CA2225470C publication Critical patent/CA2225470C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14Blood; Artificial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/10Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person
    • A61K41/17Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person by ultraviolet [UV] or infrared [IR] light, X-rays or gamma rays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3623Means for actively controlling temperature of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3681Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/05General characteristics of the apparatus combined with other kinds of therapy
    • A61M2205/051General characteristics of the apparatus combined with other kinds of therapy with radiation therapy
    • A61M2205/053General characteristics of the apparatus combined with other kinds of therapy with radiation therapy ultraviolet

Abstract

A method for inactivating parvoviruses in a blood product, wherein the blood product is exposed to one or more emissions of ultraviolet C radiation.

Claims (28)

1. Method of inactivating non-enveloped viruses present in a blood product, wherein the blood product is subjected to one or more emission(s) of type C
ultraviolet radiation and wherein the irradiation doses of ultraviolet radiation which are received by the blood product are lower than 640 joules/m2.
2. Method according to claim 1, wherein the irradiation doses of ultraviolet irradiation which are received by the blood product are between 10 and 400 joules/m2, preferably between 200 and 400 joules/m2.
3. Method according to claim 1 or 2, wherein the blood product is selected from the group consisting of whole blood or each cellular compound such as platelets and erythrocytes.
4. Method according to claim 1 or 2, wherein the blood product is selected from the group consisting of serum, plasma and blood protein compounds.
5. Method according to claim 4, wherein the blood protein compounds are selected from the group consisting of clotting factors, in particular factor VIII, factor IX, von Willebrand's factor, fibrinogen, fibronectin or a mixture thereof.
6. Method according to claim 4, wherein characterized in that the blood protein compounds are selected from the group consisting of immunoglobulins, albumin or a mixture thereof.
7. Method according to any one of the preceding claims, wherein most of the emission of type C
ultraviolet radiation occurs between 250 and 270 nm.
8. Method according to any one of the preceding claims, wherein most of the emission of type C
ultraviolet radiation occurs at a wavelength around 254 nm.
9. Method according to any one of the preceding claims, which is combined with one or more other physical or chemical viral inactivation treatments.
10. Method according to claim 9, wherein the other methods of viral inactivation are a physical or chemical viral inactivation treatment method selected from the group consisting of one or more (dry or wet) heating step(s), the addition of chemical components, one or more pasteurization step(s), subjection to one or more emission(s) of particular radiations such as .gamma. radiation or X-rays or a combination of these methods.
11. Method according to any one of the preceding claims, which is combined with a general method of isolating or separating blood derivatives from whole blood.
12. Method of viral inactivation according to any one of the preceding claims, wherein the blood product is not treated in thin layers.
13. Apparatus for viral inactivation of a blood product comprising an emitter (7) of type C
ultraviolet rays placed so as to emit the type C
ultraviolet radiation towards the blood product to be treated and placed in a quart tube (6) or a tube made of a polymerized material not allowing the absorption of type C
ultraviolet radiation, and a flow meter (11) controlling the flow rate of the blood product to be treated and possibly a pump (5).
14. Apparatus according to claim 13, wherein the emitter (7) is a UV lamp, preferably a UV tube lamp type, with a power higher than 4 Watt, preferably between 8 and 60 Watt.
15. Apparatus according to claim 13 or 14, wherein the type C ultraviolet rays have a wavelength between 250 and 270 nm, preferably a wavelength around 254 nm.
16. Apparatus according to any one of the preceding claims 13 to 15, wherein the irradiation doses received by the blood product are lower than 640 joules/m2, preferably comprised between 10 and 40 joules/m2, more preferably between 200 and 400 joules/m2.
17. Apparatus according to any one of the preceding claims 13 to 16, which comprises a reflecting chamber (8) sending the type C ultraviolet radiation towards the blood product to be treated.
18. Apparatus according to any one of the preceding claims 13 to 17, which comprises a system (10) for controlling the dose of ultraviolet C radiation which irradiates the blood product to be treated.
19. Apparatus according to any one of the preceding claims 13 to 18, which comprises a system for controlling the temperature of the blood product to be treated.
20. Use of the apparatus according to any one of the preceding claims 13 to 19, for viral inactivation of no-enveloped viruses, particularly parvoviruses, in particular parvoviruses B19 and/or H1, present in a blood product.
21. Blood product obtained by the process according to any one of the preceding claims 1 to 12 being free of non-enveloped viruses and wherein the blood protein compounds have retained more than 85% of their activity.
22. Blood product according to claim 21, wherein the blood protein compounds have retained more than 90% of their activity.
23. Blood product according to claim 21 or 22, free of parvoviruses, preferably free or parvoviruses B19 and/or H1.
24. Blood product according to any one of the preceding claims 21 to 23, which is selected from the group consisting of serum, plasma and blood protein compounds.
25. Blood product according to claim 24, wherein the blood protein compounds are selected from the group consisting of clotting factors, in particular factor VIII, factor IX, von Willebrand's factor, fibrinogen, fibronectin or a mixture thereof.
26. Blood product according to claim 25, wherein the blood protein compounds are selected from the group consisting of immunoglobulins, albumin and/or a mixture thereof.
27. Pharmaceutical composition comprising the blood product according to any one of the preceding claims 21 to 26.
28. Cosmetical composition comprising the blood product according to any one of the preceding claims 21 to 26.
CA2225470A 1995-07-14 1996-07-15 Method and apparatus for inactivating contaminants in blood products Expired - Lifetime CA2225470C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
WOPCT/BE95/00069 1995-07-14
PCT/BE1995/000069 WO1996002571A1 (en) 1994-07-14 1995-07-14 Concentrate of fibrinogene obtained from blood plasma, process and plant for its preparation
PCT/BE1996/000076 WO1997003706A1 (en) 1995-07-14 1996-07-15 Method and apparatus for inactivating contaminants in blood products

Publications (2)

Publication Number Publication Date
CA2225470A1 true CA2225470A1 (en) 1997-02-06
CA2225470C CA2225470C (en) 2010-06-29

Family

ID=3888743

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2225470A Expired - Lifetime CA2225470C (en) 1995-07-14 1996-07-15 Method and apparatus for inactivating contaminants in blood products

Country Status (9)

Country Link
US (2) US6190608B1 (en)
EP (2) EP0840624B1 (en)
JP (2) JPH11509210A (en)
AT (1) ATE367830T1 (en)
CA (1) CA2225470C (en)
DE (3) DE96923791T1 (en)
DK (1) DK0840624T3 (en)
ES (1) ES2290957T3 (en)
WO (1) WO1997003706A1 (en)

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US8900806B2 (en) 2010-04-22 2014-12-02 Biotest Ag Antibody preparations

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US20090274576A1 (en) * 2006-01-18 2009-11-05 Barry Ressler System and method for container sterilization using UV light source
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US9243056B2 (en) 2010-04-22 2016-01-26 Biotest Ag Process for preparing an immunoglobulin composition
US9518110B2 (en) 2010-04-22 2016-12-13 Biotest Ag Antibody preparations
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US10954290B2 (en) 2010-04-22 2021-03-23 Biotest Ag IgG, IgA and IgM antibody preparations, method of making and method of use in treatment
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Also Published As

Publication number Publication date
DE29624488U1 (en) 2004-04-15
DK0840624T3 (en) 2007-11-05
US6190608B1 (en) 2001-02-20
US20010046450A1 (en) 2001-11-29
DE69637181T2 (en) 2008-04-17
WO1997003706A1 (en) 1997-02-06
US6833108B2 (en) 2004-12-21
DE69637181D1 (en) 2007-09-06
JP2009077707A (en) 2009-04-16
CA2225470C (en) 2010-06-29
EP0840624A1 (en) 1998-05-13
ES2290957T3 (en) 2008-02-16
ATE367830T1 (en) 2007-08-15
EP0840624B1 (en) 2007-07-25
JPH11509210A (en) 1999-08-17
EP1842561A1 (en) 2007-10-10
DE96923791T1 (en) 2004-07-08

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Effective date: 20160715