KR100696897B1 - 바이러스의 불활성화 방법 - Google Patents
바이러스의 불활성화 방법 Download PDFInfo
- Publication number
- KR100696897B1 KR100696897B1 KR1020000026657A KR20000026657A KR100696897B1 KR 100696897 B1 KR100696897 B1 KR 100696897B1 KR 1020000026657 A KR1020000026657 A KR 1020000026657A KR 20000026657 A KR20000026657 A KR 20000026657A KR 100696897 B1 KR100696897 B1 KR 100696897B1
- Authority
- KR
- South Korea
- Prior art keywords
- plasma protein
- virus
- ammonium sulfate
- ammonium salt
- precipitate
- Prior art date
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
- C12N7/04—Inactivation or attenuation; Producing viral sub-units
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods 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
- A61L2/0023—Heat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Genetics & Genomics (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Pharmacology & Pharmacy (AREA)
- Immunology (AREA)
- Virology (AREA)
- Biotechnology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Microbiology (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
Abstract
Description
바이러스 | 바이러스 감소율(log10) |
HIV | ≥7.8 |
HAV(A형 간염 바이러스) | ≥6.1 |
PRV(가성광견병 바이러스) | ≥7.7 |
BVDV(소 바이러스 설사 바이러스) | ≥7.1 |
CPV(개 파르보바이러스) | ≥8.1 |
특허 의약품에 대한 위원회{the Committee for Proprietary Medicinal Products(CPMP)}가 발간한 유럽 연합에 대한 지침에서는 사람 혈장 단백질 제조 공정을 통한 바이러스 제거/불활성화의 단계적 조사를 요구하고 있다. 이들 지침에 따르면, 세 종류 이상의 바이러스, 즉 관련 위험 바이러스인 HIV, 상세히 외피를 갖는 바이러스 및 외피를 갖지않는 바이러스가 이런 유형의 조사에 사용되어야 한다. 위의 표로부터, 본 발명에 따르는 방법을 사용함으로써 매우 다양한 유형의 바이러스에 대해 탁월한 감소율이 달성된 것을 알 수 있다.
활성 화합물 | % 암모늄 설페이트 포화도로 표현된 침전 범위 | %(중량/용적) 암모늄 설페이트로 표현된 침전 범위 | % 암모늄 설페이트 포화도로 표현된 적정 침전 농도 | %(중량/용적) 암모늄 설페이트로 표현된 적정 침전 농도 | 잔여 활성 (침전 후) |
항트롬빈 III | 24.1-38.9% | 13-21% | 31.5% | 17% | >90% |
CI 불활성화제 | 29.6-38.9% | 16-21% | 35.2% | 19% | >90% |
트롬빈 또는 프로트롬빈 | 29.6-38.9% | 16-21% | 35.2% | 19% | 70-80% |
인자 V, 인자 VII, 인자 X | 29.6-38.9% | 16-21% | 35.2% | 19% | 70-80% |
인자 IX | 29.6-44.4% | 16-24% | 40.7% | 22% | 70-80% |
API | 20.4-35.2% | 11-19% | 24.1% | 13% | 70-80% |
Claims (9)
- 혈장 단백질 용액을 13 내지 22중량%의 암모늄 설페이트 농도하에 실온에서 항온처리하고, 침전물을 분리하고 투석에 의해 암모늄 설페이트를 제거하여 암모늄 설페이트의 잔여량이 0.5mol/L 미만으로 되도록 한 후에 60℃ ±1℃에서 10 시간 동안 저온살균(pasteurizing)한 다음, 가공하여 치료학적으로 적용 가능한 혈장 단백질 제제를 수득함을 포함하여, 암모늄 설페이트를 알칼리성 pH에서 첨가하여 혈장 단백질 용액으로부터 외피(envelope) 갖는 바이러스, 외피를 갖지않는 바이러스, 또는 외피를 갖는 바이러스 및 외피를 갖지 않는 바이러스 둘 다를 불활성화하는 방법.
- 제1항에 있어서, 13 내지 22중량%의 암모늄 설페이트 농도에서 항온처리한 후, 암모늄 설페이트 농도를 24 내지 27중량%로 증가시키고, 혼합물을 다시 항온처리하며, 이러한 방법으로 생성된 바이러스 부재 침전물을, 투석에 의해 암모늄 설페이트를 제거함으로써 암모늄 설페이트의 잔여량이 0.5mol/L 미만으로 되도록 한 후에 60℃±1℃에서 10 시간 동안 저온살균한 다음, 가공하여 치료학적으로 적용 가능한 혈장 단백질 제제를 수득하는 방법.
- 제1항 또는 제2항에 있어서, 사용되는 혈장 단백질 용액이, 친화성 크로마토그래피에 의해 예비 정제되어 추가로 바이러스가 제거된 혈장 단백질 용액인 방법.
- 제1항 또는 제2항에 있어서, pH 8 내지 11에서 수행하는 방법.
- 제1항 또는 제2항에 있어서, 제1 항온처리와 제2 항온처리를 각각 2 내지 4시간 동안 수행하는 방법.
- 삭제
- 제1항 또는 제2항에 있어서, 저온살균을 안정화제로서 수크로스 및 글리신의 존재하에 또는 수크로스 및 아세트산칼륨의 존재하에 수행하는 방법.
- 제1항 또는 제2항에 있어서, 천연 혈장 단백질 또는 생물공학적으로 생산한 혈장 단백질을 사용하여 수행하는 방법.
- 삭제
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19923027.7 | 1999-05-19 | ||
DE19923027A DE19923027C2 (de) | 1999-05-19 | 1999-05-19 | Verfahren zur Inaktivierung von Viren |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20010069197A KR20010069197A (ko) | 2001-07-23 |
KR100696897B1 true KR100696897B1 (ko) | 2007-03-21 |
Family
ID=7908550
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020000026657A KR100696897B1 (ko) | 1999-05-19 | 2000-05-18 | 바이러스의 불활성화 방법 |
Country Status (9)
Country | Link |
---|---|
US (1) | US6468778B1 (ko) |
EP (1) | EP1053754B1 (ko) |
JP (1) | JP4629831B2 (ko) |
KR (1) | KR100696897B1 (ko) |
AT (1) | ATE285255T1 (ko) |
AU (1) | AU772669B2 (ko) |
CA (1) | CA2308904C (ko) |
DE (2) | DE19923027C2 (ko) |
ES (1) | ES2232345T3 (ko) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SE0001128D0 (sv) * | 2000-03-30 | 2000-03-30 | Amersham Pharm Biotech Ab | A method of producing IgG |
CN100457896C (zh) * | 2005-10-26 | 2009-02-04 | 李法卿 | 灭活生物制品中病毒和去除细菌内毒素的方法 |
DE602006014215D1 (de) * | 2005-12-02 | 2010-06-17 | Pfenex Inc | Neue pflanzenviruspartikel und verfahren zu deren inaktivierung |
CN104023752B (zh) * | 2011-12-20 | 2017-09-08 | 诺维信公司 | 用于从蛋白质溶液中除去病毒的方法 |
WO2014004103A1 (en) * | 2012-06-29 | 2014-01-03 | Emd Millipore Corporation | Methods for inactivating viruses during a protein purification process |
DE202020001666U1 (de) | 2020-04-21 | 2020-06-08 | Walther Enßlin | Imprägnierung der Oberfläche von Kleidung, Schutzkleidung, Gewebehandschuhen gegen Viren aus den Tröpfchen der Atemluft |
DE202020003865U1 (de) | 2020-09-11 | 2021-09-22 | Karin Emde | Einfangen und Vernichten von Viren und andere Mikroorganismen in Raumluft und Raumluftfiltern |
DE102021001635A1 (de) | 2021-03-27 | 2022-09-29 | Karin Emde | Abfangen und Vernichten von Viren und andere Mikroorganismen auf Oberflächen, in Raumluft, in der Abluft von Staubsaugern und in Raumluftfiltern. |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AT376881B (de) * | 1983-05-02 | 1985-01-10 | Immuno Ag | Verfahren zur inaktivierung von vermehrungsfaehigen krankheitserregern |
DE3473407D1 (en) | 1983-05-02 | 1988-09-22 | Immuno Ag | Method of inactivating pathogens |
US4749783A (en) * | 1986-07-11 | 1988-06-07 | Miles Laboratories, Inc. | Viral inactivation and purification of active proteins |
CA2155337A1 (en) * | 1993-02-09 | 1994-08-18 | Monika Stadler | Method for inactivating viruses devoid of lipid envelopes |
AT402788B (de) * | 1993-08-03 | 1997-08-25 | Immuno Ag | Virussichere blutgerinnungsfaktor xiii-präparation |
HRP940645A2 (en) * | 1993-10-06 | 1996-12-31 | Immuno Ag | Process for virus deactivation in the presence of polyalkylene glycol and the pharmaceutical preparation thus obtained |
EP0659767B2 (de) * | 1993-12-27 | 2002-11-06 | ZLB Bioplasma AG | Verfahren zur Herstellung eines Konzentrates von Anti-D-Immunoglobulin G und pharmazeutische Zusammensetzung, die dieses enthält |
HUP9700603A3 (en) * | 1996-03-20 | 2001-08-28 | Baxter Ag | Pharmaceutical preparation for the treatment of blood coagulation disorders |
-
1999
- 1999-05-19 DE DE19923027A patent/DE19923027C2/de not_active Expired - Fee Related
-
2000
- 2000-05-09 DE DE50008992T patent/DE50008992D1/de not_active Expired - Lifetime
- 2000-05-09 AT AT00109780T patent/ATE285255T1/de active
- 2000-05-09 EP EP00109780A patent/EP1053754B1/de not_active Expired - Lifetime
- 2000-05-09 ES ES00109780T patent/ES2232345T3/es not_active Expired - Lifetime
- 2000-05-17 US US09/572,471 patent/US6468778B1/en not_active Expired - Lifetime
- 2000-05-18 KR KR1020000026657A patent/KR100696897B1/ko not_active IP Right Cessation
- 2000-05-18 CA CA002308904A patent/CA2308904C/en not_active Expired - Lifetime
- 2000-05-18 AU AU35371/00A patent/AU772669B2/en not_active Ceased
- 2000-05-19 JP JP2000147683A patent/JP4629831B2/ja not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
ATE285255T1 (de) | 2005-01-15 |
KR20010069197A (ko) | 2001-07-23 |
DE19923027A1 (de) | 2000-11-23 |
JP2001000179A (ja) | 2001-01-09 |
CA2308904A1 (en) | 2000-11-19 |
EP1053754A1 (de) | 2000-11-22 |
CA2308904C (en) | 2010-03-09 |
DE50008992D1 (de) | 2005-01-27 |
AU3537100A (en) | 2000-11-23 |
JP4629831B2 (ja) | 2011-02-09 |
AU772669B2 (en) | 2004-05-06 |
ES2232345T3 (es) | 2005-06-01 |
US6468778B1 (en) | 2002-10-22 |
EP1053754B1 (de) | 2004-12-22 |
DE19923027C2 (de) | 2002-09-19 |
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