DK3131589T3 - Fremgangsmåde og anvendelse til fortløbende inaktivering af en virus under tilvejebringelse af et biologisk produkt - Google Patents
Fremgangsmåde og anvendelse til fortløbende inaktivering af en virus under tilvejebringelse af et biologisk produkt Download PDFInfo
- Publication number
- DK3131589T3 DK3131589T3 DK15720615.2T DK15720615T DK3131589T3 DK 3131589 T3 DK3131589 T3 DK 3131589T3 DK 15720615 T DK15720615 T DK 15720615T DK 3131589 T3 DK3131589 T3 DK 3131589T3
- Authority
- DK
- Denmark
- Prior art keywords
- virus
- providing
- biological product
- continuous inactivation
- inactivation
- Prior art date
Links
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
-
- 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
- A61L2/0082—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 chemical substances
- A61L2/0088—Liquid substances
-
- 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
- A61L2/0082—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 chemical substances
-
- 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
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
-
- 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
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
-
- 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
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
-
- 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
- C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
- C12N2710/00011—Details
- C12N2710/00061—Methods of inactivation or attenuation
- C12N2710/00063—Methods of inactivation or attenuation by chemical treatment
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Analytical Chemistry (AREA)
- Biomedical Technology (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Immunology (AREA)
- General Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Virology (AREA)
- Biotechnology (AREA)
- General Chemical & Material Sciences (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461979731P | 2014-04-15 | 2014-04-15 | |
PCT/EP2015/058172 WO2015158776A1 (en) | 2014-04-15 | 2015-04-15 | Methods, apparatuses, and systems for continuously inactivating a virus during manufacture of a biological product |
Publications (1)
Publication Number | Publication Date |
---|---|
DK3131589T3 true DK3131589T3 (da) | 2023-08-07 |
Family
ID=53052800
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK15720615.2T DK3131589T3 (da) | 2014-04-15 | 2015-04-15 | Fremgangsmåde og anvendelse til fortløbende inaktivering af en virus under tilvejebringelse af et biologisk produkt |
Country Status (5)
Country | Link |
---|---|
US (3) | US10435670B2 (da) |
EP (2) | EP3131589B1 (da) |
CN (3) | CN106456813B (da) |
DK (1) | DK3131589T3 (da) |
WO (1) | WO2015158776A1 (da) |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK3131589T3 (da) | 2014-04-15 | 2023-08-07 | Boehringer Ingelheim Int | Fremgangsmåde og anvendelse til fortløbende inaktivering af en virus under tilvejebringelse af et biologisk produkt |
DE102016202139A1 (de) | 2016-02-12 | 2017-08-17 | Hamilton Bonaduz Ag | Zellvereinzelungsvorrichtung und Verwendung einer Strömungsformation zur Zellvereinzelungsvorrichtung |
US11407981B2 (en) * | 2016-03-11 | 2022-08-09 | Boehringer Ingelheim International Gmbh | Methods for continuously inactivating a virus during manufacture of a protein |
US20210149361A1 (en) * | 2016-04-04 | 2021-05-20 | Boehringer Ingelheim Rcv Gmbh & Co Kg | Real time monitoring of product purification |
CA3062519A1 (en) | 2017-05-11 | 2018-11-15 | Emd Millipore Corporation | Method of maintaining narrow residence time distributions in continuous flow systems using solid material packet interfaces |
KR102286414B1 (ko) * | 2017-05-11 | 2021-08-06 | 이엠디 밀리포어 코포레이션 | 연속 유동 시스템에서 좁은 체류 시간 분포를 유지하기 위한 기계적 방법 |
MX2020000353A (es) | 2017-07-10 | 2020-08-17 | Takeda Pharmaceuticals Co | Metodos para incubar liquidos e inactivar virus. |
TW201927346A (zh) * | 2017-12-13 | 2019-07-16 | 德商拜耳廠股份有限公司 | 單元操作及其使用 |
CN113015787A (zh) * | 2018-10-08 | 2021-06-22 | 勃林格殷格翰国际公司 | 用于低ph病毒灭活的新型连续流反应器 |
BR112021006498A2 (pt) * | 2018-11-15 | 2021-07-06 | Bayer Healthcare Llc | métodos de inativação de vírus para fabricação contínua de anticorpos |
KR20210023102A (ko) | 2019-08-22 | 2021-03-04 | (주)아모레퍼시픽 | 눈썹 또는 속눈썹 성장 촉진용 조성물 |
KR20230023785A (ko) | 2020-06-16 | 2023-02-17 | 베링거 인겔하임 인터내셔날 게엠베하 | 플러그 유동 반응기 내에서 균일한 공급 스트림을 제공하는 방법 |
CN111690057B (zh) * | 2020-06-24 | 2021-04-23 | 哈尔滨元亨生物药业有限公司 | 一种重组犬细小病毒单克隆抗体生产方法 |
DE102021107394A1 (de) | 2021-03-24 | 2022-09-29 | Sartorius Stedim Biotech Gmbh | Vorrichtung zur kontinuierlichen Vireninaktivierung |
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JPH0669961B2 (ja) * | 1984-09-25 | 1994-09-07 | 株式会社ミドリ十字 | 免疫グロブリンの加熱処理方法 |
CA2165065A1 (en) | 1993-06-23 | 1995-01-05 | Henrietta Margolis-Nunno | System for viral inactivation of blood |
US5429746A (en) | 1994-02-22 | 1995-07-04 | Smith Kline Beecham Corporation | Antibody purification |
US6136586A (en) * | 1995-08-29 | 2000-10-24 | Vi Technologies, Inc. | Methods for the selective modification of viral nucleic acids |
GB9611698D0 (en) * | 1996-06-05 | 1996-08-07 | Iatros Ltd | Fluid processing |
US5886154A (en) * | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
IL140155A (en) * | 1998-06-09 | 2005-12-18 | Statens Seruminstitut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
GB9821342D0 (en) * | 1998-10-02 | 1998-11-25 | Common Services Agency | Device for treatment of biological fluids |
CN1332646A (zh) * | 1998-10-15 | 2002-01-23 | 桑伽特股份有限公司 | 生产无基质血红蛋白的方法 |
US6214221B1 (en) * | 1999-02-22 | 2001-04-10 | Henry B. Kopf | Method and apparatus for purification of biological substances |
AUPQ984400A0 (en) * | 2000-09-01 | 2000-09-28 | Novapharm Research (Australia) Pty Ltd | Surfactant sytem |
ES2184594B1 (es) | 2001-01-17 | 2004-01-01 | Probitas Pharma Sa | Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. |
EP1419177B1 (en) * | 2001-08-14 | 2008-04-30 | Statens Serum Institut | A purification process for large scale production of gc-globulin, product obtained thereby and their use in medicine |
US7252799B2 (en) * | 2001-08-31 | 2007-08-07 | Clearant, Inc. | Methods for sterilizing preparations containing albumin |
DE10310377A1 (de) | 2003-03-07 | 2004-09-16 | Bode Chemie Gmbh & Co. Kg | Desinfektionsmittlelkonzentrate auf Basis quarternärer Ammoniumverbindungen sowie die Verwendung derselben zur chemothermischen Instrumentenaufbereitung |
JP2005095112A (ja) | 2003-08-19 | 2005-04-14 | Mitsubishi Heavy Ind Ltd | ウイルス不活化剤およびウイルス不活化方法、該不活化剤を備えたフィルター、並びに該フィルターを具備する空気調和機 |
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US7993580B2 (en) | 2004-08-24 | 2011-08-09 | Baxter International Inc. | Methods for the inactivation of microorganisms in biological fluids, flow through reactors and methods of controlling the light sum dose to effectively inactivate microorganisms in batch reactors |
AU2005229674B2 (en) * | 2004-11-18 | 2010-11-04 | Kedrion Melville Inc. | Low concentration solvent/detergent process of immuneglobulin with pre-treatment |
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CN100389193C (zh) * | 2006-01-12 | 2008-05-21 | 上海交通大学 | 安全连续封闭式细胞培养、病毒生产和灭活的方法 |
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JP2010523784A (ja) * | 2007-04-12 | 2010-07-15 | ビヨクサル | 透析ジェネレーターのための新規な洗浄、スケール除去、および消毒用組成物 |
US8012414B2 (en) * | 2007-08-10 | 2011-09-06 | Novasterilis | Sterilization of drugs using supercritical carbon dioxide sterilant |
EP2070552A1 (en) * | 2007-12-11 | 2009-06-17 | Bundesrepublik Deutschland vertreten durch das Bundesminsterium für Gesundheit, dieses vertr. durch das Robert-Koch-Institut | A formulation for broad-range disinfection including prion decontamination |
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EP2271374B1 (en) * | 2008-03-28 | 2014-03-05 | Research Foundation For Medical Devices | Method of viral inactivation of biological fluids by solvent/detergent-treatment |
CN101927011B (zh) * | 2009-06-23 | 2014-03-19 | 武汉生物制品研究所有限责任公司 | 一种球蛋白溶液的病毒灭活方法 |
ES2455567T3 (es) * | 2011-02-11 | 2014-04-16 | Oro Clean Chemie Ag | Procedimiento y dispositivo para la limpieza de instrumentos médicos |
US8956566B2 (en) | 2012-03-12 | 2015-02-17 | Pure Biosolutions, Llc | System and method for virus inactivation |
EP2682168A1 (en) * | 2012-07-02 | 2014-01-08 | Millipore Corporation | Purification of biological molecules |
ES2895173T3 (es) | 2012-06-29 | 2022-02-17 | Emd Millipore Corp | Métodos para inactivar virus durante un proceso de purificación de proteínas |
AU2013205138B2 (en) | 2012-08-09 | 2015-06-25 | Grifols, S.A. | Caprylate Viral Deactivation |
DK3131589T3 (da) | 2014-04-15 | 2023-08-07 | Boehringer Ingelheim Int | Fremgangsmåde og anvendelse til fortløbende inaktivering af en virus under tilvejebringelse af et biologisk produkt |
-
2015
- 2015-04-15 DK DK15720615.2T patent/DK3131589T3/da active
- 2015-04-15 CN CN201580031911.3A patent/CN106456813B/zh active Active
- 2015-04-15 WO PCT/EP2015/058172 patent/WO2015158776A1/en active Application Filing
- 2015-04-15 US US15/303,776 patent/US10435670B2/en active Active
- 2015-04-15 EP EP15720615.2A patent/EP3131589B1/en active Active
- 2015-04-15 CN CN202111563049.4A patent/CN114225072B/zh active Active
- 2015-04-15 EP EP23172012.9A patent/EP4234569A3/en active Pending
- 2015-04-15 CN CN202010492200.9A patent/CN111632167B/zh active Active
-
2019
- 2019-08-23 US US16/549,203 patent/US11725191B2/en active Active
-
2023
- 2023-06-29 US US18/343,861 patent/US20230340425A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
US20200087632A1 (en) | 2020-03-19 |
CN114225072B (zh) | 2024-01-02 |
CN106456813A (zh) | 2017-02-22 |
CN114225072A (zh) | 2022-03-25 |
CN111632167B (zh) | 2021-12-28 |
US10435670B2 (en) | 2019-10-08 |
EP4234569A2 (en) | 2023-08-30 |
US20230340425A1 (en) | 2023-10-26 |
EP4234569A3 (en) | 2023-10-18 |
CN106456813B (zh) | 2020-06-30 |
US11725191B2 (en) | 2023-08-15 |
EP3131589B1 (en) | 2023-05-17 |
EP3131589A1 (en) | 2017-02-22 |
CN111632167A (zh) | 2020-09-08 |
US20170037381A1 (en) | 2017-02-09 |
WO2015158776A1 (en) | 2015-10-22 |
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