DK3128014T3 - Midler og fremgangsmåder til sterilisering af biofunktionelle sammensætninger - Google Patents
Midler og fremgangsmåder til sterilisering af biofunktionelle sammensætninger Download PDFInfo
- Publication number
- DK3128014T3 DK3128014T3 DK16176458.4T DK16176458T DK3128014T3 DK 3128014 T3 DK3128014 T3 DK 3128014T3 DK 16176458 T DK16176458 T DK 16176458T DK 3128014 T3 DK3128014 T3 DK 3128014T3
- Authority
- DK
- Denmark
- Prior art keywords
- biofunctional
- sterilizing
- compositions
- methods
- sterilizing biofunctional
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54393—Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09004735A EP2236617A1 (en) | 2009-03-31 | 2009-03-31 | Methods of terminal sterilization of biofunctional compositions |
| EP10712939.7A EP2414538B1 (en) | 2009-03-31 | 2010-03-31 | Means and methods of sterilization of biofunctional compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3128014T3 true DK3128014T3 (da) | 2020-02-17 |
Family
ID=41119898
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK16176458.4T DK3128014T3 (da) | 2009-03-31 | 2010-03-31 | Midler og fremgangsmåder til sterilisering af biofunktionelle sammensætninger |
Country Status (7)
| Country | Link |
|---|---|
| US (3) | US8685459B2 (da) |
| EP (3) | EP2236617A1 (da) |
| JP (2) | JP6250281B2 (da) |
| CN (1) | CN102449162B (da) |
| DK (1) | DK3128014T3 (da) |
| ES (1) | ES2770086T3 (da) |
| WO (1) | WO2010112576A1 (da) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2236617A1 (en) | 2009-03-31 | 2010-10-06 | Leukocare Ag | Methods of terminal sterilization of biofunctional compositions |
| EP2236520A1 (en) * | 2009-03-31 | 2010-10-06 | Leukocare Ag | Stabilizing composition for immobilized biomolecules |
| EP3744833A1 (en) | 2011-06-28 | 2020-12-02 | Leukocare Ag | Stabilisation method for viruses |
| US9321848B2 (en) | 2011-06-28 | 2016-04-26 | Leukocare Ag | Method for preventing the unfolding of a (poly)peptide and/or inducing the (re-)folding of a (poly)peptide |
| US10780228B2 (en) | 2012-05-07 | 2020-09-22 | Medline Industries, Inc. | Prefilled container systems |
| CN103446600B (zh) * | 2012-05-31 | 2020-05-22 | 通用电气公司 | 为含有葡萄糖氧化酶的膜杀菌的方法和相应的生物传感器 |
| US9534029B2 (en) | 2012-10-03 | 2017-01-03 | Csl Behring Ag | Method of purifying proteins |
| JP6370792B2 (ja) * | 2012-10-03 | 2018-08-08 | ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト | タンパク質の精製方法 |
| CN103028124B (zh) * | 2012-12-21 | 2014-07-23 | 菱花集团有限公司 | 谷氨酸发酵中连实消相结合的物料灭菌方法 |
| RU2662929C2 (ru) | 2013-03-08 | 2018-07-31 | Джензим Корпорейшн | Интегрированное непрерывное производство терапевтических белковых лекарственных веществ |
| ES2502666B1 (es) * | 2013-04-02 | 2015-10-27 | Consejo Superior De Investigaciones Científicas (Csic) | Procedimiento de estabilización de biomoléculas |
| TWI709570B (zh) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析法及製法 |
| TWI709569B (zh) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析樹脂及其用於製造方法的用途 |
| WO2016143828A1 (ja) * | 2015-03-12 | 2016-09-15 | 三洋化成工業株式会社 | タンパク質組成物の製造方法及びタンパク質組成物 |
| CN105497925B (zh) * | 2015-12-25 | 2019-02-26 | 烟台正海生物科技股份有限公司 | 一种在电离辐射灭菌前对功能蛋白进行保护的方法及其专用保护剂 |
| CA3036965A1 (en) | 2016-09-16 | 2018-03-22 | Leukocare Ag | A method for stabilization of a biopharmaceutical drug product during processing |
| US20190256551A1 (en) | 2016-09-16 | 2019-08-22 | Leukocare Ag | A novel method of producing a liquid biopharmaceutical drug product |
| US11510871B2 (en) | 2016-09-16 | 2022-11-29 | Leukocare Ag | Method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation |
| US20210100744A1 (en) * | 2018-05-11 | 2021-04-08 | North Carolina State University | Bioresponsive hydrogel matrixes and methods of use |
| EP3843869A1 (en) | 2018-08-31 | 2021-07-07 | Genzyme Corporation | Sterile chromatography resin and use thereof in manufacturing processes |
| KR20210132054A (ko) * | 2019-01-31 | 2021-11-03 | 셀 메디신 가부시키가이샤 | 무기 염류 단백 복합 의료 기기 |
| CN110665478B (zh) * | 2019-09-06 | 2022-08-23 | 武汉瑞法医疗器械有限公司 | 一种用于稳定吸附剂吸附性能的填充液及其应用 |
| CN110935043B (zh) * | 2019-12-19 | 2021-01-12 | 浙江相伴乳胶制品有限公司 | 一种乳胶制品的灭菌方法 |
| CN112107720A (zh) * | 2020-09-18 | 2020-12-22 | 华熙生物科技股份有限公司 | 透气性好的医用压敏胶及依克多因在提高医用压敏胶透气性中的应用 |
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| US3051627A (en) * | 1960-08-18 | 1962-08-28 | Armour Pharma | Stabilized chymotrypsin solution |
| US3957049A (en) * | 1973-10-09 | 1976-05-18 | Neefe Charles W | Rechargeable drug delivery method |
| US4121588A (en) * | 1977-05-16 | 1978-10-24 | Becton, Dickinson And Company | Disposable hypodermic syringe and method of manufacture |
| JPS54147916A (en) * | 1978-05-12 | 1979-11-19 | Sumitomo Chem Co Ltd | Preparation of urokinase injection |
| CA1144849A (en) * | 1979-10-24 | 1983-04-19 | Brown (Albert) Limited | Sterilisation indicators |
| JPS60120823A (ja) * | 1983-12-02 | 1985-06-28 | Green Cross Corp:The | ＩｇＧ単量体 |
| IL109403A0 (en) * | 1993-04-22 | 1994-07-31 | Emisphere Tech Inc | Oral drug delivery compositions and methods |
| US5730933A (en) | 1996-04-16 | 1998-03-24 | Depuy Orthopaedics, Inc. | Radiation sterilization of biologically active compounds |
| JP3624543B2 (ja) * | 1996-05-02 | 2005-03-02 | 東ソー株式会社 | 免疫反応試薬及びその製造方法 |
| US6632648B1 (en) | 1996-05-14 | 2003-10-14 | Elan Drug Delivery Limited | Methods of terminal sterilization of fibrinogen |
| GR1002706B (el) * | 1996-05-22 | 1997-05-26 | Μικρογαλακτωματα λεκιθινης περιεχοντα πρωτεολυτικα ενζυμα α-χυμοθρυψινης η θρυψινη και μεθοδος μονιμης ενζυμικης αποτριχωσης. | |
| JP4359352B2 (ja) * | 1997-10-23 | 2009-11-04 | 田辺三菱製薬株式会社 | 室温保存製剤 |
| US6140127A (en) * | 1998-02-18 | 2000-10-31 | Cordis Corporation | Method of coating an intravascular stent with an endothelial cell adhesive five amino acid peptide |
| PT1212084E (pt) | 1999-08-17 | 2006-07-31 | Glaxosmithkline Biolog Sa | Metodos para separar variantes do rotavirus e vacina do rotavirus vivo atenuado |
| US6471979B2 (en) * | 1999-12-29 | 2002-10-29 | Estrogen Vascular Technology, Llc | Apparatus and method for delivering compounds to a living organism |
| US20030012687A1 (en) * | 2000-03-23 | 2003-01-16 | Macphee Martin J. | Methods of sterilizing biological materials |
| CA2403834A1 (en) | 2000-03-23 | 2001-09-27 | Clearant, Inc. | Methods for sterilizing biological materials |
| CA2410965C (en) * | 2000-05-31 | 2010-09-14 | Encelle, Inc. | Method of stimulating hair growth |
| CN1518479A (zh) * | 2001-04-03 | 2004-08-04 | ����˹�ж�-����˹˹����ҩƷ��˾ | 磷脂制剂的稳定化和终末消毒 |
| US20030059338A1 (en) * | 2001-09-24 | 2003-03-27 | Mann David M. | Methods for sterilizing biological materials using flavonoid/flavonol stabilizers |
| JP2003300908A (ja) * | 2002-04-08 | 2003-10-21 | Towa Yakuhin Kk | 安定なカルシトニン注射用製剤 |
| WO2004032980A1 (en) * | 2002-10-04 | 2004-04-22 | Elan Pharma International Limited | Gamma irradiation of solid nanoparticulate active agents |
| EP1571204B1 (de) * | 2004-03-04 | 2009-11-18 | LeukoCare AG | Leukozytenstimulations-Matrix |
| GB0503337D0 (en) | 2005-02-17 | 2005-03-23 | Glaxosmithkline Biolog Sa | Compositions |
| MX2007014480A (es) * | 2005-05-19 | 2008-04-22 | Albiorex Llc | Esterilizacion terminal de productos de colageno inyectables. |
| US20060280645A1 (en) * | 2005-06-02 | 2006-12-14 | Scott Sellers | Method for terminal sterilization of transdermal delivery devices |
| FR2895263B1 (fr) * | 2005-12-26 | 2008-05-30 | Lab Francais Du Fractionnement | Concentre d'immunoglobines g (lg) appauvri en anticorps anti-a et anti-b, et en igg polyreactives |
| EP1852443A1 (en) * | 2006-05-05 | 2007-11-07 | Leukocare AG | Biocompatible three dimensional matrix for the immobilization of biological substances |
| EP3266337A1 (en) * | 2006-07-10 | 2018-01-10 | Johnson & Johnson Vision Care Inc. | Packages for ophthalmic lenses containing pharmaceutical agents |
| US8747738B2 (en) * | 2006-08-15 | 2014-06-10 | Abbott Cardiovascular Systems Inc. | Sterilization methods for medical devices |
| EP2236520A1 (en) * | 2009-03-31 | 2010-10-06 | Leukocare Ag | Stabilizing composition for immobilized biomolecules |
| EP2236617A1 (en) | 2009-03-31 | 2010-10-06 | Leukocare Ag | Methods of terminal sterilization of biofunctional compositions |
| US8961984B2 (en) * | 2009-10-08 | 2015-02-24 | Arch Biophysics, Inc. | Surface-coated structures and methods |
-
2009
- 2009-03-31 EP EP09004735A patent/EP2236617A1/en not_active Ceased
-
2010
- 2010-03-31 JP JP2012502684A patent/JP6250281B2/ja active Active
- 2010-03-31 WO PCT/EP2010/054390 patent/WO2010112576A1/en active Application Filing
- 2010-03-31 ES ES16176458T patent/ES2770086T3/es active Active
- 2010-03-31 US US13/262,387 patent/US8685459B2/en active Active
- 2010-03-31 EP EP16176458.4A patent/EP3128014B1/en active Active
- 2010-03-31 CN CN201080023349.7A patent/CN102449162B/zh active Active
- 2010-03-31 DK DK16176458.4T patent/DK3128014T3/da active
- 2010-03-31 EP EP10712939.7A patent/EP2414538B1/en active Active
-
2014
- 2014-01-16 US US14/157,381 patent/US11564865B2/en active Active
-
2015
- 2015-10-01 JP JP2015195947A patent/JP6412477B2/ja active Active
-
2023
- 2023-01-18 US US18/156,151 patent/US20230225939A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JP6412477B2 (ja) | 2018-10-24 |
| EP2414538B1 (en) | 2016-06-29 |
| JP2012521776A (ja) | 2012-09-20 |
| ES2770086T3 (es) | 2020-06-30 |
| JP2016028593A (ja) | 2016-03-03 |
| EP3128014B1 (en) | 2019-11-13 |
| JP6250281B2 (ja) | 2017-12-20 |
| US11564865B2 (en) | 2023-01-31 |
| EP2236617A1 (en) | 2010-10-06 |
| US8685459B2 (en) | 2014-04-01 |
| US20140134214A1 (en) | 2014-05-15 |
| US20120093803A1 (en) | 2012-04-19 |
| CN102449162B (zh) | 2014-08-13 |
| CN102449162A (zh) | 2012-05-09 |
| EP3128014A1 (en) | 2017-02-08 |
| US20230225939A1 (en) | 2023-07-20 |
| WO2010112576A1 (en) | 2010-10-07 |
| EP2414538A1 (en) | 2012-02-08 |
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