JP2013531630A5 - - Google Patents
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- Publication number
- JP2013531630A5 JP2013531630A5 JP2013511592A JP2013511592A JP2013531630A5 JP 2013531630 A5 JP2013531630 A5 JP 2013531630A5 JP 2013511592 A JP2013511592 A JP 2013511592A JP 2013511592 A JP2013511592 A JP 2013511592A JP 2013531630 A5 JP2013531630 A5 JP 2013531630A5
- Authority
- JP
- Japan
- Prior art keywords
- antibody preparation
- antibody
- preparation according
- igm
- solution
- 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
Links
- 238000002360 preparation method Methods 0.000 claims 43
- 239000000243 solution Substances 0.000 claims 15
- 239000011541 reaction mixture Substances 0.000 claims 10
- 210000002966 serum Anatomy 0.000 claims 10
- 108060003951 Immunoglobulin Proteins 0.000 claims 9
- 102000018358 immunoglobulin Human genes 0.000 claims 9
- 102000004169 proteins and genes Human genes 0.000 claims 7
- 108090000623 proteins and genes Proteins 0.000 claims 7
- 239000000126 substance Substances 0.000 claims 7
- 102000004190 Enzymes Human genes 0.000 claims 6
- 108090000790 Enzymes Proteins 0.000 claims 6
- 230000000694 effects Effects 0.000 claims 6
- 238000003556 assay Methods 0.000 claims 5
- 238000011534 incubation Methods 0.000 claims 5
- 238000000034 method Methods 0.000 claims 5
- 238000010790 dilution Methods 0.000 claims 4
- 239000012895 dilution Substances 0.000 claims 4
- 239000000203 mixture Substances 0.000 claims 4
- 241000282412 Homo Species 0.000 claims 3
- 230000002391 anti-complement effect Effects 0.000 claims 3
- 108010008730 anticomplement Proteins 0.000 claims 3
- 238000000338 in vitro Methods 0.000 claims 3
- 238000001990 intravenous administration Methods 0.000 claims 3
- 238000002965 ELISA Methods 0.000 claims 2
- 238000013019 agitation Methods 0.000 claims 2
- 150000001732 carboxylic acid derivatives Chemical class 0.000 claims 2
- 230000024203 complement activation Effects 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 2
- 208000026278 immune system disease Diseases 0.000 claims 2
- 238000000099 in vitro assay Methods 0.000 claims 2
- 230000001678 irradiating effect Effects 0.000 claims 2
- 239000011259 mixed solution Substances 0.000 claims 2
- 238000002156 mixing Methods 0.000 claims 2
- 244000309711 non-enveloped viruses Species 0.000 claims 2
- 238000003118 sandwich ELISA Methods 0.000 claims 2
- 239000000758 substrate Substances 0.000 claims 2
- 208000035143 Bacterial infection Diseases 0.000 claims 1
- 241000282567 Macaca fascicularis Species 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 230000004872 arterial blood pressure Effects 0.000 claims 1
- 208000022362 bacterial infectious disease Diseases 0.000 claims 1
- VEZXCJBBBCKRPI-UHFFFAOYSA-N beta-propiolactone Chemical compound O=C1CCO1 VEZXCJBBBCKRPI-UHFFFAOYSA-N 0.000 claims 1
- 230000004071 biological effect Effects 0.000 claims 1
- 238000007385 chemical modification Methods 0.000 claims 1
- 230000007812 deficiency Effects 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 230000009144 enzymatic modification Effects 0.000 claims 1
- 230000001747 exhibiting effect Effects 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 238000001728 nano-filtration Methods 0.000 claims 1
- 229960000380 propiolactone Drugs 0.000 claims 1
- 201000005404 rubella Diseases 0.000 claims 1
- 238000001542 size-exclusion chromatography Methods 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1006753.6 | 2010-04-22 | ||
| GBGB1006753.6A GB201006753D0 (en) | 2010-04-22 | 2010-04-22 | Process for preparing an immunolobulin composition |
| PCT/EP2011/056487 WO2011131787A2 (en) | 2010-04-22 | 2011-04-21 | Antibody preparations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016118887A Division JP6612186B2 (ja) | 2010-04-22 | 2016-06-15 | 抗体調製物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2013531630A JP2013531630A (ja) | 2013-08-08 |
| JP2013531630A5 true JP2013531630A5 (cg-RX-API-DMAC7.html) | 2014-06-05 |
| JP6283517B2 JP6283517B2 (ja) | 2018-02-21 |
Family
ID=42270688
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013511592A Active JP6283517B2 (ja) | 2010-04-22 | 2011-04-21 | 抗体調製物 |
| JP2013511591A Active JP6118248B2 (ja) | 2010-04-22 | 2011-04-21 | 免疫グロブリン組成物を調製するためのプロセス |
| JP2016110121A Active JP6612182B2 (ja) | 2010-04-22 | 2016-06-01 | 免疫グロブリン組成物を調製するためのプロセス |
| JP2016118887A Active JP6612186B2 (ja) | 2010-04-22 | 2016-06-15 | 抗体調製物 |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013511591A Active JP6118248B2 (ja) | 2010-04-22 | 2011-04-21 | 免疫グロブリン組成物を調製するためのプロセス |
| JP2016110121A Active JP6612182B2 (ja) | 2010-04-22 | 2016-06-01 | 免疫グロブリン組成物を調製するためのプロセス |
| JP2016118887A Active JP6612186B2 (ja) | 2010-04-22 | 2016-06-15 | 抗体調製物 |
Country Status (18)
| Country | Link |
|---|---|
| US (6) | US8900806B2 (cg-RX-API-DMAC7.html) |
| EP (2) | EP2560682B2 (cg-RX-API-DMAC7.html) |
| JP (4) | JP6283517B2 (cg-RX-API-DMAC7.html) |
| KR (2) | KR101872747B1 (cg-RX-API-DMAC7.html) |
| CN (3) | CN107080842A (cg-RX-API-DMAC7.html) |
| AU (2) | AU2011244241B2 (cg-RX-API-DMAC7.html) |
| CA (2) | CA2796263C (cg-RX-API-DMAC7.html) |
| CO (2) | CO6640239A2 (cg-RX-API-DMAC7.html) |
| ES (2) | ES2551605T5 (cg-RX-API-DMAC7.html) |
| GB (1) | GB201006753D0 (cg-RX-API-DMAC7.html) |
| HU (2) | HUE028581T2 (cg-RX-API-DMAC7.html) |
| IL (2) | IL222373A (cg-RX-API-DMAC7.html) |
| MX (2) | MX338195B (cg-RX-API-DMAC7.html) |
| PL (2) | PL2560691T3 (cg-RX-API-DMAC7.html) |
| RU (4) | RU2617532C2 (cg-RX-API-DMAC7.html) |
| SG (2) | SG184843A1 (cg-RX-API-DMAC7.html) |
| WO (2) | WO2011131786A2 (cg-RX-API-DMAC7.html) |
| ZA (2) | ZA201208540B (cg-RX-API-DMAC7.html) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB201006753D0 (en) | 2010-04-22 | 2010-06-09 | Biotest Ag | Process for preparing an immunolobulin composition |
| FR2959821B1 (fr) * | 2010-05-05 | 2012-07-06 | Lab Francais Du Fractionnement | Procede de mesure de l'activation du complement par des igg |
| FR2974301B1 (fr) | 2011-04-20 | 2013-08-23 | Lab Francais Du Fractionnement | Procede de preparation d'un produit plasmatique deplete en un ou plusieurs facteurs thrombogenes |
| FR2977893B1 (fr) * | 2011-07-11 | 2015-02-20 | Lab Francais Du Fractionnement | Procede de preparation d'un concentre d'immunoglobulines polyvalentes |
| KR102142261B1 (ko) * | 2012-03-09 | 2020-08-11 | 체에스엘 베링 아게 | 분비형 면역글로불린을 포함하는 조성물 |
| EP2636684A1 (en) | 2012-03-09 | 2013-09-11 | CSL Behring AG | Prevention of infection |
| EP2636681A1 (en) | 2012-03-09 | 2013-09-11 | CSL Behring AG | Process for enriching IgA |
| KR20150115639A (ko) * | 2014-04-04 | 2015-10-14 | 전숙영 | 치료용 면역글로불린 제제 제조에 사용되는 산성 완충액, 이를 이용한 치료용 면역글로불린 제제 제조방법 및 이 제조방법으로 제조된 치료용 면역글로불린 제제 |
| WO2016011054A2 (en) * | 2014-07-15 | 2016-01-21 | The Regents Of The University Of California | Novel treatment for polycystic kidney disease |
| PT3334747T (pt) | 2015-08-13 | 2023-12-12 | Amgen Inc | Formulação de gonadotrofina líquida estável |
| EP3851123A1 (en) * | 2016-03-14 | 2021-07-21 | Biotest AG | Treatment of severe community acquired pneumonia |
| EP3275897A1 (en) * | 2016-07-27 | 2018-01-31 | Biotest AG | Process for preparing immunoglobulin compositions |
| RU2660584C1 (ru) * | 2017-06-06 | 2018-07-06 | Федеральное государственное бюджетное учреждение науки "Кировский научно-исследовательский институт гематологии и переливания крови Федерального медико-биологического агентства" | Способ определения FC-функции препаратов иммуноглобулина человека |
| WO2019105916A1 (en) * | 2017-11-29 | 2019-06-06 | F. Hoffmann-La Roche Ag | Target interference suppressed anti-drug antibody assay |
| EP3747903A1 (en) | 2019-06-07 | 2020-12-09 | Biotest AG | Method and kit for testing potency of immunoglobulin compositions |
| JP2023521178A (ja) * | 2020-04-10 | 2023-05-23 | バヌディス ゲーエムベーハー | 予防および治療における自然抗体 |
| AU2021284903A1 (en) * | 2020-06-03 | 2023-02-02 | Grifols Worldwide Operations Limited | Hyperimmune IgG and/or IgM compositions and method for preparing thereof and method for obtaining hyperimmune human plasma from a donor |
| CA3183021A1 (en) * | 2020-07-10 | 2022-01-13 | Myles Lindsay | Method for obtaining a composition comprising human plasma-derived immunoglobulin m |
| CN111944043B (zh) * | 2020-09-01 | 2023-05-09 | 华兰生物工程重庆有限公司 | 一种从血浆废弃物中提取IgM的方法 |
| US20230400453A1 (en) | 2020-11-19 | 2023-12-14 | Biotest Ag | Method and Kit for Testing Immunomodulatory Potency of Immunoglobulin Compositions for Treatment of COVID-19 |
| AU2022317368A1 (en) | 2021-07-29 | 2024-02-22 | Csl Behring Ag | Method of purifying immunoglobulin g and uses thereof |
| AU2024247735A1 (en) | 2023-03-29 | 2025-10-30 | Csl Behring Ag | Methods of identifying immunoglobulin associated with adverse reactions |
| WO2025008781A1 (en) | 2023-07-04 | 2025-01-09 | Csl Behring Ag | Method of purification |
| WO2025229607A1 (en) | 2024-05-03 | 2025-11-06 | Csl Behring Ag | Systems and methods for solid-liquid separation |
Family Cites Families (44)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US136556A (en) | 1873-03-04 | Improvements in button-fastenings | ||
| DE2901822A1 (de) * | 1979-01-18 | 1980-07-31 | Biotest Serum Institut Gmbh | Verfahren zur herstellung einer fuer die intravenoese applikation geeigneten immunglobulinloesung, die igm in ankonzentrierter form enthaelt |
| US4371520A (en) * | 1981-10-28 | 1983-02-01 | The Green Cross Corporation | Process for preparing immunoglobulin suitable for intravenous injection |
| DE3310150A1 (de) * | 1983-03-21 | 1984-09-27 | Lentia GmbH Chem. u. pharm. Erzeugnisse - Industriebedarf, 8000 München | Verfahren zur herstellung einer nebenwirkungsfreien igg-immunglobulinloesung fuer die intravenoese applikation |
| IL90281A (en) | 1988-06-06 | 1994-10-07 | Miles Inc | Preparations containing MGI antibodies |
| DE3825429C2 (de) | 1988-07-27 | 1994-02-10 | Biotest Pharma Gmbh | Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt |
| US4939176A (en) | 1988-12-20 | 1990-07-03 | Miles Inc. | Viral inactivation process |
| DE3927111C3 (de) † | 1989-08-17 | 1994-09-01 | Biotest Pharma Gmbh | Verfahren zur Herstellung nicht modifizierter intravenös verabreichbarer IgM- und/oderIgA-haltiger Immunglobulinpräparate |
| DE3927112C1 (cg-RX-API-DMAC7.html) | 1989-08-17 | 1990-10-25 | Biotest Pharma Gmbh, 6072 Dreieich, De | |
| US5256771A (en) | 1990-04-03 | 1993-10-26 | Miles Inc. | Heat treatment of IgM-containing immunoglobulins to eliminate non-specific complement activation |
| US5367054A (en) * | 1993-04-12 | 1994-11-22 | Stolle Research & Development Corp. | Large-scale purification of egg immunoglobulin |
| DE96923791T1 (de) † | 1995-07-14 | 2004-07-08 | Croix Rouge De Belgique | Verfahren und vorrichtung zur inaktivierung von verunreinigungen in blutprodukten |
| DK0764658T3 (da) | 1995-09-22 | 2002-04-22 | Zlb Bioplasma Ag | Fremgangsmåde til fremstilling af immunoglobuliner ud fra fraktioner, som opstår ved fraktionering af blodplasma fra mennesker |
| EP0835880A1 (de) * | 1996-10-14 | 1998-04-15 | Rotkreuzstiftung Zentrallaboratorium Blutspendedienst Srk | Verfahren zur Herstellung eines IgM Präparates für die intravenöse Applikation |
| JP3987599B2 (ja) * | 1996-12-05 | 2007-10-10 | 日本製薬株式会社 | 筋ジストロフィー治療剤 |
| JPH10167894A (ja) * | 1996-12-11 | 1998-06-23 | Mitsubishi Gas Chem Co Inc | ビスマス置換希土類鉄ガーネット単結晶膜の製造法 |
| US5886154A (en) | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
| US6955917B2 (en) * | 1997-06-20 | 2005-10-18 | Bayer Healthcare Llc | Chromatographic method for high yield purification and viral inactivation of antibodies |
| BR9911131A (pt) | 1998-06-09 | 2001-03-06 | Statens Seruminstitut | Processo para produção de imunoglobulinas para administração intravenosa e outros produtos de imunoglobulina |
| RU2178309C2 (ru) * | 2000-01-12 | 2002-01-20 | Российский научно-исследовательский институт геронтологии | Антитимоцитарный глобулин для внутривенного введения и способ его получения |
| RU2192279C2 (ru) * | 2000-09-07 | 2002-11-10 | Нижегородское государственное предприятие по производству бактерийных препаратов | Способ получения иммуноглобулинового препарата |
| AU2954502A (en) | 2000-11-13 | 2002-05-21 | Bayer Ag | Method of inactivating microorganisms in a fluid using ultraviolet radiation |
| FR2824568B1 (fr) | 2001-05-11 | 2004-04-09 | Lab Francais Du Fractionnement | Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique |
| US7727974B2 (en) | 2001-08-10 | 2010-06-01 | Eisai R & D Management Co., Ltd. | Methods of reducing the severity of mucositis |
| JP4191037B2 (ja) * | 2001-11-02 | 2008-12-03 | 日本テクノ株式会社 | 滅菌用振動攪拌装置並びに振動攪拌装置を用いる滅菌装置及び滅菌方法 |
| RU2255766C2 (ru) * | 2003-03-05 | 2005-07-10 | Государственное учреждение "Московский научно-исследовательский институт эпидемиологии и микробиологии им. Г.Н. Габрического Министерства здравоохранения Российской Федерации" | Способ получения иммуноглобулинового препарата для профилактики и терапии бактериальных и вирусных инфекций, иммуноглобулиновый препарат для профилактики и терапии бактериальных и вирусных инфекций (варианты) и суппозитории на основе иммуноглобулинового препарата |
| EP1615946B1 (en) | 2003-03-26 | 2020-05-06 | Sudhir Paul | Proteolytic and covalent antibodies |
| ES2418830T3 (es) | 2003-10-27 | 2013-08-16 | Wyeth Llc | Retirada de agregados de alto peso molecular usando cromatografía de hidroxiapatita |
| EP1532983A1 (en) | 2003-11-18 | 2005-05-25 | ZLB Bioplasma AG | Immunoglobulin preparations having increased stability |
| JP2008500959A (ja) | 2004-01-30 | 2008-01-17 | スオメン プナイネン リスティ ヴェリパルヴェル | ウイルスについて安全な免疫グロブリンの製造方法 |
| EP1718675B2 (en) | 2004-02-27 | 2017-01-25 | Octapharma AG | A method of providing a purified, virus safe antibody preparation |
| CA2593561C (en) | 2004-12-10 | 2017-01-03 | Novimmune S.A. | Combining therapies targeting multiple toll-like receptors and use thereof |
| WO2006064373A2 (en) | 2004-12-16 | 2006-06-22 | Genzyme Polyclonals S.A.S. | Methods of purifying immunologlobulins |
| KR101157174B1 (ko) | 2005-11-24 | 2012-06-20 | 삼성전자주식회사 | 세포 또는 바이러스의 신속한 파괴 방법 및 장치 |
| DE102005062634A1 (de) | 2005-12-23 | 2007-06-28 | Blutspendedienst der Landesverbände des Deutschen Roten Kreuzes Niedersachsen, Sachsen-Anhalt, Thüringen, Oldenburg und Bremen gGmbH | Verfahren zur Inaktivierung von Pathogenen in Spenderblut, Blutplasma oder Erythrozytenkonzentraten in flexiblen Behältnissen unter Bewegung |
| FR2899111B1 (fr) | 2006-03-31 | 2010-09-03 | Lab Francais Du Fractionnement | Concentre d'immunoglobulines specifiques du chikungunya en tant que medicament. |
| FR2899112B1 (fr) | 2006-03-31 | 2010-09-03 | Lab Francais Du Fractionnement | Concentre d'immunoglobulines et de fragments f (ab)'2 et/ou fab specifiques d'un arbovirus en tant que medicament. |
| US8354076B2 (en) | 2006-10-02 | 2013-01-15 | Palo Alto Research Center Incorporated | Fluid stirring mechanism |
| EP1950225A1 (de) | 2007-01-25 | 2008-07-30 | Octapharma AG | Verfahren zur Steigerung von Proteinausbeuten |
| CN102089005A (zh) | 2008-05-12 | 2011-06-08 | 斯特罗克斯生物制药有限责任公司 | 金黄色葡萄球菌特异性抗体制剂 |
| RU2457863C2 (ru) * | 2008-08-05 | 2012-08-10 | Виктор Владимирович Чалов | Композиция, обладающая противовирусным и антимикробным действием, содержащая консорциум иммуноглобулинов |
| RU2457861C2 (ru) * | 2008-08-05 | 2012-08-10 | Виктор Владимирович Чалов | Композиция, обладающая противовирусным и антимикробным действием, содержащая консорциум иммуноглобулинов |
| GB201006753D0 (en) | 2010-04-22 | 2010-06-09 | Biotest Ag | Process for preparing an immunolobulin composition |
| NZ591514A (en) | 2011-03-03 | 2013-11-29 | Kode Biotech Ltd | Assay method |
-
2010
- 2010-04-22 GB GBGB1006753.6A patent/GB201006753D0/en not_active Ceased
-
2011
- 2011-04-21 AU AU2011244241A patent/AU2011244241B2/en active Active
- 2011-04-21 MX MX2012012263A patent/MX338195B/es active IP Right Grant
- 2011-04-21 WO PCT/EP2011/056486 patent/WO2011131786A2/en not_active Ceased
- 2011-04-21 EP EP11715567.1A patent/EP2560682B2/en active Active
- 2011-04-21 HU HUE11715928A patent/HUE028581T2/en unknown
- 2011-04-21 AU AU2011244240A patent/AU2011244240B2/en active Active
- 2011-04-21 RU RU2012149741A patent/RU2617532C2/ru active
- 2011-04-21 RU RU2012149743A patent/RU2612899C2/ru active
- 2011-04-21 PL PL11715928T patent/PL2560691T3/pl unknown
- 2011-04-21 HU HUE11715567A patent/HUE025853T2/en unknown
- 2011-04-21 WO PCT/EP2011/056487 patent/WO2011131787A2/en not_active Ceased
- 2011-04-21 ES ES11715567T patent/ES2551605T5/es active Active
- 2011-04-21 CN CN201611045494.0A patent/CN107080842A/zh active Pending
- 2011-04-21 ES ES11715928.5T patent/ES2553385T3/es active Active
- 2011-04-21 SG SG2012076055A patent/SG184843A1/en unknown
- 2011-04-21 CA CA2796263A patent/CA2796263C/en active Active
- 2011-04-21 RU RU2016140455A patent/RU2765738C2/ru active
- 2011-04-21 RU RU2017111820A patent/RU2749732C2/ru active
- 2011-04-21 CN CN201180029338.4A patent/CN102939111B/zh active Active
- 2011-04-21 MX MX2012012262A patent/MX337060B/es active IP Right Grant
- 2011-04-21 JP JP2013511592A patent/JP6283517B2/ja active Active
- 2011-04-21 SG SG2012076063A patent/SG184844A1/en unknown
- 2011-04-21 CN CN201180029337.XA patent/CN102939107B/zh active Active
- 2011-04-21 KR KR1020127030527A patent/KR101872747B1/ko active Active
- 2011-04-21 KR KR1020127030528A patent/KR101860459B1/ko active Active
- 2011-04-21 EP EP11715928.5A patent/EP2560691B1/en active Active
- 2011-04-21 PL PL11715567.1T patent/PL2560682T5/pl unknown
- 2011-04-21 JP JP2013511591A patent/JP6118248B2/ja active Active
- 2011-04-21 CA CA2796409A patent/CA2796409A1/en not_active Abandoned
-
2012
- 2012-10-11 IL IL222373A patent/IL222373A/en active IP Right Grant
- 2012-10-11 IL IL222374A patent/IL222374A/en active IP Right Grant
- 2012-10-19 US US13/655,686 patent/US8900806B2/en active Active
- 2012-10-19 US US13/655,649 patent/US9243056B2/en active Active
- 2012-11-13 ZA ZA2012/08540A patent/ZA201208540B/en unknown
- 2012-11-13 ZA ZA2012/08541A patent/ZA201208541B/en unknown
- 2012-11-22 CO CO12211856A patent/CO6640239A2/es unknown
- 2012-11-22 CO CO12211854A patent/CO6640238A2/es not_active Application Discontinuation
-
2014
- 2014-10-31 US US14/529,400 patent/US9518110B2/en active Active
-
2016
- 2016-06-01 JP JP2016110121A patent/JP6612182B2/ja active Active
- 2016-06-15 JP JP2016118887A patent/JP6612186B2/ja active Active
- 2016-11-10 US US15/348,121 patent/US10059759B2/en active Active
-
2018
- 2018-07-09 US US16/029,781 patent/US10954290B2/en active Active
-
2021
- 2021-02-05 US US17/168,848 patent/US11780909B2/en active Active
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