CA2458386C - L-methionine as a stabilizer for nesp/epo in hsa-free formulations - Google Patents
L-methionine as a stabilizer for nesp/epo in hsa-free formulations Download PDFInfo
- Publication number
- CA2458386C CA2458386C CA2458386A CA2458386A CA2458386C CA 2458386 C CA2458386 C CA 2458386C CA 2458386 A CA2458386 A CA 2458386A CA 2458386 A CA2458386 A CA 2458386A CA 2458386 C CA2458386 C CA 2458386C
- Authority
- CA
- Canada
- Prior art keywords
- nesp
- methionine
- epo
- formulations
- free
- 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.)
- Expired - Lifetime
Links
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- 230000006641 stabilisation Effects 0.000 description 1
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- 238000006467 substitution reaction Methods 0.000 description 1
- WPLOVIFNBMNBPD-ATHMIXSHSA-N subtilin Chemical compound CC1SCC(NC2=O)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(C)CC)C(=O)NC(=C)C(=O)NC(CCCCN)C(O)=O)CSC(C)C2NC(=O)C(CC(C)C)NC(=O)C1NC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C1NC(=O)C(=C/C)/NC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)CNC(=O)C(NC(=O)C(NC(=O)C2NC(=O)CNC(=O)C3CCCN3C(=O)C(NC(=O)C3NC(=O)C(CC(C)C)NC(=O)C(=C)NC(=O)C(CCC(O)=O)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(N)CC=4C5=CC=CC=C5NC=4)CSC3)C(C)SC2)C(C)C)C(C)SC1)CC1=CC=CC=C1 WPLOVIFNBMNBPD-ATHMIXSHSA-N 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
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- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 description 1
- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 description 1
- 239000004474 valine Substances 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
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- 229960002555 zidovudine Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
- A61P7/06—Antianaemics
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/945,517 US20030104996A1 (en) | 2001-08-30 | 2001-08-30 | L-methionine as a stabilizer for NESP/EPO in HSA-free formulations |
| US09/945,517 | 2001-08-30 | ||
| PCT/US2002/027855 WO2003020299A1 (en) | 2001-08-30 | 2002-08-29 | L-methionine as a stabilizer for nesp/epo in hsa-free formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2458386A1 CA2458386A1 (en) | 2003-03-13 |
| CA2458386C true CA2458386C (en) | 2012-05-08 |
Family
ID=25483206
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2458386A Expired - Lifetime CA2458386C (en) | 2001-08-30 | 2002-08-29 | L-methionine as a stabilizer for nesp/epo in hsa-free formulations |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US20030104996A1 (enExample) |
| EP (1) | EP1439848B1 (enExample) |
| JP (2) | JP4493334B2 (enExample) |
| KR (1) | KR100596610B1 (enExample) |
| CN (1) | CN100384468C (enExample) |
| CA (1) | CA2458386C (enExample) |
| MX (1) | MXPA04001774A (enExample) |
| PL (1) | PL374122A1 (enExample) |
| TW (1) | TWI327068B (enExample) |
| WO (1) | WO2003020299A1 (enExample) |
Families Citing this family (45)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE291436T2 (de) * | 2000-05-15 | 2005-04-15 | Hoffmann La Roche | Flüssige arzneizubereitung enthaltend ein erythropoietin derivat |
| US20030104996A1 (en) * | 2001-08-30 | 2003-06-05 | Tiansheng Li | L-methionine as a stabilizer for NESP/EPO in HSA-free formulations |
| US7141544B2 (en) | 2003-10-10 | 2006-11-28 | Baxter International, Inc. | Stabilization of pharmaceutical protein formulations with small peptides |
| CA2915270C (en) | 2005-08-05 | 2017-07-11 | Amgen Inc. | Stable aqueous protein or antibody pharmaceutical formulations and their preparation |
| US8137677B2 (en) * | 2005-10-06 | 2012-03-20 | Allergan, Inc. | Non-protein stabilized clostridial toxin pharmaceutical compositions |
| US8168206B1 (en) * | 2005-10-06 | 2012-05-01 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
| TW200806317A (en) * | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| EP2170268A2 (en) * | 2007-06-25 | 2010-04-07 | Amgen, Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| JP2010532790A (ja) * | 2007-07-06 | 2010-10-14 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | 抗体処方 |
| EP3381445B1 (en) | 2007-11-15 | 2023-10-25 | Amgen Inc. | Aqueous formulation of antibody stablised by antioxidants for parenteral administration |
| EP2249801A2 (en) * | 2008-02-07 | 2010-11-17 | Amgen Inc. | Stabilized protein compositions |
| MX385591B (es) | 2008-08-15 | 2025-03-18 | Ironwood Pharmaceuticals Inc | Formulaciones que contienen linaclotida para administracion oral. |
| EP2334323A2 (en) | 2008-09-10 | 2011-06-22 | F. Hoffmann-La Roche AG | Compositions and methods for the prevention of oxidative degradation of proteins |
| US20120183531A1 (en) * | 2009-07-14 | 2012-07-19 | Biogen Idee Ma Inc | Methods for Inhibiting Yellow Color Formation in a Composition |
| MX2012001660A (es) * | 2009-08-06 | 2012-03-26 | Ironwood Pharmaceuticals Inc | Formulaciones que contienen linaclotida para adminstracion oral. |
| US20110150837A1 (en) * | 2009-12-23 | 2011-06-23 | Flamel Technologies | Amphiphilic polymer functionalized by methionine |
| FR2954325B1 (fr) | 2009-12-23 | 2012-02-03 | Flamel Tech Sa | Polymere amphiphile fonctionnalise par la methionine |
| KR20120110175A (ko) * | 2009-12-29 | 2012-10-09 | 에프. 호프만-라 로슈 아게 | 항체 제제 |
| RU2519031C1 (ru) | 2010-01-19 | 2014-06-10 | Ханми Сайенс Ко., Лтд. | Жидкие препаративные формы для длительно действующего конъюгата g-csf |
| EP2364690A1 (en) * | 2010-02-12 | 2011-09-14 | Centro De Ingenieria Genetica Y Biotecnologia | Orally administrable pharmaceutical pellet of epidermal growth factor |
| WO2011103311A2 (en) | 2010-02-17 | 2011-08-25 | Ironwood Pharmaceuticals, Inc | Treatments for gastrointestinal disorders |
| RS59978B1 (sr) | 2010-08-11 | 2020-03-31 | Ironwood Pharmaceuticals Inc | Stabilne formulacije linaklotida |
| KR101303388B1 (ko) | 2010-10-26 | 2013-09-03 | 한미사이언스 주식회사 | 지속형 인터페론 알파 결합체의 액상 제제 |
| EP2776055B1 (en) | 2011-08-17 | 2016-12-14 | Ironwood Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| CN108771655A (zh) | 2011-10-28 | 2018-11-09 | 诚信生物公司 | 含有氨基酸的蛋白质制剂 |
| AR092862A1 (es) * | 2012-07-25 | 2015-05-06 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion |
| WO2014142102A1 (ja) | 2013-03-12 | 2014-09-18 | 大日本住友製薬株式会社 | 液体水性組成物 |
| KR102236926B1 (ko) | 2013-03-13 | 2021-04-06 | 세센 바이오, 아이엔씨. | 안구 운반을 위한 키메릭 사이토카인 제제 |
| SG11201506499YA (en) | 2013-03-15 | 2015-09-29 | Glaxosmithkline Ip No 2 Ltd | Low concentration antibody formulations |
| EA202191909A1 (ru) * | 2014-01-13 | 2022-01-31 | Эмджен Инк. | Регулирование метаболизма орнитина для управления содержанием высокоманнозных гликоформ рекомбинантных белков |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| RU2599031C1 (ru) * | 2015-08-11 | 2016-10-10 | Общество с ограниченной ответственностью "АйВиФарма" | Водная композиция рекомбинантного фолликулостимулирующего гормона человека (варианты) |
| WO2017117304A1 (en) * | 2015-12-30 | 2017-07-06 | Genentech, Inc. | Use of tryptophan derivatives for protein formulations |
| US10369190B2 (en) | 2016-09-13 | 2019-08-06 | Allergan, Inc. | Non-protein clostridial toxin compositions |
| US11338018B2 (en) | 2016-12-19 | 2022-05-24 | Harrow Ip, Llc | Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof |
| JP6172880B1 (ja) * | 2017-02-01 | 2017-08-02 | 協和発酵キリン株式会社 | ダルベポエチンを含む液体医薬組成物 |
| US11110063B2 (en) | 2017-08-25 | 2021-09-07 | MAIA Pharmaceuticals, Inc. | Storage stable sincalide formulations |
| JP7188944B2 (ja) | 2017-09-07 | 2022-12-13 | Ｊｃｒファーマ株式会社 | 水性医薬組成物 |
| BR112021000965A2 (pt) * | 2018-08-07 | 2021-04-27 | Glaxosmithkline Biologicals S.A. | processos e vacinas |
| EP3849518A1 (en) * | 2018-09-13 | 2021-07-21 | F. Hoffmann-La Roche AG | Csf-1r antibody formulation |
| US20210251970A1 (en) | 2018-10-10 | 2021-08-19 | Presbyopia Therapies Inc | Compositions and methods for storage stable ophthalmic drugs |
| EP4433053A4 (en) | 2021-11-17 | 2025-09-17 | Lenz Therapeutics Operations Inc | ACECLIDINE DERIVATIVES, THEIR COMPOSITIONS AND METHODS OF USE |
| WO2023098844A1 (zh) * | 2021-12-03 | 2023-06-08 | 杰科（天津）生物医药有限公司 | 一种制剂及其制备方法和应用 |
| US11648247B1 (en) | 2021-12-16 | 2023-05-16 | Lenz Therapeutics, Inc. | Compositions and methods for the treatment of presbyopia |
| US12414942B1 (en) | 2024-03-15 | 2025-09-16 | Lenz Therapeutics Operations, Inc. | Compositions, methods, and systems for treating presbyopia |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6936694B1 (en) * | 1982-05-06 | 2005-08-30 | Intermune, Inc. | Manufacture and expression of large structural genes |
| KR850004274A (ko) * | 1983-12-13 | 1985-07-11 | 원본미기재 | 에리트로포이에틴의 제조방법 |
| US4703008A (en) * | 1983-12-13 | 1987-10-27 | Kiren-Amgen, Inc. | DNA sequences encoding erythropoietin |
| NZ210501A (en) * | 1983-12-13 | 1991-08-27 | Kirin Amgen Inc | Erythropoietin produced by procaryotic or eucaryotic expression of an exogenous dna sequence |
| US4667016A (en) * | 1985-06-20 | 1987-05-19 | Kirin-Amgen, Inc. | Erythropoietin purification |
| US4810643A (en) * | 1985-08-23 | 1989-03-07 | Kirin- Amgen Inc. | Production of pluripotent granulocyte colony-stimulating factor |
| JPS63500636A (ja) * | 1985-08-23 | 1988-03-10 | 麒麟麦酒株式会社 | 多分化能性顆粒球コロニー刺激因子をコードするｄｎａ |
| JPS6297229A (ja) * | 1985-10-21 | 1987-05-06 | Nec Kansai Ltd | 螢光膜の形成方法 |
| US4835260A (en) * | 1987-03-20 | 1989-05-30 | Genetics Institute, Inc. | Erythropoietin composition |
| US5075222A (en) * | 1988-05-27 | 1991-12-24 | Synergen, Inc. | Interleukin-1 inhibitors |
| US5372808A (en) * | 1990-10-17 | 1994-12-13 | Amgen Inc. | Methods and compositions for the treatment of diseases with consensus interferon while reducing side effect |
| US5272135A (en) * | 1991-03-01 | 1993-12-21 | Chiron Ophthalmics, Inc. | Method for the stabilization of methionine-containing polypeptides |
| US5581476A (en) * | 1993-01-28 | 1996-12-03 | Amgen Inc. | Computer-based methods and articles of manufacture for preparing G-CSF analogs |
| TW497972B (en) * | 1995-06-08 | 2002-08-11 | Kirin Brewery | Stable thrombopoietin (TPO)-containing lyophilized compositions |
| IL122732A0 (en) * | 1997-01-15 | 1998-08-16 | Akzo Nobel Nv | Liquid gonadotropin-containing formulation its preparation and a device containing same |
| JP2000247903A (ja) * | 1999-03-01 | 2000-09-12 | Chugai Pharmaceut Co Ltd | 長期安定化製剤 |
| WO2001030320A1 (en) * | 1999-10-22 | 2001-05-03 | Amgen Inc. | Biodegradable microparticles with novel erythropoietin stimulating protein |
| ATE291436T2 (de) * | 2000-05-15 | 2005-04-15 | Hoffmann La Roche | Flüssige arzneizubereitung enthaltend ein erythropoietin derivat |
| JP5490972B2 (ja) * | 2000-08-04 | 2014-05-14 | 中外製薬株式会社 | タンパク質注射製剤 |
| US20030104996A1 (en) * | 2001-08-30 | 2003-06-05 | Tiansheng Li | L-methionine as a stabilizer for NESP/EPO in HSA-free formulations |
-
2001
- 2001-08-30 US US09/945,517 patent/US20030104996A1/en not_active Abandoned
-
2002
- 2002-08-29 WO PCT/US2002/027855 patent/WO2003020299A1/en not_active Ceased
- 2002-08-29 EP EP02766203.0A patent/EP1439848B1/en not_active Expired - Lifetime
- 2002-08-29 JP JP2003524606A patent/JP4493334B2/ja not_active Expired - Lifetime
- 2002-08-29 TW TW091119907A patent/TWI327068B/zh not_active IP Right Cessation
- 2002-08-29 CN CNB028217098A patent/CN100384468C/zh not_active Expired - Lifetime
- 2002-08-29 CA CA2458386A patent/CA2458386C/en not_active Expired - Lifetime
- 2002-08-29 MX MXPA04001774A patent/MXPA04001774A/es active IP Right Grant
- 2002-08-29 PL PL02374122A patent/PL374122A1/xx not_active Application Discontinuation
- 2002-08-29 KR KR1020047002971A patent/KR100596610B1/ko not_active Ceased
-
2010
- 2010-03-09 JP JP2010052203A patent/JP2010138195A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| HK1075198A1 (zh) | 2005-12-09 |
| KR20040044194A (ko) | 2004-05-27 |
| CN100384468C (zh) | 2008-04-30 |
| JP2005527470A (ja) | 2005-09-15 |
| EP1439848B1 (en) | 2014-11-26 |
| CN1592629A (zh) | 2005-03-09 |
| EP1439848A4 (en) | 2009-06-24 |
| JP4493334B2 (ja) | 2010-06-30 |
| KR100596610B1 (ko) | 2006-07-06 |
| CA2458386A1 (en) | 2003-03-13 |
| WO2003020299A1 (en) | 2003-03-13 |
| US20030104996A1 (en) | 2003-06-05 |
| TWI327068B (en) | 2010-07-11 |
| PL374122A1 (en) | 2005-10-03 |
| JP2010138195A (ja) | 2010-06-24 |
| MXPA04001774A (es) | 2004-11-22 |
| EP1439848A1 (en) | 2004-07-28 |
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