HUP0101988A2 - Eljárás intravénás beadásra alkalmas immunglobulinok és más immunglobulin termékek előállítására - Google Patents
Eljárás intravénás beadásra alkalmas immunglobulinok és más immunglobulin termékek előállításáraInfo
- Publication number
- HUP0101988A2 HUP0101988A2 HU0101988A HUP0101988A HUP0101988A2 HU P0101988 A2 HUP0101988 A2 HU P0101988A2 HU 0101988 A HU0101988 A HU 0101988A HU P0101988 A HUP0101988 A HU P0101988A HU P0101988 A2 HUP0101988 A2 HU P0101988A2
- Authority
- HU
- Hungary
- Prior art keywords
- immunoglobulin
- intravenous administration
- product
- purification
- igg
- Prior art date
Links
- 108060003951 Immunoglobulin Proteins 0.000 title abstract 4
- 102000018358 immunoglobulin Human genes 0.000 title abstract 4
- 238000000034 method Methods 0.000 title abstract 4
- 238000001990 intravenous administration Methods 0.000 title abstract 2
- 229940072221 immunoglobulins Drugs 0.000 title 1
- 229940027941 immunoglobulin g Drugs 0.000 abstract 3
- 238000000746 purification Methods 0.000 abstract 3
- 108010088751 Albumins Proteins 0.000 abstract 1
- 102000009027 Albumins Human genes 0.000 abstract 1
- 239000008351 acetate buffer Substances 0.000 abstract 1
- 238000005571 anion exchange chromatography Methods 0.000 abstract 1
- 150000001450 anions Chemical class 0.000 abstract 1
- 238000005277 cation exchange chromatography Methods 0.000 abstract 1
- 239000003599 detergent Substances 0.000 abstract 1
- 239000000539 dimer Substances 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000000178 monomer Substances 0.000 abstract 1
- 108010058237 plasma protein fraction Proteins 0.000 abstract 1
- 229940081857 plasma protein fraction Drugs 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Immunology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biochemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Communicable Diseases (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Oncology (AREA)
- Virology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
A találmány immunglobulin G (IgG) nyers plazmafehérje-frakcióból valótisztítási eljárására vonatkozik. Az eljárás számos lépésből áll, és alépések közül az anion- és kationcserélő kromatográfiás tisztítástelőnyösen sorba kapcsolt oszlopokon végezik. A tisztítási eljárássorán előnyösen 5,0-6,0 pH-értékű és 5-25 mM molaritású acetátpufferthasználtak. A találmány oltalmi körébe tartozik a találmány szerintieljárással előállított immunglobulin termék is. A találmány olyanimmunglobulin termékre vonatkozik, melynek tisztasága 98%-nál nagyobb,az IgG monomer- és dimertartalma 98,5%-nál nagyobb, az IgA-tartalma 4mg IgA/1-nél kisebb és 0,5%-nál kisebb mennyiségben tartalmazpolimereket és aggregátumokat. Az említett termék stabilizálószerkéntnem tartalmaz detergenst, PEG-t vagy albumint. A termék stabil, vírus-biztos, folyékony és közvetlen intravénás beadásra alkalmas. Ó
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP98201909 | 1998-06-09 | ||
US10205598P | 1998-09-28 | 1998-09-28 | |
PCT/DK1999/000312 WO1999064462A1 (en) | 1998-06-09 | 1999-06-09 | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
Publications (3)
Publication Number | Publication Date |
---|---|
HUP0101988A2 true HUP0101988A2 (hu) | 2001-09-28 |
HUP0101988A3 HUP0101988A3 (en) | 2004-10-28 |
HU228076B1 HU228076B1 (en) | 2012-10-29 |
Family
ID=26150417
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HU0101988A HU228076B1 (en) | 1998-06-09 | 1999-06-09 | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
Country Status (23)
Country | Link |
---|---|
EP (4) | EP1493751A1 (hu) |
JP (1) | JP5478519B2 (hu) |
KR (1) | KR100501263B1 (hu) |
CN (1) | CN1196714C (hu) |
AT (1) | ATE277950T1 (hu) |
AU (1) | AU753468B2 (hu) |
BR (1) | BR9911131A (hu) |
CA (1) | CA2330170C (hu) |
CZ (1) | CZ297199B6 (hu) |
DE (1) | DE69920693T2 (hu) |
DK (1) | DK1084147T3 (hu) |
ES (1) | ES2229784T3 (hu) |
HK (2) | HK1151044A1 (hu) |
HU (1) | HU228076B1 (hu) |
ID (1) | ID27417A (hu) |
IL (1) | IL140155A (hu) |
NZ (1) | NZ509135A (hu) |
PL (1) | PL196770B1 (hu) |
PT (1) | PT1084147E (hu) |
RU (1) | RU2197500C2 (hu) |
SK (1) | SK288128B6 (hu) |
TR (1) | TR200100303T2 (hu) |
WO (1) | WO1999064462A1 (hu) |
Families Citing this family (70)
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ES2158776B1 (es) * | 1999-04-13 | 2002-03-16 | Apc Europ S A | Procedimiento para la obtencion de gammaglobulinas de origen animal y aplicaciones correspondientes. |
AUPQ026799A0 (en) * | 1999-05-10 | 1999-06-03 | Csl Limited | Method of increasing protein stability by removing immunoglobulin aggregates |
EP1267905B1 (en) * | 2000-03-10 | 2005-09-28 | Medinnova As | Composition for the treatment of heart failure |
SE0001128D0 (sv) * | 2000-03-30 | 2000-03-30 | Amersham Pharm Biotech Ab | A method of producing IgG |
ES2184594B1 (es) * | 2001-01-17 | 2004-01-01 | Probitas Pharma Sa | Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. |
FR2824568B1 (fr) | 2001-05-11 | 2004-04-09 | Lab Francais Du Fractionnement | Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique |
US20030223985A1 (en) * | 2002-05-29 | 2003-12-04 | The Lauridsen Group. Incorporated | Globulin protein to lower cholesterol in humans |
EP2261230B1 (en) | 2002-09-11 | 2017-05-10 | Chugai Seiyaku Kabushiki Kaisha | Protein purification method |
EP1614693A4 (en) * | 2003-03-31 | 2006-07-19 | Kirin Brewery | PURIFICATION OF A HUMAN MONOCLONAL ANTIBODY AND A HUMAN POLYCLONAL ANTIBODY |
EP1532983A1 (en) | 2003-11-18 | 2005-05-25 | ZLB Bioplasma AG | Immunoglobulin preparations having increased stability |
MXPA06008435A (es) * | 2004-01-30 | 2007-05-23 | Suomen Punainen Risti Veripalvelu | Proceso de manufactura de una inmunoglobulina libre de virus. |
AU2005209360B2 (en) | 2004-01-30 | 2009-06-25 | Takeda Pharmaceutical Company Limited | Production and purification of recombinant arylsulfatase A |
AU2005229674B2 (en) * | 2004-11-18 | 2010-11-04 | Kedrion Melville Inc. | Low concentration solvent/detergent process of immuneglobulin with pre-treatment |
TWI391399B (zh) | 2005-05-25 | 2013-04-01 | Hoffmann La Roche | 測定溶離多肽之鹽濃度之方法 |
GB2430883B (en) | 2005-09-30 | 2008-03-19 | Cambridge Antibody Tech | Interleukin-13 antibody composition |
US9309316B2 (en) | 2005-12-20 | 2016-04-12 | Bristol-Myers Squibb Company | Stable subcutaneous protein formulations and uses thereof |
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 |
DK2628746T3 (en) * | 2006-04-04 | 2019-04-01 | Chiesi Farm Spa | A method for the concentration of a polypeptide |
RU2303995C1 (ru) * | 2006-04-28 | 2007-08-10 | Халлар Абдумуслимович Алиханов | Средство, обладающее иммунорегуляторным свойством и его применение для лечения аутоиммунных заболеваний |
WO2008025748A1 (en) | 2006-08-28 | 2008-03-06 | Ares Trading S.A. | Process for the purification of fc-containing proteins |
DE102007001521A1 (de) * | 2007-01-10 | 2008-07-17 | Matthias, Torsten, Dr. | Verwendung von Cohn-Oncley-Fraktionen II und II/III zur Behandlung des systemischen Lupus erythematodes |
DK2215117T4 (en) | 2007-10-30 | 2018-04-09 | Genentech Inc | ANTISTO PURIFICATION BY CATION CHANGE CHROMATOGRAPHY |
US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
US8772461B2 (en) | 2008-04-15 | 2014-07-08 | Grifols Therapeutics Inc. | Two-stage ultrafiltration/diafiltration |
FR2939667B1 (fr) | 2008-12-17 | 2012-01-27 | Fractionnement Et Des Biotechonologies Lab Franc | Composition d'immunoglobine g comme medicament pour le traitement de l'ictere neonatal par incompatibilite foetomaternelle dans le systeme abo |
MY157239A (en) | 2009-05-27 | 2016-05-13 | Baxalta Inc | A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
US20130116413A1 (en) * | 2009-12-29 | 2013-05-09 | Dr. Reddy's Laboratories, Inc. | Purification of proteins |
AU2011212440B2 (en) | 2010-02-04 | 2015-01-22 | Csl Behring Ag | Immunoglobulin preparation |
EP2361636A1 (en) * | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
GB201006753D0 (en) | 2010-04-22 | 2010-06-09 | Biotest Ag | Process for preparing an immunolobulin composition |
RU2467783C2 (ru) * | 2010-07-30 | 2012-11-27 | Закрытое акционерное общество "БиоХимМак СТ" | Способ хроматографического выделения иммуноглобулина |
SG191781A1 (en) | 2010-12-30 | 2013-08-30 | Lab Francais Du Fractionnement | Glycols as pathogen inactivating agents |
ES2865449T3 (es) | 2011-03-16 | 2021-10-15 | Hoffmann La Roche | Cromatografía de intercambio iónico con selectividad mejorada para la separación de monómeros, agregados y fragmentos polipeptídicos por modulación de la fase móvil |
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 |
IL212911A0 (en) * | 2011-05-16 | 2011-07-31 | Omrix Biopharmaceuticals Ltd | Immunoglobulin reduced in thrombogenic contaminants and preparation thereof |
ES2625511T3 (es) | 2011-07-08 | 2017-07-19 | Shire Human Genetic Therapies, Inc. | Métodos para la purificación de arylsulfatasa A |
MX349005B (es) * | 2011-08-26 | 2017-07-06 | Baxalta Inc | Metodo para reducir el potencial tromboembolico de una composicion de inmunoglobulina derivada de plasma. |
CN102532307B (zh) * | 2012-02-22 | 2013-06-12 | 成都蓉生药业有限责任公司 | 一种制备人免疫球蛋白的方法 |
MX369444B (es) | 2012-02-29 | 2019-11-08 | Baxalta Inc | REMIELINIZACION DE NERVIOS PERIFERICOS ESTIMULADA POR IgG. |
JP2015510875A (ja) | 2012-03-09 | 2015-04-13 | ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト | 分泌様免疫グロブリンを含む組成物 |
EP2636681A1 (en) | 2012-03-09 | 2013-09-11 | CSL Behring AG | Process for enriching IgA |
EP2636684A1 (en) | 2012-03-09 | 2013-09-11 | CSL Behring AG | Prevention of infection |
ES2381828B1 (es) * | 2012-03-20 | 2012-11-16 | Grifols, S.A. | PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO |
KR102065355B1 (ko) * | 2012-05-31 | 2020-01-13 | 에이전시 포 사이언스, 테크놀로지 앤드 리서치 | 단백질 제조물 내의 응집체 양 감소를 위한 혼합 다관능 표면들의 사용 방법 |
JP6297029B2 (ja) | 2012-05-31 | 2018-03-20 | エイジェンシー・フォー・サイエンス,テクノロジー・アンド・リサーチ | 多様な官能基を有する粒子による免疫グロブリンg調製物のクロマトグラフィー精製 |
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MX2015008875A (es) | 2013-01-09 | 2015-10-22 | Shire Human Genetic Therapies | Metodos para la purificacion de arilsulfatasa a. |
AU2013203043B2 (en) | 2013-03-15 | 2016-10-06 | Takeda Pharmaceutical Company Limited | Methods to produce a human plasma-derived igg preparation enriched in brain disease-related natural iggs |
WO2014186310A1 (en) | 2013-05-13 | 2014-11-20 | Momenta Pharmaceuticals, Inc. | Methods for the treatment of neurodegeneration |
DK3016976T3 (da) | 2013-07-01 | 2020-12-07 | Csl Behring Ag | Proces |
AU2014285971A1 (en) | 2013-07-05 | 2016-02-04 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Affinity chromatography matrix |
WO2015057622A1 (en) | 2013-10-16 | 2015-04-23 | Momenta Pharmaceuticals, Inc. | Sialylated glycoproteins |
CN103665100A (zh) * | 2014-01-03 | 2014-03-26 | 华兰生物工程重庆有限公司 | 低温乙醇提取静注人免疫球蛋白的方法 |
KR101917196B1 (ko) | 2014-03-11 | 2018-11-09 | 주식회사 녹십자홀딩스 | 면역글로불린의 정제방법 |
FR3018450B1 (fr) | 2014-03-11 | 2016-04-15 | Lab Francais Du Fractionnement | Procede de preparation de proteines plasmatiques humaines |
US10435670B2 (en) * | 2014-04-15 | 2019-10-08 | Boehringer Ingelheim International Gmbh | Methods, apparatuses, and systems for continuously inactivating a virus during manufacture of a biological product |
CN104004090A (zh) * | 2014-06-12 | 2014-08-27 | 新疆德源生物工程有限公司 | 一种人免疫球蛋白的制备方法 |
CN104356231B (zh) * | 2014-11-10 | 2017-08-08 | 北海开元生物科技有限公司 | 一种有效去除人免疫球蛋白多聚体的方法 |
US9556253B2 (en) | 2014-12-02 | 2017-01-31 | Hemarus Therapeutics Limited | Process for increased yield of immunoglobulin from human plasma |
FR3035971A1 (fr) | 2015-05-07 | 2016-11-11 | Lab Francais Du Fractionnement | Composition enrichie en immunoglobulines polyclonales anti-a et/ou anti-b |
KR101657690B1 (ko) * | 2015-06-05 | 2016-09-19 | 주식회사 녹십자홀딩스 | 혈장 유래 b형 간염 사람 면역글로불린 제제의 제조방법 |
CN105950576A (zh) * | 2016-05-26 | 2016-09-21 | 成都远睿生物技术有限公司 | 一种从牛血中提取多种蛋白的方法 |
CN107880116B (zh) * | 2016-09-30 | 2023-02-03 | 盖立复集团公司 | 用于制备免疫球蛋白的方法 |
FR3064484A1 (fr) | 2017-03-31 | 2018-10-05 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Composition d'immunoglobulines utiles pour traiter des infections virales |
FR3064486A1 (fr) | 2017-03-31 | 2018-10-05 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Prevention d'une infection par le virus respiratoire syncytial dans les voies respiratoires superieures |
FR3064485A1 (fr) | 2017-03-31 | 2018-10-05 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Traitement d'une infection par le virus respiratoire syncytial |
KR20190047376A (ko) | 2017-10-27 | 2019-05-08 | 주식회사 녹십자 | 개선된 면역글로불린의 정제방법 |
CN109776675A (zh) * | 2017-11-10 | 2019-05-21 | 北京博莱得利生物技术有限责任公司 | 两步离子交换层析法制备犬免疫球蛋白的方法 |
CN112574296B (zh) * | 2020-12-30 | 2023-05-19 | 中国医学科学院输血研究所 | 一种模拟IVIg的多人份混合人血浆IgG样品的分离纯化方法 |
KR20230148961A (ko) * | 2022-04-19 | 2023-10-26 | 에스케이플라즈마 주식회사 | 면역글로불린 정제방법 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2364792A1 (de) * | 1973-01-15 | 1974-07-18 | South African Inventions | Verfahren zum reinigen von gammaglobulin |
US4296027A (en) * | 1977-08-31 | 1981-10-20 | The Regents Of The University Of Minnesota | Pure intravenous human and animal gamma globulins |
US4314997A (en) | 1980-10-06 | 1982-02-09 | Edward Shanbrom | Purification of plasma protein products |
US4315919A (en) | 1980-10-06 | 1982-02-16 | Edward Shanbrom | Depyrogenation process |
US4764369A (en) | 1983-07-14 | 1988-08-16 | New York Blood Center Inc. | Undenatured virus-free biologically active protein derivatives |
NZ216094A (en) * | 1985-05-15 | 1989-06-28 | Commw Serum Lab Commission | Method for purification of an immunoglobulin |
DE4118912C1 (hu) * | 1991-06-08 | 1992-07-02 | Biotest Pharma Gmbh, 6072 Dreieich, De | |
FR2706466B1 (fr) * | 1993-06-14 | 1995-08-25 | Aetsrn | Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré. |
-
1999
- 1999-06-09 AU AU42572/99A patent/AU753468B2/en not_active Expired
- 1999-06-09 RU RU2001101454/04A patent/RU2197500C2/ru active
- 1999-06-09 CZ CZ20004534A patent/CZ297199B6/cs not_active IP Right Cessation
- 1999-06-09 BR BR9911131-4A patent/BR9911131A/pt not_active Application Discontinuation
- 1999-06-09 PT PT99955389T patent/PT1084147E/pt unknown
- 1999-06-09 PL PL344671A patent/PL196770B1/pl unknown
- 1999-06-09 EP EP04077620A patent/EP1493751A1/en not_active Withdrawn
- 1999-06-09 KR KR10-2000-7014013A patent/KR100501263B1/ko not_active IP Right Cessation
- 1999-06-09 EP EP10184829.9A patent/EP2272870B1/en not_active Revoked
- 1999-06-09 AT AT99955389T patent/ATE277950T1/de active
- 1999-06-09 TR TR2001/00303T patent/TR200100303T2/xx unknown
- 1999-06-09 NZ NZ509135A patent/NZ509135A/xx not_active IP Right Cessation
- 1999-06-09 CN CNB998092819A patent/CN1196714C/zh not_active Expired - Lifetime
- 1999-06-09 WO PCT/DK1999/000312 patent/WO1999064462A1/en active IP Right Grant
- 1999-06-09 SK SK1866-2000A patent/SK288128B6/sk not_active IP Right Cessation
- 1999-06-09 DK DK99955389T patent/DK1084147T3/da active
- 1999-06-09 CA CA2330170A patent/CA2330170C/en not_active Expired - Fee Related
- 1999-06-09 ID IDW20010033A patent/ID27417A/id unknown
- 1999-06-09 ES ES99955389T patent/ES2229784T3/es not_active Expired - Lifetime
- 1999-06-09 DE DE69920693T patent/DE69920693T2/de not_active Expired - Lifetime
- 1999-06-09 IL IL14015599A patent/IL140155A/xx not_active IP Right Cessation
- 1999-06-09 EP EP10011725.8A patent/EP2270044B1/en not_active Revoked
- 1999-06-09 EP EP99955389A patent/EP1084147B1/en not_active Revoked
- 1999-06-09 HU HU0101988A patent/HU228076B1/hu unknown
-
2011
- 2011-01-07 JP JP2011001813A patent/JP5478519B2/ja not_active Expired - Lifetime
- 2011-05-24 HK HK11105137.0A patent/HK1151044A1/xx unknown
- 2011-05-24 HK HK11105138.9A patent/HK1151045A1/xx unknown
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