HRP20150282T4 - Purifikacija protutijela pomoću kromatografije kationskom izmjenom - Google Patents
Purifikacija protutijela pomoću kromatografije kationskom izmjenom Download PDFInfo
- Publication number
- HRP20150282T4 HRP20150282T4 HRP20150282TT HRP20150282T HRP20150282T4 HR P20150282 T4 HRP20150282 T4 HR P20150282T4 HR P20150282T T HRP20150282T T HR P20150282TT HR P20150282 T HRP20150282 T HR P20150282T HR P20150282 T4 HRP20150282 T4 HR P20150282T4
- Authority
- HR
- Croatia
- Prior art keywords
- cation exchange
- antibody
- value
- washing
- buffer
- Prior art date
Links
- 238000011091 antibody purification Methods 0.000 title 1
- 238000005277 cation exchange chromatography Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 11
- 238000005341 cation exchange Methods 0.000 claims 9
- 239000000463 material Substances 0.000 claims 9
- 239000012149 elution buffer Substances 0.000 claims 8
- 239000011534 wash buffer Substances 0.000 claims 8
- 239000000203 mixture Substances 0.000 claims 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 238000005406 washing Methods 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 3
- -1 poly(styrene-divinylbenzene) Polymers 0.000 claims 3
- 102000004169 proteins and genes Human genes 0.000 claims 3
- 108090000623 proteins and genes Proteins 0.000 claims 3
- 241000699802 Cricetulus griseus Species 0.000 claims 2
- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 claims 2
- 108010073929 Vascular Endothelial Growth Factor A Proteins 0.000 claims 2
- 102000005789 Vascular Endothelial Growth Factors Human genes 0.000 claims 2
- 108010019530 Vascular Endothelial Growth Factors Proteins 0.000 claims 2
- 229960000397 bevacizumab Drugs 0.000 claims 2
- 239000006143 cell culture medium Substances 0.000 claims 2
- 239000000356 contaminant Substances 0.000 claims 2
- 238000010828 elution Methods 0.000 claims 2
- 229940072360 garamycin Drugs 0.000 claims 2
- 239000004615 ingredient Substances 0.000 claims 2
- 210000001672 ovary Anatomy 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 230000003612 virological effect Effects 0.000 claims 2
- 101000808011 Homo sapiens Vascular endothelial growth factor A Proteins 0.000 claims 1
- 238000011109 contamination Methods 0.000 claims 1
- 102000058223 human VEGFA Human genes 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
Classifications
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- 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
- C07K1/18—Ion-exchange chromatography
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/08—Vasodilators for multiple indications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
-
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Analytical Chemistry (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Hematology (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Oncology (AREA)
- Pain & Pain Management (AREA)
- Neurosurgery (AREA)
- Ophthalmology & Optometry (AREA)
- Vascular Medicine (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
Claims (9)
1. Postupak purifikacije protutijela iz sastava koji sadrži protutijelo i najmanje jedno sredstvo kontaminacije, naznačen time, da taj postupak obuhvaća niz uzastopnih koraka kako slijedi:
(a) punjenje sastava na materijalu kationske izmjene gdje sastav prvo ima pH-vrijednost od 4,0 do 6,0;
(b) ispiranje materijala kationske izmjene s prvim puferom za ispiranje, gdje je
pH-vrijednost prvog pufera za ispiranje od 6,8 do 9,0;
(c) ispiranje materijala kationske izmjene s drugim puferom za ispiranje na
pH-vrijednosti od 5,0 do 6,0; i
(d) eluacija protutijela iz materijala kationske izmjene s puferom za eluiranje pod provodljivošću koja je najmanje 2mS/cm veća nego ona od drugog pufera za ispiranje;
pri čemu protutijelo je bevacizumab.
2. Postupak prema zahtjevu 1, naznačen time, da je pH-vrijednost od drugog pufera za ispiranje otprilike ista kao i pH-vrijednost od pufera za eluiranje.
3. Postupak prema zahtjevu 1, naznačen time, da pH-vrijednost od sastava u koraku (a) iznosi od 4,0 do 6,0, pH-vrijednost prvog pufera za ispiranje iznosi od 6,8 do 8,0,
pH-vrijednost drugog pufera za ispiranje iznosi od 5,0 do 6,0, i pH-vrijednost pufera za eluiranje iznosi od 5,0 do 6,0.
4. Postupak prema zahtjevu 1, naznačen time, da je provodljivost pufera za eluiranje od
10 mS/cm do 100 mS/cm.
5. Postupak prema zahtjevu 1, naznačen time, da pufer za eluiranje sadrži NaCl u količini od 100 do 300 mM.
6. Postupak prema zahtjevu 1, naznačen time, da materijal kationske izmjene obuhvaća šuplje protočne čestice križno povezanog poli(stiren-divinilbenzena), koje su obložene s polihidroksiliranim polimerom funkcionaliziranim sa sulfopropilnim skupinama.
7. Postupak prema zahtjevu 1, naznačen time, da je sredstvo kontaminacije odabrano iz skupine koju čine proteini jajnika kineskog hrčka (CHOP), lužinom isprani protein A, DNK, agregirano protutijelo, sastojak medija za kultiviranje stanice, garamicin i virusni kontaminant.
8. Postupak purifikacije protutijela koje se veže na ljudski vaskularni endotelijalni faktor rasta (VEGF) iz sastava koji sadrži protutijelo i jedno ili više sredstava kontaminacije odabranih iz skupine koju čine sastojak medija za kultiviranje stanice, garamicin, proteini jajnika kineskog hrčka (CHOP), DNK, virusni kontaminant i agregirano protutijelo VEGF, naznačen time, da taj postupak obuhvaća niz uzastopnih koraka kako slijedi:
(a) punjenje sastava na materijalu kationske izmjene gdje sastav ima pH-vrijednost od 4,0 do 6,0;
(b) ispiranje materijala kationske izmjene s prvim puferom za ispiranje na
pH-vrijednosti od 6,8 do 8,0;
(c) ispiranje materijala kationske izmjene s drugim puferom za ispiranje na
pH-vrijednosti od 5,0 do 6,0; i
(d) eluacija protutijela iz materijala kationske izmjene uporabom pufera za eluiranje na pH-vrijednosti od 5,0 do 6,0 i pod provodljivošću od 10 mS/cm do 100 mS/cm,
pri čemu protutijelo je bevacizumab.
9. Postupak prema zahtjevu 13, naznačen time, da pufer za eluiranje sadrži NaCl u količini od 100 do 300 mM.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US98382507P | 2007-10-30 | 2007-10-30 | |
| EP08844379.1A EP2215117B2 (en) | 2007-10-30 | 2008-10-29 | Antibody purification by cation exchange chromatography |
| PCT/US2008/081516 WO2009058812A1 (en) | 2007-10-30 | 2008-10-29 | Antibody purification by cation exchange chromatography |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20150282T1 HRP20150282T1 (hr) | 2015-06-19 |
| HRP20150282T4 true HRP20150282T4 (hr) | 2018-08-10 |
Family
ID=40262967
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150282TT HRP20150282T4 (hr) | 2007-10-30 | 2015-03-12 | Purifikacija protutijela pomoću kromatografije kationskom izmjenom |
| HRP20180943TT HRP20180943T1 (hr) | 2007-10-30 | 2018-06-18 | Pročišćavanje protutijela preko kromatografije kationske izmjene |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180943TT HRP20180943T1 (hr) | 2007-10-30 | 2018-06-18 | Pročišćavanje protutijela preko kromatografije kationske izmjene |
Country Status (32)
| Country | Link |
|---|---|
| US (3) | US20090148435A1 (hr) |
| EP (4) | EP2840090B1 (hr) |
| JP (5) | JP5237382B2 (hr) |
| KR (3) | KR20150008503A (hr) |
| CN (3) | CN101889025B (hr) |
| AR (2) | AR069097A1 (hr) |
| AU (1) | AU2008318865B2 (hr) |
| BR (1) | BRPI0817182A2 (hr) |
| CA (1) | CA2703279C (hr) |
| CL (1) | CL2008003218A1 (hr) |
| CO (1) | CO6280422A2 (hr) |
| CY (1) | CY1116129T1 (hr) |
| DK (3) | DK2215117T4 (hr) |
| ES (3) | ES2666170T3 (hr) |
| HK (4) | HK1143821A1 (hr) |
| HR (2) | HRP20150282T4 (hr) |
| HU (3) | HUE024877T2 (hr) |
| IL (4) | IL205310A0 (hr) |
| ME (1) | ME02101B (hr) |
| MX (1) | MX2010004740A (hr) |
| NZ (1) | NZ584839A (hr) |
| PE (1) | PE20091434A1 (hr) |
| PH (1) | PH12013501128A1 (hr) |
| PL (3) | PL2840090T3 (hr) |
| PT (1) | PT2215117E (hr) |
| RS (1) | RS53850B2 (hr) |
| RU (1) | RU2498991C2 (hr) |
| SG (2) | SG175597A1 (hr) |
| SI (3) | SI2215117T2 (hr) |
| TW (2) | TWI448330B (hr) |
| WO (1) | WO2009058812A1 (hr) |
| ZA (2) | ZA201002850B (hr) |
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| LT2380911T (lt) * | 2003-11-05 | 2018-07-10 | Roche Glycart Ag | Antigeną surišančios molekulės, pasižyminčios padidintu fc receptoriaus surišimo afiniškumu ir efektoriaus funkcija |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| CN101141981A (zh) * | 2005-01-21 | 2008-03-12 | 健泰科生物技术公司 | Her抗体的固定剂量给药 |
| EP2399605A1 (en) | 2005-02-23 | 2011-12-28 | Genentech, Inc. | Extending time to disease progression or survival in cancer patients |
| KR20090074040A (ko) | 2006-09-13 | 2009-07-03 | 아보트 러보러터리즈 | 세포 배양의 개선 |
| US8911964B2 (en) | 2006-09-13 | 2014-12-16 | Abbvie Inc. | Fed-batch method of making human anti-TNF-alpha antibody |
| WO2008109440A2 (en) | 2007-03-02 | 2008-09-12 | Genentech, Inc. | Predicting response to a her dimerisation inhibitor based on low her3 expression |
| ES2666170T3 (es) * | 2007-10-30 | 2018-05-03 | Genentech, Inc. | Purificación de anticuerpos mediante cromatografía de intercambio catiónico |
| TWI472339B (zh) | 2008-01-30 | 2015-02-11 | Genentech Inc | 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物 |
| BRPI0812682A2 (pt) | 2008-06-16 | 2010-06-22 | Genentech Inc | tratamento de cáncer de mama metastático |
| TW201014605A (en) | 2008-09-16 | 2010-04-16 | Genentech Inc | Methods for treating progressive multiple sclerosis |
| US8268314B2 (en) | 2008-10-08 | 2012-09-18 | Hoffmann-La Roche Inc. | Bispecific anti-VEGF/anti-ANG-2 antibodies |
| SG10201702951RA (en) | 2008-10-20 | 2017-06-29 | Abbvie Inc | Viral inactivation during purification of antibodies |
| SG10201702922VA (en) | 2008-10-20 | 2017-06-29 | Abbvie Inc | Isolation and purification of antibodies using protein a affinity chromatography |
| AR078161A1 (es) | 2009-09-11 | 2011-10-19 | Hoffmann La Roche | Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento. |
| US20120178910A1 (en) * | 2009-09-23 | 2012-07-12 | Medarex, Inc. | Cation exchange chromatography (methods) |
| CN103237810A (zh) * | 2010-02-23 | 2013-08-07 | 霍夫曼-拉罗奇有限公司 | 用于治疗卵巢癌的抗血管发生疗法 |
| AR080794A1 (es) | 2010-03-26 | 2012-05-09 | Hoffmann La Roche | Anticuerpos bivalentes biespecificos anti- vegf/ anti-ang-2 |
| PL2552961T3 (pl) * | 2010-03-30 | 2018-04-30 | Janssen Biotech, Inc. | Humanizowane przeciwciała il-25 |
| PL3333265T3 (pl) | 2010-05-14 | 2020-08-10 | Oregon Health & Science University | Rekombinowane wektory HCMV i RHCMV kodujące heterologiczny antygen wyizolowany z wirusa zapalenia wątroby typu B oraz ich zastosowania |
| CN102905718A (zh) * | 2010-05-25 | 2013-01-30 | 弗·哈夫曼-拉罗切有限公司 | 纯化多肽的方法 |
| GB201012603D0 (en) | 2010-07-27 | 2010-09-08 | Ucb Pharma Sa | Protein purification |
| EP2655412B1 (en) * | 2010-12-21 | 2018-01-17 | F. Hoffmann-La Roche AG | Isoform enriched antibody preparation and method for obtaining it |
| CA2831787A1 (en) | 2011-03-29 | 2012-10-04 | Glaxosmithkline Llc | Buffer system for protein purification |
| EP2714713B1 (en) * | 2011-05-26 | 2018-05-09 | Dr. Reddy's Laboratories Limited | Purification of anti-cd20 antibodies |
| CA2832109C (en) | 2011-06-10 | 2021-07-06 | Oregon Health & Science University | Cmv glycoproteins and recombinant vectors |
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| CN104334189A (zh) | 2011-10-14 | 2015-02-04 | 霍夫曼-拉罗奇有限公司 | Her2二聚化抑制剂帕妥珠单抗的用途和包含her2二聚化抑制剂帕妥珠单抗的制品 |
| RU2478646C1 (ru) * | 2011-11-28 | 2013-04-10 | Федеральное государственное бюджетное учреждение науки Институт молекулярной биологии им.В.А.Энгельгардта Российской академии наук (ИМБ РАН) | Способ получения высокоаффинных поликлональных антител |
| EP2794635B8 (en) | 2011-12-22 | 2018-11-14 | H. Hoffnabb-La Roche Ag | Ion exchange membrane chromatography |
| WO2014009465A1 (en) | 2012-07-13 | 2014-01-16 | Roche Glycart Ag | Bispecific anti-vegf/anti-ang-2 antibodies and their use in the treatment of ocular vascular diseases |
| EP2889617B1 (en) * | 2012-08-27 | 2017-10-11 | Asahi Kasei Medical Co., Ltd. | Antibody purification method by means of temperature-responsive chromatography |
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| UY35517A (es) * | 2013-04-04 | 2014-10-31 | Mabxience S A | Un procedimiento para aumentar la formación de ácido piroglutamico de una proteína |
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