JP2013236633A5 - - Google Patents
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- Publication number
- JP2013236633A5 JP2013236633A5 JP2013123735A JP2013123735A JP2013236633A5 JP 2013236633 A5 JP2013236633 A5 JP 2013236633A5 JP 2013123735 A JP2013123735 A JP 2013123735A JP 2013123735 A JP2013123735 A JP 2013123735A JP 2013236633 A5 JP2013236633 A5 JP 2013236633A5
- Authority
- JP
- Japan
- Prior art keywords
- arylsulfatase
- acid sequence
- composition
- amino acid
- chromatography
- 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.)
- Pending
Links
- 238000000034 method Methods 0.000 claims 18
- 102100022146 Arylsulfatase A Human genes 0.000 claims 16
- 108010036867 Cerebroside-Sulfatase Proteins 0.000 claims 16
- 239000000203 mixture Substances 0.000 claims 11
- 150000001413 amino acids Chemical group 0.000 claims 8
- 150000007523 nucleic acids Chemical group 0.000 claims 5
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 4
- 238000011210 chromatographic step Methods 0.000 claims 3
- 238000004587 chromatography analysis Methods 0.000 claims 3
- 238000001914 filtration Methods 0.000 claims 3
- MTCFGRXMJLQNBG-REOHCLBHSA-N (2S)-2-Amino-3-hydroxypropansäure Chemical compound OC[C@H](N)C(O)=O MTCFGRXMJLQNBG-REOHCLBHSA-N 0.000 claims 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 201000011442 Metachromatic leukodystrophy Diseases 0.000 claims 2
- 238000001042 affinity chromatography Methods 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims 2
- 238000004255 ion exchange chromatography Methods 0.000 claims 2
- 239000000644 isotonic solution Substances 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims 2
- 238000003259 recombinant expression Methods 0.000 claims 2
- 239000006228 supernatant Substances 0.000 claims 2
- QKNYBSVHEMOAJP-UHFFFAOYSA-N 2-amino-2-(hydroxymethyl)propane-1,3-diol;hydron;chloride Chemical compound Cl.OCC(N)(CO)CO QKNYBSVHEMOAJP-UHFFFAOYSA-N 0.000 claims 1
- 102000009133 Arylsulfatases Human genes 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 229940024606 amino acid Drugs 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 238000005119 centrifugation Methods 0.000 claims 1
- 238000009295 crossflow filtration Methods 0.000 claims 1
- 238000011026 diafiltration Methods 0.000 claims 1
- 238000007865 diluting Methods 0.000 claims 1
- 238000001704 evaporation Methods 0.000 claims 1
- 230000008020 evaporation Effects 0.000 claims 1
- 239000012537 formulation buffer Substances 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 239000011148 porous material Substances 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
- 229960001153 serine Drugs 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 claims 1
- 238000006467 substitution reaction Methods 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 108060007951 sulfatase Proteins 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- 238000000108 ultra-filtration Methods 0.000 claims 1
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200600488 | 2006-04-04 | ||
| DKPA200600488 | 2006-04-04 | ||
| DKPA200600922 | 2006-07-05 | ||
| DKPA200600922 | 2006-07-05 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2009503414A Division JP2009532394A (ja) | 2006-04-04 | 2007-04-04 | ポリペプチドの濃縮方法 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015223865A Division JP2016104000A (ja) | 2006-04-04 | 2015-11-16 | ポリペプチドの濃縮方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2013236633A JP2013236633A (ja) | 2013-11-28 |
| JP2013236633A5 true JP2013236633A5 (https=) | 2014-08-07 |
Family
ID=38472949
Family Applications (6)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2009503414A Pending JP2009532394A (ja) | 2006-04-04 | 2007-04-04 | ポリペプチドの濃縮方法 |
| JP2009162789A Active JP5384232B2 (ja) | 2006-04-04 | 2009-07-09 | ポリペプチドの濃縮方法 |
| JP2013123735A Pending JP2013236633A (ja) | 2006-04-04 | 2013-06-12 | ポリペプチドの濃縮方法 |
| JP2013207384A Active JP5878152B2 (ja) | 2006-04-04 | 2013-10-02 | ポリペプチドの濃縮方法 |
| JP2013207365A Withdrawn JP2014058521A (ja) | 2006-04-04 | 2013-10-02 | ポリペプチドの濃縮方法 |
| JP2015223865A Pending JP2016104000A (ja) | 2006-04-04 | 2015-11-16 | ポリペプチドの濃縮方法 |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2009503414A Pending JP2009532394A (ja) | 2006-04-04 | 2007-04-04 | ポリペプチドの濃縮方法 |
| JP2009162789A Active JP5384232B2 (ja) | 2006-04-04 | 2009-07-09 | ポリペプチドの濃縮方法 |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013207384A Active JP5878152B2 (ja) | 2006-04-04 | 2013-10-02 | ポリペプチドの濃縮方法 |
| JP2013207365A Withdrawn JP2014058521A (ja) | 2006-04-04 | 2013-10-02 | ポリペプチドの濃縮方法 |
| JP2015223865A Pending JP2016104000A (ja) | 2006-04-04 | 2015-11-16 | ポリペプチドの濃縮方法 |
Country Status (20)
| Country | Link |
|---|---|
| US (6) | US20090246187A1 (https=) |
| EP (4) | EP2628746B1 (https=) |
| JP (6) | JP2009532394A (https=) |
| KR (3) | KR101504969B1 (https=) |
| CN (1) | CN105233276A (https=) |
| AU (2) | AU2007234195B2 (https=) |
| BR (1) | BRPI0709737A2 (https=) |
| CA (3) | CA2644642C (https=) |
| DK (1) | DK2628746T3 (https=) |
| ES (3) | ES2928096T3 (https=) |
| HU (1) | HUE042402T2 (https=) |
| IL (4) | IL194267A (https=) |
| MX (1) | MX2008012748A (https=) |
| NO (3) | NO347673B1 (https=) |
| NZ (7) | NZ607595A (https=) |
| PL (3) | PL2631242T3 (https=) |
| PT (1) | PT2628746T (https=) |
| SI (1) | SI2628746T1 (https=) |
| WO (1) | WO2007112757A2 (https=) |
| ZA (2) | ZA200805346B (https=) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1713904B1 (en) | 2004-01-30 | 2016-06-29 | Shire Pharmaceuticals Ireland Limited | Production and purification of recombinant arylsulfatase a |
| HUE042402T2 (hu) * | 2006-04-04 | 2019-06-28 | Chiesi Farm Spa | Eljárás polipeptid töményítésére |
| CA2790786C (en) * | 2010-02-24 | 2019-09-24 | Zymenex A/S | Process for production and purification of recombinant lysosomal alpha-mannosidase |
| LT2588130T (lt) * | 2010-06-25 | 2016-12-12 | Shire Human Genetic Therapies, Inc. | Terapinės priemonės pristatymas cns |
| JP6073783B2 (ja) | 2010-06-25 | 2017-02-01 | シャイアー ヒューマン ジェネティック セラピーズ インコーポレイテッド | ヘパランｎ−スルファターゼのｃｎｓ送達のための方法および組成物 |
| HRP20191923T1 (hr) * | 2010-06-25 | 2020-01-10 | Shire Human Genetic Therapies, Inc. | Postupci i sastavi za isporuku arilsulfataze a u cns |
| PT3103469T (pt) | 2010-06-25 | 2021-03-04 | Shire Human Genetic Therapies | Administração de agentes terapêuticos no snc |
| US10336992B2 (en) | 2011-07-08 | 2019-07-02 | Shire Human Genetic Therapies, Inc. | Methods for purification of arylsulfatase A |
| US20140377244A1 (en) | 2011-12-23 | 2014-12-25 | Shire Human Genetic Therapies, Inc. | Stable formulations for cns delivery of arylsulfatase a |
| NZ707753A (en) * | 2012-11-13 | 2019-07-26 | Chiesi Farm Spa | Purification of recombinant human galactocerebroside β-galactosidase (rhgalc) |
| CA2893609A1 (en) * | 2012-12-11 | 2014-06-19 | Centogene Ag | Method for the diagnosis of metachromatic leukodystrophy |
| CN112126634A (zh) | 2013-01-09 | 2020-12-25 | 夏尔人类遗传性治疗公司 | 含用于纯化芳基硫酸酯酶a的方法 |
| WO2014144549A1 (en) | 2013-03-15 | 2014-09-18 | Biogen Idec Ma Inc. | Factor ix polypeptide formulations |
| AU2015236340B2 (en) * | 2014-03-24 | 2020-02-06 | Bioverativ Therapeutics Inc. | Lyophilized factor IX formulations |
| EP3676375A4 (en) * | 2017-08-31 | 2021-04-07 | Green Cross Corporation | PROCESS FOR PURIFYING A SULFATASE PROTEIN |
| KR102290596B1 (ko) * | 2020-09-10 | 2021-08-19 | 주식회사 파이안바이오테크놀로지 | 분리된 미토콘드리아를 포함하는 주사용 조성물 및 이의 용도 |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2041280A1 (en) | 1990-05-10 | 1991-11-11 | Yosuke Sawada | Arylsulfatase |
| NO960163D0 (no) * | 1996-01-15 | 1996-01-15 | Thomas Berg | Mutasjonsdeteksjon av bovin |
| DE69901536T2 (de) | 1998-01-27 | 2003-01-16 | Hemebiotech A/S, Hellerod | Behandlung von akuter intermittierender porphyria oder anderen porphyrischen krankheiten |
| IL140155A (en) * | 1998-06-09 | 2005-12-18 | Statens Seruminstitut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
| DK2270044T3 (en) * | 1998-06-09 | 2015-01-26 | Csl Behring Ag | Liquid immunoglobulin G (IgG) product |
| US6537777B1 (en) | 1998-07-27 | 2003-03-25 | Hemebiotech A/S | Human porphobilinogen deaminase sequences |
| AUPQ026799A0 (en) * | 1999-05-10 | 1999-06-03 | Csl Limited | Method of increasing protein stability by removing immunoglobulin aggregates |
| JP2003505057A (ja) | 1999-07-27 | 2003-02-12 | ヘム−バイオテック エイ／エス | ｒｈＰＢＧＤの製造及び急性間欠性ポルフィリン症（ＡＩＰ）及び他のポルフィリン症の患者を処置するための新規な治療方法 |
| US6812339B1 (en) * | 2000-09-08 | 2004-11-02 | Applera Corporation | Polymorphisms in known genes associated with human disease, methods of detection and uses thereof |
| CA2429210A1 (en) | 2000-11-15 | 2002-05-23 | Jason C. Goodrick | Expression system for recombinant proteins |
| WO2002099092A2 (en) * | 2001-06-07 | 2002-12-12 | Hemebiotech A/S | Production of recombinant human lysosomal alpha-mannosidase |
| AU2002317700A1 (en) * | 2001-06-07 | 2002-12-16 | Hemebiotech A/S | Production of recombinant human arylsulfatase a |
| EP1402014A1 (en) | 2001-06-29 | 2004-03-31 | Hemebiotech A/S | A process for purification of recombinant porphobilinogen deaminase |
| US7232670B2 (en) * | 2001-09-28 | 2007-06-19 | St. Jude Children's Research Hospital | Targeting proteins to cells expressing mannose receptors via expression in insect cells |
| WO2003057179A2 (en) | 2002-01-11 | 2003-07-17 | Biomarin Pharmaceutical, Inc. | Use of p97 as an enzyme delivery system for the delivery of therapeutic lysosomal enzymes |
| WO2003066669A2 (en) * | 2002-02-04 | 2003-08-14 | Millipore Corporation | Process for removing protein aggregates and virus from a protein solution |
| CH694697A5 (de) | 2004-01-29 | 2005-06-15 | Koelbl Engineering Und Consult | Gummimehl-enthaltende Elastomerlegierungen. |
| EP1713904B1 (en) * | 2004-01-30 | 2016-06-29 | Shire Pharmaceuticals Ireland Limited | Production and purification of recombinant arylsulfatase a |
| WO2005094874A1 (en) | 2004-04-01 | 2005-10-13 | Zymenex A/S | Medical use of alpha-mannosidase |
| US20060051347A1 (en) * | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| HUE042402T2 (hu) * | 2006-04-04 | 2019-06-28 | Chiesi Farm Spa | Eljárás polipeptid töményítésére |
-
2007
- 2007-04-04 HU HUE13167427A patent/HUE042402T2/hu unknown
- 2007-04-04 PT PT13167427T patent/PT2628746T/pt unknown
- 2007-04-04 KR KR1020087026971A patent/KR101504969B1/ko active Active
- 2007-04-04 KR KR1020147010563A patent/KR20140057678A/ko not_active Ceased
- 2007-04-04 MX MX2008012748A patent/MX2008012748A/es active IP Right Grant
- 2007-04-04 NZ NZ607595A patent/NZ607595A/en unknown
- 2007-04-04 EP EP13167427.7A patent/EP2628746B1/en active Active
- 2007-04-04 AU AU2007234195A patent/AU2007234195B2/en active Active
- 2007-04-04 BR BRPI0709737-9A patent/BRPI0709737A2/pt not_active Application Discontinuation
- 2007-04-04 ES ES13167428T patent/ES2928096T3/es active Active
- 2007-04-04 ES ES08166902T patent/ES2744499T3/es active Active
- 2007-04-04 KR KR1020157023398A patent/KR20150103339A/ko not_active Ceased
- 2007-04-04 SI SI200732097T patent/SI2628746T1/sl unknown
- 2007-04-04 DK DK13167427.7T patent/DK2628746T3/en active
- 2007-04-04 PL PL13167428.5T patent/PL2631242T3/pl unknown
- 2007-04-04 EP EP08166902.0A patent/EP2100898B1/en active Active
- 2007-04-04 EP EP07711305.8A patent/EP2004672B1/en active Active
- 2007-04-04 NZ NZ568728A patent/NZ568728A/en unknown
- 2007-04-04 CA CA2644642A patent/CA2644642C/en active Active
- 2007-04-04 PL PL13167427T patent/PL2628746T3/pl unknown
- 2007-04-04 CN CN201510510807.4A patent/CN105233276A/zh active Pending
- 2007-04-04 NZ NZ588903A patent/NZ588903A/xx unknown
- 2007-04-04 US US12/295,848 patent/US20090246187A1/en not_active Abandoned
- 2007-04-04 CA CA2632528A patent/CA2632528C/en active Active
- 2007-04-04 NO NO20211305A patent/NO347673B1/no unknown
- 2007-04-04 PL PL08166902T patent/PL2100898T3/pl unknown
- 2007-04-04 NZ NZ582045A patent/NZ582045A/en unknown
- 2007-04-04 WO PCT/DK2007/000177 patent/WO2007112757A2/en not_active Ceased
- 2007-04-04 CA CA2882501A patent/CA2882501C/en active Active
- 2007-04-04 NZ NZ62312307A patent/NZ623123A/en unknown
- 2007-04-04 NZ NZ571610A patent/NZ571610A/en unknown
- 2007-04-04 JP JP2009503414A patent/JP2009532394A/ja active Pending
- 2007-04-04 NZ NZ597548A patent/NZ597548A/xx unknown
- 2007-04-04 EP EP13167428.5A patent/EP2631242B1/en active Active
- 2007-04-04 ES ES13167427T patent/ES2713488T3/es active Active
-
2008
- 2008-05-30 NO NO20082510A patent/NO20082510L/no not_active Application Discontinuation
- 2008-06-19 ZA ZA2008/05346A patent/ZA200805346B/en unknown
- 2008-09-22 IL IL194267A patent/IL194267A/en active IP Right Grant
- 2008-09-26 AU AU2008229659A patent/AU2008229659B2/en active Active
- 2008-11-07 ZA ZA2008/09540A patent/ZA200809540B/en unknown
- 2008-11-12 NO NO20084776A patent/NO346368B1/no unknown
-
2009
- 2009-07-09 JP JP2009162789A patent/JP5384232B2/ja active Active
-
2011
- 2011-03-24 IL IL211905A patent/IL211905A0/en unknown
- 2011-04-26 US US13/094,321 patent/US8809055B2/en active Active
-
2013
- 2013-06-12 JP JP2013123735A patent/JP2013236633A/ja active Pending
- 2013-10-02 JP JP2013207384A patent/JP5878152B2/ja active Active
- 2013-10-02 JP JP2013207365A patent/JP2014058521A/ja not_active Withdrawn
-
2014
- 2014-07-01 US US14/321,642 patent/US20140314735A1/en not_active Abandoned
- 2014-11-30 IL IL235982A patent/IL235982A0/en unknown
-
2015
- 2015-09-16 IL IL241654A patent/IL241654B/en active IP Right Grant
- 2015-11-16 JP JP2015223865A patent/JP2016104000A/ja active Pending
-
2016
- 2016-02-11 US US15/041,841 patent/US9713634B2/en active Active
-
2017
- 2017-03-29 US US15/473,460 patent/US20170202927A1/en not_active Abandoned
- 2017-05-03 US US15/585,916 patent/US20180289777A1/en not_active Abandoned
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