JP2012528190A5 - - Google Patents
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- Publication number
- JP2012528190A5 JP2012528190A5 JP2012513260A JP2012513260A JP2012528190A5 JP 2012528190 A5 JP2012528190 A5 JP 2012528190A5 JP 2012513260 A JP2012513260 A JP 2012513260A JP 2012513260 A JP2012513260 A JP 2012513260A JP 2012528190 A5 JP2012528190 A5 JP 2012528190A5
- Authority
- JP
- Japan
- Prior art keywords
- igg
- ultrafiltration
- ultrafiltration membrane
- diafiltration
- ultra
- 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
- 238000000108 ultra-filtration Methods 0.000 claims description 65
- 238000000034 method Methods 0.000 claims description 37
- 239000012528 membrane Substances 0.000 claims description 36
- 239000000203 mixture Substances 0.000 claims description 31
- 238000011026 diafiltration Methods 0.000 claims description 29
- 102000004169 proteins and genes Human genes 0.000 claims description 21
- 108090000623 proteins and genes Proteins 0.000 claims description 21
- 239000000243 solution Substances 0.000 claims description 14
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 10
- 239000012538 diafiltration buffer Substances 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 6
- 239000004471 Glycine Substances 0.000 claims description 5
- 239000000706 filtrate Substances 0.000 claims description 5
- 229940027941 immunoglobulin g Drugs 0.000 claims 44
- 239000012141 concentrate Substances 0.000 claims 15
- 238000005406 washing Methods 0.000 claims 6
- 239000000872 buffer Substances 0.000 claims 4
- 230000003134 recirculating effect Effects 0.000 claims 4
- 238000000502 dialysis Methods 0.000 claims 3
- 239000011534 wash buffer Substances 0.000 claims 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 7
- 239000002244 precipitate Substances 0.000 description 6
- 239000007788 liquid Substances 0.000 description 5
- 238000005119 centrifugation Methods 0.000 description 4
- 206010061598 Immunodeficiency Diseases 0.000 description 2
- 208000029462 Immunodeficiency disease Diseases 0.000 description 2
- 108060003951 Immunoglobulin Proteins 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 230000001363 autoimmune Effects 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 230000007813 immunodeficiency Effects 0.000 description 2
- 102000018358 immunoglobulin Human genes 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 229910004298 SiO 2 Inorganic materials 0.000 description 1
- 238000005571 anion exchange chromatography Methods 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 238000005277 cation exchange chromatography Methods 0.000 description 1
- 239000012459 cleaning agent Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US18160609P | 2009-05-27 | 2009-05-27 | |
| US61/181,606 | 2009-05-27 | ||
| PCT/US2010/036430 WO2010138736A2 (en) | 2009-05-27 | 2010-05-27 | A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2012528190A JP2012528190A (ja) | 2012-11-12 |
| JP2012528190A5 true JP2012528190A5 (cg-RX-API-DMAC7.html) | 2013-07-11 |
| JP5341252B2 JP5341252B2 (ja) | 2013-11-13 |
Family
ID=42335649
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012513260A Active JP5341252B2 (ja) | 2009-05-27 | 2010-05-27 | 皮下使用の高濃度免疫グロブリン製剤を生成する方法 |
Country Status (18)
| Country | Link |
|---|---|
| US (5) | US8546548B2 (cg-RX-API-DMAC7.html) |
| EP (3) | EP3708581A3 (cg-RX-API-DMAC7.html) |
| JP (1) | JP5341252B2 (cg-RX-API-DMAC7.html) |
| KR (1) | KR101464032B1 (cg-RX-API-DMAC7.html) |
| CN (1) | CN102459331B (cg-RX-API-DMAC7.html) |
| AR (1) | AR076607A1 (cg-RX-API-DMAC7.html) |
| AU (6) | AU2010253830B2 (cg-RX-API-DMAC7.html) |
| BR (1) | BRPI1012082B1 (cg-RX-API-DMAC7.html) |
| CA (1) | CA2763138A1 (cg-RX-API-DMAC7.html) |
| CL (2) | CL2011002996A1 (cg-RX-API-DMAC7.html) |
| CO (1) | CO6480954A2 (cg-RX-API-DMAC7.html) |
| EA (1) | EA023382B1 (cg-RX-API-DMAC7.html) |
| HK (1) | HK1200843A1 (cg-RX-API-DMAC7.html) |
| MX (1) | MX2011012576A (cg-RX-API-DMAC7.html) |
| MY (1) | MY157239A (cg-RX-API-DMAC7.html) |
| SG (1) | SG176256A1 (cg-RX-API-DMAC7.html) |
| TW (1) | TWI445714B (cg-RX-API-DMAC7.html) |
| WO (1) | WO2010138736A2 (cg-RX-API-DMAC7.html) |
Families Citing this family (34)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI532498B (zh) | 2008-03-17 | 2016-05-11 | 巴克斯特保健公司 | 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法 |
| US8546548B2 (en) * | 2009-05-27 | 2013-10-01 | Baxter International Inc. | Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
| EP2462158B1 (en) | 2009-08-06 | 2018-01-10 | F. Hoffmann-La Roche AG | Method to improve virus removal in protein purification |
| DK2477603T3 (en) * | 2009-09-17 | 2016-06-13 | Baxalta Inc | STABLE CO-DEVELOPMENT OF hyaluronidase and Immunoglobulin, AND METHODS OF USE THEREOF |
| AU2010202125B1 (en) | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
| US8796430B2 (en) | 2010-05-26 | 2014-08-05 | Baxter International Inc. | Method to produce an immunoglobulin preparation with improved yield |
| US8772462B2 (en) | 2010-05-26 | 2014-07-08 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
| FR2962650B1 (fr) * | 2010-07-19 | 2013-04-05 | Lab Francais Du Fractionnement | Composition d'immunoglobulines humaines concentrees |
| JP2013544762A (ja) | 2010-09-17 | 2013-12-19 | バクスター、インターナショナル、インコーポレイテッド | 弱酸性〜中性のｐＨにおける、塩化ナトリウムを有する水性製剤を介した免疫グロブリンおよび他のタンパク質の安定化 |
| 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 |
| JP6165143B2 (ja) * | 2011-08-26 | 2017-07-19 | バクスアルタ ゲーエムベーハー | 血漿由来の免疫グロブリン組成物の血栓塞栓症の可能性を軽減する方法 |
| EP2758076B1 (en) | 2011-09-24 | 2018-12-12 | CSL Behring GmbH | Combination therapy using immunoglobulin and c1-inhibitor |
| HUE038441T2 (hu) | 2011-12-13 | 2018-10-29 | Baxalta GmbH | Autoantitestek mérése alacsony vezetõképességû körülmények között |
| 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 |
| TWI629283B (zh) | 2012-02-23 | 2018-07-11 | 巴克斯歐塔公司 | 來自血漿中的免疫球蛋白之ｉ-ｉｖ-１部分沉澱 |
| US20150157619A1 (en) * | 2012-07-10 | 2015-06-11 | Takeda Pharmaceutical Company Limited | Pharmaceutical preparation for injection |
| CN105188750A (zh) | 2013-03-08 | 2015-12-23 | 德国杰特贝林生物制品有限公司 | 治疗和预防远端缺血-再灌注损伤 |
| 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 |
| WO2015057622A1 (en) | 2013-10-16 | 2015-04-23 | Momenta Pharmaceuticals, Inc. | Sialylated glycoproteins |
| KR102238133B1 (ko) * | 2013-11-15 | 2021-04-09 | 제넨테크, 인크. | 환경-친화적 세제를 사용한 바이러스 불활성화 방법 |
| WO2016161418A1 (en) * | 2015-04-02 | 2016-10-06 | Kieu Hoang | A method of manufacturing an afod intra venous injection from fraction iv |
| EP3302529A4 (en) | 2015-06-03 | 2019-02-06 | The Children's Hospital Medical Center | COMPOSITIONS AND METHODS FOR TREATING GALLENA GANGATRESIA IN NEWBORNS |
| US11186858B1 (en) | 2016-03-15 | 2021-11-30 | Fresenius Kabi Deutschland Gmbh | Methods for increasing biosimilarity |
| EP3275897A1 (en) * | 2016-07-27 | 2018-01-31 | Biotest AG | Process for preparing immunoglobulin compositions |
| US10259865B2 (en) | 2017-03-15 | 2019-04-16 | Adma Biologics, Inc. | Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection |
| ES2991988T3 (es) | 2017-10-30 | 2024-12-05 | Takeda Pharmaceuticals Co | Detergentes compatibles con el medio ambiente para la inactivación de virus con envoltura lipídica |
| FR3081328B1 (fr) * | 2018-05-24 | 2021-01-01 | Lab Francais Du Fractionnement | Composition d'immunoglobulines humaines concentrees |
| KR102337683B1 (ko) * | 2018-09-21 | 2021-12-13 | 주식회사 녹십자 | 고효율 항-tfpi 항체 조성물 |
| WO2020215021A1 (en) * | 2019-04-18 | 2020-10-22 | Momenta Pharmaceuticals, Inc. | Sialylated glycoproteins |
| WO2023170553A1 (en) | 2022-03-07 | 2023-09-14 | Takeda Pharmaceutical Company Limited | Affinity chromatographic production of clinical human igg products |
| CN117069836B (zh) * | 2023-09-22 | 2024-08-27 | 武汉中生毓晋生物医药有限责任公司 | 一种抗人t细胞兔免疫球蛋白的制备方法 |
| WO2025068923A2 (en) * | 2023-09-26 | 2025-04-03 | Takeda Pharmaceutical Company Limited | IMMUNOGLOBULIN FORMULATIONS DEPLETED IN IgA |
Family Cites Families (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE348942B (cg-RX-API-DMAC7.html) | 1970-06-02 | 1972-09-18 | Statens Bakteriologiska Labor | |
| US4136094A (en) * | 1977-08-31 | 1979-01-23 | The Regents Of The University Of Minnesota | Preparation of intravenous human and animal gamma globulins and isolation of albumin |
| DK166763B1 (da) | 1983-03-16 | 1993-07-12 | Immuno Ag | Immunoglobulin-g-holdig fraktion |
| DE3929411A1 (de) | 1988-09-22 | 1990-03-29 | Siegfried Natterer | Pharmazeutische zubereitung sowie verfahren zu ihrer herstellung |
| US4892826A (en) | 1988-10-11 | 1990-01-09 | Abbott Laboratories | Process for the preparation of urokinase derivatives |
| US4897465A (en) | 1988-10-12 | 1990-01-30 | Abbott Laboratories | Enrichment and concentration of proteins by ultrafiltration |
| JP2871709B2 (ja) | 1988-11-21 | 1999-03-17 | 住友製薬株式会社 | 免疫グロブリンｇ結合活性を有する新規な蛋白質プロテインｈ、該蛋白質をコードする遺伝子及び該蛋白質の製造法 |
| US5177194A (en) * | 1990-02-01 | 1993-01-05 | Baxter International, Inc. | Process for purifying immune serum globulins |
| AT402261B (de) | 1991-01-25 | 1997-03-25 | Immuno Ag | Komplex enthaltend den gerinnungsfaktor ix |
| FR2706466B1 (fr) | 1993-06-14 | 1995-08-25 | Aetsrn | Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré. |
| GB9418092D0 (en) * | 1994-09-08 | 1994-10-26 | Red Cross Found Cent Lab Blood | Organic compounds |
| TW491855B (en) | 1996-08-07 | 2002-06-21 | Csl Ltd | Purification of immunoglobulins |
| US5886154A (en) * | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
| AT405739B (de) | 1997-09-19 | 1999-11-25 | Immuno Ag | Verfahren zur reinigung von antithrombin iii |
| US20020114802A1 (en) | 1998-02-10 | 2002-08-22 | Tjellstrom Bo Arthur Einar | Oral immunoglobulin treatment for inflammatory bowel disease |
| DK2270044T3 (en) * | 1998-06-09 | 2015-01-26 | Csl Behring Ag | Liquid immunoglobulin G (IgG) product |
| BR9911131A (pt) * | 1998-06-09 | 2001-03-06 | Statens Seruminstitut | Processo para produção de imunoglobulinas para administração intravenosa e outros produtos de imunoglobulina |
| AUPQ026799A0 (en) * | 1999-05-10 | 1999-06-03 | Csl Limited | Method of increasing protein stability by removing immunoglobulin aggregates |
| SE0001128D0 (sv) | 2000-03-30 | 2000-03-30 | Amersham Pharm Biotech Ab | A method of producing IgG |
| US20020098182A1 (en) | 2000-09-28 | 2002-07-25 | Richard Weisbart | Treatment of immune-mediated diseases by oral administration of plasma fractions enriched in immunoglobulin G |
| FR2824568B1 (fr) | 2001-05-11 | 2004-04-09 | Lab Francais Du Fractionnement | Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique |
| GB0113179D0 (en) | 2001-05-31 | 2001-07-25 | Novartis Ag | Organic compounds |
| EP1463527A4 (en) | 2001-10-04 | 2005-05-11 | Protein Therapeutics Inc | USE OF GAMMAGLOBULIN FOR THE TREATMENT OF IMMUNE-MEDIATED DISEASES |
| EP1664119A1 (en) | 2003-09-08 | 2006-06-07 | Medical Research Council | Method for the treatment or prophylaxis of tuberculosis |
| 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 |
| US20060051347A1 (en) * | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| CA2695972A1 (en) | 2007-08-13 | 2009-02-19 | Baxter Healthcare S.A. | Ivig modulation of chemokines for treatment of multiple sclerosis, alzheimer's disease, and parkinson's disease |
| CN101279246B (zh) * | 2007-12-28 | 2011-07-27 | 华侨大学 | 一种嗜硫性磁性复合微球的制备方法和用此复合微球分离免疫球蛋白g的方法 |
| AU2009236305B2 (en) * | 2008-04-15 | 2014-04-10 | Grifols Therapeutics Inc. | Two-stage ultrafiltration/diafiltration |
| US8546548B2 (en) * | 2009-05-27 | 2013-10-01 | Baxter International Inc. | Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
-
2010
- 2010-05-27 US US12/789,345 patent/US8546548B2/en active Active
- 2010-05-27 EP EP19198667.8A patent/EP3708581A3/en active Pending
- 2010-05-27 MY MYPI2011005708A patent/MY157239A/en unknown
- 2010-05-27 WO PCT/US2010/036430 patent/WO2010138736A2/en not_active Ceased
- 2010-05-27 KR KR1020117030990A patent/KR101464032B1/ko active Active
- 2010-05-27 CA CA2763138A patent/CA2763138A1/en not_active Abandoned
- 2010-05-27 EP EP14162703.4A patent/EP2762492A3/en not_active Withdrawn
- 2010-05-27 AR ARP100101845A patent/AR076607A1/es active IP Right Grant
- 2010-05-27 SG SG2011087566A patent/SG176256A1/en unknown
- 2010-05-27 AU AU2010253830A patent/AU2010253830B2/en active Active
- 2010-05-27 MX MX2011012576A patent/MX2011012576A/es active IP Right Grant
- 2010-05-27 BR BRPI1012082-3A patent/BRPI1012082B1/pt active IP Right Grant
- 2010-05-27 EP EP10722883A patent/EP2435474A2/en not_active Withdrawn
- 2010-05-27 TW TW099117121A patent/TWI445714B/zh active
- 2010-05-27 EA EA201171481A patent/EA023382B1/ru not_active IP Right Cessation
- 2010-05-27 JP JP2012513260A patent/JP5341252B2/ja active Active
- 2010-05-27 CN CN201080032613.3A patent/CN102459331B/zh active Active
-
2011
- 2011-11-25 CL CL2011002996A patent/CL2011002996A1/es unknown
- 2011-12-27 CO CO11179041A patent/CO6480954A2/es not_active Application Discontinuation
-
2013
- 2013-06-11 CL CL2013001673A patent/CL2013001673A1/es unknown
- 2013-07-24 US US13/949,565 patent/US9175068B2/en active Active
-
2015
- 2015-02-04 HK HK15101161.4A patent/HK1200843A1/en unknown
- 2015-09-16 US US14/855,686 patent/US10125189B2/en active Active
-
2016
- 2016-05-30 AU AU2016203542A patent/AU2016203542B2/en active Active
-
2018
- 2018-01-23 AU AU2018200548A patent/AU2018200548B2/en active Active
- 2018-11-13 US US16/188,839 patent/US11242380B2/en active Active
-
2020
- 2020-06-25 AU AU2020204244A patent/AU2020204244B2/en active Active
-
2022
- 2022-01-31 US US17/589,519 patent/US20220153823A1/en active Pending
- 2022-09-07 AU AU2022228125A patent/AU2022228125B2/en active Active
-
2024
- 2024-05-29 AU AU2024203600A patent/AU2024203600A1/en active Pending
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