JP2012244993A5 - - Google Patents
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- Publication number
- JP2012244993A5 JP2012244993A5 JP2012119327A JP2012119327A JP2012244993A5 JP 2012244993 A5 JP2012244993 A5 JP 2012244993A5 JP 2012119327 A JP2012119327 A JP 2012119327A JP 2012119327 A JP2012119327 A JP 2012119327A JP 2012244993 A5 JP2012244993 A5 JP 2012244993A5
- Authority
- JP
- Japan
- Prior art keywords
- composition
- daclizumab
- dac hyp
- administered
- cell
- 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
- 239000000203 mixture Substances 0.000 claims 81
- 229960002806 daclizumab Drugs 0.000 claims 72
- 238000000034 method Methods 0.000 claims 57
- 210000004027 cell Anatomy 0.000 claims 34
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 claims 14
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 claims 14
- 239000002609 medium Substances 0.000 claims 12
- 102000001708 Protein Isoforms Human genes 0.000 claims 10
- 108010029485 Protein Isoforms Proteins 0.000 claims 10
- 102000004169 proteins and genes Human genes 0.000 claims 10
- 108090000623 proteins and genes Proteins 0.000 claims 10
- 230000004988 N-glycosylation Effects 0.000 claims 8
- 238000004113 cell culture Methods 0.000 claims 7
- 102000003996 Interferon-beta Human genes 0.000 claims 6
- 108090000467 Interferon-beta Proteins 0.000 claims 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims 6
- 239000012539 chromatography resin Substances 0.000 claims 6
- 229960001388 interferon-beta Drugs 0.000 claims 6
- 238000010923 batch production Methods 0.000 claims 5
- 239000013024 dilution buffer Substances 0.000 claims 5
- 229920001542 oligosaccharide Polymers 0.000 claims 5
- 150000002482 oligosaccharides Chemical class 0.000 claims 5
- 239000008194 pharmaceutical composition Substances 0.000 claims 5
- 241000700605 Viruses Species 0.000 claims 4
- 238000001042 affinity chromatography Methods 0.000 claims 4
- 238000003556 assay Methods 0.000 claims 4
- 239000000872 buffer Substances 0.000 claims 4
- 239000012636 effector Substances 0.000 claims 4
- 238000004128 high performance liquid chromatography Methods 0.000 claims 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 4
- 229920000053 polysorbate 80 Polymers 0.000 claims 4
- 229940068968 polysorbate 80 Drugs 0.000 claims 4
- 238000011012 sanitization Methods 0.000 claims 4
- 238000001542 size-exclusion chromatography Methods 0.000 claims 4
- 239000001509 sodium citrate Substances 0.000 claims 4
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 4
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 239000007640 basal medium Substances 0.000 claims 3
- 235000012000 cholesterol Nutrition 0.000 claims 3
- 239000006167 equilibration buffer Substances 0.000 claims 3
- 239000008103 glucose Substances 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 238000003860 storage Methods 0.000 claims 3
- 230000001225 therapeutic effect Effects 0.000 claims 3
- 101001057504 Homo sapiens Interferon-stimulated gene 20 kDa protein Proteins 0.000 claims 2
- 101001055144 Homo sapiens Interleukin-2 receptor subunit alpha Proteins 0.000 claims 2
- 102100026878 Interleukin-2 receptor subunit alpha Human genes 0.000 claims 2
- 241001465754 Metazoa Species 0.000 claims 2
- 230000010056 antibody-dependent cellular cytotoxicity Effects 0.000 claims 2
- 238000005277 cation exchange chromatography Methods 0.000 claims 2
- 238000012258 culturing Methods 0.000 claims 2
- 230000003013 cytotoxicity Effects 0.000 claims 2
- 231100000135 cytotoxicity Toxicity 0.000 claims 2
- 238000007865 diluting Methods 0.000 claims 2
- 239000012149 elution buffer Substances 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 238000003306 harvesting Methods 0.000 claims 2
- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 claims 2
- 230000003204 osmotic effect Effects 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 238000002203 pretreatment Methods 0.000 claims 2
- 239000011347 resin Substances 0.000 claims 2
- 229920005989 resin Polymers 0.000 claims 2
- 238000009097 single-agent therapy Methods 0.000 claims 2
- 229940074404 sodium succinate Drugs 0.000 claims 2
- ZDQYSKICYIVCPN-UHFFFAOYSA-L sodium succinate (anhydrous) Chemical compound [Na+].[Na+].[O-]C(=O)CCC([O-])=O ZDQYSKICYIVCPN-UHFFFAOYSA-L 0.000 claims 2
- MDYOLVRUBBJPFM-UHFFFAOYSA-N tropolone Chemical compound OC1=CC=CC=CC1=O MDYOLVRUBBJPFM-UHFFFAOYSA-N 0.000 claims 2
- 238000000108 ultra-filtration Methods 0.000 claims 2
- 238000005406 washing Methods 0.000 claims 2
- 238000003989 weak cation exchange chromatography Methods 0.000 claims 2
- 239000012608 weak cation exchange resin Substances 0.000 claims 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical group [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims 1
- 235000019445 benzyl alcohol Nutrition 0.000 claims 1
- 239000006143 cell culture medium Substances 0.000 claims 1
- 238000004587 chromatography analysis Methods 0.000 claims 1
- 238000004440 column chromatography Methods 0.000 claims 1
- 239000000356 contaminant Substances 0.000 claims 1
- 238000010790 dilution Methods 0.000 claims 1
- 239000012895 dilution Substances 0.000 claims 1
- 230000001747 exhibiting effect Effects 0.000 claims 1
- 239000012526 feed medium Substances 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 239000001963 growth medium Substances 0.000 claims 1
- 229960000890 hydrocortisone Drugs 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 230000000415 inactivating effect Effects 0.000 claims 1
- 210000004962 mammalian cell Anatomy 0.000 claims 1
- 239000003550 marker Substances 0.000 claims 1
- 230000004048 modification Effects 0.000 claims 1
- 238000012986 modification Methods 0.000 claims 1
- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- 230000003472 neutralizing effect Effects 0.000 claims 1
- 102000039446 nucleic acids Human genes 0.000 claims 1
- 108020004707 nucleic acids Proteins 0.000 claims 1
- 150000007523 nucleic acids Chemical class 0.000 claims 1
- 230000003248 secreting effect Effects 0.000 claims 1
- 210000002966 serum Anatomy 0.000 claims 1
- 229910052938 sodium sulfate Inorganic materials 0.000 claims 1
- 235000011152 sodium sulphate Nutrition 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- 238000002305 strong-anion-exchange chromatography Methods 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 239000011534 wash buffer Substances 0.000 claims 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161490998P | 2011-05-27 | 2011-05-27 | |
| US61/490,998 | 2011-05-27 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016161679A Division JP2016210796A (ja) | 2011-05-27 | 2016-08-22 | Ｄａｃ ｈｙｐ組成物および方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2012244993A JP2012244993A (ja) | 2012-12-13 |
| JP2012244993A5 true JP2012244993A5 (enExample) | 2015-04-09 |
| JP6055615B2 JP6055615B2 (ja) | 2016-12-27 |
Family
ID=46177353
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012119327A Expired - Fee Related JP6055615B2 (ja) | 2011-05-27 | 2012-05-25 | Ｄａｃｈｙｐ組成物および方法 |
| JP2016161679A Pending JP2016210796A (ja) | 2011-05-27 | 2016-08-22 | Ｄａｃ ｈｙｐ組成物および方法 |
| JP2018073025A Pending JP2018134091A (ja) | 2011-05-27 | 2018-04-05 | Ｄａｃ ｈｙｐ組成物および方法 |
| JP2020034673A Withdrawn JP2020078348A (ja) | 2011-05-27 | 2020-03-02 | Ｄａｃ ｈｙｐ組成物および方法 |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016161679A Pending JP2016210796A (ja) | 2011-05-27 | 2016-08-22 | Ｄａｃ ｈｙｐ組成物および方法 |
| JP2018073025A Pending JP2018134091A (ja) | 2011-05-27 | 2018-04-05 | Ｄａｃ ｈｙｐ組成物および方法 |
| JP2020034673A Withdrawn JP2020078348A (ja) | 2011-05-27 | 2020-03-02 | Ｄａｃ ｈｙｐ組成物および方法 |
Country Status (10)
| Country | Link |
|---|---|
| US (7) | US20120301429A1 (enExample) |
| EP (1) | EP2527429A3 (enExample) |
| JP (4) | JP6055615B2 (enExample) |
| CN (2) | CN107090040A (enExample) |
| AU (4) | AU2012203095B2 (enExample) |
| BR (1) | BR102012012673A8 (enExample) |
| CA (1) | CA2777978A1 (enExample) |
| MX (1) | MX339533B (enExample) |
| RU (2) | RU2661764C2 (enExample) |
| SG (1) | SG185920A1 (enExample) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107090040A (zh) * | 2011-05-27 | 2017-08-25 | 艾伯维生物技术有限公司 | Dac hyp组合物和方法 |
| US9809652B2 (en) | 2011-08-08 | 2017-11-07 | Abbvie Biotherapeutics Inc. | Methods of treating progressive forms of multiple sclerosis comprising subcutaneously administering daclizumab |
| CA2857298A1 (en) * | 2011-11-30 | 2013-06-06 | Abbvie Biotherapeutics Inc. | Vectors and host cells comprising a modified sv40 promoter for protein expression |
| US9217168B2 (en) | 2013-03-14 | 2015-12-22 | Momenta Pharmaceuticals, Inc. | Methods of cell culture |
| EP3041857B1 (en) | 2013-09-04 | 2019-05-08 | EMD Millipore Corporation | Protein a chromatography |
| GB201503578D0 (en) * | 2015-03-03 | 2015-04-15 | Ge Healthcare Bio Sciences Ab | Sanitization method for affinity chromatography matrices |
| WO2016154290A1 (en) * | 2015-03-23 | 2016-09-29 | Alexion Pharmaceuticals, Inc. | Virus filtration |
| CA2938333A1 (en) * | 2015-08-12 | 2017-02-12 | Pfizer Inc. | Capped and uncapped antibody cysteines, and their use in antibody-drug conjugation |
| EP3408397B1 (en) | 2016-01-27 | 2020-07-15 | Just-Evotec Biologics, Inc. | Hybrid promoter and uses thereof |
| US11261462B2 (en) | 2016-01-27 | 2022-03-01 | Just-Evotec Biologics, Inc. | Inducible expression from transposon-based vectors and uses |
| US11098310B2 (en) | 2016-01-27 | 2021-08-24 | Just-Evotec Biologics, Inc. | Expression from transposon-based vectors and uses |
| WO2018027195A1 (en) | 2016-08-05 | 2018-02-08 | Abbvie Biotherapeutics Inc. | Compositions containing reduced amounts of daclizumab acidic isoforms and methods for preparing the same |
| CN110267721B (zh) * | 2017-01-30 | 2022-03-01 | 瑞泽恩制药公司 | 用于降低色谱中生物负载的组合物和方法 |
| AU2018392697B2 (en) * | 2017-12-21 | 2025-08-14 | Genzyme Corporation | Methods for enhanced removal of impurities during protein a chromatography |
| KR20210148349A (ko) * | 2019-04-17 | 2021-12-07 | 브리스톨-마이어스 스큅 컴퍼니 | 크로마토그래피 수지의 재생 방법 |
| KR102731889B1 (ko) * | 2019-07-18 | 2024-11-19 | 에이비온 주식회사 | 2당화된 인터페론-베타 단백질의 정제 방법 |
| MX2022001166A (es) * | 2019-08-01 | 2022-02-23 | Regeneron Pharma | Metodo para inactivacion viral. |
| JP2022548197A (ja) | 2019-12-06 | 2022-11-17 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 抗ｖｅｇｆタンパク質組成物及びその製造方法 |
| CN115803009A (zh) | 2020-05-08 | 2023-03-14 | 瑞泽恩制药公司 | 用于治疗眼病和癌症的vegf阱和微阱及方法 |
| JP7631742B2 (ja) * | 2020-11-10 | 2025-02-19 | 東ソー株式会社 | ペプチド性リガンド固定化カラムの洗浄方法 |
| CN114181300A (zh) * | 2021-12-20 | 2022-03-15 | 方坦思(上海)生物医药有限公司 | 一种高纯度单克隆抗体的制备方法 |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1430566A (en) * | 1974-11-15 | 1976-03-31 | Nestel Sa | Isolation of proteins |
| US7442777B2 (en) * | 2000-11-29 | 2008-10-28 | Arius Research Inc. | Cytotoxicity mediation of cells evidencing surface expression of CD63 |
| RU2318537C2 (ru) * | 2001-04-06 | 2008-03-10 | Юниверсити Оф Бристоль | Применение cd25-связывающих молекул для лечения пациентов, устойчивых к стероидам |
| JP2005325133A (ja) * | 2001-10-15 | 2005-11-24 | Kirin Brewery Co Ltd | 抗ｈｌａ−ｄｒ抗体の利用 |
| US20040002135A1 (en) * | 2002-03-28 | 2004-01-01 | Sauer Paul W. | Adapted NS0 cell lines with the ability to grow under glutamine-free conditions |
| US7365168B2 (en) * | 2002-10-15 | 2008-04-29 | Pdl Biopharma, Inc. | Alteration of FcRn binding affinities or serum half-lives of antibodies by mutagenesis |
| JPWO2004087761A1 (ja) * | 2003-03-31 | 2006-07-27 | 麒麟麦酒株式会社 | ヒトモノクローナル抗体およびヒトポリクローナル抗体の精製 |
| US20070190057A1 (en) * | 2006-01-23 | 2007-08-16 | Jian Wu | Methods for modulating mannose content of recombinant proteins |
| US20100173323A1 (en) * | 2006-06-09 | 2010-07-08 | University Of Maryland, Baltimore | Glycosylation engineered antibody therapy |
| US20100234577A1 (en) * | 2006-06-14 | 2010-09-16 | Smithkline Beecham Corporation | Methods for purifying antibodies using ceramic hydroxyapatite |
| WO2008004931A1 (en) * | 2006-07-06 | 2008-01-10 | Ge Healthcare Bio-Sciences Ab | Disinfection/sanitation method where the material is treated with a solution comprising benzyl alcohol and c2-3 alcohol |
| WO2009114641A1 (en) * | 2008-03-11 | 2009-09-17 | Genentech, Inc. | Antibodies with enhanced adcc function |
| US20100055098A1 (en) * | 2008-08-28 | 2010-03-04 | Facet Biotech Corporation | Method for treating multiple sclerosis patients with anti-il2r antibodies |
| AU2010254215A1 (en) * | 2009-05-26 | 2011-12-01 | Momenta Pharmaceuticals, Inc. | Production of glycoproteins |
| WO2010141855A1 (en) | 2009-06-05 | 2010-12-09 | Momenta Pharmaceuticals, Inc. | Methods of modulating fucosylation of glycoproteins |
| CN102574911B (zh) * | 2009-08-07 | 2017-06-06 | Emd密理博公司 | 从样品的一或多种杂质中纯化靶蛋白的方法 |
| WO2011019622A1 (en) | 2009-08-14 | 2011-02-17 | Genentech, Inc. | Cell culture methods to make antibodies with enhanced adcc function |
| US10087236B2 (en) * | 2009-12-02 | 2018-10-02 | Academia Sinica | Methods for modifying human antibodies by glycan engineering |
| IL300733B1 (en) | 2010-03-05 | 2025-10-01 | Univ Johns Hopkins | Compositions and methods for antibodies and fusion proteins targeted for immune modulation |
| CN107090040A (zh) | 2011-05-27 | 2017-08-25 | 艾伯维生物技术有限公司 | Dac hyp组合物和方法 |
-
2012
- 2012-05-25 CN CN201710204584.8A patent/CN107090040A/zh active Pending
- 2012-05-25 SG SG2012038774A patent/SG185920A1/en unknown
- 2012-05-25 RU RU2012121876A patent/RU2661764C2/ru active
- 2012-05-25 EP EP12169595.1A patent/EP2527429A3/en not_active Withdrawn
- 2012-05-25 AU AU2012203095A patent/AU2012203095B2/en not_active Ceased
- 2012-05-25 US US13/481,081 patent/US20120301429A1/en not_active Abandoned
- 2012-05-25 CN CN2012102472614A patent/CN102796705A/zh active Pending
- 2012-05-25 RU RU2018119112A patent/RU2018119112A/ru not_active Application Discontinuation
- 2012-05-25 CA CA2777978A patent/CA2777978A1/en not_active Abandoned
- 2012-05-25 JP JP2012119327A patent/JP6055615B2/ja not_active Expired - Fee Related
- 2012-05-25 MX MX2012006115A patent/MX339533B/es active IP Right Grant
- 2012-05-25 BR BR102012012673A patent/BR102012012673A8/pt not_active Application Discontinuation
-
2015
- 2015-01-21 US US14/601,909 patent/US9676860B2/en not_active Expired - Fee Related
- 2015-03-27 US US14/671,653 patent/US9340619B2/en not_active Expired - Fee Related
- 2015-06-09 US US14/735,062 patent/US9260528B2/en not_active Expired - Fee Related
-
2016
- 2016-05-04 AU AU2016202873A patent/AU2016202873B2/en not_active Ceased
- 2016-08-22 JP JP2016161679A patent/JP2016210796A/ja active Pending
-
2017
- 2017-05-04 US US15/587,127 patent/US9815903B2/en not_active Expired - Fee Related
- 2017-10-04 US US15/724,443 patent/US20180127506A1/en not_active Abandoned
-
2018
- 2018-01-29 AU AU2018200654A patent/AU2018200654A1/en not_active Abandoned
- 2018-04-05 JP JP2018073025A patent/JP2018134091A/ja active Pending
-
2020
- 2020-01-31 US US16/779,336 patent/US20200157230A1/en not_active Abandoned
- 2020-03-02 JP JP2020034673A patent/JP2020078348A/ja not_active Withdrawn
- 2020-03-31 AU AU2020202298A patent/AU2020202298A1/en not_active Abandoned
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