JP2009524595A5 - - Google Patents
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- Publication number
- JP2009524595A5 JP2009524595A5 JP2008547721A JP2008547721A JP2009524595A5 JP 2009524595 A5 JP2009524595 A5 JP 2009524595A5 JP 2008547721 A JP2008547721 A JP 2008547721A JP 2008547721 A JP2008547721 A JP 2008547721A JP 2009524595 A5 JP2009524595 A5 JP 2009524595A5
- Authority
- JP
- Japan
- Prior art keywords
- amount
- formulation
- surfactant
- buffer
- lysine
- 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
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 20
- 239000000203 mixture Substances 0.000 claims 16
- 238000009472 formulation Methods 0.000 claims 14
- 239000004094 surface-active agent Substances 0.000 claims 14
- 239000000872 buffer Substances 0.000 claims 13
- 239000004471 Glycine Substances 0.000 claims 12
- 239000004472 Lysine Substances 0.000 claims 12
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims 12
- 235000004279 alanine Nutrition 0.000 claims 12
- 150000001413 amino acids Chemical group 0.000 claims 12
- 229930182817 methionine Natural products 0.000 claims 12
- 239000012931 lyophilized formulation Substances 0.000 claims 11
- 125000003295 alanine group Chemical group N[C@@H](C)C(=O)* 0.000 claims 9
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 8
- 239000001488 sodium phosphate Substances 0.000 claims 8
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 8
- 239000008227 sterile water for injection Substances 0.000 claims 8
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 8
- 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 6
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims 6
- 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 6
- 229930006000 Sucrose Natural products 0.000 claims 6
- 229920001993 poloxamer 188 Polymers 0.000 claims 6
- 229940044519 poloxamer 188 Drugs 0.000 claims 6
- 239000005720 sucrose Substances 0.000 claims 6
- 125000003630 glycyl group Chemical group [H]N([H])C([H])([H])C(*)=O 0.000 claims 4
- 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 claims 4
- 125000001360 methionine group Chemical group N[C@@H](CCSC)C(=O)* 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims 3
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 2
- 239000002577 cryoprotective agent Substances 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 238000010790 dilution Methods 0.000 claims 1
- 239000012895 dilution Substances 0.000 claims 1
- 238000010253 intravenous injection Methods 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 230000035772 mutation Effects 0.000 claims 1
- 239000003223 protective agent Substances 0.000 claims 1
- 235000018102 proteins Nutrition 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US75215005P | 2005-12-20 | 2005-12-20 | |
| US60/752,150 | 2005-12-20 | ||
| PCT/US2006/062297 WO2007076354A2 (en) | 2005-12-20 | 2006-12-19 | Stable protein formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011141983A Division JP5538309B2 (ja) | 2005-12-20 | 2011-06-27 | 安定なタンパク質製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2009524595A JP2009524595A (ja) | 2009-07-02 |
| JP2009524595A5 true JP2009524595A5 (enExample) | 2010-02-12 |
| JP5247467B2 JP5247467B2 (ja) | 2013-07-24 |
Family
ID=38057529
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008547721A Active JP5247467B2 (ja) | 2005-12-20 | 2006-12-19 | 安定なタンパク質製剤 |
| JP2011141983A Active JP5538309B2 (ja) | 2005-12-20 | 2011-06-27 | 安定なタンパク質製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011141983A Active JP5538309B2 (ja) | 2005-12-20 | 2011-06-27 | 安定なタンパク質製剤 |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US8476239B2 (enExample) |
| EP (1) | EP1962886B2 (enExample) |
| JP (2) | JP5247467B2 (enExample) |
| KR (1) | KR101378194B1 (enExample) |
| CN (3) | CN101584858A (enExample) |
| AR (2) | AR058567A1 (enExample) |
| AU (1) | AU2006330593B2 (enExample) |
| BR (1) | BRPI0622256A2 (enExample) |
| CA (1) | CA2634547C (enExample) |
| CL (1) | CL2010000816A1 (enExample) |
| DK (1) | DK1962886T4 (enExample) |
| EA (1) | EA014232B1 (enExample) |
| ES (1) | ES2436616T5 (enExample) |
| HR (1) | HRP20131196T4 (enExample) |
| IL (1) | IL192104A (enExample) |
| NO (1) | NO347247B1 (enExample) |
| NZ (1) | NZ569108A (enExample) |
| PE (1) | PE20071063A1 (enExample) |
| PL (1) | PL1962886T6 (enExample) |
| PT (1) | PT1962886E (enExample) |
| RS (1) | RS53127B2 (enExample) |
| SG (1) | SG153832A1 (enExample) |
| TW (3) | TW200738261A (enExample) |
| WO (1) | WO2007076354A2 (enExample) |
Families Citing this family (72)
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| JP5096369B2 (ja) | 2005-12-20 | 2012-12-12 | ブリストル−マイヤーズ スクイブ カンパニー | 組成物および組成物の製造方法 |
| US9309316B2 (en) | 2005-12-20 | 2016-04-12 | Bristol-Myers Squibb Company | Stable subcutaneous protein formulations and uses thereof |
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| CN101584858A (zh) * | 2005-12-20 | 2009-11-25 | 布里斯托尔-迈尔斯斯奎布公司 | 稳定蛋白质制剂 |
| US7915222B2 (en) | 2008-05-05 | 2011-03-29 | Bristol-Myers Squibb Company | Method of preventing the development of rheumatoid arthritis in subjects with undifferentiated arthritis |
| ES2821436T3 (es) | 2008-10-06 | 2021-04-26 | 3 D Matrix Ltd | Tapón de tejidos |
| EP2445616B1 (en) * | 2009-06-23 | 2018-05-02 | GE Healthcare Bio-Sciences AB | Simulator device |
| GB201009676D0 (en) | 2010-06-10 | 2010-07-21 | Glaxosmithkline Biolog Sa | Novel process |
| JP5847418B2 (ja) | 2011-03-30 | 2016-01-20 | 富士フイルム株式会社 | 細胞接着性タンパク質 |
| WO2012142434A2 (en) * | 2011-04-15 | 2012-10-18 | THE UNITED STATES OF AMERICA, as represented by the secretary, Depart.of Healtth and Human Services | Aav mediated ctla-4 gene transfer to treat sjogren's syndrome |
| EP2709653B1 (en) | 2011-04-20 | 2017-11-22 | The U.S.A. as represented by the Secretary, Department of Health and Human Services | Aav mediated exendin-4 gene transfer to salivary glands to protect subjects from diabetes or obesity |
| TWI527590B (zh) * | 2011-06-17 | 2016-04-01 | 艾瑞斯貿易公司 | Fgf-18之凍乾調配物 |
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| ES2354610T5 (es) | 2002-12-23 | 2020-09-14 | Bristol Myers Squibb Co | Mejora de la calidad del producto en procedimientos de cultivo de células de mamífero para la producción de proteína |
| DK2335725T3 (en) * | 2003-04-04 | 2017-01-23 | Genentech Inc | Highly concentrated antibody and protein formulations |
| JP2007501243A (ja) * | 2003-08-04 | 2007-01-25 | ブリストル−マイヤーズ スクイブ カンパニー | 可溶性ctla4分子を用いる心臓血管疾患の治療方法 |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| EP1916997B1 (en) * | 2005-08-05 | 2018-04-18 | Amgen Inc. | Stable aqueous protein pharmaceutical formulations and their preparation |
| CN101584858A (zh) * | 2005-12-20 | 2009-11-25 | 布里斯托尔-迈尔斯斯奎布公司 | 稳定蛋白质制剂 |
-
2006
- 2006-12-19 CN CNA2009101398246A patent/CN101584858A/zh active Pending
- 2006-12-19 JP JP2008547721A patent/JP5247467B2/ja active Active
- 2006-12-19 CN CN200910139825A patent/CN101822820A/zh active Pending
- 2006-12-19 US US12/086,876 patent/US8476239B2/en active Active
- 2006-12-19 AR ARP060105626A patent/AR058567A1/es not_active Application Discontinuation
- 2006-12-19 EP EP06846683.8A patent/EP1962886B2/en active Active
- 2006-12-19 AU AU2006330593A patent/AU2006330593B2/en active Active
- 2006-12-19 PE PE2006001649A patent/PE20071063A1/es active IP Right Grant
- 2006-12-19 DK DK06846683.8T patent/DK1962886T4/da active
- 2006-12-19 ES ES06846683T patent/ES2436616T5/es active Active
- 2006-12-19 KR KR1020087017544A patent/KR101378194B1/ko active Active
- 2006-12-19 CN CN2006800530514A patent/CN101378773B/zh active Active
- 2006-12-19 TW TW095147647A patent/TW200738261A/zh unknown
- 2006-12-19 CA CA2634547A patent/CA2634547C/en active Active
- 2006-12-19 TW TW098139142A patent/TWI393575B/zh active
- 2006-12-19 HR HRP20131196TT patent/HRP20131196T4/hr unknown
- 2006-12-19 TW TW098139141A patent/TW201008595A/zh unknown
- 2006-12-19 EA EA200801570A patent/EA014232B1/ru active Protection Beyond IP Right Term
- 2006-12-19 NZ NZ569108A patent/NZ569108A/en unknown
- 2006-12-19 BR BRPI0622256-0A patent/BRPI0622256A2/pt not_active Application Discontinuation
- 2006-12-19 SG SG200904148-4A patent/SG153832A1/en unknown
- 2006-12-19 PT PT68466838T patent/PT1962886E/pt unknown
- 2006-12-19 PL PL06846683.8T patent/PL1962886T6/pl unknown
- 2006-12-19 NO NO20082628A patent/NO347247B1/no unknown
- 2006-12-19 WO PCT/US2006/062297 patent/WO2007076354A2/en not_active Ceased
- 2006-12-20 RS RS20130553A patent/RS53127B2/sr unknown
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2008
- 2008-06-12 IL IL192104A patent/IL192104A/en active IP Right Grant
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2010
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2014
- 2014-09-04 AR ARP140103315A patent/AR097561A2/es unknown
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