JP2013510158A5 - - Google Patents
Download PDFInfo
- Publication number
- JP2013510158A5 JP2013510158A5 JP2012537945A JP2012537945A JP2013510158A5 JP 2013510158 A5 JP2013510158 A5 JP 2013510158A5 JP 2012537945 A JP2012537945 A JP 2012537945A JP 2012537945 A JP2012537945 A JP 2012537945A JP 2013510158 A5 JP2013510158 A5 JP 2013510158A5
- Authority
- JP
- Japan
- Prior art keywords
- composition
- amino acid
- period
- temperature
- present
- 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.)
- Withdrawn
Links
- 239000000203 mixture Substances 0.000 claims description 33
- 150000001413 amino acids Chemical class 0.000 claims description 15
- 229920002307 Dextran Polymers 0.000 claims description 4
- 235000001014 amino acid Nutrition 0.000 claims 13
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 229920001612 Hydroxyethyl starch Polymers 0.000 claims 2
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims 2
- 235000004279 alanine Nutrition 0.000 claims 2
- 229940050526 hydroxyethylstarch Drugs 0.000 claims 2
- 238000001990 intravenous administration Methods 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 230000004845 protein aggregation Effects 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
- MTCFGRXMJLQNBG-REOHCLBHSA-N (2S)-2-Amino-3-hydroxypropansäure Chemical compound OC[C@H](N)C(O)=O MTCFGRXMJLQNBG-REOHCLBHSA-N 0.000 claims 1
- DNIAPMSPPWPWGF-GSVOUGTGSA-N (R)-(-)-Propylene glycol Chemical compound C[C@@H](O)CO DNIAPMSPPWPWGF-GSVOUGTGSA-N 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 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
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- PMMYEEVYMWASQN-DMTCNVIQSA-N Hydroxyproline Chemical compound O[C@H]1CN[C@H](C(O)=O)C1 PMMYEEVYMWASQN-DMTCNVIQSA-N 0.000 claims 1
- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-Proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 claims 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims 1
- AYFVYJQAPQTCCC-GBXIJSLDSA-N L-threonine Chemical compound C[C@@H](O)[C@H](N)C(O)=O AYFVYJQAPQTCCC-GBXIJSLDSA-N 0.000 claims 1
- ROHFNLRQFUQHCH-UHFFFAOYSA-N Leucine Natural products CC(C)CC(N)C(O)=O ROHFNLRQFUQHCH-UHFFFAOYSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 claims 1
- MTCFGRXMJLQNBG-UHFFFAOYSA-N Serine Natural products OCC(N)C(O)=O MTCFGRXMJLQNBG-UHFFFAOYSA-N 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
- AYFVYJQAPQTCCC-UHFFFAOYSA-N Threonine Natural products CC(O)C(N)C(O)=O AYFVYJQAPQTCCC-UHFFFAOYSA-N 0.000 claims 1
- 239000004473 Threonine Substances 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
- 102000015395 alpha 1-Antitrypsin Human genes 0.000 claims 1
- 108010050122 alpha 1-Antitrypsin Proteins 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
- PMMYEEVYMWASQN-UHFFFAOYSA-N dl-hydroxyproline Natural products OC1C[NH2+]C(C([O-])=O)C1 PMMYEEVYMWASQN-UHFFFAOYSA-N 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 229960002591 hydroxyproline Drugs 0.000 claims 1
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- DNIAPMSPPWPWGF-UHFFFAOYSA-N monopropylene glycol Natural products CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 1
- 230000007935 neutral effect Effects 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 235000013772 propylene glycol Nutrition 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- FGMPLJWBKKVCDB-UHFFFAOYSA-N trans-L-hydroxy-proline Natural products ON1CCCC1C(O)=O FGMPLJWBKKVCDB-UHFFFAOYSA-N 0.000 claims 1
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 description 6
- 229920000642 polymer Polymers 0.000 description 6
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 description 6
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25771109P | 2009-11-03 | 2009-11-03 | |
| US61/257,711 | 2009-11-03 | ||
| PCT/US2010/055135 WO2011056793A2 (en) | 2009-11-03 | 2010-11-02 | Composition, method, and kit for alpha-1 proteinase inhibitor |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015175001A Division JP6030201B2 (ja) | 2009-11-03 | 2015-09-04 | α‐１プロテイナーゼインヒビターのための組成物、方法およびキット |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2013510158A JP2013510158A (ja) | 2013-03-21 |
| JP2013510158A5 true JP2013510158A5 (enExample) | 2013-09-26 |
Family
ID=43970713
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012537945A Withdrawn JP2013510158A (ja) | 2009-11-03 | 2010-11-02 | α‐１プロテイナーゼインヒビターのための組成物、方法およびキット |
| JP2015175001A Active JP6030201B2 (ja) | 2009-11-03 | 2015-09-04 | α‐１プロテイナーゼインヒビターのための組成物、方法およびキット |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015175001A Active JP6030201B2 (ja) | 2009-11-03 | 2015-09-04 | α‐１プロテイナーゼインヒビターのための組成物、方法およびキット |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US20130131192A1 (enExample) |
| EP (1) | EP2496246B1 (enExample) |
| JP (2) | JP2013510158A (enExample) |
| KR (1) | KR20120114235A (enExample) |
| CN (1) | CN102655876B (enExample) |
| AU (1) | AU2010315325B2 (enExample) |
| BR (1) | BR112012010392B8 (enExample) |
| CA (1) | CA2779369C (enExample) |
| CL (1) | CL2012001159A1 (enExample) |
| ES (1) | ES2679819T3 (enExample) |
| HU (1) | HUE039240T2 (enExample) |
| IL (1) | IL219485A (enExample) |
| MX (1) | MX2012005132A (enExample) |
| NZ (1) | NZ599783A (enExample) |
| PL (1) | PL2496246T3 (enExample) |
| PT (1) | PT2496246T (enExample) |
| RU (1) | RU2555332C2 (enExample) |
| TR (1) | TR201809898T4 (enExample) |
| WO (1) | WO2011056793A2 (enExample) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112014007127A2 (pt) * | 2011-12-30 | 2017-04-04 | Grifols Sa | métodos para retardar o início ou diminuir a progressão de um ou mais sintomas, para retardar o início ou a progressão de um ou mais sintomas, para identificar um indivíduo em necessidade de terapia de manutenção de a1pi, e para identificar indivíduos com risco elevado para exacerbações pulmonares, uso de a1pi, aparelho e meio para a administração aerossolizada de a1pi para a inalação, e, kit |
| WO2018116300A1 (en) * | 2016-12-22 | 2018-06-28 | Kamada Ltd. | Dry powder formulations of alpha-1 antitrypsin |
| WO2018132874A1 (en) * | 2017-01-19 | 2018-07-26 | Csl Limited | Method of preventing an immune response with alpha- 1 anti-trypsin |
| IL267923B2 (en) | 2018-08-02 | 2023-06-01 | Grifols Worldwide Operations Ltd | The composition containing the most concentrated alpha-1 type protein inhibitor and a method for obtaining it |
| KR102824423B1 (ko) * | 2019-03-04 | 2025-06-25 | 티에이이 라이프 사이언시스 엘엘씨 | 붕소 중성자 포획 요법에서 사용하기 위한 보릴화된 아미노산 조성물 및 그의 방법 |
| WO2021170531A1 (en) | 2020-02-25 | 2021-09-02 | Grifols Worldwide Operations Limited | Method for obtaining alpha-1 proteinase inhibitor |
Family Cites Families (45)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5029005B2 (enExample) * | 1972-05-08 | 1975-09-19 | ||
| JPS51118819A (en) * | 1975-04-08 | 1976-10-19 | Green Cross Corp:The | A process for preparing heat stable antitrypsin |
| JPS597693B2 (ja) | 1978-01-07 | 1984-02-20 | 株式会社ミドリ十字 | 抗トロンビン製剤及びその製法 |
| US4337242A (en) | 1980-02-05 | 1982-06-29 | Merck & Co., Inc. | Vaccine stabilizer containing L-glutamic acid and L-arginine |
| US4623717A (en) * | 1980-03-05 | 1986-11-18 | Miles Laboratories, Inc. | Pasteurized therapeutically active protein compositions |
| EP0082481B2 (en) | 1981-12-23 | 1990-09-12 | Schering Corporation | Stabilised alpha-interferon formulations and their preparation |
| US4517294A (en) | 1982-03-03 | 1985-05-14 | Genentech, Inc. | Human antithrombin III |
| US4632981A (en) | 1982-07-30 | 1986-12-30 | Genentech, Inc. | Human antithrombin III |
| US5218091A (en) | 1982-08-13 | 1993-06-08 | Zymogenetics, Inc. | Glycolytic promoters for regulated protein expression: protease inhibitor |
| US4711848A (en) | 1984-03-14 | 1987-12-08 | Zymogenetics, Inc. | Site specific mutagenesis in alpha-1-antitrypsin |
| US4931373A (en) | 1984-05-25 | 1990-06-05 | Zymogenetics, Inc. | Stable DNA constructs for expression of α-1 antitrypsin |
| US4732973A (en) | 1984-06-14 | 1988-03-22 | Chiron Corporation | Active site modified protease α-1-antitrypsin inhibitors |
| JP2599585B2 (ja) | 1984-06-19 | 1997-04-09 | トランスジ−ン ソシエテ アノニム | ヒトα▲下１▼−アンチトリプシン誘導体及びその製造法 |
| US5366894A (en) | 1986-06-30 | 1994-11-22 | Pharmaceutical Proteins Limited | Peptide production |
| US4873316A (en) | 1987-06-23 | 1989-10-10 | Biogen, Inc. | Isolation of exogenous recombinant proteins from the milk of transgenic mammals |
| DE3901917A1 (de) | 1989-01-24 | 1990-07-26 | Behringwerke Ag | Mutanten von humanem antithrombin iii |
| GB8913183D0 (en) | 1989-06-08 | 1989-07-26 | Central Blood Lab Authority | Chemical products |
| US5079336A (en) | 1989-06-23 | 1992-01-07 | The Trustees Of The University Of Pennsylvania | α-1-antichymotrypsin, analogues and methods of production |
| US5032405A (en) | 1989-09-27 | 1991-07-16 | Warner-Lambert Company | Oral pharmaceutical composition for acid sensitive proteinaceous agents |
| US5134119A (en) | 1990-10-16 | 1992-07-28 | Lezdey John | Treatment of inflammation using 358 substituted alpha-antitrypsin |
| JP3479539B2 (ja) | 1992-04-10 | 2003-12-15 | エーザイ株式会社 | ヒトアンチトロンビンｉｉｉ変異体 |
| US6051256A (en) * | 1994-03-07 | 2000-04-18 | Inhale Therapeutic Systems | Dispersible macromolecule compositions and methods for their preparation and use |
| FR2719479B1 (fr) * | 1994-05-04 | 1996-07-26 | Sanofi Elf | Formulation stable lyophilisée comprenant une protéine: kit de dosage. |
| US5561115A (en) | 1994-08-10 | 1996-10-01 | Bayer Corporation | Low temperature albumin fractionation using sodium caprylate as a partitioning agent |
| US5843705A (en) | 1995-02-21 | 1998-12-01 | Genzyme Transgenic Corporation | Transgenically produced antithrombin III |
| AT407114B (de) | 1997-06-10 | 2000-12-27 | Immuno Ag | Alpha 1-antitrypsin-präparation sowie verfahren zu deren herstellung |
| JP4441116B2 (ja) | 1998-05-12 | 2010-03-31 | スーザン シー． ボック， | ヒトアンチトロンビンｉｉｉおよびこれに関する方法 |
| EP1820516B1 (en) | 1999-02-22 | 2013-07-24 | University of Connecticut | Novel albumin-free factor VIII formulations |
| AU3731400A (en) * | 1999-03-05 | 2000-09-21 | Trustees Of University Technology Corporation, The | Methods and compositions useful in inhibiting apoptosis |
| US20040157911A1 (en) | 1999-08-31 | 2004-08-12 | Spiridon Spireas | Storage-stable and bio-stable formulations of ace inhibitors, and methods for preparation thereof |
| DE10022092A1 (de) * | 2000-05-08 | 2001-11-15 | Aventis Behring Gmbh | Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung |
| EP1298217A4 (en) | 2000-07-05 | 2004-09-08 | Mitsubishi Pharma Corp | Process for the production of a glycoprotein |
| US20050013867A1 (en) * | 2001-10-19 | 2005-01-20 | Lehrman S. Russ | Use of proton sequestering agents in drug formulations |
| US20030235555A1 (en) | 2002-04-05 | 2003-12-25 | David Shealey | Asthma-related anti-IL-13 immunoglobulin derived proteins, compositions, methods and uses |
| NZ536796A (en) * | 2002-04-25 | 2007-03-30 | Scripps Research Inst | Treatment and prevention of pulmonary conditions comprising at least one lung surfactant polypeptide and at least one protease inhibitor, lipase inhibitor or an anti-oxidant |
| US7777006B2 (en) * | 2002-12-31 | 2010-08-17 | Csl Behring L.L.C. | Method for purification of alpha-1-antitrypsin |
| DK1664123T4 (da) | 2003-09-22 | 2012-03-05 | Kamada Ltd | Storskalafremstilling af alfa-1-proteinaseinhibitor og anvendelse deraf |
| US7691810B2 (en) | 2003-10-09 | 2010-04-06 | Kyowa Hakko Kirin Co., Ltd | Method of producing recombinant antithrombin III composition |
| WO2005049801A2 (en) | 2003-11-14 | 2005-06-02 | Arriva Pharmaceuticals, Inc. | Dry protein formulation |
| PT1684719E (pt) | 2003-11-14 | 2012-02-03 | Baxter Int | Composições de alfa-1-antitripsina e métodos de tratamento utilizando estas composições |
| JP2007526329A (ja) | 2004-03-04 | 2007-09-13 | ワイス | 賦形剤の結晶化を改善するための凍結乾燥法 |
| US20070105768A1 (en) * | 2004-11-10 | 2007-05-10 | Rajiv Nayar | Dry recombinant human alpha 1-antitrypsin formulation |
| KR20080071192A (ko) | 2005-11-22 | 2008-08-01 | 와이어쓰 | 면역글로불린 융합 단백질 제형 |
| RU2433841C2 (ru) | 2006-02-09 | 2011-11-20 | Пари Фарма Гмбх | Доставка в легкие альфа-1-ингибитора протеиназ |
| BR112012012460B1 (pt) | 2009-11-24 | 2020-06-23 | Grifols Therapeutics Inc. | Método de liofilização de uma composição |
-
2010
- 2010-11-02 CN CN201080054535.7A patent/CN102655876B/zh active Active
- 2010-11-02 EP EP10828979.4A patent/EP2496246B1/en not_active Revoked
- 2010-11-02 CA CA2779369A patent/CA2779369C/en active Active
- 2010-11-02 HU HUE10828979A patent/HUE039240T2/hu unknown
- 2010-11-02 WO PCT/US2010/055135 patent/WO2011056793A2/en not_active Ceased
- 2010-11-02 RU RU2012122793/15A patent/RU2555332C2/ru active
- 2010-11-02 NZ NZ599783A patent/NZ599783A/xx unknown
- 2010-11-02 PL PL10828979T patent/PL2496246T3/pl unknown
- 2010-11-02 AU AU2010315325A patent/AU2010315325B2/en active Active
- 2010-11-02 MX MX2012005132A patent/MX2012005132A/es active IP Right Grant
- 2010-11-02 KR KR1020127013706A patent/KR20120114235A/ko not_active Ceased
- 2010-11-02 TR TR2018/09898T patent/TR201809898T4/tr unknown
- 2010-11-02 PT PT108289794T patent/PT2496246T/pt unknown
- 2010-11-02 JP JP2012537945A patent/JP2013510158A/ja not_active Withdrawn
- 2010-11-02 ES ES10828979.4T patent/ES2679819T3/es active Active
- 2010-11-02 US US13/504,783 patent/US20130131192A1/en not_active Abandoned
- 2010-11-02 BR BR112012010392A patent/BR112012010392B8/pt active IP Right Grant
-
2012
- 2012-04-30 IL IL219485A patent/IL219485A/en active IP Right Grant
- 2012-05-03 CL CL2012001159A patent/CL2012001159A1/es unknown
-
2015
- 2015-09-04 JP JP2015175001A patent/JP6030201B2/ja active Active
- 2015-10-29 US US14/926,450 patent/US9616126B2/en active Active