JP2017514868A5 - - Google Patents
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- Publication number
- JP2017514868A5 JP2017514868A5 JP2016566811A JP2016566811A JP2017514868A5 JP 2017514868 A5 JP2017514868 A5 JP 2017514868A5 JP 2016566811 A JP2016566811 A JP 2016566811A JP 2016566811 A JP2016566811 A JP 2016566811A JP 2017514868 A5 JP2017514868 A5 JP 2017514868A5
- Authority
- JP
- Japan
- Prior art keywords
- concentration
- composition
- polysorbate
- present
- surfactant
- 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 description 43
- 102000004457 Granulocyte-Macrophage Colony-Stimulating Factor Human genes 0.000 claims description 16
- 108010017213 Granulocyte-Macrophage Colony-Stimulating Factor Proteins 0.000 claims description 16
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 16
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 16
- 229920000053 polysorbate 80 Polymers 0.000 claims description 16
- 229940068968 polysorbate 80 Drugs 0.000 claims description 16
- 150000001875 compounds Chemical class 0.000 claims description 14
- 230000003472 neutralizing effect Effects 0.000 claims description 14
- 239000004094 surface-active agent Substances 0.000 claims description 14
- 239000000872 buffer Substances 0.000 claims description 12
- 239000003795 chemical substances by application Substances 0.000 claims description 12
- 230000003204 osmotic effect Effects 0.000 claims description 12
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
- 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 description 6
- 239000012634 fragment Substances 0.000 claims description 6
- 229960002885 histidine Drugs 0.000 claims description 6
- 239000000600 sorbitol Substances 0.000 claims description 6
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 4
- 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims description 4
- 102000004169 proteins and genes Human genes 0.000 claims description 4
- 108090000623 proteins and genes Proteins 0.000 claims description 4
- 239000003963 antioxidant agent Substances 0.000 claims description 3
- 230000003078 antioxidant effect Effects 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 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 description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 2
- 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 description 2
- 102000016355 Granulocyte-Macrophage Colony-Stimulating Factor Receptors Human genes 0.000 claims description 2
- 108010092372 Granulocyte-Macrophage Colony-Stimulating Factor Receptors Proteins 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- 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 description 2
- 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 description 2
- 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 description 2
- 229940024606 amino acid Drugs 0.000 claims description 2
- 150000001413 amino acids Chemical class 0.000 claims description 2
- 239000002738 chelating agent Substances 0.000 claims description 2
- 239000007979 citrate buffer Substances 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- 229960000502 poloxamer Drugs 0.000 claims description 2
- 229920001983 poloxamer Polymers 0.000 claims description 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 2
- 229940068977 polysorbate 20 Drugs 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 229920001184 polypeptide Polymers 0.000 description 2
- 102000004196 processed proteins & peptides Human genes 0.000 description 2
- 108090000765 processed proteins & peptides Proteins 0.000 description 2
- 102000039446 nucleic acids Human genes 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 239000000816 peptidomimetic Substances 0.000 description 1
- 229940071643 prefilled syringe Drugs 0.000 description 1
- 150000003384 small molecules Chemical class 0.000 description 1
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14167405.1 | 2014-05-07 | ||
| EP14167405 | 2014-05-07 | ||
| US201461994319P | 2014-05-16 | 2014-05-16 | |
| US61/994,319 | 2014-05-16 | ||
| US201462043636P | 2014-08-29 | 2014-08-29 | |
| US62/043,636 | 2014-08-29 | ||
| PCT/EP2015/059709 WO2015169742A1 (en) | 2014-05-07 | 2015-05-04 | Liquid formulation comprising gm-csf neutralizing compound |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017514868A JP2017514868A (ja) | 2017-06-08 |
| JP2017514868A5 true JP2017514868A5 (enExample) | 2018-06-14 |
| JP6769879B2 JP6769879B2 (ja) | 2020-10-14 |
Family
ID=50721582
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016566811A Active JP6769879B2 (ja) | 2014-05-07 | 2015-05-04 | Ｇｍ−ｃｓｆ中和化合物を含む液体製剤 |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US11173208B2 (enExample) |
| EP (1) | EP3139960B1 (enExample) |
| JP (1) | JP6769879B2 (enExample) |
| KR (1) | KR102385802B1 (enExample) |
| CN (1) | CN106659785B (enExample) |
| AR (1) | AR100268A1 (enExample) |
| AU (1) | AU2015257798C1 (enExample) |
| BR (1) | BR112016025126B1 (enExample) |
| EA (1) | EA201691883A1 (enExample) |
| ES (1) | ES2974895T3 (enExample) |
| MX (1) | MX387451B (enExample) |
| PH (1) | PH12016502100A1 (enExample) |
| TW (1) | TWI682788B (enExample) |
| WO (1) | WO2015169742A1 (enExample) |
| ZA (1) | ZA201607097B (enExample) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JOP20190255A1 (ar) | 2017-04-28 | 2019-10-27 | Amgen Inc | صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها |
| CN107167613B (zh) * | 2017-06-22 | 2018-10-02 | 深圳清华大学研究院 | 用于等离子体金芯片的蛋白点样缓冲液 |
| CA3112655A1 (en) * | 2018-10-01 | 2020-04-09 | Amgen Inc. | Methods for reducing aggregation of bispecific antibodies |
| US11267858B2 (en) | 2019-05-31 | 2022-03-08 | Spectrum Pharmaceuticals, Inc. | Methods of treatment using G-CSF protein complex |
| US11684655B2 (en) | 2019-05-31 | 2023-06-27 | Spectrum Pharmaceuticals, Inc. | Methods of treating neutorpenia using G-CSF protein complex |
| WO2021081326A1 (en) * | 2019-10-25 | 2021-04-29 | Amgen Inc. | Compositions and methods for minimizing protein loss at low protein concentrations |
| WO2021243284A1 (en) * | 2020-05-29 | 2021-12-02 | Amgen Inc. | Antibody formulations and uses thereof |
| KR20230124910A (ko) * | 2020-12-04 | 2023-08-28 | 씨에스엘 이노베이션 피티와이 엘티디 | 염증성 피부 상태 치료 방법 |
| WO2022133519A1 (en) * | 2020-12-21 | 2022-06-30 | CSL Innovation Pty Ltd | Methods for treating or preventing acute respiratory distress syndrome |
| KR102375269B1 (ko) * | 2021-01-27 | 2022-03-17 | 한미약품 주식회사 | 단백질 액상 제제 및 이의 제조방법 |
| KR20240021800A (ko) * | 2021-05-12 | 2024-02-19 | 아납티스바이오, 아이엔씨. | 항체 조성물 |
| EP4626406A1 (en) * | 2022-12-01 | 2025-10-08 | I-Mab Biopharma (Hangzhou) Co., Ltd. | Liquid pharmaceutical formulation of anti-gm-csf antibody and uses thereof |
Family Cites Families (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2916711A1 (de) | 1979-04-25 | 1980-11-06 | Behringwerke Ag | Blutgerinnungsfaktoren und verfahren zu ihrer herstellung |
| US4783441A (en) | 1979-04-30 | 1988-11-08 | Hoechst Aktiengesellschaft | Aqueous protein solutions stable to denaturation |
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| EP0158487B1 (en) | 1984-04-09 | 1991-08-28 | Takeda Chemical Industries, Ltd. | Stable composition of interleukin-2 |
| DE3883899T3 (de) | 1987-03-18 | 1999-04-22 | Sb2, Inc., Danville, Calif. | Geänderte antikörper. |
| GB8903593D0 (en) | 1989-02-16 | 1989-04-05 | Pafra Ltd | Storage of materials |
| WO1994009149A1 (en) | 1990-08-10 | 1994-04-28 | Amrad Corporation Limited | Monoclonal antibody |
| US5580856A (en) | 1994-07-15 | 1996-12-03 | Prestrelski; Steven J. | Formulation of a reconstituted protein, and method and kit for the production thereof |
| DK2275119T3 (da) * | 1995-07-27 | 2013-11-11 | Genentech Inc | Stabil, isotonisk lyofiliseret proteinformulering |
| US6685940B2 (en) | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| NZ507381A (en) | 1998-04-21 | 2003-12-19 | Micromet Ag | CD19xCD3 specific polypeptides and uses thereof |
| CN1292655C (zh) * | 2001-11-08 | 2007-01-03 | 蛋白质设计实验室股份有限公司 | IgG抗体稳定的液态药物制剂 |
| WO2003072060A2 (en) | 2002-02-27 | 2003-09-04 | Immunex Corporation | Polypeptide formulation |
| US7511476B2 (en) * | 2005-01-04 | 2009-03-31 | Digisensors, Inc. | Electromagnetic sensor systems and methods of use thereof |
| ES2545769T3 (es) | 2005-04-18 | 2015-09-15 | Amgen Research (Munich) Gmbh | Anticuerpos neutralizantes del factor estimulante de colonias de granulocitos y macrófagos humano |
| RS53743B1 (sr) | 2005-05-18 | 2015-06-30 | Morphosys Ag | Anti-gm-csf antitela i njihova upotreba |
| JP4736037B2 (ja) | 2005-10-26 | 2011-07-27 | 株式会社イーベック | ヒトｇｍ−ｃｓｆに結合するヒトのモノクローナル抗体並びにその抗原結合部分 |
| ES2609088T3 (es) | 2006-02-08 | 2017-04-18 | Morphotek, Inc. | Péptidos GM-CSF antigénicos y anticuerpos anti-GM-CSF |
| RU2495050C2 (ru) | 2006-03-27 | 2013-10-10 | Медимьюн Лимитед | Связующий элемент для рецептора gm-csf |
| EP1970384A1 (en) * | 2007-03-14 | 2008-09-17 | Ganymed Pharmaceuticals AG | Monoclonal antibodies for treatment of cancer |
| AU2008269086B2 (en) | 2007-06-25 | 2014-06-12 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| TW200918553A (en) | 2007-09-18 | 2009-05-01 | Amgen Inc | Human GM-CSF antigen binding proteins |
| RU2517596C2 (ru) | 2007-11-13 | 2014-05-27 | Эвек Инк. | МОНОКЛОНАЛЬНЫЕ АНТИТЕЛА, КОТОРЫЕ СВЯЗЫВАЮТСЯ С hGM-CSF, И СОДЕРЖАЩИЕ ИХ КОМПОЗИЦИИ МЕДИЦИНСКОГО НАЗНАЧЕНИЯ |
| DK2280732T3 (en) | 2008-04-28 | 2019-01-28 | Humanigen Inc | ANTIBODIES AGAINST GRANULOCYT MACROPHAG COLONY STIMULATING FACTOR |
| BRPI0919979A2 (pt) * | 2008-10-29 | 2015-12-15 | Wyeth Llc | formulações de moléculas de ligação de antígeno de domínio único |
| WO2011080209A2 (en) * | 2009-12-29 | 2011-07-07 | F. Hoffmann-La Roche Ag | Novel antibody formulation |
| SG10201803778PA (en) * | 2012-09-20 | 2018-06-28 | Morphosys Ag | Treatment for rheumatoid arthritis |
| AR093297A1 (es) * | 2012-10-31 | 2015-05-27 | Amgen Res Munich Gmbh | Formulacion liquida que comprende un compuesto neutralizante de gm-csf |
-
2015
- 2015-05-04 BR BR112016025126-1A patent/BR112016025126B1/pt active IP Right Grant
- 2015-05-04 MX MX2016014411A patent/MX387451B/es unknown
- 2015-05-04 US US15/307,214 patent/US11173208B2/en active Active
- 2015-05-04 KR KR1020167031014A patent/KR102385802B1/ko active Active
- 2015-05-04 CN CN201580037108.0A patent/CN106659785B/zh active Active
- 2015-05-04 ES ES15720968T patent/ES2974895T3/es active Active
- 2015-05-04 WO PCT/EP2015/059709 patent/WO2015169742A1/en not_active Ceased
- 2015-05-04 EA EA201691883A patent/EA201691883A1/ru unknown
- 2015-05-04 EP EP15720968.5A patent/EP3139960B1/en active Active
- 2015-05-04 JP JP2016566811A patent/JP6769879B2/ja active Active
- 2015-05-04 AU AU2015257798A patent/AU2015257798C1/en active Active
- 2015-05-04 AR ARP150101336A patent/AR100268A1/es not_active Application Discontinuation
- 2015-05-07 TW TW104114614A patent/TWI682788B/zh active
-
2016
- 2016-10-14 ZA ZA2016/07097A patent/ZA201607097B/en unknown
- 2016-10-20 PH PH12016502100A patent/PH12016502100A1/en unknown
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