JP2019504825A5 - - Google Patents
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- Publication number
- JP2019504825A5 JP2019504825A5 JP2018531166A JP2018531166A JP2019504825A5 JP 2019504825 A5 JP2019504825 A5 JP 2019504825A5 JP 2018531166 A JP2018531166 A JP 2018531166A JP 2018531166 A JP2018531166 A JP 2018531166A JP 2019504825 A5 JP2019504825 A5 JP 2019504825A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical powder
- formulated pharmaceutical
- heat stabilizer
- aqueous solution
- formulated
- 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
- 239000000843 powder Substances 0.000 claims description 66
- 238000000034 method Methods 0.000 claims description 64
- 239000012760 heat stabilizer Substances 0.000 claims description 38
- 239000007864 aqueous solution Substances 0.000 claims description 32
- 102000003886 Glycoproteins Human genes 0.000 claims description 25
- 108090000288 Glycoproteins Proteins 0.000 claims description 25
- 239000000872 buffer Substances 0.000 claims description 22
- 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 12
- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-Proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 claims description 12
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 claims description 12
- 229930195725 Mannitol Natural products 0.000 claims description 12
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 claims description 12
- AGPKZVBTJJNPAG-UHFFFAOYSA-N isoleucine Natural products CCC(C)C(N)C(O)=O AGPKZVBTJJNPAG-UHFFFAOYSA-N 0.000 claims description 12
- 229960000310 isoleucine Drugs 0.000 claims description 12
- 239000000594 mannitol Substances 0.000 claims description 12
- 235000010355 mannitol Nutrition 0.000 claims description 12
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
- 238000001035 drying Methods 0.000 claims description 10
- 239000002736 nonionic surfactant Substances 0.000 claims description 10
- 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 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 description 6
- 229930006000 Sucrose Natural products 0.000 claims description 6
- 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 6
- 230000002776 aggregation Effects 0.000 claims description 6
- 238000004220 aggregation Methods 0.000 claims description 6
- 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 6
- 238000010438 heat treatment Methods 0.000 claims description 6
- 239000005720 sucrose Substances 0.000 claims description 6
- 229920002988 biodegradable polymer Polymers 0.000 claims description 5
- 239000004621 biodegradable polymer Substances 0.000 claims description 5
- 239000000243 solution Substances 0.000 claims description 4
- 238000001694 spray drying Methods 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- 239000013628 high molecular weight specie Substances 0.000 claims description 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 2
- 108091006020 Fc-tagged proteins Proteins 0.000 claims description 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 2
- 229910019142 PO4 Inorganic materials 0.000 claims description 2
- 239000011248 coating agent Substances 0.000 claims description 2
- 238000000576 coating method Methods 0.000 claims description 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 2
- 239000010452 phosphate Substances 0.000 claims description 2
- 125000002467 phosphate group Chemical group [H]OP(=O)(O[H])O[*] 0.000 claims description 2
- 229920000642 polymer Polymers 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 101710088235 Envelope glycoprotein C homolog Proteins 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022157741A JP7554243B2 (ja) | 2015-12-16 | 2022-09-30 | タンパク質微粒子の組成物及び製造方法 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562268259P | 2015-12-16 | 2015-12-16 | |
| US62/268,259 | 2015-12-16 | ||
| PCT/US2016/067280 WO2017106716A1 (en) | 2015-12-16 | 2016-12-16 | Compositions and methods of manufacturing protein microparticles |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022157741A Division JP7554243B2 (ja) | 2015-12-16 | 2022-09-30 | タンパク質微粒子の組成物及び製造方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019504825A JP2019504825A (ja) | 2019-02-21 |
| JP2019504825A5 true JP2019504825A5 (enExample) | 2019-04-18 |
| JP7185526B2 JP7185526B2 (ja) | 2022-12-07 |
Family
ID=57708873
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018531166A Active JP7185526B2 (ja) | 2015-12-16 | 2016-12-16 | タンパク質微粒子の組成物及び製造方法 |
| JP2022157741A Active JP7554243B2 (ja) | 2015-12-16 | 2022-09-30 | タンパク質微粒子の組成物及び製造方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022157741A Active JP7554243B2 (ja) | 2015-12-16 | 2022-09-30 | タンパク質微粒子の組成物及び製造方法 |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US20200022917A1 (enExample) |
| EP (2) | EP3389636B1 (enExample) |
| JP (2) | JP7185526B2 (enExample) |
| KR (1) | KR102714544B1 (enExample) |
| CN (2) | CN114404371A (enExample) |
| AU (2) | AU2016369557B2 (enExample) |
| BR (1) | BR112018010743B1 (enExample) |
| CA (1) | CA3003654A1 (enExample) |
| CL (2) | CL2018001623A1 (enExample) |
| CO (1) | CO2018005920A2 (enExample) |
| DK (1) | DK3389636T3 (enExample) |
| EA (2) | EA201891164A1 (enExample) |
| ES (2) | ES2981791T3 (enExample) |
| HU (1) | HUE060148T2 (enExample) |
| IL (3) | IL286601B2 (enExample) |
| MX (2) | MX2018005384A (enExample) |
| MY (1) | MY200764A (enExample) |
| PH (2) | PH12018500830A1 (enExample) |
| PL (1) | PL3389636T3 (enExample) |
| SG (2) | SG11201803197UA (enExample) |
| WO (1) | WO2017106716A1 (enExample) |
| ZA (2) | ZA201802706B (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2909777T3 (es) | 2011-11-18 | 2022-05-10 | Regeneron Pharma | Formulación de liberación prolongada que comprende micropartículas para su uso en el humor vítreo del ojo para tratar trastornos oculares vasculares |
| AU2017364077A1 (en) | 2016-11-22 | 2019-06-20 | Elektrofi, Inc. | Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof |
| WO2019023392A1 (en) | 2017-07-25 | 2019-01-31 | Elektrofi, Inc. | FORMATION OF PARTICLES COMPRISING AGENTS |
| EP4650360A2 (en) * | 2017-08-18 | 2025-11-19 | Regeneron Pharmaceuticals, Inc. | Image capillary isoelectric focusing to analyze protein variants in a sample matrix |
| GB201718888D0 (en) * | 2017-11-15 | 2017-12-27 | Ucb Biopharma Sprl | Method |
| US12156900B2 (en) | 2017-11-17 | 2024-12-03 | Amgen Inc. | VEGFR-Fc fusion protein formulations |
| US12115262B2 (en) | 2018-05-24 | 2024-10-15 | Elektrofi, Inc. | Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof |
| EP3917500A2 (en) | 2019-01-31 | 2021-12-08 | Elektrofi, Inc. | Particle formation and morphology |
| JP7781743B2 (ja) | 2019-09-13 | 2025-12-08 | エレクトロフィ，インコーポレイテッド | 疾患の処置のための治療用生物学的作用剤の送達のための組成物及び方法 |
| EP4057941A4 (en) * | 2019-11-15 | 2024-05-29 | Silk Technologies Ltd. | STABLE SILK-DERIVED PROTEIN FORMULATIONS |
| US11730793B2 (en) * | 2019-11-25 | 2023-08-22 | Regeneron Pharmaceuticals, Inc. | Sustained release formulations using non-aqueous emulsions |
| US20230094393A1 (en) * | 2020-02-07 | 2023-03-30 | Elektrofi, Inc. | Peptide particles and methods of formation |
| AU2021257476A1 (en) | 2020-04-17 | 2022-11-03 | Elektrofi, Inc. | Methods of forming particles by continuous droplet formation and dehydration |
| US12239687B2 (en) * | 2020-11-25 | 2025-03-04 | Regeneron Pharmaceuticals, Inc. | Sustained release formulations using non-aqueous membrane emulsification |
Family Cites Families (38)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4210529A (en) | 1974-12-26 | 1980-07-01 | Midwest Research Institute | Blood compatible polymers and applications thereof |
| US4304767A (en) | 1980-05-15 | 1981-12-08 | Sri International | Polymers of di- (and higher functionality) ketene acetals and polyols |
| US4764364A (en) | 1986-02-25 | 1988-08-16 | S R I International | Method of preparing bioerodible polymers having pH sensitivity in the acid range and resulting product |
| US5468468A (en) | 1989-02-09 | 1995-11-21 | The United States Of America, As Represented By The Secretary Of The Department Of Health & Human Services | Method for making a monoclonal antibody, monoclonal antibodies to α PD |
| US5104221A (en) | 1989-03-03 | 1992-04-14 | Coulter Electronics Of New England, Inc. | Particle size analysis utilizing polarization intensity differential scattering |
| DK0939121T4 (da) | 1989-09-12 | 2008-02-04 | Ahp Mfg B V | TNF-bindende proteiner |
| US5814464A (en) | 1994-10-07 | 1998-09-29 | Regeneron Pharma | Nucleic acids encoding TIE-2 ligand-2 |
| US6019968A (en) * | 1995-04-14 | 2000-02-01 | Inhale Therapeutic Systems, Inc. | Dispersible antibody compositions and methods for their preparation and use |
| US5968543A (en) | 1996-01-05 | 1999-10-19 | Advanced Polymer Systems, Inc. | Polymers with controlled physical state and bioerodibility |
| EP0913177A1 (de) * | 1997-11-03 | 1999-05-06 | Roche Diagnostics GmbH | Verfahren zur Herstellung trockener, amorpher Produkte enthaltend biologisch aktive Materialien mittels Konvektionstrocknung, insbesondere Sprühtrocknung |
| US6284282B1 (en) * | 1998-04-29 | 2001-09-04 | Genentech, Inc. | Method of spray freeze drying proteins for pharmaceutical administration |
| US6927044B2 (en) | 1998-09-25 | 2005-08-09 | Regeneron Pharmaceuticals, Inc. | IL-1 receptor based cytokine traps |
| US7303746B2 (en) | 1999-06-08 | 2007-12-04 | Regeneron Pharmaceuticals, Inc. | Methods of treating eye disorders with modified chimeric polypeptides |
| US7306799B2 (en) | 1999-06-08 | 2007-12-11 | Regeneron Pharmaceuticals, Inc. | Use of VEGF inhibitors for treatment of eye disorders |
| US7070959B1 (en) | 1999-06-08 | 2006-07-04 | Regeneron Pharmaceuticals, Inc. | Modified chimeric polypeptides with improved pharmacokinetic properties |
| US7087411B2 (en) | 1999-06-08 | 2006-08-08 | Regeneron Pharmaceuticals, Inc. | Fusion protein capable of binding VEGF |
| US7205275B2 (en) | 2001-10-11 | 2007-04-17 | Amgen Inc. | Methods of treatment using specific binding agents of human angiopoietin-2 |
| US7521053B2 (en) | 2001-10-11 | 2009-04-21 | Amgen Inc. | Angiopoietin-2 specific binding agents |
| US7658924B2 (en) | 2001-10-11 | 2010-02-09 | Amgen Inc. | Angiopoietin-2 specific binding agents |
| KR100562195B1 (ko) | 2002-03-08 | 2006-03-20 | 에이에스엠엘 네델란즈 비.브이. | 리소그래피용 마스크, 마스크 제조방법, 리소그래피장치및 디바이스제조방법 |
| DE10339197A1 (de) * | 2003-08-22 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Sprühgetrocknete amorphe Pulver mit geringer Restfeuchte und guter Lagerstabilität |
| JP4627425B2 (ja) | 2004-09-29 | 2011-02-09 | 本田技研工業株式会社 | 無段変速機の変速制御装置 |
| CN105085678B (zh) | 2004-12-21 | 2019-05-07 | 阿斯利康公司 | 血管生成素-2的抗体及其应用 |
| PL2100618T3 (pl) | 2005-06-17 | 2014-07-31 | Imclone Llc | Przeciwciało anty-PDGFR alfa do zastosowania w leczeniu przerzutowego raka kości |
| WO2007033216A2 (en) | 2005-09-12 | 2007-03-22 | Beth Israel Deaconess Medical Center | Methods and compositions for the treatment and diagnosis of diseases characterized by vascular leak, hypotension, or a procoagulant state |
| CN104434770A (zh) * | 2006-06-16 | 2015-03-25 | 瑞泽恩制药公司 | 适合玻璃体内施用的vegf拮抗剂的制剂 |
| BRPI0810374A2 (pt) | 2007-04-17 | 2014-10-29 | Imclone Llc | Inibidores específicos do pdgfrbeta |
| AU2009204863B2 (en) * | 2008-01-15 | 2015-07-16 | AbbVie Deutschland GmbH & Co. KG | Powdered protein compositions and methods of making same |
| PL2274008T3 (pl) | 2008-03-27 | 2014-07-31 | Zymogenetics Inc | Kompozycje i sposoby hamowania PDGFRbeta i VEGF-A |
| JP2012520311A (ja) * | 2009-03-11 | 2012-09-06 | プレキシコン インコーポレーテッド | Ｒａｆキナーゼの阻害のためのピロロ［２，３−ｂ］ピリジン誘導体 |
| JO3182B1 (ar) | 2009-07-29 | 2018-03-08 | Regeneron Pharma | مضادات حيوية بشرية عالية الالفة مع تولد الاوعية البشرية - 2 |
| US8754195B2 (en) | 2010-07-02 | 2014-06-17 | Medimmune, Llc | Antibody formulations |
| JOP20190250A1 (ar) * | 2010-07-14 | 2017-06-16 | Regeneron Pharma | صيغ مستقرة تحتوي على الأجسام المضادة لمضاد عامل نمو الأعصاب |
| AR087305A1 (es) * | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| ES2909777T3 (es) * | 2011-11-18 | 2022-05-10 | Regeneron Pharma | Formulación de liberación prolongada que comprende micropartículas para su uso en el humor vítreo del ojo para tratar trastornos oculares vasculares |
| NZ701915A (en) | 2012-05-18 | 2016-11-25 | Genentech Inc | High-concentration monoclonal antibody formulations |
| AR091967A1 (es) * | 2012-08-02 | 2015-03-11 | Sanofi Sa | Articulo de fabricacion que comprende aflibercept o 2iv-aflibercept |
| JO3405B1 (ar) | 2013-01-09 | 2019-10-20 | Regeneron Pharma | الأجسام المضادة لمضاد مستقبل عامل النمو المشتق من الصفائح الدموية - بيتا واستخداماتها |
-
2016
- 2016-12-16 AU AU2016369557A patent/AU2016369557B2/en not_active Ceased
- 2016-12-16 IL IL286601A patent/IL286601B2/en unknown
- 2016-12-16 CN CN202210095360.9A patent/CN114404371A/zh active Pending
- 2016-12-16 US US15/775,479 patent/US20200022917A1/en not_active Abandoned
- 2016-12-16 JP JP2018531166A patent/JP7185526B2/ja active Active
- 2016-12-16 EP EP16820541.7A patent/EP3389636B1/en active Active
- 2016-12-16 EA EA201891164A patent/EA201891164A1/ru unknown
- 2016-12-16 BR BR112018010743-3A patent/BR112018010743B1/pt not_active IP Right Cessation
- 2016-12-16 ES ES22172044T patent/ES2981791T3/es active Active
- 2016-12-16 PL PL16820541.7T patent/PL3389636T3/pl unknown
- 2016-12-16 WO PCT/US2016/067280 patent/WO2017106716A1/en not_active Ceased
- 2016-12-16 MX MX2018005384A patent/MX2018005384A/es unknown
- 2016-12-16 HU HUE16820541A patent/HUE060148T2/hu unknown
- 2016-12-16 EP EP22172044.4A patent/EP4059492B1/en active Active
- 2016-12-16 DK DK16820541.7T patent/DK3389636T3/da active
- 2016-12-16 CA CA3003654A patent/CA3003654A1/en active Pending
- 2016-12-16 KR KR1020187016572A patent/KR102714544B1/ko active Active
- 2016-12-16 MY MYPI2018701526A patent/MY200764A/en unknown
- 2016-12-16 CN CN201680072951.7A patent/CN108366968B/zh not_active Expired - Fee Related
- 2016-12-16 ES ES16820541T patent/ES2927348T3/es active Active
- 2016-12-16 SG SG11201803197UA patent/SG11201803197UA/en unknown
- 2016-12-16 SG SG10202007834VA patent/SG10202007834VA/en unknown
- 2016-12-16 IL IL302211A patent/IL302211A/en unknown
- 2016-12-16 EA EA202192290A patent/EA202192290A1/ru unknown
-
2018
- 2018-04-18 PH PH12018500830A patent/PH12018500830A1/en unknown
- 2018-04-23 ZA ZA2018/02706A patent/ZA201802706B/en unknown
- 2018-04-26 MX MX2024000362A patent/MX2024000362A/es unknown
- 2018-05-08 IL IL259204A patent/IL259204B/en unknown
- 2018-06-08 CO CONC2018/0005920A patent/CO2018005920A2/es unknown
- 2018-06-15 CL CL2018001623A patent/CL2018001623A1/es unknown
-
2021
- 2021-03-17 PH PH12021550603A patent/PH12021550603A1/en unknown
-
2022
- 2022-09-30 JP JP2022157741A patent/JP7554243B2/ja active Active
- 2022-12-22 AU AU2022291549A patent/AU2022291549B2/en not_active Expired - Fee Related
-
2023
- 2023-04-13 ZA ZA2023/04376A patent/ZA202304376B/en unknown
- 2023-08-09 CL CL2023002345A patent/CL2023002345A1/es unknown
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