JP2017525680A5 - - Google Patents
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- JP2017525680A5 JP2017525680A5 JP2017502195A JP2017502195A JP2017525680A5 JP 2017525680 A5 JP2017525680 A5 JP 2017525680A5 JP 2017502195 A JP2017502195 A JP 2017502195A JP 2017502195 A JP2017502195 A JP 2017502195A JP 2017525680 A5 JP2017525680 A5 JP 2017525680A5
- Authority
- JP
- Japan
- Prior art keywords
- seq
- sodium
- crystals
- crystal
- sequence
- 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- Withdrawn
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- 239000013078 crystal Substances 0.000 claims description 36
- 238000000034 method Methods 0.000 claims description 18
- 238000008214 LDL Cholesterol Methods 0.000 claims description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 8
- 210000002966 serum Anatomy 0.000 claims description 8
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 7
- 239000000243 solution Substances 0.000 claims description 7
- 239000011548 crystallization buffer Substances 0.000 claims description 6
- 150000003839 salts Chemical class 0.000 claims description 6
- 238000009472 formulation Methods 0.000 claims description 5
- BDKLKNJTMLIAFE-UHFFFAOYSA-N 2-(3-fluorophenyl)-1,3-oxazole-4-carbaldehyde Chemical compound FC1=CC=CC(C=2OC=C(C=O)N=2)=C1 BDKLKNJTMLIAFE-UHFFFAOYSA-N 0.000 claims description 4
- 239000008001 CAPS buffer Substances 0.000 claims description 4
- 239000008000 CHES buffer Substances 0.000 claims description 4
- MKWKNSIESPFAQN-UHFFFAOYSA-N N-cyclohexyl-2-aminoethanesulfonic acid Chemical compound OS(=O)(=O)CCNC1CCCCC1 MKWKNSIESPFAQN-UHFFFAOYSA-N 0.000 claims description 4
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims description 4
- 239000007983 Tris buffer Substances 0.000 claims description 4
- 125000003275 alpha amino acid group Chemical group 0.000 claims description 4
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 claims description 4
- 229910052921 ammonium sulfate Inorganic materials 0.000 claims description 4
- 229940044197 ammonium sulfate Drugs 0.000 claims description 4
- 235000011130 ammonium sulphate Nutrition 0.000 claims description 4
- VSGNNIFQASZAOI-UHFFFAOYSA-L calcium acetate Chemical compound [Ca+2].CC([O-])=O.CC([O-])=O VSGNNIFQASZAOI-UHFFFAOYSA-L 0.000 claims description 4
- 239000001639 calcium acetate Substances 0.000 claims description 4
- 235000011092 calcium acetate Nutrition 0.000 claims description 4
- 229960005147 calcium acetate Drugs 0.000 claims description 4
- MNNHAPBLZZVQHP-UHFFFAOYSA-N diammonium hydrogen phosphate Chemical compound [NH4+].[NH4+].OP([O-])([O-])=O MNNHAPBLZZVQHP-UHFFFAOYSA-N 0.000 claims description 4
- 235000019838 diammonium phosphate Nutrition 0.000 claims description 4
- 229910000388 diammonium phosphate Inorganic materials 0.000 claims description 4
- OGGXGZAMXPVRFZ-UHFFFAOYSA-M dimethylarsinate Chemical compound C[As](C)([O-])=O OGGXGZAMXPVRFZ-UHFFFAOYSA-M 0.000 claims description 4
- ZPWVASYFFYYZEW-UHFFFAOYSA-L dipotassium hydrogen phosphate Chemical compound [K+].[K+].OP([O-])([O-])=O ZPWVASYFFYYZEW-UHFFFAOYSA-L 0.000 claims description 4
- INHCSSUBVCNVSK-UHFFFAOYSA-L lithium sulfate Inorganic materials [Li+].[Li+].[O-]S([O-])(=O)=O INHCSSUBVCNVSK-UHFFFAOYSA-L 0.000 claims description 4
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 4
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 4
- 229910000160 potassium phosphate Inorganic materials 0.000 claims description 4
- 235000011009 potassium phosphates Nutrition 0.000 claims description 4
- LJCNRYVRMXRIQR-OLXYHTOASA-L potassium sodium L-tartrate Chemical compound [Na+].[K+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O LJCNRYVRMXRIQR-OLXYHTOASA-L 0.000 claims description 4
- 229940074439 potassium sodium tartrate Drugs 0.000 claims description 4
- VZOPRCCTKLAGPN-ZFJVMAEJSA-L potassium;sodium;(2r,3r)-2,3-dihydroxybutanedioate;tetrahydrate Chemical compound O.O.O.O.[Na+].[K+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O VZOPRCCTKLAGPN-ZFJVMAEJSA-L 0.000 claims description 4
- 235000017281 sodium acetate Nutrition 0.000 claims description 4
- 229940087562 sodium acetate trihydrate Drugs 0.000 claims description 4
- 239000011780 sodium chloride Substances 0.000 claims description 4
- 229960002668 sodium chloride Drugs 0.000 claims description 4
- 235000002639 sodium chloride Nutrition 0.000 claims description 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 description 4
- 229960000999 sodium citrate dihydrate Drugs 0.000 claims description 4
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 4
- 239000001488 sodium phosphate Substances 0.000 claims description 4
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 4
- 235000011008 sodium phosphates Nutrition 0.000 claims description 4
- 235000011006 sodium potassium tartrate Nutrition 0.000 claims description 4
- 229940074446 sodium potassium tartrate tetrahydrate Drugs 0.000 claims description 4
- 229910052938 sodium sulfate Inorganic materials 0.000 claims description 4
- 235000011152 sodium sulphate Nutrition 0.000 claims description 4
- RBTVSNLYYIMMKS-UHFFFAOYSA-N tert-butyl 3-aminoazetidine-1-carboxylate;hydrochloride Chemical compound Cl.CC(C)(C)OC(=O)N1CC(N)C1 RBTVSNLYYIMMKS-UHFFFAOYSA-N 0.000 claims description 4
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims description 4
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 4
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 2
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims description 2
- 238000005119 centrifugation Methods 0.000 claims description 2
- 239000003153 chemical reaction reagent Substances 0.000 claims description 2
- 238000002425 crystallisation Methods 0.000 claims description 2
- 230000008025 crystallization Effects 0.000 claims description 2
- 229910001873 dinitrogen Inorganic materials 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 239000006259 organic additive Substances 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 238000009101 premedication Methods 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462024393P | 2014-07-14 | 2014-07-14 | |
| US62/024,393 | 2014-07-14 | ||
| PCT/US2015/040217 WO2016010927A1 (en) | 2014-07-14 | 2015-07-13 | Crystalline antibody formulations |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018091269A Division JP2018150337A (ja) | 2014-07-14 | 2018-05-10 | 結晶性抗体製剤 |
| JP2020115765A Division JP2020172526A (ja) | 2014-07-14 | 2020-07-03 | 結晶性抗体製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2017525680A JP2017525680A (ja) | 2017-09-07 |
| JP2017525680A5 true JP2017525680A5 (enExample) | 2018-06-21 |
Family
ID=53836192
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017502195A Withdrawn JP2017525680A (ja) | 2014-07-14 | 2015-07-13 | 結晶性抗体製剤 |
| JP2018091269A Pending JP2018150337A (ja) | 2014-07-14 | 2018-05-10 | 結晶性抗体製剤 |
| JP2020115765A Pending JP2020172526A (ja) | 2014-07-14 | 2020-07-03 | 結晶性抗体製剤 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018091269A Pending JP2018150337A (ja) | 2014-07-14 | 2018-05-10 | 結晶性抗体製剤 |
| JP2020115765A Pending JP2020172526A (ja) | 2014-07-14 | 2020-07-03 | 結晶性抗体製剤 |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US20170198059A1 (enExample) |
| EP (1) | EP3169710A1 (enExample) |
| JP (3) | JP2017525680A (enExample) |
| AU (2) | AU2015289874A1 (enExample) |
| CA (1) | CA2954767A1 (enExample) |
| MX (1) | MX2017000527A (enExample) |
| WO (1) | WO2016010927A1 (enExample) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10611850B2 (en) | 2014-07-14 | 2020-04-07 | Amgen Inc. | Crystalline antibody formulations |
| CA2954767A1 (en) * | 2014-07-14 | 2016-01-21 | Amgen Inc. | Crystalline antibody formulations |
| US20170056504A1 (en) * | 2015-09-02 | 2017-03-02 | Kenneth I. Kohn | Method of extending half-life of crystaline antibodies |
| JP7229933B2 (ja) | 2017-03-14 | 2023-02-28 | アムジェン インコーポレイテッド | 結晶性生体分子を対象にする方法 |
| US12257343B2 (en) | 2017-04-28 | 2025-03-25 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| AU2018258676B2 (en) * | 2017-04-28 | 2024-09-19 | Amgen Inc. | N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides |
| WO2019064125A1 (en) * | 2017-09-26 | 2019-04-04 | Biocon Limited | INTEGRATED AUTOMATED FILTRATION FOR THE SEPARATION, WASHING AND DRYING OF PEPTIDE CRYSTALS |
| GB2584687B (en) * | 2019-06-11 | 2023-08-23 | Univ Newcastle | Crystallisation of chemical molecules |
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| WO2008109871A2 (en) * | 2007-03-08 | 2008-09-12 | Irm Llc | Crystal structure of proprotein convertase 9 (pcsk9) and uses thereof |
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| WO2009131740A2 (en) * | 2008-04-23 | 2009-10-29 | Amgen Inc. | Neutralizing proprotein convertase subtilisin kexin type 9 (pcsk9) variants and uses thereof |
| KR100985090B1 (ko) * | 2008-05-23 | 2010-10-04 | 한국과학기술연구원 | 크라이센 노출 여부 확인용 바이오마커 및 이를 이용한확인 방법 |
| WO2011028938A1 (en) * | 2009-09-02 | 2011-03-10 | Alnylam Pharmaceuticals, Inc. | Methods for lowering serum cholestrol in a subject using inhibition of pcsk9 |
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| WO2013170367A1 (en) * | 2012-05-17 | 2013-11-21 | The University Of British Columbia | Methods and uses for proprotein convert ase subtilisin kexin 9 (pcsk9) inhibitors |
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| CA2954767A1 (en) * | 2014-07-14 | 2016-01-21 | Amgen Inc. | Crystalline antibody formulations |
| US10611850B2 (en) | 2014-07-14 | 2020-04-07 | Amgen Inc. | Crystalline antibody formulations |
| KR20170029613A (ko) * | 2014-07-16 | 2017-03-15 | 사노피 바이오테크놀로지 | 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법 |
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| KR102551269B1 (ko) * | 2016-09-29 | 2023-07-05 | 암젠 인크 | 저-점도 항원 결합 단백질 및 이의 제조 방법 |
| MA46466A (fr) * | 2016-10-06 | 2019-08-14 | Amgen Inc | Formulations pharmaceutiques de protéines à viscosité réduite |
| JOP20190112A1 (ar) * | 2016-11-14 | 2019-05-14 | Amgen Inc | علاجات مدمجة لتصلب الشرايين، شاملة مرض قلبي وعائي تصلبي |
| US20190031774A1 (en) * | 2017-06-09 | 2019-01-31 | Sanofi Biotechnology | Methods for treating hyperlipidemia in diabetic patients by administering a pcsk9 inhibitor |
| AU2018350992A1 (en) * | 2017-10-18 | 2020-05-21 | Regenxbio Inc. | Fully-human post-translationally modified antibody therapeutics |
| CA3106115A1 (en) * | 2018-07-08 | 2020-01-16 | Specifica Inc. | Antibody libraries with maximized antibody developability characteristics |
-
2015
- 2015-07-13 CA CA2954767A patent/CA2954767A1/en not_active Abandoned
- 2015-07-13 EP EP15750159.4A patent/EP3169710A1/en active Pending
- 2015-07-13 AU AU2015289874A patent/AU2015289874A1/en not_active Abandoned
- 2015-07-13 WO PCT/US2015/040217 patent/WO2016010927A1/en not_active Ceased
- 2015-07-13 US US15/326,341 patent/US20170198059A1/en not_active Abandoned
- 2015-07-13 JP JP2017502195A patent/JP2017525680A/ja not_active Withdrawn
- 2015-07-13 MX MX2017000527A patent/MX2017000527A/es unknown
-
2018
- 2018-05-10 JP JP2018091269A patent/JP2018150337A/ja active Pending
- 2018-11-06 US US16/182,279 patent/US11267902B2/en active Active
-
2020
- 2020-07-03 JP JP2020115765A patent/JP2020172526A/ja active Pending
-
2021
- 2021-03-04 AU AU2021201422A patent/AU2021201422A1/en not_active Abandoned
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