JP2020506691A5 - - Google Patents
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- Publication number
- JP2020506691A5 JP2020506691A5 JP2019539953A JP2019539953A JP2020506691A5 JP 2020506691 A5 JP2020506691 A5 JP 2020506691A5 JP 2019539953 A JP2019539953 A JP 2019539953A JP 2019539953 A JP2019539953 A JP 2019539953A JP 2020506691 A5 JP2020506691 A5 JP 2020506691A5
- Authority
- JP
- Japan
- Prior art keywords
- composition according
- aqueous mixture
- sorbitol
- composition
- amorphous sugar
- 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 71
- 239000004094 surface-active agent Substances 0.000 claims description 17
- 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 13
- 239000000600 sorbitol Substances 0.000 claims description 13
- 239000013598 vector Substances 0.000 claims description 13
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 8
- 241000701161 unidentified adenovirus Species 0.000 claims description 7
- 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
- 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
- 150000003839 salts Chemical class 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 4
- 239000007983 Tris buffer Substances 0.000 claims description 4
- 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 4
- 239000000872 buffer Substances 0.000 claims description 4
- YMAWOPBAYDPSLA-UHFFFAOYSA-N glycylglycine Chemical compound [NH3+]CC(=O)NCC([O-])=O YMAWOPBAYDPSLA-UHFFFAOYSA-N 0.000 claims description 4
- 239000011780 sodium chloride Substances 0.000 claims description 4
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 claims description 3
- 229920001993 poloxamer 188 Polymers 0.000 claims description 3
- 229940044519 poloxamer 188 Drugs 0.000 claims description 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 3
- 229940068968 polysorbate 80 Drugs 0.000 claims description 3
- 229920000053 polysorbate 80 Polymers 0.000 claims description 3
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims description 3
- 239000008215 water for injection Substances 0.000 claims description 3
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 2
- 241000282693 Cercopithecidae Species 0.000 claims description 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 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
- 239000004471 Glycine Substances 0.000 claims description 2
- 108010008488 Glycylglycine 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
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims description 2
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims description 2
- 239000004472 Lysine Substances 0.000 claims description 2
- 229910019142 PO4 Inorganic materials 0.000 claims description 2
- 238000000137 annealing Methods 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims description 2
- 238000007710 freezing Methods 0.000 claims description 2
- 230000008014 freezing Effects 0.000 claims description 2
- 229940043257 glycylglycine Drugs 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
- 239000002184 metal Substances 0.000 claims description 2
- 229910021645 metal ion Inorganic materials 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 2
- 239000010452 phosphate Substances 0.000 claims description 2
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims description 2
- POSZUTFLHGNLHX-KSBRXOFISA-N tris maleate Chemical compound OCC(N)(CO)CO.OCC(N)(CO)CO.OC(=O)\C=C/C(O)=O POSZUTFLHGNLHX-KSBRXOFISA-N 0.000 claims description 2
- 241000990167 unclassified Simian adenoviruses Species 0.000 claims 2
- 241001217856 Chimpanzee adenovirus Species 0.000 claims 1
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 3
- 229930006000 Sucrose Natural products 0.000 description 3
- 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 description 3
- 239000005720 sucrose Substances 0.000 description 3
- 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 description 2
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 description 2
- 229920002307 Dextran Polymers 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- 229920002675 Polyoxyl Polymers 0.000 description 2
- MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 description 2
- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 description 2
- 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 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose 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[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 description 2
- 125000000647 trehalose group Chemical group 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- SHBUUTHKGIVMJT-UHFFFAOYSA-N Hydroxystearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OO SHBUUTHKGIVMJT-UHFFFAOYSA-N 0.000 description 1
- 241000282577 Pan troglodytes Species 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- 229940072106 hydroxystearate Drugs 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- HEGSGKPQLMEBJL-RKQHYHRCSA-N octyl beta-D-glucopyranoside Chemical compound CCCCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HEGSGKPQLMEBJL-RKQHYHRCSA-N 0.000 description 1
- 229920001983 poloxamer Polymers 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1701239.4 | 2017-01-25 | ||
| GBGB1701239.4A GB201701239D0 (en) | 2017-01-25 | 2017-01-25 | Novel formulation |
| PCT/IB2018/050453 WO2018138667A1 (en) | 2017-01-25 | 2018-01-25 | Novel formulation |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020506691A JP2020506691A (ja) | 2020-03-05 |
| JP2020506691A5 true JP2020506691A5 (enExample) | 2021-02-12 |
| JP7090089B2 JP7090089B2 (ja) | 2022-06-23 |
Family
ID=58462949
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019539953A Active JP7090089B2 (ja) | 2017-01-25 | 2018-01-25 | 新規配合物 |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US11590243B2 (enExample) |
| EP (1) | EP3573598A1 (enExample) |
| JP (1) | JP7090089B2 (enExample) |
| CN (1) | CN110430867B (enExample) |
| BE (1) | BE1025187B1 (enExample) |
| BR (1) | BR112019015245A2 (enExample) |
| CA (1) | CA3050629A1 (enExample) |
| GB (1) | GB201701239D0 (enExample) |
| MX (1) | MX2019008798A (enExample) |
| WO (1) | WO2018138667A1 (enExample) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB201513010D0 (en) * | 2015-07-23 | 2015-09-09 | Glaxosmithkline Biolog Sa | Novel formulation |
| EP3587581A1 (en) * | 2018-06-26 | 2020-01-01 | GlaxoSmithKline Biologicals S.A. | Formulations for simian adenoviral vectors having enhanced storage stability |
| BR112021025025A2 (pt) * | 2019-06-11 | 2022-02-22 | Glaxosmithkline Biologicals Sa | Formulações de vacinas de mucosa |
| JP2023548838A (ja) * | 2020-10-29 | 2023-11-21 | フラッグシップ パイオニアリング イノベーションズ ブイ， インコーポレイテッド | ニワトリ貧血ウイルス（ｃａｖ）に基づくベクター |
| US20230414516A1 (en) * | 2020-11-16 | 2023-12-28 | BioNTech SE | Enhanced formulation stabilization and improved lyophilization processes |
| CN116782889A (zh) * | 2020-11-16 | 2023-09-19 | 生物技术欧洲股份公司 | 增强的制剂稳定性和改善的冻干工艺 |
| CN114903922B (zh) * | 2021-02-09 | 2024-04-26 | 武汉博沃生物科技有限公司 | 包含腺病毒的医药配制品及其保存方法 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9808922D0 (en) * | 1998-04-24 | 1998-06-24 | Cantab Pharmaceuticals Res Ltd | Virus preparations |
| US7456009B2 (en) * | 2000-03-07 | 2008-11-25 | Merck & Co., Inc. | Adenovirus formulations |
| SI1409012T1 (sl) | 2001-06-22 | 2009-08-31 | Wistar Inst | Postopki za induciranje citotoksičnega imunskega odziva in za to uporabni sestavki rekombinantnih opičjih adenovirusov |
| WO2005071093A2 (en) | 2004-01-23 | 2005-08-04 | Istituto Di Ricerche Di Biologia Molecolare P Angeletti Spa | Chimpanzee adenovirus vaccine carriers |
| PT1954308E (pt) | 2005-09-16 | 2011-11-03 | Merial Ltd | Estabilizadores para vacinas liofilizadas |
| EA021391B1 (ru) | 2007-03-02 | 2015-06-30 | Глаксосмитклайн Байолоджикалс С.А. | Способ индукции иммунного ответа, вакцинная композиция, ее применение и набор |
| WO2010085984A1 (en) | 2009-02-02 | 2010-08-05 | Okairos Ag | Simian adenovirus nucleic acid- and amino acid-sequences, vectors containing same, and uses thereof |
| SI2391638T1 (sl) | 2009-02-02 | 2018-10-30 | Glaxosmithkline Biologicals Sa | Nukleinskokislinske in aminokislinske sekvence opičjega adenovirusa, vektorji, ki le-te vsebujejo, in njihova uporaba |
| CN102028954B (zh) | 2009-09-29 | 2012-11-07 | 成都康弘生物科技有限公司 | 一种重组腺病毒的制剂 |
| US9526777B2 (en) | 2010-04-16 | 2016-12-27 | The United States Of America As Represented By The Department Of Health And Human Services | Methods for the induction of ebola virus-specific immune responses comprising administering a replication-defective chimpanzee adenovirus vector expressing the ebola virus glycoprotein |
| WO2012089231A1 (en) | 2010-12-30 | 2012-07-05 | Okairòs Ag | Paramyxovirus vaccines |
| BR112014008167B1 (pt) | 2011-10-05 | 2022-05-24 | Genvec Inc | Adenovírus ou vetor adenoviral e composição os compreendendo |
| CN107574154A (zh) | 2011-10-05 | 2018-01-12 | 金维克有限公司 | 猴(大猩猩)腺病毒或腺病毒载体及其使用方法 |
| CN103974970B (zh) | 2011-10-05 | 2018-01-02 | 金维克有限公司 | 猴腺病毒(大猩猩)或腺病毒载体及其使用方法 |
| CN102631672B (zh) | 2012-04-27 | 2014-04-02 | 天津百若克医药生物技术有限责任公司 | 一种冻干灭活乙型脑炎疫苗 |
| AR097762A1 (es) | 2013-09-27 | 2016-04-13 | Intervet Int Bv | Formulaciones secas de vacunas que son estables a temperatura ambiente |
| JP6664338B2 (ja) | 2014-06-13 | 2020-03-13 | グラクソスミスクライン バイオロジカルズ ソシエテ アノニム | 免疫原性組合せ物 |
-
2017
- 2017-01-25 GB GBGB1701239.4A patent/GB201701239D0/en not_active Ceased
-
2018
- 2018-01-25 BE BE2018/5040A patent/BE1025187B1/fr not_active IP Right Cessation
- 2018-01-25 JP JP2019539953A patent/JP7090089B2/ja active Active
- 2018-01-25 EP EP18703633.0A patent/EP3573598A1/en not_active Withdrawn
- 2018-01-25 MX MX2019008798A patent/MX2019008798A/es unknown
- 2018-01-25 US US16/478,232 patent/US11590243B2/en active Active
- 2018-01-25 WO PCT/IB2018/050453 patent/WO2018138667A1/en not_active Ceased
- 2018-01-25 CA CA3050629A patent/CA3050629A1/en active Pending
- 2018-01-25 CN CN201880021100.9A patent/CN110430867B/zh not_active Expired - Fee Related
- 2018-01-25 BR BR112019015245A patent/BR112019015245A2/pt not_active IP Right Cessation
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