AR121079A2 - Formulación - Google Patents
FormulaciónInfo
- Publication number
- AR121079A2 AR121079A2 ARP210100121A ARP210100121A AR121079A2 AR 121079 A2 AR121079 A2 AR 121079A2 AR P210100121 A ARP210100121 A AR P210100121A AR P210100121 A ARP210100121 A AR P210100121A AR 121079 A2 AR121079 A2 AR 121079A2
- Authority
- AR
- Argentina
- Prior art keywords
- amount
- mixture
- frozen
- aqueous mixture
- temperature
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 14
- 238000009472 formulation Methods 0.000 title abstract 3
- 239000013598 vector Substances 0.000 abstract 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 2
- 230000008014 freezing Effects 0.000 abstract 2
- 238000007710 freezing Methods 0.000 abstract 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 abstract 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 abstract 1
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 abstract 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 abstract 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 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- 108700019146 Transgenes Proteins 0.000 abstract 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 abstract 1
- 239000007983 Tris buffer Substances 0.000 abstract 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 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 230000009477 glass transition Effects 0.000 abstract 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 1
- 238000009396 hybridization Methods 0.000 abstract 1
- 230000002163 immunogen Effects 0.000 abstract 1
- 239000011777 magnesium Substances 0.000 abstract 1
- 229910052749 magnesium Inorganic materials 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 230000008018 melting Effects 0.000 abstract 1
- 238000002844 melting Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 229920001993 poloxamer 188 Polymers 0.000 abstract 1
- 229940044519 poloxamer 188 Drugs 0.000 abstract 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 1
- 229920000053 polysorbate 80 Polymers 0.000 abstract 1
- 229940068968 polysorbate 80 Drugs 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000011780 sodium chloride Substances 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 abstract 1
- 230000003612 virological effect Effects 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
- A61K2039/5256—Virus expressing foreign proteins
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
- C12N2710/00011—Details
- C12N2710/10011—Adenoviridae
- C12N2710/10041—Use of virus, viral particle or viral elements as a vector
- C12N2710/10043—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
- C12N2760/00011—Details
- C12N2760/14011—Filoviridae
- C12N2760/14111—Ebolavirus, e.g. Zaire ebolavirus
- C12N2760/14134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Virology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Microbiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La presente se refiere a la formulación de vectores adenovirales en una mezcla acuosa o una composición liofilizada en presencia de azúcar amorfo y una concentración de sal baja, su formulación así como a un procedimiento de obtención de la composición seca. Reivindicación 1: Un método para producir un vector adenoviral de simio que codifica un transgén inmunogénico, caracterizado porque comprende: a) suministrar una mezcla acuosa que comprende un vector adenoviral de simio en una cantidad de 10⁹ a 10¹² partículas virales por mililitro, cloruro de sodio en una cantidad de 8 mM, sacarosa en una cantidad de 2,5%, trehalosa en una cantidad de 9%, un agente tensioactivo seleccionado de poloxámero 188 y polisorbato 80 en una cantidad de 0,02% (p/v), cloruro de magnesio en una cantidad de 1 mM, histidina en una cantidad de 10 mM y Tris en una cantidad de 10 mM, donde el pH está entre 8 y 9; b) congelar la mezcla acuosa: 1) congelar la mezcla acuosa reduciendo la temperatura por debajo de Tv de la mezcla; 2) aplicar una fase de hibridación a la mezcla congelada elevando la temperatura sin la fusión la mezcla congelada durante tres horas y 3) reducir nuevamente la temperatura por debajo de la temperatura de transición vítrea en el estado congelado (Tv); c) secar la mezcla congelada bajo presión reducida durante seis horas; y d) reconstituir la mezcla seca en agua.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1513010.7A GB201513010D0 (en) | 2015-07-23 | 2015-07-23 | Novel formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR121079A2 true AR121079A2 (es) | 2022-04-13 |
Family
ID=54106515
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP160102193A AR105401A1 (es) | 2015-07-23 | 2016-07-20 | Mezcla acuosa que comprende un vector adenoviral, composición liofilizada, procedimiento |
| ARP210100121A AR121079A2 (es) | 2015-07-23 | 2021-01-20 | Formulación |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP160102193A AR105401A1 (es) | 2015-07-23 | 2016-07-20 | Mezcla acuosa que comprende un vector adenoviral, composición liofilizada, procedimiento |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US10722470B2 (es) |
| EP (1) | EP3325016B1 (es) |
| JP (1) | JP6797891B2 (es) |
| CN (1) | CN108025081B (es) |
| AR (2) | AR105401A1 (es) |
| BE (1) | BE1023537B1 (es) |
| BR (1) | BR112018001260A2 (es) |
| CA (1) | CA2992922A1 (es) |
| GB (1) | GB201513010D0 (es) |
| MX (1) | MX391216B (es) |
| WO (1) | WO2017013169A1 (es) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11047534B2 (en) | 2016-01-28 | 2021-06-29 | EcoSense Lighting, Inc. | Multizone mixing cup illumination system |
| KR20200066349A (ko) * | 2017-10-16 | 2020-06-09 | 글락소스미스클라인 바이오로지칼즈 에스.에이. | 복제 가능 아데노바이러스 벡터 |
| EP3720500A4 (en) * | 2017-12-05 | 2021-08-25 | Applied Genetic Technologies Corporation | FORMULATION OPTIMIZATION FOR VIRAL PARTICLES |
| GB201721069D0 (en) | 2017-12-15 | 2018-01-31 | Glaxosmithkline Biologicals Sa | Hepatitis B Immunisation regimen and compositions |
| WO2019202083A1 (en) * | 2018-04-20 | 2019-10-24 | Laboratorio Reig Jofré, S.A. | Stable adenovirus compositions |
| EP3587581A1 (en) * | 2018-06-26 | 2020-01-01 | GlaxoSmithKline Biologicals S.A. | Formulations for simian adenoviral vectors having enhanced storage stability |
| CN109055432B (zh) * | 2018-08-16 | 2020-10-13 | 南京科佰生物科技有限公司 | 慢病毒感染试剂及其制备方法与应用 |
| CN120775062A (zh) | 2019-07-16 | 2025-10-14 | 吉利德科学公司 | Hiv疫苗及其制备和使用方法 |
| SI4037708T1 (sl) | 2019-09-30 | 2025-01-31 | Gilead Sciences, Inc. | Cepiva proti hbv in postopki zdravljenja hbv |
| KR20220129088A (ko) | 2020-02-04 | 2022-09-22 | 리제너론 파아마슈티컬스, 인크. | 동결건조 의약품의 목표 잔류 수분 함량 |
| US20220040305A1 (en) * | 2020-08-07 | 2022-02-10 | Janssen Biotech, Inc. | Formulations for highly purified viral particles |
| KR20230092820A (ko) * | 2020-08-22 | 2023-06-26 | 페더럴 스테이트 버지터리 인스티튜션 “내셔널 리서치 센터 포 에피데미올로지 앤드 마이크로바이올로지 네임드 애프터 더 아너러리 아카데미시안 엔.에프. 감마레야” 오브 더 미니스트리 오브 헬스 오브 더 러시안 페더레이션 | Sars-cov-2에 대한 특이적 면역을 유도하기 위한 약제학적 제제 |
| WO2022067273A1 (en) * | 2020-09-24 | 2022-03-31 | Nant Holdings Ip, Llc | Vaccine compositions for mucosal immune response |
| CN116348134A (zh) * | 2020-10-23 | 2023-06-27 | 河谷控股Ip有限责任公司 | 用于黏膜免疫应答的疫苗组合物 |
| CA3198538A1 (en) * | 2020-11-16 | 2022-05-19 | Bakul Subodh BHATNAGAR | Enhanced formulation stabilization and improved lyophilization processes |
| CN116829134A (zh) * | 2020-11-16 | 2023-09-29 | 生物技术欧洲股份公司 | 包含rna的lnp组合物及其制备、储存和使用方法 |
| US20240033334A1 (en) * | 2020-12-04 | 2024-02-01 | Gritstone Bio, Inc. | Compositions and methods of use thereof |
| 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 |
| CN119677546A (zh) | 2022-07-12 | 2025-03-21 | 吉利德科学公司 | Hiv免疫原性多肽和疫苗及其用途 |
| CN116350801A (zh) | 2022-11-22 | 2023-06-30 | 四川至善唯新生物科技有限公司 | 一种重组腺相关病毒载体的药物组合物及其用途 |
| TW202426017A (zh) * | 2022-11-24 | 2024-07-01 | 俄羅斯聯邦商拜奧卡德聯合股份公司 | 非包膜病毒的藥物組合物 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7732129B1 (en) * | 1998-12-01 | 2010-06-08 | Crucell Holland B.V. | Method for the production and purification of adenoviral vectors |
| US6689600B1 (en) * | 1998-11-16 | 2004-02-10 | Introgen Therapeutics, Inc. | Formulation of adenovirus for gene therapy |
| ATE449105T1 (de) * | 2004-01-23 | 2009-12-15 | Angeletti P Ist Richerche Bio | Impfstoffträger für schimpansen-adenovirus |
| ES2349472T3 (es) * | 2004-08-12 | 2011-01-03 | Schering Corporation | Formulación estable de interferón pegilado. |
| BRPI0618893A2 (pt) * | 2005-11-22 | 2011-09-13 | Wyeth Corp | formulações de proteìna de fusão de imunoglobulina |
| CN1883707A (zh) * | 2006-05-19 | 2006-12-27 | 吉林大学 | 重组腺病毒的冻干制剂及其制备方法 |
| HUE033656T2 (en) * | 2010-03-31 | 2017-12-28 | Stabilitech Ltd | Binders for stabilizing virus particles |
| EA201390812A1 (ru) * | 2010-12-02 | 2013-11-29 | Онколитикс Байотек Инк. | Лиофилизированные вирусные составы |
| HUE027839T2 (en) * | 2012-03-12 | 2016-11-28 | Crucell Holland Bv | Recombinant adenoviruses with altered terminals |
| US8932607B2 (en) * | 2012-03-12 | 2015-01-13 | Crucell Holland B.V. | Batches of recombinant adenovirus with altered terminal ends |
| WO2015040234A1 (en) * | 2013-09-23 | 2015-03-26 | Crucell Holland B.V. | Adenovirus formulations |
| GB201701239D0 (en) * | 2017-01-25 | 2017-03-08 | Glaxosmithkline Biologicals Sa | Novel formulation |
-
2015
- 2015-07-23 GB GBGB1513010.7A patent/GB201513010D0/en not_active Ceased
-
2016
- 2016-07-20 BR BR112018001260A patent/BR112018001260A2/pt not_active IP Right Cessation
- 2016-07-20 WO PCT/EP2016/067280 patent/WO2017013169A1/en not_active Ceased
- 2016-07-20 CA CA2992922A patent/CA2992922A1/en active Pending
- 2016-07-20 AR ARP160102193A patent/AR105401A1/es unknown
- 2016-07-20 MX MX2018001006A patent/MX391216B/es unknown
- 2016-07-20 CN CN201680054923.2A patent/CN108025081B/zh not_active Expired - Fee Related
- 2016-07-20 JP JP2018503207A patent/JP6797891B2/ja not_active Expired - Fee Related
- 2016-07-20 US US15/746,473 patent/US10722470B2/en active Active
- 2016-07-20 EP EP16751192.2A patent/EP3325016B1/en active Active
- 2016-07-20 BE BE2016/5605A patent/BE1023537B1/fr not_active IP Right Cessation
-
2021
- 2021-01-20 AR ARP210100121A patent/AR121079A2/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US20180214379A1 (en) | 2018-08-02 |
| MX391216B (es) | 2025-03-21 |
| GB201513010D0 (en) | 2015-09-09 |
| BE1023537A1 (fr) | 2017-04-26 |
| US10722470B2 (en) | 2020-07-28 |
| AR105401A1 (es) | 2017-09-27 |
| JP6797891B2 (ja) | 2020-12-09 |
| MX2018001006A (es) | 2018-06-06 |
| CN108025081B (zh) | 2021-11-02 |
| BR112018001260A2 (pt) | 2018-09-11 |
| JP2018521078A (ja) | 2018-08-02 |
| BE1023537B1 (fr) | 2017-04-26 |
| EP3325016C0 (en) | 2023-12-20 |
| WO2017013169A1 (en) | 2017-01-26 |
| EP3325016B1 (en) | 2023-12-20 |
| EP3325016A1 (en) | 2018-05-30 |
| CA2992922A1 (en) | 2017-01-26 |
| CN108025081A (zh) | 2018-05-11 |
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