BR112012022223A8 - Formulação de proteína concentrada, uso e método de preparação da mesma - Google Patents
Formulação de proteína concentrada, uso e método de preparação da mesmaInfo
- Publication number
- BR112012022223A8 BR112012022223A8 BR112012022223A BR112012022223A BR112012022223A8 BR 112012022223 A8 BR112012022223 A8 BR 112012022223A8 BR 112012022223 A BR112012022223 A BR 112012022223A BR 112012022223 A BR112012022223 A BR 112012022223A BR 112012022223 A8 BR112012022223 A8 BR 112012022223A8
- Authority
- BR
- Brazil
- Prior art keywords
- preparation
- formulations
- concentrated protein
- protein formulation
- protein drug
- Prior art date
Links
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
- A61K9/08—Solutions
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Abstract
FORMULAÇÕES DE PROTEÍNA CONCENTRADA E SEU MÉTODO DE PREPARAÇÃO. A presente invenção refere-se a viscosidade, hipotônica formulações contendo um ou mais proteínas, por exemplo, anticorpos, a altas concentrações, usos das formulações e artigos de manufatura. Em particular, as formulações são úteis e benéficas para a administração ou distribuição subcutânea de uma alta concentração de um fármaco de proteína, tal como um anticorpo, a um indivíduo que está sofrendo com uma doença ou condição que e tratável por um fármaco de proteína.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US33919110P | 2010-03-01 | 2010-03-01 | |
US61/339,191 | 2010-03-01 | ||
PCT/US2011/026647 WO2011109365A2 (en) | 2010-03-01 | 2011-03-01 | Concentrated protein formulations and uses thereof |
Publications (3)
Publication Number | Publication Date |
---|---|
BR112012022223A2 BR112012022223A2 (pt) | 2016-07-05 |
BR112012022223A8 true BR112012022223A8 (pt) | 2017-12-05 |
BR112012022223B1 BR112012022223B1 (pt) | 2022-08-09 |
Family
ID=44542798
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112012022223-6A BR112012022223B1 (pt) | 2010-03-01 | 2011-03-01 | Formulação de proteína concentrada, uso e método de preparação da mesma |
Country Status (16)
Country | Link |
---|---|
US (2) | US9956165B2 (pt) |
EP (1) | EP2542221A4 (pt) |
JP (2) | JP5937523B2 (pt) |
KR (1) | KR101853981B1 (pt) |
CN (2) | CN102946861B (pt) |
AU (2) | AU2011223805B2 (pt) |
BR (1) | BR112012022223B1 (pt) |
CA (1) | CA2794929C (pt) |
HK (1) | HK1223835A1 (pt) |
IL (1) | IL221748B (pt) |
MX (1) | MX347504B (pt) |
NZ (1) | NZ602685A (pt) |
RU (1) | RU2626512C2 (pt) |
SG (1) | SG184355A1 (pt) |
WO (1) | WO2011109365A2 (pt) |
ZA (1) | ZA201207331B (pt) |
Families Citing this family (47)
Publication number | Priority date | Publication date | Assignee | Title |
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US9956165B2 (en) * | 2010-03-01 | 2018-05-01 | Cytodyn Inc. | Concentrated protein formulations and uses thereof |
CA3017116A1 (en) | 2010-11-04 | 2012-05-10 | Boehringer Ingelheim International Gmbh | Anti-il-23 antibodies |
MX352823B (es) * | 2011-10-28 | 2017-12-04 | Integritybio Inc | Formulaciones de proteinas que contienen aminoacidos. |
US10316095B2 (en) * | 2012-02-16 | 2019-06-11 | Santarus, Inc. | Antibody formulations |
ES2908474T3 (es) | 2012-05-03 | 2022-04-29 | Boehringer Ingelheim Int | Anticuerpos anti-IL-23p19 |
PE20191815A1 (es) | 2012-09-07 | 2019-12-27 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
KR20210021153A (ko) * | 2012-09-20 | 2021-02-24 | 모르포시스 아게 | 류마티스 관절염에 대한 치료 |
KR20150056846A (ko) * | 2012-09-20 | 2015-05-27 | 모르포시스 아게 | 류마티스 관절염에 대한 치료 |
EP3043774B1 (en) | 2013-09-11 | 2020-11-04 | Eagle Biologics, Inc. | Liquid protein formulations containing ionic liquids |
US9732154B2 (en) | 2014-02-28 | 2017-08-15 | Janssen Biotech, Inc. | Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia |
EP2946765B1 (en) | 2014-05-23 | 2016-08-31 | Ares Trading S.A. | Liquid pharmaceutical composition |
EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
ES2607489T3 (es) | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
US11357857B2 (en) | 2014-06-20 | 2022-06-14 | Comera Life Sciences, Inc. | Excipient compounds for protein processing |
WO2015196091A1 (en) * | 2014-06-20 | 2015-12-23 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
EP3708679A1 (en) | 2014-07-24 | 2020-09-16 | Boehringer Ingelheim International GmbH | Biomarkers useful in the treatment of il-23a related diseases |
AU2015305401A1 (en) | 2014-08-20 | 2017-03-02 | Cytodyn Inc. | HIV antibody therapy as treatment substitute |
TWI711629B (zh) | 2014-09-03 | 2020-12-01 | 德商包林格因蓋爾漢國際股份有限公司 | 靶向IL-23A與TNF-α之化合物及其用途 |
EP3200804A4 (en) | 2014-10-01 | 2018-04-18 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
RU2017111228A (ru) * | 2014-10-18 | 2018-11-21 | Пфайзер Инк. | Композиции антитела против IL-7R |
KR101776879B1 (ko) | 2015-01-19 | 2017-09-08 | 주식회사 녹십자 | 항-egfr 항체를 포함하는 약학 제제 |
MX2017009759A (es) | 2015-01-28 | 2017-10-27 | Pfizer | Formulacion de anticuerpo del anti-factor de crecimiento endotelial vascular (vegf) acuosa estable. |
EP3053572A1 (en) * | 2015-02-06 | 2016-08-10 | Ares Trading S.A. | Liquid pharmaceutical composition |
LT3256154T (lt) * | 2015-02-09 | 2020-01-10 | UCB Biopharma SRL | Farmacinė kompozicija, apimanti antikūną |
EP3081942A1 (en) * | 2015-04-17 | 2016-10-19 | Roche Diagniostics GmbH | Pressure transmission liquid for cellular analyzer, cellular analyzer and method for analyzing a liquid cellular sample |
CN113648410A (zh) * | 2015-06-23 | 2021-11-16 | 西托戴恩股份有限公司 | Ccr5受体竞争性抑制剂、其应用和治疗方法 |
US20170044265A1 (en) | 2015-06-24 | 2017-02-16 | Janssen Biotech, Inc. | Immune Modulation and Treatment of Solid Tumors with Antibodies that Specifically Bind CD38 |
TW201726111A (zh) * | 2015-09-30 | 2017-08-01 | 持田製藥股份有限公司 | 含高濃度抗體之液體製劑 |
US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
EA202190808A2 (ru) | 2015-11-03 | 2021-12-31 | Янссен Байотек, Инк. | Составы антител к cd38 для подкожного введения и их применение |
SG11201807402PA (en) | 2016-03-31 | 2018-09-27 | Vhsquared Ltd | Compositions |
US11071782B2 (en) | 2016-04-20 | 2021-07-27 | Coherus Biosciences, Inc. | Method of filling a container with no headspace |
TWI826351B (zh) * | 2016-05-31 | 2023-12-21 | 大陸商鴻運華寧(杭州)生物醫藥有限公司 | R抗體,其藥物組合物及其應用 |
CN109562149A (zh) | 2016-08-05 | 2019-04-02 | 德国杰特贝林生物制品有限公司 | C1酯酶抑制剂的药物制剂 |
BR112019018022A2 (pt) * | 2017-03-01 | 2020-06-02 | Medimmune Limited | Formulações de anticorpos monoclonais |
AU2018269656A1 (en) * | 2017-05-16 | 2019-11-07 | Octapharma Ag | C1-esterase inhibitor preparation |
JP2020530004A (ja) * | 2017-08-03 | 2020-10-15 | ジャズ ファーマシューティカルズ アイルランド リミテッド | 核酸を高濃度で含む製剤 |
KR102208378B1 (ko) * | 2017-08-17 | 2021-01-28 | 주식회사 녹십자 | 항-egfr 항체를 포함하는 약학 제제 |
US20190085086A1 (en) | 2017-09-18 | 2019-03-21 | Cytodyn Inc. | Screening methods for identifying and treating hiv-1 infected patient sub-populations suitable for long term anti-ccr5 agent therapy |
MA50514A (fr) | 2017-10-31 | 2020-09-09 | Janssen Biotech Inc | Méthodes de traitement du myélome multiple à haut risque |
GB201719447D0 (en) | 2017-11-23 | 2018-01-10 | Ucb Biopharma Sprl | Pharmaceutical composition |
WO2019217927A1 (en) | 2018-05-10 | 2019-11-14 | Regeneron Pharmaceuticals, Inc. | High concentration vegf receptor fusion protein containing formulations |
MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
BR112021016198A2 (pt) | 2019-03-08 | 2021-11-03 | Boehringer Ingelheim Int | Formulações de anticorpo anti-il-36r |
US11045546B1 (en) | 2020-03-30 | 2021-06-29 | Cytodyn Inc. | Methods of treating coronavirus infection |
CN111595658B (zh) * | 2020-06-06 | 2023-11-14 | 宾傲 | 一种提取细胞中蛋白的裂解液及其制备方法 |
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CA2226575C (en) | 1995-07-27 | 2011-10-18 | Genentech, Inc. | Stabile isotonic lyophilized protein formulation |
IL155002A0 (en) * | 2000-10-12 | 2003-10-31 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
KR100913714B1 (ko) * | 2001-11-08 | 2009-08-24 | 패시트 바이오테크 코포레이션 | Igg 항체의 안정한 액상 약학 제형물 |
RU2357751C2 (ru) * | 2001-12-21 | 2009-06-10 | Ново Нордиск Хелт Кэр Аг | Жидкая композиция полипептидов фактора vii |
KR101080021B1 (ko) * | 2002-02-14 | 2011-11-04 | 추가이 세이야쿠 가부시키가이샤 | 항체함유 용액제제 |
NZ561465A (en) | 2002-02-22 | 2009-04-30 | Pdl Biopharma Inc | Anti-CCR5 antibody |
US7122185B2 (en) * | 2002-02-22 | 2006-10-17 | Progenics Pharmaceuticals, Inc. | Anti-CCR5 antibody |
WO2003072060A2 (en) * | 2002-02-27 | 2003-09-04 | Immunex Corporation | Polypeptide formulation |
WO2004075913A1 (ja) | 2003-02-28 | 2004-09-10 | Chugai Seiyaku Kabushiki Kaisha | タンパク質含有安定化製剤 |
RU2332986C2 (ru) * | 2003-04-04 | 2008-09-10 | Дженентек, Инк. | Высококонцентрированные композиции антител и белков |
US8333995B2 (en) | 2004-05-12 | 2012-12-18 | Baxter International, Inc. | Protein microspheres having injectable properties at high concentrations |
EA010979B1 (ru) * | 2004-06-01 | 2008-12-30 | Арес Трейдинг С.А. | Стабилизированные жидкие препаративные формы интерферона |
WO2006007412A2 (en) * | 2004-06-16 | 2006-01-19 | Nastech Pharmaceutical Company Inc. | Peptide yy formulations having increased stability and resistance to microbial agents |
AR057807A1 (es) | 2005-09-12 | 2007-12-19 | Novimmune Sa | Formulaciones de anticuerpo anti-cd3 |
EP1942868B2 (en) * | 2005-11-01 | 2023-10-04 | Wyeth LLC | Sodium chloride solution for drug reconstitution or dilution |
US7390786B2 (en) * | 2005-12-21 | 2008-06-24 | Wyeth | Protein formulations with reduced viscosity and uses thereof |
EP2094247B1 (en) * | 2006-10-20 | 2022-06-29 | Amgen Inc. | Stable polypeptide formulations |
US9956165B2 (en) * | 2010-03-01 | 2018-05-01 | Cytodyn Inc. | Concentrated protein formulations and uses thereof |
-
2011
- 2011-03-01 US US13/582,243 patent/US9956165B2/en active Active
- 2011-03-01 RU RU2012141655A patent/RU2626512C2/ru active
- 2011-03-01 CN CN201180019594.5A patent/CN102946861B/zh active Active
- 2011-03-01 CN CN201510815109.5A patent/CN105521491B/zh active Active
- 2011-03-01 AU AU2011223805A patent/AU2011223805B2/en active Active
- 2011-03-01 MX MX2012010114A patent/MX347504B/es active IP Right Grant
- 2011-03-01 KR KR1020127025849A patent/KR101853981B1/ko active IP Right Grant
- 2011-03-01 JP JP2012556165A patent/JP5937523B2/ja active Active
- 2011-03-01 WO PCT/US2011/026647 patent/WO2011109365A2/en active Application Filing
- 2011-03-01 CA CA2794929A patent/CA2794929C/en active Active
- 2011-03-01 NZ NZ602685A patent/NZ602685A/en unknown
- 2011-03-01 BR BR112012022223-6A patent/BR112012022223B1/pt active IP Right Grant
- 2011-03-01 EP EP11751179.0A patent/EP2542221A4/en active Pending
- 2011-03-01 SG SG2012072542A patent/SG184355A1/en unknown
-
2012
- 2012-09-02 IL IL221748A patent/IL221748B/en active IP Right Grant
- 2012-10-01 ZA ZA2012/07331A patent/ZA201207331B/en unknown
-
2016
- 2016-01-28 AU AU2016200495A patent/AU2016200495B2/en active Active
- 2016-05-11 JP JP2016095589A patent/JP6229007B2/ja active Active
- 2016-10-20 HK HK16112125.5A patent/HK1223835A1/zh unknown
-
2018
- 2018-03-19 US US15/925,255 patent/US11571383B2/en active Active
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Legal Events
Date | Code | Title | Description |
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B25A | Requested transfer of rights approved |
Owner name: CYTODYN INC. (US) |
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B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
B15K | Others concerning applications: alteration of classification |
Ipc: A61K 9/00 (2006.01), A61K 39/395 (2006.01), A61K 4 |
|
B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] |
Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI |
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B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
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B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
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