MX2011013722A - Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños. - Google Patents
Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.Info
- Publication number
- MX2011013722A MX2011013722A MX2011013722A MX2011013722A MX2011013722A MX 2011013722 A MX2011013722 A MX 2011013722A MX 2011013722 A MX2011013722 A MX 2011013722A MX 2011013722 A MX2011013722 A MX 2011013722A MX 2011013722 A MX2011013722 A MX 2011013722A
- Authority
- MX
- Mexico
- Prior art keywords
- small modular
- provides
- present
- lyophilized formulations
- formulations
- Prior art date
Links
Classifications
-
- 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
- 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
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
-
- 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
- C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
- C07K2317/622—Single chain antibody (scFv)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Abstract
La presente invención proporciona, entre otras cosas, formulaciones estables para proteínas inmunofarmacéuticas modulares pequeñas (SMIPTM). En ciertas modalidades, la presente invención proporciona una formulación que contiene una mezcla liofilizada de una proteína inmunofarmacéutica modular pequeña, en donde menos de 7% de la proteína inmunofarmacéutica modular pequeña liofilizada existe en forma agregada. Las formulaciones de acuerdo con la invención pueden contener agentes reguladores, estabilizadores, agente espesantes, agentes tensioactivos y/u otros excipientes. La presente invención proporciona también formulaciones para liofilización, reconstitución y métodos de uso.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US21838809P | 2009-06-18 | 2009-06-18 | |
US21838609P | 2009-06-18 | 2009-06-18 | |
PCT/US2010/039227 WO2010148337A1 (en) | 2009-06-18 | 2010-06-18 | Lyophilized formulations for small modular immunopharmaceuticals |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2011013722A true MX2011013722A (es) | 2012-05-08 |
Family
ID=43356778
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2011013722A MX2011013722A (es) | 2009-06-18 | 2010-06-18 | Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños. |
Country Status (11)
Country | Link |
---|---|
US (1) | US20120114646A1 (es) |
EP (1) | EP2442798A4 (es) |
JP (1) | JP2012530721A (es) |
KR (1) | KR20120027031A (es) |
CN (1) | CN102695499A (es) |
AU (1) | AU2010263058A1 (es) |
CA (1) | CA2764180A1 (es) |
IL (1) | IL217065A0 (es) |
MX (1) | MX2011013722A (es) |
RU (1) | RU2011151286A (es) |
WO (1) | WO2010148337A1 (es) |
Families Citing this family (40)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8158757B2 (en) | 2007-07-02 | 2012-04-17 | Oncomed Pharmaceuticals, Inc. | Compositions and methods for treating and diagnosing cancer |
JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
CA3101298A1 (en) | 2010-03-01 | 2011-09-09 | Bayer Healthcare Llc | Optimized monoclonal antibodies against tissue factor pathway inhibitor (tfpi) |
PE20140372A1 (es) | 2011-01-28 | 2014-03-24 | Sanofi Sa | Composiciones farmaceuticas que comprenden anticuerpos humanos frente a pcsk9 |
BR112013023609A8 (pt) | 2011-03-15 | 2018-04-03 | Biogen Idec Inc | Método para a redução de sintomas parecidos com a gripe associado com a administração intramuscular de interferon ao usar um regime de dosagem escalonado de titulação rápida |
CN106167526A (zh) | 2011-07-15 | 2016-11-30 | 昂考梅德药品有限公司 | Rspo结合剂和其应用 |
AR087305A1 (es) * | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
ES2369945B1 (es) * | 2011-07-29 | 2012-10-15 | Eduardo Anitua Aldecoa | Procedimiento de obtención de una composición que contiene factores de crecimiento a partir de un compuesto sanguíneo, y composición obtenible por dicho procedimiento. |
JP6158813B2 (ja) | 2011-09-16 | 2017-07-05 | リジェネロン・ファーマシューティカルズ・インコーポレイテッドRegeneron Pharmaceuticals, Inc. | プロタンパク質転換酵素サブチリシンケキシン−9(PCSK9)の阻害剤を投与することによってリポタンパク質(a)レベルを低下させる方法 |
MX2015000565A (es) | 2012-07-13 | 2015-04-10 | Oncomed Pharm Inc | Agentes de union de proteina de r-espondina humana (rspo3) y usos de los mismos. |
US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
TWI615158B (zh) | 2012-11-06 | 2018-02-21 | 拜耳製藥股份有限公司 | 多肽之調配物 |
EP2968498A4 (en) | 2013-03-15 | 2016-09-07 | Biogen Ma Inc | PREPARATIONS CONTAINING FACTOR IX POLYPEPTIDE |
US11576863B2 (en) | 2013-03-15 | 2023-02-14 | Takeda Pharmaceutical Company Limited | Formulation of an antibody and use thereof |
US10111953B2 (en) | 2013-05-30 | 2018-10-30 | Regeneron Pharmaceuticals, Inc. | Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9) |
CA2914721A1 (en) | 2013-06-07 | 2014-12-11 | Regeneron Pharmaceuticals, Inc. | Methods for inhibiting atherosclerosis by administering an inhibitor of pcsk9 |
MX2016006226A (es) | 2013-11-12 | 2016-09-07 | Sanofi Biotechnology | Regimenes de dosificacion para uso con inhibidores de pcsk9. |
JP6461005B2 (ja) * | 2013-11-21 | 2019-01-30 | 協和メデックス株式会社 | 血清又は血漿中の低密度リポ蛋白の凍結乾燥による変性抑制剤及び変性抑制方法 |
EP3123090A4 (en) | 2014-03-24 | 2017-12-13 | Bioverativ Therapeutics Inc. | Lyophilized factor ix formulations |
US9937239B2 (en) | 2014-05-21 | 2018-04-10 | The Johns Hopkins University | Preservation and reconstitution of cell-free protein expression systems |
CA2952609A1 (en) * | 2014-06-26 | 2015-12-30 | Amgen Inc. | Solid protein formulations comprising stabilizer, sugar alcohol, sugar and surfactant |
PL3169353T3 (pl) | 2014-07-16 | 2020-06-01 | Sanofi Biotechnology | SPOSOBY LECZENIA PACJENTÓW Z HETEROZYGOTYCZNĄ HIPERCHOLESTEROLEMIĄ RODZINNĄ (heFH) |
JP2017526356A (ja) * | 2014-08-15 | 2017-09-14 | オンコメッド ファーマシューティカルズ インコーポレイテッド | Rspo1結合剤およびその使用 |
CA2961374A1 (en) | 2014-09-16 | 2016-03-24 | Oncomed Pharmaceuticals, Inc. | Treatment of fibrotic diseases |
US10772956B2 (en) | 2015-08-18 | 2020-09-15 | Regeneron Pharmaceuticals, Inc. | Methods for reducing or eliminating the need for lipoprotein apheresis in patients with hyperlipidemia by administering alirocumab |
JP7109369B2 (ja) | 2016-02-24 | 2022-07-29 | バイオマリン ファーマシューティカル インコーポレイテッド | ターゲティングされた治療用リソソーム酵素融合タンパク質、関連する製剤、およびその使用 |
GB201608323D0 (en) * | 2016-05-12 | 2016-06-29 | Ucb Biopharma Sprl | Pharmaceutical compositions |
IL301948B1 (en) * | 2016-08-29 | 2024-05-01 | Tiziana Life Sciences Plc | Anti-CD3 antibody formulations |
EP3522867A1 (en) * | 2016-10-07 | 2019-08-14 | Regeneron Pharmaceuticals, Inc. | Room temperature stable lyophilized protein |
CN107088224B (zh) * | 2017-02-10 | 2020-06-26 | 温州医科大学 | 人fgf21冻干制剂 |
MA50501A (fr) * | 2017-05-02 | 2020-09-09 | Merck Sharp & Dohme | Formulations stables d'anticorps anti-ctla4 seuls et en combinaison avec des anticorps anti-récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation |
CN112739323A (zh) | 2018-05-10 | 2021-04-30 | 瑞泽恩制药公司 | 含有高浓度vegf受体融合蛋白的制剂 |
UY38238A (es) * | 2018-05-25 | 2019-12-31 | Genzyme Corp | Composiciones farmacéuticas para el tratamiento de la deficiencia de esfingomielinasa ácida |
KR102649069B1 (ko) | 2018-05-31 | 2024-03-19 | 주식회사 엑소코바이오 | 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 안면 홍조 개선용 조성물 |
CN112261871B (zh) | 2018-07-28 | 2022-05-17 | 韩国外泌体生技有限公司 | 用于使外排体冻干的方法 |
KR102163806B1 (ko) | 2018-07-30 | 2020-10-07 | 주식회사 엑소코바이오 | 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 피지분비 감소용 조성물 |
US20210079111A1 (en) * | 2018-08-04 | 2021-03-18 | AbCyte Therapeutics Inc. | Cd19-cd20 bispecific and dual passway car-t and methods for use thereof |
CR20210435A (es) | 2019-02-18 | 2021-09-20 | Lilly Co Eli | Formulación de anticuerpos terapéuticos |
JP2024522116A (ja) * | 2021-05-28 | 2024-06-11 | エックスワイワン セラピューティクス インコーポレイテッド | Muc1-c/細胞外ドメイン(muc1-c/ecd)に対する多重特異性抗体構築物 |
CN116479088A (zh) * | 2022-11-15 | 2023-07-25 | 江苏默乐生物科技股份有限公司 | 一种生物试剂冻干保存的试剂组合、试剂盒、方法及应用 |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
US6685940B2 (en) * | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
PT917879E (pt) * | 1997-11-22 | 2002-12-31 | Roche Diagnostics Gmbh | Processo melhorado para estabilizacao de proteinas |
KR20080071192A (ko) * | 2005-11-22 | 2008-08-01 | 와이어쓰 | 면역글로불린 융합 단백질 제형 |
RU2491094C2 (ru) * | 2007-03-30 | 2013-08-27 | Медиммун, Ллк | Препарат антитела |
US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
CA2726837A1 (en) * | 2008-06-26 | 2009-12-30 | Wyeth Llc | Lyophilization cycle robustness strategy |
-
2010
- 2010-06-18 CA CA2764180A patent/CA2764180A1/en not_active Abandoned
- 2010-06-18 WO PCT/US2010/039227 patent/WO2010148337A1/en active Application Filing
- 2010-06-18 AU AU2010263058A patent/AU2010263058A1/en not_active Abandoned
- 2010-06-18 US US13/378,751 patent/US20120114646A1/en not_active Abandoned
- 2010-06-18 MX MX2011013722A patent/MX2011013722A/es not_active Application Discontinuation
- 2010-06-18 EP EP10790288A patent/EP2442798A4/en not_active Withdrawn
- 2010-06-18 KR KR1020117030171A patent/KR20120027031A/ko not_active Application Discontinuation
- 2010-06-18 JP JP2012516348A patent/JP2012530721A/ja not_active Withdrawn
- 2010-06-18 RU RU2011151286/15A patent/RU2011151286A/ru not_active Application Discontinuation
- 2010-06-18 CN CN2010800271836A patent/CN102695499A/zh active Pending
-
2011
- 2011-12-18 IL IL217065A patent/IL217065A0/en unknown
Also Published As
Publication number | Publication date |
---|---|
AU2010263058A1 (en) | 2012-01-12 |
CA2764180A1 (en) | 2010-12-23 |
US20120114646A1 (en) | 2012-05-10 |
WO2010148337A1 (en) | 2010-12-23 |
CN102695499A (zh) | 2012-09-26 |
KR20120027031A (ko) | 2012-03-20 |
EP2442798A4 (en) | 2013-03-13 |
IL217065A0 (en) | 2012-02-29 |
RU2011151286A (ru) | 2013-07-27 |
EP2442798A1 (en) | 2012-04-25 |
JP2012530721A (ja) | 2012-12-06 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
FA | Abandonment or withdrawal |