AR095451A1 - Formulación de anticuerpos - Google Patents
Formulación de anticuerposInfo
- Publication number
- AR095451A1 AR095451A1 ARP130101508A ARP130101508A AR095451A1 AR 095451 A1 AR095451 A1 AR 095451A1 AR P130101508 A ARP130101508 A AR P130101508A AR P130101508 A ARP130101508 A AR P130101508A AR 095451 A1 AR095451 A1 AR 095451A1
- Authority
- AR
- Argentina
- Prior art keywords
- antibody
- aqueous
- lyophilisate
- concentration
- formulation
- Prior art date
Links
Classifications
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- 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
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- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
-
- 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
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- 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
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- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
-
- 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
-
- 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
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- 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
-
- 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
- C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Rheumatology (AREA)
- Biomedical Technology (AREA)
- Oncology (AREA)
- Endocrinology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Transplantation (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Los anticuerpos anti-CD40 se formulan como un liofilizado o una formulación líquida. Los liofilizados se pueden reconstituir para proporcionar una solución con una alta concentración del ingrediente activo de anticuerpo para la entrega a un paciente sin altos niveles de agregación de anticuerpos. El liofilizado puede ser reconstituido con un reconstituyente acuoso para proporcionar una composición acuosa en la que el anticuerpo tiene una concentración de por lo menos 50 mg/ml. El liofilizado o composición farmacéutica acuosa puede incluir uno o más de un azúcar, un agente amortiguador, un surfactante, y/o un aminoácido libre. Reivindicación 1: Una formulación liofilizada preparada al liofilizar una formulación acuosa que tiene un pH de 5.0 - 7.0 y que comprende (i) un anticuerpo anti-CD40 en donde el anticuerpo tiene una concentración de 20 - 150 mg/ml, y en donde dicho anticuerpo anti-CD40 incluye las CDR1, CDR2 y CDR3 de cadena pesada de las SEQ ID Nº 3, 4 y 5 respectivamente, y las CDR1, CDR2 y CDR3 de cadena ligera de SEQ ID Nº 6, 7 y 8; (ii) un estabilizador, (iii) un agente amortiguador, (iv) un surfactante, y opcionalmente (v) un aminoácido.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261642644P | 2012-05-04 | 2012-05-04 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR095451A1 true AR095451A1 (es) | 2015-10-21 |
Family
ID=48626495
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP130101508A AR095451A1 (es) | 2012-05-04 | 2013-05-03 | Formulación de anticuerpos |
Country Status (29)
Country | Link |
---|---|
US (5) | US20140004131A1 (es) |
EP (2) | EP3693016A1 (es) |
JP (1) | JP6007316B2 (es) |
KR (1) | KR101782203B1 (es) |
CN (1) | CN104302320B (es) |
AR (1) | AR095451A1 (es) |
AU (2) | AU2013255457A1 (es) |
BR (1) | BR112014027116B1 (es) |
CA (1) | CA2870338C (es) |
CL (1) | CL2014002823A1 (es) |
CO (1) | CO7111300A2 (es) |
DK (1) | DK2844286T3 (es) |
EA (1) | EA031436B1 (es) |
ES (1) | ES2788515T3 (es) |
HK (1) | HK1202050A1 (es) |
HU (1) | HUE048895T2 (es) |
IL (1) | IL235216A0 (es) |
MA (1) | MA37471A1 (es) |
MX (1) | MX357845B (es) |
PE (1) | PE20142407A1 (es) |
PH (1) | PH12014502460A1 (es) |
PL (1) | PL2844286T3 (es) |
PT (1) | PT2844286T (es) |
SG (1) | SG11201406335PA (es) |
SI (1) | SI2844286T1 (es) |
TN (1) | TN2014000431A1 (es) |
TW (1) | TW201347791A (es) |
WO (1) | WO2013164789A2 (es) |
ZA (1) | ZA201407192B (es) |
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KR101760242B1 (ko) | 2010-03-31 | 2017-07-21 | 베링거 인겔하임 인터내셔날 게엠베하 | 항-cd40 항체 |
AR083847A1 (es) | 2010-11-15 | 2013-03-27 | Novartis Ag | Variantes de fc (fragmento constante) silenciosas de los anticuerpos anti-cd40 |
US20140004131A1 (en) | 2012-05-04 | 2014-01-02 | Novartis Ag | Antibody formulation |
TWI660972B (zh) | 2012-09-10 | 2019-06-01 | 愛爾蘭商尼歐托普生物科學公司 | 抗mcam抗體及相關使用方法 |
WO2015136469A1 (en) | 2014-03-12 | 2015-09-17 | Prothena Biosciences Limited | Anti-mcam antibodies and associated methods of use |
KR20160131073A (ko) | 2014-03-12 | 2016-11-15 | 프로테나 바이오사이언시즈 리미티드 | Lg4-5에 대해 특이적인 항-라미닌4 항체 |
WO2016068333A1 (ja) * | 2014-10-30 | 2016-05-06 | 中外製薬株式会社 | シリンジキャップを具備した、針付プレフィルドシリンジ製剤 |
AU2015360502A1 (en) | 2014-12-10 | 2017-06-29 | Regents Of The University Of Minnesota | Genetically modified cells, tissues, and organs for treating disease |
US20170058038A1 (en) * | 2015-09-01 | 2017-03-02 | Boehringer Ingelheim International Gmbh | Use of anti-cd40 antibodies for treatment of lupus nephritis |
WO2017046776A2 (en) * | 2015-09-16 | 2017-03-23 | Prothena Biosciences Limited | Use of anti-mcam antibodies for treatment or prophylaxis of giant cell arteritis, polymyalgia rheumatica or takayasu's arteritis |
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 |
EP3471754A1 (en) | 2016-06-20 | 2019-04-24 | Kymab Limited | Anti-pd-l1 antibodies |
TWI761453B (zh) | 2017-03-01 | 2022-04-21 | 英商梅迪繆思有限公司 | 抗rsv單株抗體配製物 |
JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
US11845798B2 (en) | 2017-05-02 | 2023-12-19 | Merck Sharp & Dohme Llc | Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies |
KR20200074993A (ko) * | 2017-11-03 | 2020-06-25 | 노파르티스 아게 | 쇼그렌 증후군 치료에 사용하기 위한 항-cd40 항체 |
US20210251994A1 (en) | 2018-06-15 | 2021-08-19 | Flagship Pioneering Innovations V, Inc. | Increasing immune activity through modulation of postcellular signaling factors |
SG11202103907PA (en) * | 2018-10-18 | 2021-05-28 | Merck Sharp & Dohme | Formulations of anti-rsv antibodies and methods of use thereof |
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JOP20210152A1 (ar) | 2018-12-18 | 2023-01-30 | Novartis Ag | صياغة محلول بروتيني محتوية على تركيز عالٍ من جسم مضاد لـ vegf |
CR20210435A (es) | 2019-02-18 | 2021-09-20 | Lilly Co Eli | Formulación de anticuerpos terapéuticos |
EP3962493A2 (en) | 2019-05-03 | 2022-03-09 | Flagship Pioneering Innovations V, Inc. | Methods of modulating immune activity/level of irf or sting or of treating cancer, comprising the administration of a sting modulator and/or purinergic receptor modulator or postcellular signaling factor |
US20230114107A1 (en) | 2019-12-17 | 2023-04-13 | Flagship Pioneering Innovations V, Inc. | Combination anti-cancer therapies with inducers of iron-dependent cellular disassembly |
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AR083847A1 (es) * | 2010-11-15 | 2013-03-27 | Novartis Ag | Variantes de fc (fragmento constante) silenciosas de los anticuerpos anti-cd40 |
EP2648750B1 (en) * | 2010-12-10 | 2017-01-25 | Novartis AG | Antibody formulation |
US20140004131A1 (en) | 2012-05-04 | 2014-01-02 | Novartis Ag | Antibody formulation |
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2013
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