[go: up one dir, main page]

AR074958A2 - Composicion farmaceutica liofilizada de anticuerpos monoclonales o policlonales y procedimiento para su produccion - Google Patents

Composicion farmaceutica liofilizada de anticuerpos monoclonales o policlonales y procedimiento para su produccion

Info

Publication number
AR074958A2
AR074958A2 ARP090105181A ARP090105181A AR074958A2 AR 074958 A2 AR074958 A2 AR 074958A2 AR P090105181 A ARP090105181 A AR P090105181A AR P090105181 A ARP090105181 A AR P090105181A AR 074958 A2 AR074958 A2 AR 074958A2
Authority
AR
Argentina
Prior art keywords
pharmaceutical composition
monoclonal
composition
polyclonal antibodies
procedure
Prior art date
Application number
ARP090105181A
Other languages
English (en)
Inventor
Georg Kallmeyer
Gerhard Winter
Christian Klessen
Heinrich Woog
Original Assignee
Roche Diagnostics Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=8223412&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR074958(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Roche Diagnostics Gmbh filed Critical Roche Diagnostics Gmbh
Publication of AR074958A2 publication Critical patent/AR074958A2/es

Links

Classifications

    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K39/39591—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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0019—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
    • 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
    • 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
    • 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
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/081—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from DNA viruses
    • C07K16/082—Hepadnaviridae, e.g. hepatitis B virus
    • 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
    • C07K16/2863—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 growth factors, growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • Virology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Composición farmacéutica liofilizada de anticuerpos monoclonales o policlonales, caracterizada porque contiene un azúcar seleccionado entre sacarosa, maltosa, trehalosa o rafinosa, el aminoácido básico solo histidina, un agente tensioactivo, y un ácido inorgánico, ácido acético, o una sal de los mismos. Un procedimiento para su producción. La composición tiene finalidades terapéuticas y de diagnóstico. Reivindicación 5: Composición farmacéutica acuosa de anticuerpos monoclonales o policlonales, caracterizada porque ha sido obtenida por redisolución de la composición liofilizada como se describe en una de las reivindicaciones 1 a 4, con la condición que la composición farmacéutica acuosa no se obtiene por redisolución de la composición liofilizada en solución salina tamponada con fosfato, solución salina estéril o solución de Ringer. Reivindicación 13: Composición de acuerdo con una cualquiera de las reivindicaciones precedentes, caracterizada porque el agente tensioactivo es polisorbato. Reivindicación 16: Composición de acuerdo con la reivindicación 15, caracterizada porque el ácido inorgánico es ácido clorhídrico.
ARP090105181A 1996-11-19 2009-12-30 Composicion farmaceutica liofilizada de anticuerpos monoclonales o policlonales y procedimiento para su produccion AR074958A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP96118489A EP0852951A1 (de) 1996-11-19 1996-11-19 Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern

Publications (1)

Publication Number Publication Date
AR074958A2 true AR074958A2 (es) 2011-02-23

Family

ID=8223412

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP970105404A AR012540A1 (es) 1996-11-19 1997-11-19 COMPOSICIoN FARMACÉUTICA LIOFILIZADA DE ANTICUERPOS MONOCLONALES O POLICLONALES, PROCEDIMIENTO PARA SU PRODUCCIoN
ARP090105181A AR074958A2 (es) 1996-11-19 2009-12-30 Composicion farmaceutica liofilizada de anticuerpos monoclonales o policlonales y procedimiento para su produccion

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP970105404A AR012540A1 (es) 1996-11-19 1997-11-19 COMPOSICIoN FARMACÉUTICA LIOFILIZADA DE ANTICUERPOS MONOCLONALES O POLICLONALES, PROCEDIMIENTO PARA SU PRODUCCIoN

Country Status (19)

Country Link
US (2) US8758747B2 (es)
EP (2) EP0852951A1 (es)
JP (2) JP4536829B2 (es)
KR (1) KR100514207B1 (es)
CN (1) CN1155408C (es)
AR (2) AR012540A1 (es)
AT (1) ATE276762T1 (es)
AU (2) AU735411C (es)
BR (1) BR9713521A (es)
CA (1) CA2272245C (es)
DE (1) DE59711959D1 (es)
DK (1) DK0941121T3 (es)
ES (1) ES2227727T3 (es)
ID (1) ID19029A (es)
PT (1) PT941121E (es)
TR (1) TR199901696T2 (es)
TW (1) TW520291B (es)
WO (1) WO1998022136A2 (es)
ZA (1) ZA9710409B (es)

Families Citing this family (130)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
DE59804785D1 (de) * 1997-11-22 2002-08-22 Roche Diagnostics Gmbh Verbessertes Verfahren zur Stabilisierung von Proteinen
CA2371427A1 (en) * 1999-04-28 2000-11-09 Yamanouchi Pharmaceutical Co., Ltd. Parenteral pharmaceutical composition containing humanized monoclonal antibody fragment and stabilizing method thereof
ES2477996T3 (es) 2000-08-11 2014-07-18 Chugai Seiyaku Kabushiki Kaisha Preparaciones estabilizadas que contienen un anticuerpo
US7138262B1 (en) 2000-08-18 2006-11-21 Shire Human Genetic Therapies, Inc. High mannose proteins and methods of making high mannose proteins
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
TWI232102B (en) 2001-07-17 2005-05-11 Shionogi & Co A pharmaceutical formulation for injection
WO2003018056A1 (fr) * 2001-08-29 2003-03-06 Chugai Seiyaku Kabushiki Kaisha Preparations stabilisees contenant un anticorps
CN1292655C (zh) * 2001-11-08 2007-01-03 蛋白质设计实验室股份有限公司 IgG抗体稳定的液态药物制剂
DE10163459A1 (de) * 2001-12-21 2003-07-03 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
AU2003211991B2 (en) * 2002-02-14 2008-08-21 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution formulations
PT1478394E (pt) 2002-02-27 2008-10-08 Immunex Corp Composição estabilizada compreendendo tnfr - fc e arginina
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
JP5057648B2 (ja) * 2002-09-26 2012-10-24 塩野義製薬株式会社 安定化されたタンパク組成物
AU2003271175A1 (en) 2002-10-11 2004-05-04 Masahiro Abe Cell death-inducing agent
EP1592440A4 (en) * 2003-02-10 2007-07-11 Elan Pharm Inc IMMUNOGLOBULIN PREPARATION AND METHOD OF PRODUCING THE SAME
JP4607010B2 (ja) * 2003-02-28 2011-01-05 中外製薬株式会社 タンパク質含有安定化製剤
CA2519408C (en) 2003-04-04 2011-01-18 Genentech, Inc. High concentration antibody and protein formulations
WO2005048985A2 (en) * 2003-11-14 2005-06-02 Baxter International Inc. Alpha 1-antitrypsin compositions and treatment methods using such compositions
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
DE10355251A1 (de) * 2003-11-26 2005-06-23 Merck Patent Gmbh Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor
DE10355904A1 (de) 2003-11-29 2005-06-30 Merck Patent Gmbh Feste Formen von anti-EGFR-Antikörpern
TW200530269A (en) 2003-12-12 2005-09-16 Chugai Pharmaceutical Co Ltd Anti-Mpl antibodies
CA2548929A1 (en) * 2003-12-12 2005-06-23 Chugai Seiyaku Kabushiki Kaisha Cell death inducing agent
WO2005056602A1 (ja) * 2003-12-12 2005-06-23 Chugai Seiyaku Kabushiki Kaisha アゴニスト活性を有する改変抗体のスクリーニング方法
WO2005100560A1 (ja) * 2004-04-09 2005-10-27 Chugai Seiyaku Kabushiki Kaisha 細胞死誘導剤
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
JP2007277094A (ja) * 2004-06-29 2007-10-25 Chemo Sero Therapeut Res Inst 改変ダニ主要アレルゲン含有医薬組成物
KR20150043558A (ko) 2004-07-22 2015-04-22 제넨테크, 인크. Ｈｅｒ２ 항체 조성물
TW200621282A (en) 2004-08-13 2006-07-01 Wyeth Corp Stabilizing formulations
MX2007003062A (es) * 2004-09-15 2007-05-21 Otsuka Pharma Co Ltd Composicion de permucosa y metodo de mejorar la absorcion de permucosa.
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
RU2438705C2 (ru) * 2005-01-21 2012-01-10 Дженентек, Инк. Введение фиксированных доз her-антител
CN1313161C (zh) * 2005-01-27 2007-05-02 北京大学临床肿瘤学院 结直肠癌放射免疫导向手术药物及其制备方法
CA2596133C (en) * 2005-02-23 2016-11-15 Genentech, Inc. Extending time to disease progression or survival in cancer patients
EP1870458B1 (en) 2005-03-31 2018-05-09 Chugai Seiyaku Kabushiki Kaisha sc(Fv)2 STRUCTURAL ISOMERS
CN101166763B (zh) * 2005-04-18 2012-09-19 伊达研究和发展有限公司 稳定的抗乙肝病毒(hbv)抗体配制剂
JP5085322B2 (ja) 2005-06-10 2012-11-28 中外製薬株式会社 ｓｃ（Ｆｖ）２を含有する医薬組成物
JP5068167B2 (ja) * 2005-06-10 2012-11-07 中外製薬株式会社 メグルミンを含有するタンパク質製剤の安定化剤、およびその利用
EP1909831A4 (en) 2005-06-14 2013-02-20 Amgen Inc SELF-BUFFING PROTEIN FORMULATIONS
KR20080098504A (ko) * 2006-02-03 2008-11-10 메디뮨 엘엘씨 단백질 제제
AU2013224728B2 (en) * 2006-02-07 2016-10-20 Takeda Pharmaceutical Company Limited Stabilized Compositions of Proteins Having a Free Thiol Moiety
JP5364382B2 (ja) 2006-02-07 2013-12-11 シャイアー ヒューマン ジェネティック セラピーズ インコーポレイテッド 遊離チオール部分を有するタンパク質の安定化された組成物
JP2009526856A (ja) * 2006-02-15 2009-07-23 イムクローン・リミテッド・ライアビリティ・カンパニー 抗体製剤
US7846724B2 (en) 2006-04-11 2010-12-07 Hoffmann-La Roche Inc. Method for selecting CHO cell for production of glycosylated antibodies
EP2048230A4 (en) * 2006-07-13 2010-01-20 Chugai Pharmaceutical Co Ltd Cell death inducer
WO2008029908A1 (fr) * 2006-09-07 2008-03-13 Kyowa Hakko Kirin Co., Ltd. Préparation pharmaceutique lyophilisée stable comprenant un anticorps
AU2008223069B2 (en) 2007-03-02 2012-12-13 F. Hoffmann-La Roche Ag Predicting response to a HER dimerisation inhibitor based on low HER3 expression
MX2009013886A (es) * 2007-06-25 2010-01-27 Amgen Inc Composiciones de agentes de aglutinacion especifica al factor de crecimiento de los hepatocitos.
JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
WO2009070642A1 (en) 2007-11-28 2009-06-04 Medimmune, Llc Protein formulation
KR20090056543A (ko) * 2007-11-30 2009-06-03 주식회사 녹십자 Ｂ형 간염 바이러스(ｈｂｖ) 중화 인간 항체를 포함하는약학적 제제
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
TWI472339B (zh) 2008-01-30 2015-02-11 Genentech Inc 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物
BRPI0812682A2 (pt) 2008-06-16 2010-06-22 Genentech Inc tratamento de cáncer de mama metastático
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).
US20130064834A1 (en) 2008-12-15 2013-03-14 Regeneron Pharmaceuticals, Inc. Methods for treating hypercholesterolemia using antibodies to pcsk9
AR075715A1 (es) * 2009-03-05 2011-04-20 Novartis Ag Formulacion de anticuerpo liofilizado
EP2403874A1 (en) 2009-03-06 2012-01-11 Genentech, Inc. Antibody formulation
MX344786B (es) 2009-07-28 2017-01-06 Shire Human Genetic Therapies Composiciones y metodos para tratar enfermedad de gaucher.
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
US8852954B2 (en) 2009-08-21 2014-10-07 Nec Solution Innovators, Ltd. Nucleic acid molecule having binding affinity to rodent-derived IgG antibody, binder, detection reagent, and detection kit
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
US20110117087A1 (en) 2009-10-26 2011-05-19 Reinhard Franze Method for the production of a glycosylated immunoglobulin
KR101912169B1 (ko) 2010-02-04 2018-10-26 체에스엘 베링 아게 면역글로불린 제제
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
SG10201502587SA (en) 2010-03-01 2015-06-29 Bayer Healthcare Llc Optimized monoclonal antibodies against tissue factor pathway inhibitor (tfpi)
AU2011274363A1 (en) * 2010-07-02 2013-01-24 Medimmune, Llc Antibody formulations
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
ES2639617T3 (es) 2010-10-12 2017-10-27 Merz Pharma Gmbh & Co. Kgaa Formulación adecuada para estabilizar proteínas, que carece de excipientes de mamíferos
TWI616204B (zh) 2010-11-05 2018-03-01 諾華公司 Ｉｌ-１７抗體用於製備治療牛皮癬性關節炎之藥物之用途
PL2637690T3 (pl) 2010-11-11 2017-03-31 Abbvie Biotechnology Ltd Płynne formulacje zawierające przeciwciało anty-tnf alfa o wysokim stężeniu
KR20200133826A (ko) 2011-01-28 2020-11-30 사노피 바이오테크놀로지, 소시에떼 빠르 악씨옹 셍쁠리피에 특정 대상자 그룹의 치료 방법에 이용하기 위한 ｐｃｓｋ9에 대한 인간 항체
ES2734076T3 (es) 2011-02-17 2019-12-04 Kyowa Hakko Kirin Co Ltd Preparación farmacéutica de anticuerpo anti-CD40 muy concentrada
SI2691112T1 (en) * 2011-03-31 2018-07-31 Merck Sharp & Dohme Corp. STABILITY FORMULATION PROTITELES FOR HUMAN PROGRAMMED DEPRESSOR RECEPTOR PD-1 AND RELATED HEALTH
UA116189C2 (uk) * 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
CN103501825B (zh) * 2011-05-02 2017-03-15 免疫医疗公司 用于小体积施用的同种异型选择的抗体的超滤浓缩
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
HUE069234T2 (hu) 2011-09-16 2025-02-28 Regeneron Pharma Eljárások lipoprotein(a)-szint csökkentésére proprotein-konvertáz szubtilizin/kexin 9 (PCSK9) inhibitorának beadásával
CN104334189A (zh) 2011-10-14 2015-02-04 霍夫曼-拉罗奇有限公司 Her2二聚化抑制剂帕妥珠单抗的用途和包含her2二聚化抑制剂帕妥珠单抗的制品
TWI595883B (zh) 2011-10-18 2017-08-21 柯赫勒斯生物科學有限公司 用木糖醇穩定化之依那西普調配物
US10485869B2 (en) 2011-10-18 2019-11-26 Coherus Biosciences, Inc. Etanercept formulations stabilized with meglumine
JP6431372B2 (ja) 2011-10-25 2018-11-28 プロシーナ バイオサイエンシーズ リミテッド 抗体製剤および方法
EA033387B1 (ru) 2012-01-23 2019-10-31 Regeneron Pharma СТАБИЛИЗИРОВАННЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ АНТИТЕЛА ПРОТИВ Ang-2
US9623090B2 (en) 2012-03-02 2017-04-18 Shire Human Genetic Therapies, Inc. Compositions and methods for treating type III gaucher disease
SG10201609982PA (en) * 2012-03-07 2017-01-27 Cadila Healthcare Ltd Pharmaceutical formulations of tnf-alpha anitbodies
AR092325A1 (es) 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
WO2014011672A1 (en) 2012-07-09 2014-01-16 Coherus Biosciences, Inc. Etanercept formulations exhibiting marked reduction in sub-visible particles
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
PE20150964A1 (es) 2012-09-07 2015-07-25 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab
BR112015005161A2 (pt) 2012-09-11 2017-07-04 Coherus Biosciences Inc etanercepte corretamente dobrado em alta pureza e excelente rendimento
CN102961745B (zh) * 2012-09-27 2015-02-18 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
CA2907776C (en) 2013-04-16 2020-04-14 Genentech, Inc. Pertuzumab variants and evaluation 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)
WO2014197752A1 (en) 2013-06-07 2014-12-11 Regeneron Pharmaceuticals, Inc. Methods fo inhibting atherosclerosis by administering an inhibitor of pcsk9
US10428157B2 (en) 2013-11-12 2019-10-01 Sanofi Biotechnology Dosing regimens for use with PCSK9 inhibitors
AU2015249633B2 (en) 2014-04-25 2020-10-15 Genentech, Inc. Methods of treating early breast cancer with Trastuzumab-MCC-DM1 and Pertuzumab
IS3008B (is) * 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
AU2015289613B2 (en) 2014-07-16 2021-07-01 Regeneron Pharmaceuticals, Inc. Methods for treating patients with heterozygous familial hypercholesterolemia (heFH)
US9821059B2 (en) * 2014-10-17 2017-11-21 Alteogen Inc. Composition for stabilizing protein and pharmaceutical formulation comprising the same
AU2015357068B2 (en) 2014-12-03 2021-07-29 Csl Behring Ag Pharmaceutical product with increased stability comprising immunoglobulins
CN107205923B (zh) 2014-12-17 2021-03-05 辉瑞大药厂 用于静脉内给药的pi3k/mtor-抑制剂的制剂
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
LT3284480T (lt) 2015-04-14 2025-08-11 Chugai Seiyaku Kabushiki Kaisha Farmacinė kompozicija, skirta atopinio dermatito profilaktikai ir (arba) gydymui, savo sudėtyje turinti il-31 antagonistą kaip veikliąją medžiagą
CA2980992C (en) 2015-04-14 2024-01-23 Akihisa Kaneko Pharmaceutical composition for prevention and/or treatment of atopic dermatitis containing il-31 antagonist as active ingredient
US11077193B2 (en) 2015-04-21 2021-08-03 Staidson (Beijing) Biopharmaceuticals Co., Ltd. Nerve growth factor composition and powder injection
DK3302551T3 (da) 2015-05-30 2024-08-26 Hoffmann La Roche Fremgangsmåder til behandling af HER2-positiv tidligere ubehandlet metastatisk brystkræft
MX2018002000A (es) 2015-08-18 2018-06-19 Regeneron Pharma Anticuerpos inhibidores de anti-pcsk9 para el tratamiento de pacientes con hiperlipidemia que se someten aferesis de lipoproteina.
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
WO2017087280A1 (en) 2015-11-16 2017-05-26 Genentech, Inc. Methods of treating her2-positive cancer
TWI836745B (zh) 2015-12-18 2024-03-21 美商上游生物公司 含有抗人類ｔｓｌｐ受體抗體之醫藥組成物
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
ES2968923T3 (es) 2016-08-10 2024-05-14 Celltrion Inc Preparación farmacéutica líquida estable de anticuerpo contra el virus de la gripe
CN118873480A (zh) 2016-10-07 2024-11-01 瑞泽恩制药公司 室温稳定的冻干蛋白质
KR102446838B1 (ko) 2016-10-21 2022-09-26 암젠 인크 약학적 제형 및 그의 제조 방법
EP3868404A1 (en) 2017-01-17 2021-08-25 F. Hoffmann-La Roche AG Subcutaneous her2 antibody formulations
US11077189B2 (en) 2017-03-02 2021-08-03 Genentech Inc. Adjuvant treatment of HER2-positive breast cancer
RU2770366C2 (ru) * 2017-08-31 2022-04-15 Кселлия Фармасьютикалз Апс Препараты даптомицина
EP3923928B1 (en) 2019-02-15 2025-10-08 The Regents Of The University Of California Methods for converting colloidal systems to resuspendable/redispersible powders that preserve the original properties of the colloids
CN112206320B (zh) * 2019-07-12 2025-02-25 鲁南制药集团股份有限公司 一种cd47单克隆抗体冻干粉制剂及其制备工艺
CN112516301B (zh) * 2019-09-17 2025-03-18 鲁南制药集团股份有限公司 一种cd47单克隆抗体的液体制剂及其制备方法
AU2020387034A1 (en) 2019-11-20 2022-06-02 Chugai Seiyaku Kabushiki Kaisha Antibody-containing preparation
WO2022005499A1 (en) 2020-06-29 2022-01-06 Genentech, Inc. Pertuzumab plus trastuzumab fixed dose combination
JP2025538151A (ja) 2022-11-07 2025-11-26 アップストリーム バイオ インコーポレイテッド 抗ヒトｔｓｌｐ受容体抗体を含む医薬組成物及びその使用方法

Family Cites Families (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4016043A (en) * 1975-09-04 1977-04-05 Akzona Incorporated Enzymatic immunological method for the determination of antigens and antibodies
US4165370A (en) 1976-05-21 1979-08-21 Coval M L Injectable gamma globulin
JPS56113713A (en) * 1980-02-14 1981-09-07 Chemo Sero Therapeut Res Inst Preparation of immunoglobulin with high content of monomer
US4439421A (en) 1982-08-30 1984-03-27 Baxter Travenol Laboratories, Inc. Stabilized gamma globulin concentrate
JPS60146833A (ja) 1984-01-10 1985-08-02 Green Cross Corp:The モノクロ−ナル抗体製剤
US4650772A (en) 1984-08-09 1987-03-17 Abbott Laboratories Monoclonal antibody stabilization
US4597966A (en) 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
JPH0825902B2 (ja) 1985-02-21 1996-03-13 株式会社ミドリ十字 γ−グロブリンの加熱処理方法
JPS6388197A (ja) 1986-09-30 1988-04-19 Tosoh Corp モノクロナル抗体の安定化方法
DE3877015T2 (de) 1987-02-20 1993-05-06 Akzo Nv Antikoerper enthaltende stabilisierte waesserige zusammensetzung.
DE3883899T3 (de) 1987-03-18 1999-04-22 Sb2, Inc., Danville, Calif. Geänderte antikörper.
DE3875852T2 (de) 1987-08-10 1993-03-18 Miles Inc Gereinigtes igm.
JPS6475433A (en) 1987-09-16 1989-03-22 Teijin Ltd Remedy for herpes simplex virus infection
WO1989007945A1 (en) 1988-02-26 1989-09-08 Genentech, Inc. Human relaxin formulation
US5096885A (en) 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
EP0417193B1 (en) 1988-05-27 1993-08-04 Centocor, Inc. Freeze-dried formulation for antibody products
EP0417191B1 (en) 1988-05-27 1993-03-10 Centocor, Inc. Formulation for antibody reagents
DE3825429C2 (de) 1988-07-27 1994-02-10 Biotest Pharma Gmbh Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt
US5468468A (en) * 1989-02-09 1995-11-21 The United States Of America, As Represented By The Secretary Of The Department Of Health & Human Services Method for making a monoclonal antibody, monoclonal antibodies to α PD
DE3927111C3 (de) 1989-08-17 1994-09-01 Biotest Pharma Gmbh Verfahren zur Herstellung nicht modifizierter intravenös verabreichbarer IgM- und/oderIgA-haltiger Immunglobulinpräparate
GB9015824D0 (en) 1990-07-18 1990-09-05 Erba Carlo Spa Stable pharmaceutical compositions containing a fibroblast growth factor
JPH0565233A (ja) 1991-03-08 1993-03-19 Mitsui Toatsu Chem Inc モノクローナル抗体含有凍結乾燥製剤
US5440021A (en) 1991-03-29 1995-08-08 Chuntharapai; Anan Antibodies to human IL-8 type B receptor
AU2309692A (en) 1991-07-03 1993-02-11 Cryolife, Inc. Method for stabilization of biomaterials
JP2966592B2 (ja) * 1991-07-20 1999-10-25 萩原 義秀 安定化されたヒトモノクローナル抗体製剤
GB9120304D0 (en) * 1991-09-24 1991-11-06 Erba Carlo Spa Stable pharmaceutical compositions containing a granulocyte macrophage colony stimulating factor
IL101007A (en) 1992-02-18 1997-08-14 Pharmos Ltd Dry stable compositions prepared by lyophilization
US5639641A (en) 1992-09-09 1997-06-17 Immunogen Inc. Resurfacing of rodent antibodies
KR100303872B1 (ko) * 1992-10-02 2001-11-22 크리스터 발스트룀, 프레드릭 베르그, 하랄트 알름 응고인자ⅷ제형을포함하는조성물,이것의제조방법및안정화제로서의계면활성제의사용방법
HUT72546A (en) 1992-11-06 1996-05-28 Sandoz Ag Production of human monoclonal antibodies active against hepatitis b surface antigen
FI952658A0 (fi) 1992-12-01 1995-05-31 Protein Design Labs Inc L-selektiinin kanssa reaktiivisia humanisoituja vasta-aineita
DE4242863A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
US5385887A (en) * 1993-09-10 1995-01-31 Genetics Institute, Inc. Formulations for delivery of osteogenic proteins
WO1995016460A1 (en) * 1993-12-17 1995-06-22 Mochida Pharmaceutical Co., Ltd. Composition containing soluble thrombomodulins
DE4344824C1 (de) 1993-12-28 1995-08-31 Immuno Ag Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung
FR2719479B1 (fr) 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.
WO1996017078A1 (en) 1994-11-30 1996-06-06 Ajinomoto Co., Inc. Antithrombotic agent and anti-von willebrand factor monoclonal antibodies
US6033876A (en) 1995-01-18 2000-03-07 Boehringer Mannheim Gmbh Anti-CD30 antibodies preventing proteolytic cleavage and release of membrane-bound CD30 antigen
DE19508192A1 (de) 1995-03-09 1996-09-12 Behringwerke Ag Stabile Transglutaminasepräparate und Verfahren zu ihrer Herstellung
PT1516628E (pt) * 1995-07-27 2013-09-24 Genentech Inc Formulação de proteína liofilizada isotónica estável
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
DE19539574A1 (de) * 1995-10-25 1997-04-30 Boehringer Mannheim Gmbh Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern

Also Published As

Publication number Publication date
KR100514207B1 (ko) 2005-09-13
EP0852951A1 (de) 1998-07-15
PT941121E (pt) 2005-01-31
AU735411C (en) 2004-08-05
DE59711959D1 (de) 2004-10-28
CA2272245C (en) 2013-09-10
CN1155408C (zh) 2004-06-30
JP4536829B2 (ja) 2010-09-01
DK0941121T3 (da) 2005-01-31
AU5484198A (en) 1998-06-10
CN1244805A (zh) 2000-02-16
JP2009046494A (ja) 2009-03-05
AU7824201A (en) 2001-11-22
ZA9710409B (en) 1999-05-19
WO1998022136A2 (de) 1998-05-28
AU735411B2 (en) 2001-07-05
BR9713521A (es) 2000-03-21
AR012540A1 (es) 2000-11-08
US20140248274A1 (en) 2014-09-04
AU772940B2 (en) 2004-05-13
EP0941121A2 (de) 1999-09-15
JP2001503781A (ja) 2001-03-21
ES2227727T3 (es) 2005-04-01
ID19029A (id) 1998-06-04
TW520291B (en) 2003-02-11
WO1998022136A3 (de) 1998-08-20
US8758747B2 (en) 2014-06-24
JP5153532B2 (ja) 2013-02-27
EP0941121B1 (de) 2004-09-22
KR20000053328A (ko) 2000-08-25
TR199901696T2 (xx) 1999-09-21
ATE276762T1 (de) 2004-10-15
US20080286280A1 (en) 2008-11-20
CA2272245A1 (en) 1998-05-28

Similar Documents

Publication Publication Date Title
AR074958A2 (es) Composicion farmaceutica liofilizada de anticuerpos monoclonales o policlonales y procedimiento para su produccion
CO5280094A1 (es) Un analogo de a o app y una composicion inmunogenica que comprende dicho analogo
BR0310088A (pt) Pré-direcionamento de droga por meio de anticorpos biespecìficos e constructos haptênicos compreendendo um veìculo peptìdico e o(s) agente(s) ativo(s)
ES2109929T3 (es) Procedimiento para preparar un glucano de levadura
ES2127409T3 (es) Metodo para la modulacion de la respuesta sexual en el hombre.
ES2110060T3 (es) Uso de acidos grasos para aumentar la absorcion intestinal del calcio.
ES2169128T3 (es) Procedimientos para el tratamiento de enfermedades utilizando celulas de sertoli y aloinjertos o xenoinjertos.
ES2196024T3 (es) Vacunas conjugadas de gangliosido-klh con qs-21.
ES2130217T3 (es) Uso de tiloxapol como dispersante y estabilizante de nanoparticulas.
ES2149971T3 (es) Derivados 5-sustituidos del acido micofenolico.
ES2233931T3 (es) Fenilacetato y derivados, solos o en combinacion con otros compuestos, contra estados neoplasicos y otros trastornos.
ES2152986T3 (es) Genoterapia de celulas mesoteliales.
DE69524389D1 (de) 6-substituierte mycophenolsäurederivate mit immun suppressiver wirkung
ES2074701T3 (es) Anticuerpo recombinante especifico cd3.
ES2089797T3 (es) Procedimiento para aislar la lactoferrina y la lactoperoxidasa de la leche y de los productos lacteos.
ES2157447T3 (es) Composicion de vacuna que comprende un antigeno de polisacarido conjugado adsorbido en fosfato de aluminio.
ES2119411T3 (es) Combinaciones de proteinas y anticoagulantes tromboliticamente activos, y usos de los mismos.
ES2073678T3 (es) Formulaciones radiofarmaceuticas, su metodo de administracion y procedimiento de preparacion.
MX9306220A (es) Ptp 1d: una proteina tirosina fosfatasa novedosa.
MX9401312A (es) Nuevo procedimiento para la elaboracion del liofilizado cetrorelix.
AR018020A1 (es) Procedimiento perfeccionado para estabilizar proteinas particularmente anticuerpos, su almacenamiento y reconstitucion
ES2155450T3 (es) Anticuerpos opsonicos fuertemente reactivos, que reaccionan a los antigenos comunes de los staphylococcus.
MX9301014A (es) Composiciones citoprotectora y metodos para preparar y usar las mismas.
DK0424043T3 (da) Flydende vandigt ophthalmisk præparat, der overgår fra væske- til gelfase
EA199800717A1 (ru) Способ лечения заболеваний млекопитающих и цвиттерионная композиция

Legal Events

Date Code Title Description
FC Refusal