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ES2531385T3 - Formulación que comprende un anticuerpo contra la selectina P - Google Patents

Formulación que comprende un anticuerpo contra la selectina P Download PDF

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Publication number
ES2531385T3
ES2531385T3 ES09782818T ES09782818T ES2531385T3 ES 2531385 T3 ES2531385 T3 ES 2531385T3 ES 09782818 T ES09782818 T ES 09782818T ES 09782818 T ES09782818 T ES 09782818T ES 2531385 T3 ES2531385 T3 ES 2531385T3
Authority
ES
Spain
Prior art keywords
selectin
antibody against
formulation
mab
chain variable
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES09782818T
Other languages
English (en)
Inventor
Ulla Grauschopf
Hanns-Christian Mahler
Oliver Boris Stauch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
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
Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Application granted granted Critical
Publication of ES2531385T3 publication Critical patent/ES2531385T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/0012—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
    • A61K9/08—Solutions
    • 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
    • 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
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • A61P37/08—Antiallergic agents
    • 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
    • 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
    • C07K16/2851—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 lectin superfamily, e.g. CD23, CD72
    • C07K16/2854—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 lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
    • 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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Formulación farmacéutica que comprende: mAb_hu-selectina P 1 a 50 mg/ml, tampón de HCl de L-histidina 20 mM, polisorbato al 0,02%, trehalosa 240 mM, a pH 6,0, en la que el mAb_hu-selectina P es un anticuerpo contra la selectina P que comprende el dominio variable de cadena ligera definido por la secuencia de aminoácidos SEC ID nº 3 y el dominio variable de cadena pesada definido por SEC ID nº 4.
ES09782818T 2008-09-19 2009-09-09 Formulación que comprende un anticuerpo contra la selectina P Active ES2531385T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08164746 2008-09-19
PCT/EP2009/061692 WO2010031720A2 (en) 2008-09-19 2009-09-09 Novel antibody formulation

Publications (1)

Publication Number Publication Date
ES2531385T3 true ES2531385T3 (es) 2015-03-13

Family

ID=41231968

Family Applications (1)

Application Number Title Priority Date Filing Date
ES09782818T Active ES2531385T3 (es) 2008-09-19 2009-09-09 Formulación que comprende un anticuerpo contra la selectina P

Country Status (16)

Country Link
US (4) US20100074903A1 (es)
EP (1) EP2328559B1 (es)
JP (2) JP5524967B2 (es)
KR (2) KR20140019035A (es)
CN (1) CN102159194A (es)
AU (1) AU2009294680A1 (es)
BR (1) BRPI0918419A2 (es)
CA (1) CA2736198A1 (es)
CL (1) CL2011000561A1 (es)
ES (1) ES2531385T3 (es)
IL (1) IL211190A0 (es)
MX (1) MX2011002402A (es)
PE (1) PE20110302A1 (es)
SG (1) SG2014011365A (es)
WO (1) WO2010031720A2 (es)
ZA (1) ZA201101343B (es)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
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.
KR20120130757A (ko) 2010-02-26 2012-12-03 노보 노르디스크 에이/에스 안정한 항체 함유 조성물
CA2800188A1 (en) 2010-05-28 2011-12-01 Novo Nordisk A/S Stable multi-dose compositions comprising an antibody and a preservative
AU2011312191B2 (en) * 2010-10-06 2015-07-02 Regeneron Pharmaceuticals, Inc. Stabilized formulations containing anti-interleukin-4 receptor (IL-4R) antibodies
BR112013018740A2 (pt) 2011-01-28 2019-01-08 Sanofi Sa anticorpos humanos para pcsk9 para uso em métodos de tratamento de grupos específicos de indivíduos
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
PE20141413A1 (es) 2011-10-25 2014-10-25 Onclave Therapeutics Ltd Formulaciones de anticuerpo y metodos
AR090244A1 (es) * 2012-03-08 2014-10-29 Hoffmann La Roche Formulacion de anticuerpo anti-selectina p
TW201513882A (zh) 2013-03-15 2015-04-16 Bayer Healthcare Llc 抗－催乳激素受體抗體調配物
SI3060229T1 (sl) * 2013-10-24 2021-11-30 Astrazeneca Ab Stabilne vodne formulacije protiteles
GB201403775D0 (en) 2014-03-04 2014-04-16 Kymab Ltd Antibodies, uses & methods
KR20240172758A (ko) 2015-08-18 2024-12-10 리제너론 파아마슈티컬스, 인크. 지단백질 분리반출술을 경험하고 있는 고지혈증을 갖는 환자를 치료하기 위한 항-pcsk9 억제성 항체
WO2017095848A1 (en) * 2015-11-30 2017-06-08 Medimmune, Llc Optimized ratios of amino acids and sugars as amorphous stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
WO2017132827A1 (en) 2016-02-02 2017-08-10 Innovent Biologics (Suzhou) Co., Ltd. Pd-1 antibodies
JP7461741B2 (ja) 2016-06-20 2024-04-04 カイマブ・リミテッド 抗ｐｄ－ｌ１およびｉｌ－２サイトカイン
WO2018083248A1 (en) 2016-11-03 2018-05-11 Kymab Limited Antibodies, combinations comprising antibodies, biomarkers, uses & methods
EP3569224B1 (en) * 2017-01-11 2022-12-14 Celltrion Inc. Stable liquid formula
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
WO2022187834A1 (en) * 2021-03-03 2022-09-09 Allakos Inc. Anti-siglec-8 antibody formulations

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5800815A (en) * 1903-05-05 1998-09-01 Cytel Corporation Antibodies to P-selectin and their uses
US4783399A (en) 1984-05-04 1988-11-08 Scripps Clinic And Research Foundation Diagnostic system for the detection of cytomegalovirus
EP0606391B1 (en) 1991-09-30 1998-08-05 Biogen, Inc. Inhibition of vascular narrowing using anti-padgem antibodies
NZ252542A (en) * 1992-05-05 1997-08-22 Cytel Corp Compositions of blocking p-selectin antibodies and their use in treating inflammatory or thrombotic disease
IL133220A0 (en) * 1997-06-13 2001-03-19 Genentech Inc Stabilized antibody formulation
ES2392073T3 (es) * 2001-11-08 2012-12-04 Abbott Biotherapeutics Corp. Formulación farmacéutica líquida estable de anticuerpos IGG
US7317091B2 (en) * 2002-03-01 2008-01-08 Xencor, Inc. Optimized Fc variants
US8188231B2 (en) * 2002-09-27 2012-05-29 Xencor, Inc. Optimized FC variants
KR100891620B1 (ko) * 2004-04-13 2009-04-02 에프. 호프만-라 로슈 아게 항-ｐ-셀렉틴 항체
EP1868646A2 (en) * 2005-03-08 2007-12-26 Pharmacia & Upjohn Company LLC Composition comprising an antibody against macrophage colony-stimulating factor (m-csf) and a chelating agent
EP1988922A4 (en) * 2006-02-03 2010-06-02 Medimmune Llc PROTEIN FORMULATIONS
TW200806317A (en) * 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
RU2009126420A (ru) * 2006-12-11 2011-01-20 Ф.Хоффманн-Ля Рош Аг (Ch) Парентеральная лекарственная форма антитела к абета

Also Published As

Publication number Publication date
BRPI0918419A2 (pt) 2015-11-24
MX2011002402A (es) 2011-04-05
US20130209478A1 (en) 2013-08-15
JP2012502942A (ja) 2012-02-02
CL2011000561A1 (es) 2011-09-02
JP5524967B2 (ja) 2014-06-18
US20120321638A1 (en) 2012-12-20
EP2328559A2 (en) 2011-06-08
SG2014011365A (en) 2014-05-29
ZA201101343B (en) 2011-11-30
US20100074903A1 (en) 2010-03-25
EP2328559B1 (en) 2015-01-07
PE20110302A1 (es) 2011-05-21
JP2014094958A (ja) 2014-05-22
KR20140019035A (ko) 2014-02-13
CA2736198A1 (en) 2010-03-25
AU2009294680A1 (en) 2010-03-25
CN102159194A (zh) 2011-08-17
US20140093512A1 (en) 2014-04-03
IL211190A0 (en) 2011-04-28
WO2010031720A3 (en) 2010-09-23
WO2010031720A2 (en) 2010-03-25
KR20110047232A (ko) 2011-05-06

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