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CY1117363T1 - Σκευασμα αντισωματος κατα abeta - Google Patents

Σκευασμα αντισωματος κατα abeta

Info

Publication number
CY1117363T1
CY1117363T1 CY20161100295T CY161100295T CY1117363T1 CY 1117363 T1 CY1117363 T1 CY 1117363T1 CY 20161100295 T CY20161100295 T CY 20161100295T CY 161100295 T CY161100295 T CY 161100295T CY 1117363 T1 CY1117363 T1 CY 1117363T1
Authority
CY
Cyprus
Prior art keywords
abeta
antibody package
antibody
package
poloxamer
Prior art date
Application number
CY20161100295T
Other languages
English (en)
Inventor
Pierre Goldbach
Hanns-Christian Mahler
Robert Mueller
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
Publication of CY1117363T1 publication Critical patent/CY1117363T1/el

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

Η παρούσα εφεύρεση αναφέρεται σε ένα φαρμακευτικό σκεύασμα που περιλαμβάνει περίπου 50mg/ml -200 mg/ml ενός αντισώματος κατά Abeta, περίπου 0,01% -0,1% ενός πολοξαμερούς, περίπου 5mM - 50mM ενός ρυθμιστικού διαλύματος, περίπου 100mM - 300mM ενός σταθεροποιητή με pΗ περίπου 4,5 -7,0.
CY20161100295T 2012-03-08 2016-04-12 Σκευασμα αντισωματος κατα abeta CY1117363T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP12158602 2012-03-08
EP13707176.7A EP2822587B1 (en) 2012-03-08 2013-03-05 Abeta antibody formulation

Publications (1)

Publication Number Publication Date
CY1117363T1 true CY1117363T1 (el) 2017-04-26

Family

ID=47780075

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20161100295T CY1117363T1 (el) 2012-03-08 2016-04-12 Σκευασμα αντισωματος κατα abeta

Country Status (26)

Country Link
US (1) US20150030589A1 (el)
EP (1) EP2822587B1 (el)
JP (1) JP5859148B2 (el)
KR (1) KR101666289B1 (el)
CN (1) CN104159613B (el)
AR (2) AR090272A1 (el)
AU (1) AU2013229613B2 (el)
BR (1) BR112014019667B1 (el)
CA (1) CA2860543C (el)
CY (1) CY1117363T1 (el)
DK (1) DK2822587T3 (el)
ES (1) ES2564281T3 (el)
HK (1) HK1200717A1 (el)
HR (1) HRP20160434T1 (el)
HU (1) HUE028440T2 (el)
IL (1) IL234120B (el)
MX (1) MX351148B (el)
MY (1) MY166045A (el)
NZ (1) NZ626955A (el)
PL (1) PL2822587T3 (el)
RS (1) RS54644B1 (el)
RU (1) RU2014140137A (el)
SG (1) SG11201404481RA (el)
SI (1) SI2822587T1 (el)
WO (1) WO2013131866A1 (el)
ZA (1) ZA201405103B (el)

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EP4218801A3 (en) 2006-03-31 2023-08-23 Chugai Seiyaku Kabushiki Kaisha Antibody modification method for purifying bispecific antibody
ES2595638T3 (es) 2007-09-26 2017-01-02 Chugai Seiyaku Kabushiki Kaisha Método para modificar el punto isoeléctrico de un anticuerpo mediante la sustitución de aminoácidos en una CDR
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).
CN106267189B (zh) * 2010-10-06 2021-02-26 瑞泽恩制药公司 含有抗白介素-4受体(il-4r)的抗体的稳定制剂
CN105859889B (zh) 2010-11-17 2020-01-07 中外制药株式会社 具有代替凝血因子viii的功能的功能的多特异性抗原结合分子
KR20140012075A (ko) 2011-01-28 2014-01-29 사노피 Pcsk9에 대한 인간 항체를 포함하는 약제학적 조성물
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
PT3050896T (pt) 2013-09-27 2021-08-24 Chugai Pharmaceutical Co Ltd Processo para a produção de heteromultímeros de polipéptidos
TWI701435B (zh) 2014-09-26 2020-08-11 日商中外製藥股份有限公司 測定fviii的反應性之方法
TWI700300B (zh) 2014-09-26 2020-08-01 日商中外製藥股份有限公司 中和具有第viii凝血因子(fviii)機能替代活性的物質之抗體
WO2016159213A1 (ja) 2015-04-01 2016-10-06 中外製薬株式会社 ポリペプチド異種多量体の製造方法
CN113999312A (zh) 2015-06-24 2022-02-01 豪夫迈·罗氏有限公司 具有定制亲和力的抗转铁蛋白受体抗体
EA201890519A1 (ru) 2015-08-18 2018-07-31 Ридженерон Фармасьютикалз, Инк. Ингибирующие антитела против pcsk9 для лечения пациентов с гиперлипидемией, подвергающихся аферезу липопротеинов
WO2017055542A1 (en) 2015-10-02 2017-04-06 F. Hoffmann-La Roche Ag Bispecific anti-human cd20/human transferrin receptor antibodies and methods of use
AR106189A1 (es) 2015-10-02 2017-12-20 Hoffmann La Roche ANTICUERPOS BIESPECÍFICOS CONTRA EL A-b HUMANO Y EL RECEPTOR DE TRANSFERRINA HUMANO Y MÉTODOS DE USO
US20200270363A1 (en) 2015-12-25 2020-08-27 Chugai Seiyaku Kabushiki Kaisha Antibody having enhanced activity, and method for modifying same
EP3398965A4 (en) 2015-12-28 2019-09-18 Chugai Seiyaku Kabushiki Kaisha METHOD FOR PROMOTING THE EFFICACY OF PURIFYING A POLYPEPTIDE CONTAINING AN FC REGION
TW202402326A (zh) 2016-04-28 2024-01-16 日商中外製藥股份有限公司 含抗體製劑
ES3000618T3 (en) 2016-09-06 2025-03-03 Chugai Pharmaceutical Co Ltd Methods of using a bispecific antibody that recognizes coagulation factor ix and/or activated coagulation factor ix and coagulation factor x and/or activated coagulation factor x
WO2018221244A1 (ja) * 2017-05-30 2018-12-06 森永乳業株式会社 脳機能改善用組成物
RS64289B1 (sr) 2017-08-22 2023-07-31 Biogen Ma Inc Farmaceutske kompozicije koje sadrže anti-amiloid beta antitela
CA3071236A1 (en) 2017-09-29 2019-04-04 Chugai Seiyaku Kabushiki Kaisha Multispecific antigen-binding molecule having blood coagulation factor viii (fviii) cofactor function-substituting activity, and pharmaceutical formulation containing said molecule as active ingredient
EP4175669A1 (en) * 2020-07-03 2023-05-10 CSL Innovation Pty Ltd High concentration formulation of factor xii antigen binding proteins
US20250042984A1 (en) * 2021-12-20 2025-02-06 CSL Innovation Pty Ltd Protein formulations and uses thereof
TW202406572A (zh) * 2022-05-02 2024-02-16 美商再生元醫藥公司 抗介白素-4受體(il-4r)抗體調配物
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Also Published As

Publication number Publication date
ZA201405103B (en) 2015-04-29
EP2822587A1 (en) 2015-01-14
RU2014140137A (ru) 2016-04-27
CA2860543C (en) 2018-04-24
MX2014009662A (es) 2014-09-25
BR112014019667B1 (pt) 2022-11-01
SG11201404481RA (en) 2014-09-26
HUE028440T2 (en) 2016-12-28
HK1200717A1 (en) 2015-08-14
SI2822587T1 (sl) 2016-04-29
ES2564281T3 (es) 2016-03-21
DK2822587T3 (en) 2016-02-29
WO2013131866A1 (en) 2013-09-12
HRP20160434T1 (hr) 2016-05-20
CA2860543A1 (en) 2013-09-12
CN104159613A (zh) 2014-11-19
PL2822587T3 (pl) 2016-07-29
AR122746A2 (es) 2022-10-05
AU2013229613A1 (en) 2014-07-24
KR101666289B1 (ko) 2016-10-13
AR090272A1 (es) 2014-10-29
AU2013229613B2 (en) 2015-07-30
CN104159613B (zh) 2016-11-23
BR112014019667A2 (pt) 2017-06-27
MX351148B (es) 2017-10-04
EP2822587B1 (en) 2016-02-03
JP5859148B2 (ja) 2016-02-10
KR20140120942A (ko) 2014-10-14
IL234120B (en) 2019-03-31
RS54644B1 (en) 2016-08-31
US20150030589A1 (en) 2015-01-29
MY166045A (en) 2018-05-22
JP2015510871A (ja) 2015-04-13
NZ626955A (en) 2016-01-29

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