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MX2008012295A - Formulacion de un anticuerpo monoclonal humano anti-igf-1r. - Google Patents

Formulacion de un anticuerpo monoclonal humano anti-igf-1r.

Info

Publication number
MX2008012295A
MX2008012295A MX2008012295A MX2008012295A MX2008012295A MX 2008012295 A MX2008012295 A MX 2008012295A MX 2008012295 A MX2008012295 A MX 2008012295A MX 2008012295 A MX2008012295 A MX 2008012295A MX 2008012295 A MX2008012295 A MX 2008012295A
Authority
MX
Mexico
Prior art keywords
igf
histidine
polysorbate
humab
nacl
Prior art date
Application number
MX2008012295A
Other languages
English (en)
Spanish (es)
Inventor
Hanns-Christian Mahler
Edelbert Grossmann
Astrid Pappenberger
Oliver Boris Stauch
Jan Olaf Stracke
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of MX2008012295A publication Critical patent/MX2008012295A/es

Links

Classifications

    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
MX2008012295A 2006-03-28 2007-03-19 Formulacion de un anticuerpo monoclonal humano anti-igf-1r. MX2008012295A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06111848 2006-03-28
PCT/EP2007/052569 WO2007110339A1 (en) 2006-03-28 2007-03-19 Anti-igf-1r human monoclonal antibody formulation

Publications (1)

Publication Number Publication Date
MX2008012295A true MX2008012295A (es) 2008-10-09

Family

ID=37025222

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2008012295A MX2008012295A (es) 2006-03-28 2007-03-19 Formulacion de un anticuerpo monoclonal humano anti-igf-1r.

Country Status (18)

Country Link
EP (1) EP1998806A1 (ru)
JP (1) JP2009531371A (ru)
KR (1) KR20080104160A (ru)
CN (1) CN101410137A (ru)
AR (1) AR060130A1 (ru)
AU (1) AU2007229554A1 (ru)
BR (1) BRPI0709229A2 (ru)
CA (1) CA2647111A1 (ru)
CL (1) CL2007000797A1 (ru)
CR (1) CR10295A (ru)
EC (1) ECSP088778A (ru)
IL (1) IL193904A0 (ru)
MA (1) MA30345B1 (ru)
MX (1) MX2008012295A (ru)
NO (1) NO20083895L (ru)
RU (1) RU2008142359A (ru)
TW (1) TW200815029A (ru)
WO (1) WO2007110339A1 (ru)

Families Citing this family (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2671968A1 (en) * 2006-12-11 2008-06-19 F. Hoffmann-La Roche Ag Abeta antibody parenteral formulation
GB0702888D0 (en) * 2007-02-14 2007-03-28 Glaxo Group Ltd Novel Antibodies
MX2009010179A (es) * 2007-03-22 2010-03-15 Imclone Llc Formulaciones estables de anticuerpo.
CN101687038A (zh) * 2007-07-10 2010-03-31 霍夫曼-拉罗奇有限公司 新型制剂
US20100249384A1 (en) * 2007-11-29 2010-09-30 Stefan Hepbildikler Immunoglobulin aggregates
NZ585516A (en) * 2007-12-21 2012-07-27 Hoffmann La Roche Anti-cd20 antibody formulation
WO2010069858A1 (en) * 2008-12-19 2010-06-24 F. Hoffmann-La Roche Ag Pharmaceutical composition
WO2010146059A2 (en) 2009-06-16 2010-12-23 F. Hoffmann-La Roche Ag Biomarkers for igf-1r inhibitor therapy
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.
EP2519262A2 (en) * 2009-12-29 2012-11-07 F. Hoffmann-La Roche AG Antibody formulation
US20130136733A1 (en) * 2010-05-28 2013-05-30 Novo Nordisk A/S Stable Multi-Dose Compositions Comprising an Antibody and a Preservative
KR102031020B1 (ko) 2011-03-31 2019-10-14 머크 샤프 앤드 돔 코포레이션 인간 프로그램화된 사멸 수용체 pd-1에 대한 항체의 안정한 제제 및 관련된 치료
CN102363040B (zh) * 2011-10-21 2013-05-01 北京锐瑟科技有限公司 用于粘膜组织的抗微生物肽制剂
US20160068613A1 (en) 2013-04-29 2016-03-10 Hoffmann-La Roche Inc. Fc-receptor binding modified asymmetric antibodies and methods of use
KR20210094669A (ko) 2013-04-29 2021-07-29 에프. 호프만-라 로슈 아게 인간 fcrn-결합 변형된 항체 및 사용 방법
CN103505729B (zh) * 2013-05-24 2015-10-28 华北制药集团新药研究开发有限责任公司 一种稳定的狂犬病毒人源抗体组合制剂
CN104707146B (zh) * 2013-12-16 2019-04-16 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
MX380658B (es) 2014-01-15 2025-03-11 Hoffmann La Roche Variantes de region fc con union mejorada de la proteina a.
JP6707469B2 (ja) * 2014-05-28 2020-06-10 ノノ インコーポレイテッド アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤
TW201628649A (zh) 2014-10-09 2016-08-16 再生元醫藥公司 減少醫藥調配物中微可見顆粒之方法
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
IL302486A (en) 2015-06-24 2023-06-01 Hoffmann La Roche Antibodies against the transnephrine receptor with adapted affinity
RU2731418C2 (ru) * 2015-09-28 2020-09-02 Сучжоу Санкадия Биофармасьютикалз Ко., Лтд. Стабильный фармацевтический препарат на основе антитела к pd-1 и его применение в медицине
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
CN114057885A (zh) 2015-10-02 2022-02-18 豪夫迈·罗氏有限公司 双特异性抗人cd20/人转铁蛋白受体抗体及使用方法
CN106199007B (zh) * 2016-08-03 2017-04-05 烟台普罗吉生物科技发展有限公司 蛋白保护剂
SG11201900201YA (en) 2016-08-16 2019-02-27 Regeneron Pharma Methods for quantitating individual antibodies from a mixture
AU2017350807B2 (en) 2016-10-25 2022-07-07 Regeneron Pharmaceuticals, Inc. Methods and systems for chromatography data analysis
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
WO2018204374A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
CN118416215A (zh) 2017-09-19 2024-08-02 里珍纳龙药品有限公司 减少粒子形成的方法以及由其形成的组合物
TWI853823B (zh) 2018-07-02 2024-09-01 美商里珍納龍藥品有限公司 自混合物製備多肽之系統及方法
KR20210089215A (ko) 2018-11-07 2021-07-15 머크 샤프 앤드 돔 코포레이션 항-lag3 항체 및 항-pd-1 항체의 공동-제제
CN114324882B (zh) * 2020-10-12 2022-12-27 广东菲鹏生物有限公司 蛋白稳定剂及其应用

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3919235B2 (ja) * 1997-06-13 2007-05-23 ジェネンテク,インコーポレイテッド 抗体製剤
UY27087A1 (es) * 2001-01-05 2002-06-20 Pfizer Anticuerpos contra el receptor del factor de crecimiento similar a insulina
CA2454587C (en) * 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
JP4473257B2 (ja) * 2003-04-02 2010-06-02 エフ.ホフマン−ラ ロシュ アーゲー インスリン様成長因子i受容体に対する抗体及びその使用
DK2335725T3 (en) * 2003-04-04 2017-01-23 Genentech Inc Highly concentrated antibody and protein formulations
US7579157B2 (en) * 2003-07-10 2009-08-25 Hoffmann-La Roche Inc. Antibody selection method against IGF-IR
ES2351395T3 (es) * 2003-08-13 2011-02-04 Pfizer Products Inc. Anticuerpos humanos modificados anti-igf-1r.

Also Published As

Publication number Publication date
NO20083895L (no) 2008-10-24
IL193904A0 (en) 2011-08-01
CN101410137A (zh) 2009-04-15
CR10295A (es) 2008-10-06
AU2007229554A1 (en) 2007-10-04
AR060130A1 (es) 2008-05-28
MA30345B1 (fr) 2009-04-01
EP1998806A1 (en) 2008-12-10
JP2009531371A (ja) 2009-09-03
RU2008142359A (ru) 2010-05-10
BRPI0709229A2 (pt) 2011-06-28
WO2007110339A1 (en) 2007-10-04
CL2007000797A1 (es) 2008-01-25
KR20080104160A (ko) 2008-12-01
ECSP088778A (es) 2008-10-31
TW200815029A (en) 2008-04-01
CA2647111A1 (en) 2007-10-04

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