CO6251275A2 - Formulaciones de inmunoglobulina liofilizadas y metodos para su preparacion - Google Patents

Formulaciones de inmunoglobulina liofilizadas y metodos para su preparacion

Info

Publication number
CO6251275A2
CO6251275A2 CO09147977A CO09147977A CO6251275A2 CO 6251275 A2 CO6251275 A2 CO 6251275A2 CO 09147977 A CO09147977 A CO 09147977A CO 09147977 A CO09147977 A CO 09147977A CO 6251275 A2 CO6251275 A2 CO 6251275A2
Authority
CO
Colombia
Prior art keywords
formulation
stable
stable lyophilized
natalizumab
lyophilized formulation
Prior art date
Application number
CO09147977A
Other languages
English (en)
Inventor
Barbara Horsey Oconner
Shuan E Buckey
David J Burke
Sherwood Russell Lehrman
Original Assignee
Elan Pharm Inc
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 Elan Pharm Inc filed Critical Elan Pharm Inc
Publication of CO6251275A2 publication Critical patent/CO6251275A2/es

Links

Classifications

    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • C07K16/2839—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 integrin superfamily
    • 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
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

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

Abstract

La presente invención se refiere en general al cambio de la formulación farmacéutica de inmunoglobulinas. Específicamente, la presente invención se refiere a formulaciones de inmunoglobulina estables, liofilizadas y de alta concentración. Esta invención se ejemplifica con una formulación liofilizada estabilizada del anticuerpo contra la integrina alfa 4 humanizado recombinante natalizumab. 1.- Una formulación liofilizada estable elaborada liofilizando una formulación acuosa, donde la formulación acuosa comprende: entre aproximadamente 20 mg/ml y aproximadamente 80 mg/ml de natalizumab.un búfer con un pH de aproximadamente 5,5 a aproximadamente 6,5; (c) entre aproximadamente 20 mg/ml yaproximadamente 80 mg/ml de sacarosa; y (d) entre aproximadamente 0,02 y aproximadamente0,08% de polisorbato. 2.- La formulación liofilizada estable de la reivindicación 1, donde dicha formulación acuosa comprende entre aproximadamente 30 mg/ml y aproximadamente 80 mg/ml de natalizumab. 3.- La formulación liofilizada estable de la reivindicación 2, donde dicha formulación acuosa comprende aproximadamente 40 mg/ml de natalizumab. 4.- La formulación liofilizada estable de la reivindicación 1, donde dicho búfer tiene un pH de aproximadamente 6,0. 5.- La formulación liofilizada estable de la reivindicación 1, donde dicho búfer es histidina. 6.- La formulación liofilizada estable de la reivindicación 5, donde dicha histidina está presente en dicha formulación acuosa en una concentración de aproximadamente 1 mM a aproximadamente 12 mM. 7.- La formulación liofilizada estable de la reivindicación 6, donde dicha histidina está presente en dicha formulación acuosa en una concentración de aproximadamente 6 mM.
CO09147977A 2007-06-14 2009-12-28 Formulaciones de inmunoglobulina liofilizadas y metodos para su preparacion CO6251275A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US92913307P 2007-06-14 2007-06-14
US12/138,075 US20090208492A1 (en) 2007-06-14 2008-06-12 Lyophilized Immunoglobulin Formulations and Methods of Preparation

Publications (1)

Publication Number Publication Date
CO6251275A2 true CO6251275A2 (es) 2011-02-21

Family

ID=40156638

Family Applications (1)

Application Number Title Priority Date Filing Date
CO09147977A CO6251275A2 (es) 2007-06-14 2009-12-28 Formulaciones de inmunoglobulina liofilizadas y metodos para su preparacion

Country Status (15)

Country Link
US (1) US20090208492A1 (es)
EP (1) EP2167126A4 (es)
JP (1) JP2010530003A (es)
KR (1) KR20100038100A (es)
CN (1) CN101827608A (es)
AU (1) AU2008265930A1 (es)
BR (1) BRPI0812561A2 (es)
CA (1) CA2691855A1 (es)
CO (1) CO6251275A2 (es)
EA (1) EA201000018A1 (es)
EC (1) ECSP099837A (es)
IL (1) IL202660A0 (es)
MA (1) MA31519B1 (es)
MX (1) MX2009013558A (es)
WO (1) WO2008157409A1 (es)

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EP2397034A1 (en) 2005-07-14 2011-12-21 Lithera, Inc. Sustained Release Enhanced Lipolytic Formulation for Regional Adipose Tissue Treatment
PL2993186T3 (pl) 2008-03-14 2020-02-28 Biocon Limited Przeciwciało monoklonalne i sposób jego otrzymywania
US9132084B2 (en) 2009-05-27 2015-09-15 Neothetics, Inc. Methods for administration and formulations for the treatment of regional adipose tissue
KR20120027031A (ko) * 2009-06-18 2012-03-20 와이어쓰 엘엘씨 소형 모듈 면역제약용 동결건조 제제
PL3721904T3 (pl) * 2009-11-20 2022-01-31 Biocon Limited Formulacje przeciwciała t1h
US20110224176A1 (en) * 2010-01-15 2011-09-15 Lithera, Inc. Lyophilized Cake Formulations
BR112012021576A2 (pt) 2010-02-26 2016-10-25 Novo Nordisk As composições estáveis contendo anticorpo.
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
WO2011147921A1 (en) 2010-05-28 2011-12-01 Novo Nordisk A/S Stable multi-dose compositions comprising an antibody and a preservative
PT2616090T (pt) * 2010-09-17 2023-10-16 Takeda Pharmaceuticals Co Estabilização de imunoglobulinas através de formulação aquosa com histidina em ph fracamente ácido a neutro
EA201270784A1 (ru) 2010-11-24 2013-04-30 ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "НоваМедика" Монотерапевтические композиции селективного липофильного и бета-агониста длительного действия и способы косметического лечения ожирения и контурного выпячивания
LT2691112T (lt) * 2011-03-31 2018-07-25 Merck Sharp & Dohme Corp. Stabilios antikūnų kompozicijos prieš žmogaus programuojamos mirties receptorių pd-1 ir susiję gydymo būdai
CA2868401C (en) * 2012-03-26 2021-08-24 Sanofi Stable anti-cxcr5 igg4 antibody formulations
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
UA117466C2 (uk) * 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
CN105189559B (zh) 2013-03-15 2021-07-13 塔科达有限责任公司 抗体制剂及其用途
EP3024485B1 (en) 2013-07-23 2020-11-18 Biocon Limited Use of a cd6 binding partner and method based thereon
WO2017015198A1 (en) * 2015-07-17 2017-01-26 Coherus Biosciences, Inc. Stable aqeous formulations of natalizumab
JP7020913B2 (ja) 2015-09-07 2022-02-16 持田製薬株式会社 アルギン酸凍結乾燥製剤
WO2018068012A1 (en) 2016-10-07 2018-04-12 Regeneron Pharmaceuticals, Inc. Room temperature stable lyophilized protein
DK3529274T3 (da) 2016-10-21 2024-06-17 Biocon Ltd Monoklonalt antistof og fremgangsmåde til anvendelse til behandling af lupus
EP3618871A4 (en) 2017-05-02 2021-01-06 Merck Sharp & Dohme Corp. ANTI-LAG3 ANTIBODIES ETCO-FORMULATIONS ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
WO2019198100A1 (en) * 2018-04-10 2019-10-17 Dr. Reddy's Laboratories Limited Antibody formulation
US12024561B2 (en) * 2018-04-10 2024-07-02 Dr. Reddy's Laboratories Limited Stable antibody formulation
US20210401982A1 (en) * 2018-04-10 2021-12-30 Dr. Reddy's Laboratories Limited Stable formulations of therapeutic antibody
JP2022532965A (ja) * 2018-11-21 2022-07-21 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 高濃度タンパク質製剤
WO2020172002A1 (en) 2019-02-18 2020-08-27 Eli Lilly And Company Therapeutic antibody formulation
CN112538111B (zh) * 2020-12-09 2022-04-29 深圳市亚辉龙生物科技股份有限公司 新冠病毒单链抗体及质控品和制备方法

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ES2338218T3 (es) * 2001-07-25 2010-05-05 Facet Biotech Corporation Formulacion farmacologica liofilizada estable de anticuerpos igg daclizumab.
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Also Published As

Publication number Publication date
JP2010530003A (ja) 2010-09-02
IL202660A0 (en) 2011-08-01
EA201000018A1 (ru) 2010-06-30
ECSP099837A (es) 2010-01-29
EP2167126A1 (en) 2010-03-31
BRPI0812561A2 (pt) 2014-10-29
AU2008265930A1 (en) 2008-12-24
MA31519B1 (fr) 2010-07-01
US20090208492A1 (en) 2009-08-20
CN101827608A (zh) 2010-09-08
KR20100038100A (ko) 2010-04-12
EP2167126A4 (en) 2012-03-07
WO2008157409A1 (en) 2008-12-24
MX2009013558A (es) 2010-03-08
WO2008157409A8 (en) 2010-03-11
CA2691855A1 (en) 2008-12-24

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