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PE20120204A1 - Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas - Google Patents

Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas

Info

Publication number
PE20120204A1
PE20120204A1 PE2011001039A PE2011001039A PE20120204A1 PE 20120204 A1 PE20120204 A1 PE 20120204A1 PE 2011001039 A PE2011001039 A PE 2011001039A PE 2011001039 A PE2011001039 A PE 2011001039A PE 20120204 A1 PE20120204 A1 PE 20120204A1
Authority
PE
Peru
Prior art keywords
formulation
macromolecle
aggregation
reduce
physiological conditions
Prior art date
Application number
PE2011001039A
Other languages
English (en)
Inventor
Brian Lobo
Sabrina Lo
Aditya Wakankar
Yuchang John Wang
Rita L Wong
Pierre Goldbach
Hanns-Christian Mahler
Original Assignee
Genentech Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42170394&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20120204(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech Inc, Hoffmann La Roche filed Critical Genentech Inc
Publication of PE20120204A1 publication Critical patent/PE20120204A1/es

Links

Classifications

    • 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
    • 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
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Obesity (AREA)
  • Mycology (AREA)
  • Transplantation (AREA)
  • Oncology (AREA)

Abstract

REFERIDA A UNA FORMULACION QUE COMPRENDE: A) UNA MACROMOLECULA TAL COMO ANTICUERPO ANTI-CD20, DONDE EL ANTICUERPO COMPRENDE LA SECUENCIA DE AMINOACIDOS SELECCIONADA DEL GRUPO FORMADO POR SEC ID NO:1-15 Y ESTA PRESENTE EN LA FORMULACION EN UN RANGO DE CONCENTRACION DE 30-150 mg/mL; B) DE 5-20% DE POLIVINILPIRROLIDONA (PVP) QUE TIENE UN RANGO DE PESO MOLECULAR DE 2000-54000 DALTONS; C) 30mM DE ACETATO DE SODIO, 5% DE DIHIDRATO DE TREHALOSA Y 0,03% DE POLISORBATO 20, A pH 5.3. DICHA FORMULACION ES UTIL PARA REDUCIR AL MINIMO LA INFLAMACION EN EL SITIO DE INYECCION DURANTE LA ADMINISTRACION DEL ANTICUERPO
PE2011001039A 2008-11-17 2009-11-16 Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas PE20120204A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11543908P 2008-11-17 2008-11-17

Publications (1)

Publication Number Publication Date
PE20120204A1 true PE20120204A1 (es) 2012-03-03

Family

ID=42170394

Family Applications (2)

Application Number Title Priority Date Filing Date
PE2011001039A PE20120204A1 (es) 2008-11-17 2009-11-16 Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas
PE2014001174A PE20142332A1 (es) 2008-11-17 2009-11-16 Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas

Family Applications After (1)

Application Number Title Priority Date Filing Date
PE2014001174A PE20142332A1 (es) 2008-11-17 2009-11-16 Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas

Country Status (17)

Country Link
US (2) US20110300135A1 (es)
EP (1) EP2358394A4 (es)
JP (2) JP2012509270A (es)
KR (2) KR20110097772A (es)
CN (2) CN103705930A (es)
AR (1) AR074196A1 (es)
AU (1) AU2009313756B2 (es)
BR (1) BRPI0916042A2 (es)
CA (1) CA2742990A1 (es)
CL (1) CL2011001131A1 (es)
IL (1) IL212532A0 (es)
MX (1) MX2011005056A (es)
PE (2) PE20120204A1 (es)
RU (1) RU2011124527A (es)
TW (1) TW201021831A (es)
WO (1) WO2010057109A1 (es)
ZA (1) ZA201102998B (es)

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DE602004026470D1 (de) 2003-11-05 2010-05-20 Roche Glycart Ag Fc-rezeptor und effektorfunktion
TW201438738A (zh) 2008-09-16 2014-10-16 Genentech Inc 治療進展型多發性硬化症之方法
SI2946765T1 (sl) 2014-05-23 2016-11-30 Ares Trading S.A. Tekoči farmacevtski sestavek
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
KR20170005142A (ko) * 2014-05-27 2017-01-11 아카데미아 시니카 증진된 항체 효능을 위한 범용 당형태에 관한 조성물 및 방법
EP3053572A1 (en) * 2015-02-06 2016-08-10 Ares Trading S.A. Liquid pharmaceutical composition
HK1252158A1 (zh) * 2015-05-01 2019-05-17 Genentech, Inc. 掩蔽抗cd3抗體和使用方法
TWI791471B (zh) 2016-11-15 2023-02-11 美商建南德克公司 用於用抗cd20/抗cd3雙特異性抗體進行治療之給藥
AU2017364077A1 (en) 2016-11-22 2019-06-20 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
BR112019022873A8 (pt) 2017-05-02 2023-04-11 Merck Sharp & Dohme Formulação, e, vaso ou dispositivo de injeção.
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
US11077059B2 (en) 2017-07-25 2021-08-03 Elektrofi, Inc. Electrospraying formation of particles including agents
US12115262B2 (en) 2018-05-24 2024-10-15 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
JP7503056B6 (ja) 2018-11-07 2024-07-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗lag3抗体および抗pd-1抗体の共-製剤
WO2020160323A2 (en) 2019-01-31 2020-08-06 Elektrofi, Inc. Particle formation and morphology
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
WO2020264313A1 (en) * 2019-06-28 2020-12-30 Zymo Research Corporation Compositions for the stabilization of cell-free nucleic acids and methods thereof
EP4027978A1 (en) 2019-09-13 2022-07-20 Elektrofi, Inc. Compositions and methods for the delivery of therapeutic biologics for treatment of disease
JP2023522627A (ja) 2020-04-17 2023-05-31 エレクトロフィ,インコーポレイテッド 連続的な液滴形成及び脱水によって粒子を形成する方法
CN113797162B (zh) * 2020-06-17 2023-05-05 成都瑞沐生物医药科技有限公司 一种滴眼给药治疗黄斑水肿、视神经炎和非感染性眼内炎的眼用制剂
US12351643B2 (en) 2020-11-04 2025-07-08 Genentech, Inc. Dosing for treatment with anti-CD20/anti-CD3 bispecific antibodies
WO2022241235A1 (en) 2021-05-14 2022-11-17 Genentech, Inc. Methods for treatment of cd20-positive proliferative disorder with mosunetuzumab and polatuzumab vedotin
TW202519266A (zh) 2022-04-13 2025-05-16 美商建南德克公司 莫蘇妥珠單抗之醫藥組成物及其使用方法

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AU1234383A (en) * 1982-03-17 1983-09-22 Inter-Yeda Ltd. Interferon stabilised with polyvinyl-pyrrolidone
US5961955A (en) * 1997-06-03 1999-10-05 Coulter Pharmaceutical, Inc. Radioprotectant for peptides labeled with radioisotope
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JP2010531137A (ja) * 2007-06-12 2010-09-24 ワイス・エルエルシー 抗cd20治療用組成物および方法

Also Published As

Publication number Publication date
JP2012509270A (ja) 2012-04-19
CL2011001131A1 (es) 2012-02-03
CN102281902A (zh) 2011-12-14
EP2358394A1 (en) 2011-08-24
IL212532A0 (en) 2011-06-30
PE20142332A1 (es) 2015-01-29
CA2742990A1 (en) 2010-05-20
CN103705930A (zh) 2014-04-09
KR20140133588A (ko) 2014-11-19
EP2358394A4 (en) 2013-03-06
KR20110097772A (ko) 2011-08-31
AU2009313756A1 (en) 2010-05-20
AR074196A1 (es) 2010-12-29
WO2010057109A1 (en) 2010-05-20
CN102281902B (zh) 2013-11-13
HK1164750A1 (en) 2012-09-28
US20110300135A1 (en) 2011-12-08
MX2011005056A (es) 2011-05-31
TW201021831A (en) 2010-06-16
BRPI0916042A2 (pt) 2015-11-10
JP2015157820A (ja) 2015-09-03
US20140308270A1 (en) 2014-10-16
ZA201102998B (en) 2013-06-26
AU2009313756B2 (en) 2015-02-26
RU2011124527A (ru) 2012-12-27

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