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

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    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • A61P37/02—Immunomodulators
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Rheumatology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Obesity (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Endocrinology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Transplantation (AREA)
  • Microbiology (AREA)
  • Mycology (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 (18)

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)
HK (1) HK1164750A1 (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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LT2348051T (lt) 2003-11-05 2019-02-25 Roche Glycart Ag Cd20 antikūnai su padidintu fc receptoriaus prisijungimo giminingumu ir efektorine funkcija
TW201014605A (en) 2008-09-16 2010-04-16 Genentech Inc Methods for treating progressive multiple sclerosis
HUE029849T2 (en) 2014-05-23 2017-04-28 Ares Trading Sa Liquid pharmaceutical composition
ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
EP3149045B1 (en) * 2014-05-27 2023-01-18 Academia Sinica Compositions and methods relating to universal glycoforms for enhanced antibody efficacy
EP3053572A1 (en) * 2015-02-06 2016-08-10 Ares Trading S.A. Liquid pharmaceutical composition
WO2016179003A1 (en) * 2015-05-01 2016-11-10 Genentech, Inc. Masked anti-cd3 antibodies and methods of use
US11466094B2 (en) 2016-11-15 2022-10-11 Genentech, Inc. Dosing for treatment with anti-CD20/anti-CD3 bispecific antibodies
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
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
JP2022523510A (ja) 2019-01-31 2022-04-25 エレクトロフィ，インコーポレイテッド 粒子形成及び形態構造
CN113474360A (zh) 2019-02-18 2021-10-01 伊莱利利公司 治疗性抗体制剂
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
CN116370408A (zh) * 2020-06-17 2023-07-04 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
AR129061A1 (es) 2022-04-13 2024-07-10 Genentech Inc Composiciones farmacéuticas de mosunetuzumab y métodos de uso

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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
US7829084B2 (en) * 2001-01-17 2010-11-09 Trubion Pharmaceuticals, Inc. Binding constructs and methods for use thereof
EP2301966A1 (en) * 2002-12-16 2011-03-30 Genentech, Inc. Immunoglobulin variants and uses thereof
JP2006522811A (ja) * 2003-04-09 2006-10-05 ジェネンテック・インコーポレーテッド ＴＮＦαインヒビターに対して不十分な反応を示す患者の自己免疫疾患治療法
KR20070057839A (ko) * 2004-08-19 2007-06-07 제넨테크, 인크. 변경된 이펙터 기능을 갖는 폴리펩티드 변이체
WO2006083761A2 (en) * 2005-02-03 2006-08-10 Alza Corporation Solvent/polymer solutions as suspension vehicles
DOP2006000029A (es) * 2005-02-07 2006-08-15 Genentech Inc Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas)
KR20100044160A (ko) * 2007-06-12 2010-04-29 와이어쓰 엘엘씨 항-ｃｄ20 치료 조성물 및 방법

Also Published As

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

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