CA2769221A1 - Concentrated polypeptide formulations with reduced viscosity - Google Patents

Concentrated polypeptide formulations with reduced viscosity Download PDF

Info

Publication number
CA2769221A1
CA2769221A1 CA2769221A CA2769221A CA2769221A1 CA 2769221 A1 CA2769221 A1 CA 2769221A1 CA 2769221 A CA2769221 A CA 2769221A CA 2769221 A CA2769221 A CA 2769221A CA 2769221 A1 CA2769221 A1 CA 2769221A1
Authority
CA
Canada
Prior art keywords
formulation
polypeptide
antibody
dmso
dma
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
CA2769221A
Other languages
English (en)
French (fr)
Inventor
Tim Kamerzell
Sheryl Martin-Moe
Yuchang John Wang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Genentech Inc
Original Assignee
Genentech 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 Genentech Inc filed Critical Genentech Inc
Publication of CA2769221A1 publication Critical patent/CA2769221A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/08—Solutions
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/249—Interferons
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins 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)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CA2769221A 2009-08-04 2010-08-03 Concentrated polypeptide formulations with reduced viscosity Abandoned CA2769221A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US23114009P 2009-08-04 2009-08-04
US61/231,140 2009-08-04
PCT/US2010/044258 WO2011017330A1 (en) 2009-08-04 2010-08-03 Concentrated polypeptide formulations with reduced viscosity

Publications (1)

Publication Number Publication Date
CA2769221A1 true CA2769221A1 (en) 2011-02-10

Family

ID=43544629

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2769221A Abandoned CA2769221A1 (en) 2009-08-04 2010-08-03 Concentrated polypeptide formulations with reduced viscosity

Country Status (15)

Country Link
US (1) US20130236448A1 (cg-RX-API-DMAC10.html)
EP (1) EP2461677A4 (cg-RX-API-DMAC10.html)
JP (1) JP2013501058A (cg-RX-API-DMAC10.html)
KR (1) KR20120047995A (cg-RX-API-DMAC10.html)
CN (1) CN102573459A (cg-RX-API-DMAC10.html)
AU (1) AU2010279569A1 (cg-RX-API-DMAC10.html)
BR (1) BR112012002596A2 (cg-RX-API-DMAC10.html)
CA (1) CA2769221A1 (cg-RX-API-DMAC10.html)
IL (1) IL217887A0 (cg-RX-API-DMAC10.html)
MX (1) MX2012001560A (cg-RX-API-DMAC10.html)
NZ (1) NZ598518A (cg-RX-API-DMAC10.html)
RU (1) RU2012108108A (cg-RX-API-DMAC10.html)
SG (1) SG178226A1 (cg-RX-API-DMAC10.html)
WO (1) WO2011017330A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA201200760B (cg-RX-API-DMAC10.html)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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.
CN107837395A (zh) 2011-02-09 2018-03-27 葛兰素史密斯克莱有限责任公司 冻干制剂
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
IL312865B2 (en) * 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
CN111402950B (zh) * 2013-11-29 2024-03-19 豪夫迈·罗氏有限公司 抗体选择装置和方法
WO2016019969A1 (en) 2014-08-08 2016-02-11 Ludwig-Maximilians-Universität München Subcutaneously administered bispecific antibodies for use in the treatment of cancer
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
IL307684B2 (en) 2016-09-29 2025-04-01 Amgen Inc Low viscosity antigen binding proteins and methods for preparing them
RS67656B1 (sr) 2018-05-10 2026-02-27 Regeneron Pharma Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR013202A1 (es) * 1997-07-10 2000-12-13 Biotech Australia Pty Ltd Vacunas no acuosas
DE60139944D1 (de) * 2000-10-12 2009-10-29 Genentech Inc Niederviskose konzentrierte proteinformulierungen
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
AU2003251592A1 (en) * 2002-06-21 2004-01-06 Biogen Idec Inc. Buffered formulations for concentrating antibodies and methods of use thereof
US20050158303A1 (en) * 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
GB0412530D0 (en) * 2004-06-04 2004-07-07 Camurus Ab Formulation
PL1768650T3 (pl) * 2004-06-04 2009-01-30 Camurus Ab Ciekłe formulacje depot
CA2560007A1 (en) * 2004-06-14 2005-12-22 Usv Limited Process for the preparation of peptides
EP1909824B1 (en) * 2005-04-08 2011-05-18 Amylin Pharmaceuticals, Inc. Pharmaceutical formulations comprising incretin peptide and aprotic polar solvent
JP5405122B2 (ja) * 2005-12-21 2014-02-05 ワイス・エルエルシー 低粘度のタンパク質製剤およびその用途

Also Published As

Publication number Publication date
WO2011017330A1 (en) 2011-02-10
AU2010279569A1 (en) 2012-03-01
IL217887A0 (en) 2012-03-29
EP2461677A1 (en) 2012-06-13
CN102573459A (zh) 2012-07-11
NZ598518A (en) 2014-12-24
WO2011017330A8 (en) 2011-04-21
US20130236448A1 (en) 2013-09-12
JP2013501058A (ja) 2013-01-10
SG178226A1 (en) 2012-03-29
RU2012108108A (ru) 2013-09-10
MX2012001560A (es) 2012-06-01
EP2461677A4 (en) 2014-01-08
BR112012002596A2 (pt) 2015-09-15
KR20120047995A (ko) 2012-05-14
ZA201200760B (en) 2013-05-29

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Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20160803