AU2012240050B2 - Formulations with reduced viscosity - Google Patents

Formulations with reduced viscosity Download PDF

Info

Publication number
AU2012240050B2
AU2012240050B2 AU2012240050A AU2012240050A AU2012240050B2 AU 2012240050 B2 AU2012240050 B2 AU 2012240050B2 AU 2012240050 A AU2012240050 A AU 2012240050A AU 2012240050 A AU2012240050 A AU 2012240050A AU 2012240050 B2 AU2012240050 B2 AU 2012240050B2
Authority
AU
Australia
Prior art keywords
formulation
viscosity
less
concentration
proline
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.)
Ceased
Application number
AU2012240050A
Other languages
English (en)
Other versions
AU2012240050A1 (en
Inventor
Myrna A. Monck
Man Yi Wong
Kai Zhang
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.)
GlaxoSmithKline LLC
Original Assignee
GlaxoSmithKline LLC
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 GlaxoSmithKline LLC filed Critical GlaxoSmithKline LLC
Publication of AU2012240050A1 publication Critical patent/AU2012240050A1/en
Application granted granted Critical
Publication of AU2012240050B2 publication Critical patent/AU2012240050B2/en
Priority to AU2016202355A priority Critical patent/AU2016202355A1/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • 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
    • 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
    • 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
    • C07K16/244—Interleukins [IL]
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
AU2012240050A 2011-04-07 2012-04-06 Formulations with reduced viscosity Ceased AU2012240050B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2016202355A AU2016202355A1 (en) 2011-04-07 2016-04-14 Formulations with reduced viscosity

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161473121P 2011-04-07 2011-04-07
US61/473,121 2011-04-07
PCT/US2012/032462 WO2012138958A1 (en) 2011-04-07 2012-04-06 Formulations with reduced viscosity

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2016202355A Division AU2016202355A1 (en) 2011-04-07 2016-04-14 Formulations with reduced viscosity

Publications (2)

Publication Number Publication Date
AU2012240050A1 AU2012240050A1 (en) 2013-10-17
AU2012240050B2 true AU2012240050B2 (en) 2016-01-21

Family

ID=46969561

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2012240050A Ceased AU2012240050B2 (en) 2011-04-07 2012-04-06 Formulations with reduced viscosity
AU2016202355A Abandoned AU2016202355A1 (en) 2011-04-07 2016-04-14 Formulations with reduced viscosity

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2016202355A Abandoned AU2016202355A1 (en) 2011-04-07 2016-04-14 Formulations with reduced viscosity

Country Status (12)

Country Link
US (1) US20140023655A1 (enExample)
EP (2) EP2694100A4 (enExample)
JP (1) JP2014516924A (enExample)
KR (1) KR20140018966A (enExample)
CN (1) CN103596585A (enExample)
AU (2) AU2012240050B2 (enExample)
BR (1) BR112013025866A2 (enExample)
CA (1) CA2832556A1 (enExample)
EA (1) EA201391488A1 (enExample)
IL (1) IL228591A0 (enExample)
SG (1) SG193963A1 (enExample)
WO (1) WO2012138958A1 (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI2523688T1 (en) * 2010-01-15 2018-03-30 Kirin-Amgen, Inc. Formulation of antibodies and therapeutic regimes
AU2012328524B2 (en) * 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
WO2014141149A1 (en) * 2013-03-15 2014-09-18 Glaxosmithkline Intellectual Property (No.2) Limited Formulations with reduced viscosity
WO2014169153A1 (en) * 2013-04-10 2014-10-16 Echogen, Inc. Peptide complexes and therapeutic uses
JP6179939B2 (ja) * 2013-07-09 2017-08-16 国立大学法人 筑波大学 高濃度γグロブリン製剤の粘度低下方法
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
EP3256147B8 (en) * 2015-01-18 2020-10-21 Gloriana Therapeutics, Inc. Therapeutic protein formulations
ES3053874T3 (en) * 2015-08-24 2026-01-27 Glaxosmithkline Ip No 2 Ltd Biopharmaceutical compositions
US11603407B2 (en) * 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
US10646569B2 (en) 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
JP7641908B2 (ja) 2019-03-29 2025-03-07 ジエンス ヘンルイ メデイシンカンパニー リミテッド Ｉｌ－５に対する抗体を含有する医薬組成物及びその使用
CA3187322A1 (en) * 2020-07-13 2022-01-20 Merck Patent Gmbh Viscosity reducing excipients and combinations thereof for highly concentrated protein formulations
KR20230167968A (ko) * 2022-06-03 2023-12-12 주식회사 녹십자홀딩스 점도 감소 부형제 조성물 및 이를 포함하는 저점도 고농축 단백질 제형

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5747447A (en) * 1992-04-30 1998-05-05 Cor Therapeutics Stable polypeptide composition
US20080160014A1 (en) * 2005-12-21 2008-07-03 Wyeth Protein Formulations With Reduced Viscosity and Uses Thereof
WO2011095543A1 (en) * 2010-02-04 2011-08-11 Csl Behring Ag Immunoglobulin preparation

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS57106673A (en) 1980-12-24 1982-07-02 Chugai Pharmaceut Co Ltd Dibenzo(b,f)(1,4)oxazepin derivative
GB8607679D0 (en) 1986-03-27 1986-04-30 Winter G P Recombinant dna product
IL127127A0 (en) 1998-11-18 1999-09-22 Peptor Ltd Small functional units of antibody heavy chain variable regions
DE60139944D1 (de) * 2000-10-12 2009-10-29 Genentech Inc Niederviskose konzentrierte proteinformulierungen
AU2002319544B2 (en) 2001-08-10 2008-07-10 Aberdeen University Antigen binding domains from fish
CA2503871C (en) * 2002-11-01 2012-12-11 Glaxosmithkline Biologicals S.A. An immunogenic composition for generating an immune response against polio virus
WO2004060343A1 (en) * 2002-12-31 2004-07-22 Nektar Therapeutics Antibody-containing particles and compositions
PT1610820E (pt) * 2003-04-04 2010-12-16 Novartis Ag Formulações de elevada concentração de anticorpos e proteínas
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
JP5231810B2 (ja) * 2005-12-28 2013-07-10 中外製薬株式会社 抗体含有安定化製剤
EP2129401B8 (en) * 2006-12-21 2020-01-15 Amgen Inc. Stable buffered formulations containing polypeptides
AU2008304111B2 (en) * 2007-09-27 2014-04-24 Amgen Inc. Pharmaceutical formulations
TW200944231A (en) * 2007-11-30 2009-11-01 Glaxo Group Ltd Antigen-binding constructs
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
SI2523688T1 (en) * 2010-01-15 2018-03-30 Kirin-Amgen, Inc. Formulation of antibodies and therapeutic regimes
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
BR112013025845A2 (pt) * 2011-04-07 2018-09-04 Glaxosmithkline Llc formulações com viscosidade reduzida

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5747447A (en) * 1992-04-30 1998-05-05 Cor Therapeutics Stable polypeptide composition
US20080160014A1 (en) * 2005-12-21 2008-07-03 Wyeth Protein Formulations With Reduced Viscosity and Uses Thereof
WO2011095543A1 (en) * 2010-02-04 2011-08-11 Csl Behring Ag Immunoglobulin preparation

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
SAMPATHKUMAR, K. et al. "Formulation and process development strategies for manufacturing biopharmaceuticals." Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals (01 January 2010). pages 383-427 *
SHIRE, S.J. et al. "High-concentration antibody formulations." Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals (01 January 2010). John Wiley & Sons, Inc. (eds F. Jameel and S. Hershenson), pages 349-381. *

Also Published As

Publication number Publication date
CN103596585A (zh) 2014-02-19
EP2694100A4 (en) 2014-10-01
WO2012138958A1 (en) 2012-10-11
BR112013025866A2 (pt) 2016-12-20
EP2694100A1 (en) 2014-02-12
CA2832556A1 (en) 2012-10-11
AU2016202355A1 (en) 2016-05-05
SG193963A1 (en) 2013-11-29
KR20140018966A (ko) 2014-02-13
EP3058952A1 (en) 2016-08-24
JP2014516924A (ja) 2014-07-17
AU2012240050A1 (en) 2013-10-17
US20140023655A1 (en) 2014-01-23
EA201391488A1 (ru) 2014-01-30
IL228591A0 (en) 2013-12-31

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired