ATE246005T1 - Flüssige immunoglobinformulierungen - Google Patents

Flüssige immunoglobinformulierungen

Info

Publication number
ATE246005T1
ATE246005T1 AT95932006T AT95932006T ATE246005T1 AT E246005 T1 ATE246005 T1 AT E246005T1 AT 95932006 T AT95932006 T AT 95932006T AT 95932006 T AT95932006 T AT 95932006T AT E246005 T1 ATE246005 T1 AT E246005T1
Authority
AT
Austria
Prior art keywords
immunoglobin
formulations
liquid
immunoglobulin
preparations
Prior art date
Application number
AT95932006T
Other languages
English (en)
Inventor
Rene Bruegger
Katharina Gennari
Gerhard Hodler
Bernard Wuest
Original Assignee
Zlb Bioplasma Ag
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 Zlb Bioplasma Ag filed Critical Zlb Bioplasma Ag
Application granted granted Critical
Publication of ATE246005T1 publication Critical patent/ATE246005T1/de

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
    • A61K9/0012—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
    • 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
    • A61K47/06—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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AT95932006T 1994-09-08 1995-09-07 Flüssige immunoglobinformulierungen ATE246005T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9418092A GB9418092D0 (en) 1994-09-08 1994-09-08 Organic compounds
PCT/EP1995/003522 WO1996007429A1 (en) 1994-09-08 1995-09-07 Liquid immunoglobulin formulations

Publications (1)

Publication Number Publication Date
ATE246005T1 true ATE246005T1 (de) 2003-08-15

Family

ID=10761028

Family Applications (1)

Application Number Title Priority Date Filing Date
AT95932006T ATE246005T1 (de) 1994-09-08 1995-09-07 Flüssige immunoglobinformulierungen

Country Status (27)

Country Link
US (1) US5871736A (de)
EP (1) EP0779818B1 (de)
JP (1) JP3004729B2 (de)
KR (1) KR100370631B1 (de)
CN (1) CN1157572A (de)
AT (1) ATE246005T1 (de)
AU (1) AU700788B2 (de)
BR (1) BR9508821A (de)
CA (1) CA2197432C (de)
CZ (1) CZ285967B6 (de)
DE (1) DE69531400T2 (de)
DK (1) DK0779818T3 (de)
FI (1) FI970603L (de)
GB (1) GB9418092D0 (de)
HU (1) HU223668B1 (de)
IL (1) IL115226A (de)
MX (1) MX9701510A (de)
NO (1) NO971016D0 (de)
NZ (1) NZ292919A (de)
PL (1) PL182738B1 (de)
PT (1) PT779818E (de)
RO (1) RO118568B1 (de)
RU (1) RU2158605C2 (de)
SK (1) SK282332B6 (de)
TW (1) TW407056B (de)
WO (1) WO1996007429A1 (de)
ZA (1) ZA957583B (de)

Families Citing this family (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69719265T2 (de) * 1996-09-06 2003-12-04 Juridical Foundation The Chemo-Sero-Therapeutic Research Institute, Kumamoto Medizinische Zusammensetzung die Gewebeplasminogenaktivator und Nikotinamid enthält
GB9705810D0 (en) * 1997-03-20 1997-05-07 Common Services Agency Intravenous immune globulin
EP1176195B1 (de) 1999-04-09 2013-05-22 Kyowa Hakko Kirin Co., Ltd. Verfahren zur kontrolle der aktivität von immunologisch funktionellem molekül
FR2814446B1 (fr) 2000-09-22 2002-12-20 Oreal Pot distributeur pour produit de consistance visqueuse
US6946292B2 (en) 2000-10-06 2005-09-20 Kyowa Hakko Kogyo Co., Ltd. Cells producing antibody compositions with increased antibody dependent cytotoxic activity
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
AU2002213441B2 (en) * 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US7132100B2 (en) 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-RSV antibody formulations
US7425618B2 (en) * 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (RSV) antibody formulations
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
MY150740A (en) 2002-10-24 2014-02-28 Abbvie Biotechnology Ltd Low dose methods for treating disorders in which tnf? activity is detrimental
US20040208869A1 (en) * 2003-01-30 2004-10-21 Medimmune, Inc. Uses of anti-integrin alphanubeta3 antibody formulations
CN1798575A (zh) 2003-04-04 2006-07-05 健泰科生物技术公司 高浓度抗体和蛋白制剂
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
CN100522998C (zh) 2003-10-01 2009-08-05 协和发酵麒麟株式会社 抗体的稳定化方法和被稳定的溶液状抗体制剂
EP1532983A1 (de) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulinpräparationen mit erhöhter Stabilität
AU2014201388C1 (en) * 2006-12-21 2017-02-02 Amgen Inc. Stable Buffered Formulations Containing Polypeptides
JP5577098B2 (ja) * 2006-12-21 2014-08-20 アムジエン・インコーポレーテツド ポリペプチドを含有する安定な緩衝化された製剤
EP2170268A2 (de) * 2007-06-25 2010-04-07 Amgen, Inc. Zusammensetzungen von spezifischen bindungsmitteln für den hepatozyten-wachstumsfaktor
US8617568B2 (en) * 2007-07-10 2013-12-31 Medy-Tox, Inc. Pharmaceutical liquid composition of botulinum toxin with improved stability
TWI489994B (zh) 2008-03-17 2015-07-01 Baxter Healthcare Sa 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法
AR076640A1 (es) * 2009-03-06 2011-06-29 Genentech Inc Formulacion con anticuerpo. metodo para estabilizar anticuerpo. articulo de manufactura
MX2011012576A (es) * 2009-05-27 2012-05-08 Baxter Int Metodo para producir una preparacion altamente concentrada de inmunoglobulina de uso subcutaneo.
MX2012003282A (es) 2009-09-17 2012-04-30 Baxter Healthcare Sa Co-formulacion estable de hialuronidasa e inmunoglobulina, y metodos de su uso.
DK2531218T3 (en) 2010-02-04 2019-04-01 Csl Behring Ag immunoglobulin
EP2361636A1 (de) 2010-02-26 2011-08-31 CSL Behring AG Immunglobulinpräparat und Aufbewahrungssystem für ein Immunglobulinpräparat
HUE047173T2 (hu) 2010-03-01 2020-04-28 Bayer Healthcare Llc Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen
AU2010202125B1 (en) 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A method to produce an immunoglobulin preparation with improved yield
FR2961107B1 (fr) * 2010-06-15 2012-07-27 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines stabilisee
CA2810731A1 (en) 2010-09-17 2012-03-22 Baxter International Inc. Stabilization of immunoglobulins and other proteins through aqueous formulation with sodium chloride at weak acidic to neutral ph
EP2873422A4 (de) * 2012-07-10 2015-12-30 Takeda Pharmaceutical Pharmazeutische zubereitung zur injektion
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
EP3200804A4 (de) 2014-10-01 2018-04-18 Eagle Biologics, Inc. Polysaccharid- und nukleinsäureformulierungen mit viskositätssenkenden mitteln
ES2825704T3 (es) 2014-12-03 2021-05-17 Csl Behring Ag Producto farmacéutico con mayor estabilidad que comprende inmunoglobulinas
US20240052020A1 (en) * 2020-09-27 2024-02-15 Emergent Biosolutions Canada Inc. Hyperimmune globulin formulations

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4362661A (en) * 1979-08-09 1982-12-07 Teijin Limited Immunoglobulin composition having a high monomer content, and process for production thereof
CA1153695A (en) * 1979-08-30 1983-09-13 Syoji Ono S-sulfonated immunoglobulin composition having a high monomer content and a process for production thereof
JPS56135418A (en) * 1980-03-27 1981-10-22 Green Cross Corp:The Heat treatment of aqueous solution containing 8 factor of coagulation of blood derived from human
JPS60120823A (ja) * 1983-12-02 1985-06-28 Green Cross Corp:The ＩｇＧ単量体
US4597966A (en) * 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
JPH0825902B2 (ja) * 1985-02-21 1996-03-13 株式会社ミドリ十字 γ−グロブリンの加熱処理方法
JPH0825903B2 (ja) * 1985-05-16 1996-03-13 株式会社ミドリ十字 γ―グロブリン含有水溶液
CA2013600A1 (en) * 1989-04-04 1990-10-04 Michael J. Pikal Pharmaceutical formulations
JP2942412B2 (ja) * 1991-12-26 1999-08-30 鐘紡株式会社 化粧料

Also Published As

Publication number Publication date
GB9418092D0 (en) 1994-10-26
IL115226A0 (en) 1995-12-31
JP3004729B2 (ja) 2000-01-31
NZ292919A (en) 1998-12-23
EP0779818A1 (de) 1997-06-25
TW407056B (en) 2000-10-01
SK282332B6 (sk) 2002-01-07
ZA957583B (en) 1997-03-10
CA2197432A1 (en) 1996-03-14
MX9701510A (es) 1997-05-31
NO971016L (no) 1997-03-05
NO971016D0 (no) 1997-03-05
DE69531400D1 (de) 2003-09-04
RU2158605C2 (ru) 2000-11-10
SK30097A3 (en) 1997-10-08
KR100370631B1 (ko) 2003-04-18
DK0779818T3 (da) 2003-11-24
CN1157572A (zh) 1997-08-20
PL182738B1 (pl) 2002-02-28
CZ68497A3 (en) 1997-06-11
RO118568B1 (ro) 2003-07-30
FI970603A7 (fi) 1997-02-12
AU700788B2 (en) 1999-01-14
PT779818E (pt) 2003-11-28
BR9508821A (pt) 1997-12-23
PL318265A1 (en) 1997-05-26
CZ285967B6 (cs) 1999-12-15
FI970603A0 (fi) 1997-02-12
US5871736A (en) 1999-02-16
CA2197432C (en) 2008-11-04
WO1996007429A1 (en) 1996-03-14
HUT77122A (hu) 1998-03-02
AU3522995A (en) 1996-03-27
IL115226A (en) 1999-08-17
JPH10502938A (ja) 1998-03-17
EP0779818B1 (de) 2003-07-30
DE69531400T2 (de) 2004-05-27
HU223668B1 (hu) 2004-11-29
FI970603L (fi) 1997-02-12

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Legal Events

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RER Ceased as to paragraph 5 lit. 3 law introducing patent treaties