DK0779818T3 - Flydende immunglobulinformuleringer - Google Patents

Flydende immunglobulinformuleringer

Info

Publication number
DK0779818T3
DK0779818T3 DK95932006T DK95932006T DK0779818T3 DK 0779818 T3 DK0779818 T3 DK 0779818T3 DK 95932006 T DK95932006 T DK 95932006T DK 95932006 T DK95932006 T DK 95932006T DK 0779818 T3 DK0779818 T3 DK 0779818T3
Authority
DK
Denmark
Prior art keywords
immunoglobulin
immunoglobulin formulations
liquid immunoglobulin
preparations
amphiphilic stabilizers
Prior art date
Application number
DK95932006T
Other languages
Danish (da)
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 DK0779818T3 publication Critical patent/DK0779818T3/da

Links

Classifications

    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
DK95932006T 1994-09-08 1995-09-07 Flydende immunglobulinformuleringer DK0779818T3 (da)

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
DK0779818T3 true DK0779818T3 (da) 2003-11-24

Family

ID=10761028

Family Applications (1)

Application Number Title Priority Date Filing Date
DK95932006T DK0779818T3 (da) 1994-09-08 1995-09-07 Flydende immunglobulinformuleringer

Country Status (27)

Country Link
US (1) US5871736A (cs)
EP (1) EP0779818B1 (cs)
JP (1) JP3004729B2 (cs)
KR (1) KR100370631B1 (cs)
CN (1) CN1157572A (cs)
AT (1) ATE246005T1 (cs)
AU (1) AU700788B2 (cs)
BR (1) BR9508821A (cs)
CA (1) CA2197432C (cs)
CZ (1) CZ285967B6 (cs)
DE (1) DE69531400T2 (cs)
DK (1) DK0779818T3 (cs)
FI (1) FI970603A (cs)
GB (1) GB9418092D0 (cs)
HU (1) HU223668B1 (cs)
IL (1) IL115226A (cs)
MX (1) MX9701510A (cs)
NO (1) NO971016L (cs)
NZ (1) NZ292919A (cs)
PL (1) PL182738B1 (cs)
PT (1) PT779818E (cs)
RO (1) RO118568B1 (cs)
RU (1) RU2158605C2 (cs)
SK (1) SK282332B6 (cs)
TW (1) TW407056B (cs)
WO (1) WO1996007429A1 (cs)
ZA (1) ZA957583B (cs)

Families Citing this family (38)

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US6139838A (en) * 1996-09-06 2000-10-31 Juridical Foundation The Chemo-Sero-Therapeutic Research Institute Tissue plasminogen activator medicinal composition
GB9705810D0 (en) * 1997-03-20 1997-05-07 Common Services Agency Intravenous immune globulin
PT1914244E (pt) 1999-04-09 2013-07-26 Kyowa Hakko Kirin Co Ltd Processo para regular a actividade de moléculas funcionais sob o ponto de vista imunológico
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
IL155002A0 (en) * 2000-10-12 2003-10-31 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
RU2332986C2 (ru) * 2003-04-04 2008-09-10 Дженентек, Инк. Высококонцентрированные композиции антител и белков
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
US8496930B2 (en) 2003-10-01 2013-07-30 Kyowa Hakko Kirin Co., Ltd Method of stabilizing antibody and stabilized solution-type antibody preparation
EP1532983A1 (en) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
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
AU2014201388C1 (en) * 2006-12-21 2017-02-02 Amgen Inc. Stable Buffered Formulations Containing Polypeptides
AU2008269086B2 (en) * 2007-06-25 2014-06-12 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
KR101087017B1 (ko) * 2007-07-10 2011-12-09 (주)메디톡스 보툴리눔 독소의 안정성이 개선된 약제학적 액상 조성물
US7560263B2 (en) * 2007-08-17 2009-07-14 Biomarin Pharmaceutical Inc. Compositions of prokaryotic phenylalanine ammonia-lyase and methods of treating cancer using compositions thereof
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
CA2754528A1 (en) * 2009-03-06 2010-09-10 Genetech, Inc. Antibody formulation
EP3708581A3 (en) * 2009-05-27 2021-10-20 Takeda Pharmaceutical Company Limited A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
CA2774053C (en) 2009-09-17 2015-04-28 Baxter Healthcare, S.A. Stable co-formulation of hyaluronidase and immunoglobulin, and methods of use thereof
ES2716088T3 (es) * 2010-02-04 2019-06-10 Csl Behring Ag Preparado de inmunoglobulina
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
NZ602115A (en) 2010-03-01 2014-12-24 Bayer Healthcare Llc Optimized monoclonal antibodies against tissue factor pathway inhibitor (tfpi)
FR2961107B1 (fr) * 2010-06-15 2012-07-27 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines stabilisee
SG188487A1 (en) 2010-09-17 2013-05-31 Baxter Int Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph
JP6224586B2 (ja) * 2012-07-10 2017-11-01 武田薬品工業株式会社 注射用製剤
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
EP3043774B1 (en) 2013-09-11 2020-11-04 Eagle Biologics, Inc. Liquid protein formulations containing ionic liquids
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
EP3200804A4 (en) 2014-10-01 2018-04-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
CA3193071A1 (en) * 2020-09-27 2022-03-31 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
US4360457A (en) * 1979-08-30 1982-11-23 Teijin Limited 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
IL93986A0 (en) * 1989-04-04 1991-01-31 Lilly Co Eli Improvements in and relating to 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
IL115226A (en) 1999-08-17
CZ68497A3 (en) 1997-06-11
NO971016D0 (no) 1997-03-05
TW407056B (en) 2000-10-01
RU2158605C2 (ru) 2000-11-10
JP3004729B2 (ja) 2000-01-31
NZ292919A (en) 1998-12-23
CA2197432A1 (en) 1996-03-14
FI970603A0 (fi) 1997-02-12
RO118568B1 (ro) 2003-07-30
CN1157572A (zh) 1997-08-20
US5871736A (en) 1999-02-16
IL115226A0 (en) 1995-12-31
SK30097A3 (en) 1997-10-08
PL182738B1 (pl) 2002-02-28
PL318265A1 (en) 1997-05-26
ATE246005T1 (de) 2003-08-15
JPH10502938A (ja) 1998-03-17
BR9508821A (pt) 1997-12-23
FI970603A (fi) 1997-02-12
MX9701510A (es) 1997-05-31
KR100370631B1 (ko) 2003-04-18
AU700788B2 (en) 1999-01-14
PT779818E (pt) 2003-11-28
CA2197432C (en) 2008-11-04
EP0779818A1 (en) 1997-06-25
CZ285967B6 (cs) 1999-12-15
HUT77122A (hu) 1998-03-02
HU223668B1 (hu) 2004-11-29
AU3522995A (en) 1996-03-27
EP0779818B1 (en) 2003-07-30
DE69531400T2 (de) 2004-05-27
SK282332B6 (sk) 2002-01-07
WO1996007429A1 (en) 1996-03-14
NO971016L (no) 1997-03-05
ZA957583B (en) 1997-03-10
GB9418092D0 (en) 1994-10-26
DE69531400D1 (de) 2003-09-04

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