DE69531400D1 - Flüssige immunoglobinformulierungen - Google Patents

Flüssige immunoglobinformulierungen

Info

Publication number
DE69531400D1
DE69531400D1 DE69531400T DE69531400T DE69531400D1 DE 69531400 D1 DE69531400 D1 DE 69531400D1 DE 69531400 T DE69531400 T DE 69531400T DE 69531400 T DE69531400 T DE 69531400T DE 69531400 D1 DE69531400 D1 DE 69531400D1
Authority
DE
Germany
Prior art keywords
immunoglobin
formulations
liquid
immunoglobulin
preparations
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.)
Expired - Lifetime
Application number
DE69531400T
Other languages
English (en)
Other versions
DE69531400T2 (de
Inventor
Rene Bruegger
Katharina Gennari
Gerhard Hodler
Bernard Wuest
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.)
CSL Behring AG
Original Assignee
ZLB Behring 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 Behring AG filed Critical ZLB Behring AG
Application granted granted Critical
Publication of DE69531400D1 publication Critical patent/DE69531400D1/de
Publication of DE69531400T2 publication Critical patent/DE69531400T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61K9/0012—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
DE69531400T 1994-09-08 1995-09-07 Flüssige immunoglobinformulierungen Expired - Lifetime DE69531400T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9418092 1994-09-08
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 (2)

Publication Number Publication Date
DE69531400D1 true DE69531400D1 (de) 2003-09-04
DE69531400T2 DE69531400T2 (de) 2004-05-27

Family

ID=10761028

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69531400T Expired - Lifetime DE69531400T2 (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) FI970603A0 (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 (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
EP2270148A3 (de) 1999-04-09 2011-06-08 Kyowa Hakko Kirin Co., Ltd. Verfahren zur Kontrolle der Aktivität von immunologisch funktionellem Molekül
US6946292B2 (en) 2000-10-06 2005-09-20 Kyowa Hakko Kogyo Co., Ltd. Cells producing antibody compositions with increased antibody dependent cytotoxic activity
AU1344102A (en) * 2000-10-12 2002-04-22 Genentech Inc Reduced-viscosity concentrated protein formulations
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US7425618B2 (en) * 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (RSV) antibody formulations
US7132100B2 (en) 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-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
JP4869064B2 (ja) 2003-04-04 2012-02-01 ジェネンテック， インコーポレイテッド 高濃度抗体及びタンパク質製剤
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
EP3006463A1 (de) 2003-10-01 2016-04-13 Kyowa Hakko Kirin Co., Ltd. Verfahren zur stabilisierung von antikörpern und stabilisierte antikörperzubereitung vom lösungstyp
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
AU2007338791B2 (en) * 2006-12-21 2014-03-13 Amgen Inc Stable buffered formulations containing polypeptides
CA2692165A1 (en) * 2007-06-25 2008-12-31 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
US7537923B2 (en) * 2007-08-17 2009-05-26 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
RU2011140498A (ru) * 2009-03-06 2013-04-20 Дженентек, Инк. Препарат антител
BRPI1012082B1 (pt) 2009-05-27 2022-08-16 Takeda Pharmaceutical Company Limited Método para preparar uma composição de igg concentrada a partir de plasma
DK2477603T3 (en) 2009-09-17 2016-06-13 Baxalta Inc STABLE CO-DEVELOPMENT OF hyaluronidase and Immunoglobulin, AND METHODS OF USE THEREOF
JP6078344B2 (ja) 2010-02-04 2017-02-08 ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト 免疫グロブリン製剤
EP2361636A1 (de) 2010-02-26 2011-08-31 CSL Behring AG Immunglobulinpräparat und Aufbewahrungssystem für ein Immunglobulinpräparat
SI3345615T1 (sl) 2010-03-01 2020-03-31 Bayer Healthcare Llc Optimizirana monoklonska protitelesa proti zaviralcu poti tkivnega faktorja (TFPI)
FR2961107B1 (fr) * 2010-06-15 2012-07-27 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines stabilisee
TW201213342A (en) 2010-09-17 2012-04-01 Baxter Int Stabilization of immunoglobulins and other proteins through aqueous formulation with sodium chloride at weak acidic to neutral pH
US20150157619A1 (en) * 2012-07-10 2015-06-11 Takeda Pharmaceutical Company Limited Pharmaceutical preparation for injection
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
MX2016003182A (es) 2013-09-11 2017-03-31 Arsia Therapeutics Inc Formulaciones de proteínas líquidas que contienen líquidos iónicos.
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
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
MX2017004306A (es) 2014-10-01 2017-12-20 Eagle Biologics Inc Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad.
WO2022064448A1 (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
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
ZA902519B (en) * 1989-04-04 1991-12-24 Lilly Co Eli 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
EP0779818A1 (de) 1997-06-25
RO118568B1 (ro) 2003-07-30
DE69531400T2 (de) 2004-05-27
TW407056B (en) 2000-10-01
CZ285967B6 (cs) 1999-12-15
IL115226A (en) 1999-08-17
NZ292919A (en) 1998-12-23
CA2197432A1 (en) 1996-03-14
ATE246005T1 (de) 2003-08-15
HUT77122A (hu) 1998-03-02
PL318265A1 (en) 1997-05-26
SK282332B6 (sk) 2002-01-07
NO971016L (no) 1997-03-05
GB9418092D0 (en) 1994-10-26
JPH10502938A (ja) 1998-03-17
FI970603A (fi) 1997-02-12
ZA957583B (en) 1997-03-10
PL182738B1 (pl) 2002-02-28
WO1996007429A1 (en) 1996-03-14
EP0779818B1 (de) 2003-07-30
MX9701510A (es) 1997-05-31
FI970603A0 (fi) 1997-02-12
KR100370631B1 (ko) 2003-04-18
RU2158605C2 (ru) 2000-11-10
AU700788B2 (en) 1999-01-14
CZ68497A3 (en) 1997-06-11
IL115226A0 (en) 1995-12-31
DK0779818T3 (da) 2003-11-24
JP3004729B2 (ja) 2000-01-31
CA2197432C (en) 2008-11-04
PT779818E (pt) 2003-11-28
HU223668B1 (hu) 2004-11-29
BR9508821A (pt) 1997-12-23
US5871736A (en) 1999-02-16
SK30097A3 (en) 1997-10-08
NO971016D0 (no) 1997-03-05
AU3522995A (en) 1996-03-27
CN1157572A (zh) 1997-08-20

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Legal Events

Date Code Title Description
8364 No opposition during term of opposition
8327 Change in the person/name/address of the patent owner

Owner name: ZLB BEHRING AG, BERN, CH

8327 Change in the person/name/address of the patent owner

Owner name: CSL BEHRING AG, BERN, CH