CA2197432A1 - Liquid immunoglobulin formulations - Google Patents

Liquid immunoglobulin formulations

Info

Publication number
CA2197432A1
CA2197432A1 CA002197432A CA2197432A CA2197432A1 CA 2197432 A1 CA2197432 A1 CA 2197432A1 CA 002197432 A CA002197432 A CA 002197432A CA 2197432 A CA2197432 A CA 2197432A CA 2197432 A1 CA2197432 A1 CA 2197432A1
Authority
CA
Canada
Prior art keywords
immunoglobulin
immunoglobulin formulations
liquid immunoglobulin
preparations
amphiphilic stabilizers
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.)
Granted
Application number
CA002197432A
Other languages
French (fr)
Other versions
CA2197432C (en
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
Individual
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 Individual filed Critical Individual
Publication of CA2197432A1 publication Critical patent/CA2197432A1/en
Application granted granted Critical
Publication of CA2197432C publication Critical patent/CA2197432C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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

Abstract

Immunoglobulin preparations, particularly liquid preparations of immunoglobulin G for intravenous infusion, are stabilized against dimer formation by the addition of one or more amphiphilic stabilizers.
Preferred amphiphilic stabilizers are nicotinic acid derivatives, particularly nicotinamide, and naturally-occuring .alpha.-amino acids having a lipophilic side chain, for example phenylalanine, proline, leucine and isoleucine.
CA002197432A 1994-09-08 1995-09-07 Liquid immunoglobulin formulations Expired - Fee Related CA2197432C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9418092A GB9418092D0 (en) 1994-09-08 1994-09-08 Organic compounds
GB9418092.4 1994-09-08
PCT/EP1995/003522 WO1996007429A1 (en) 1994-09-08 1995-09-07 Liquid immunoglobulin formulations

Publications (2)

Publication Number Publication Date
CA2197432A1 true CA2197432A1 (en) 1996-03-14
CA2197432C CA2197432C (en) 2008-11-04

Family

ID=10761028

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002197432A Expired - Fee Related CA2197432C (en) 1994-09-08 1995-09-07 Liquid immunoglobulin formulations

Country Status (27)

Country Link
US (1) US5871736A (en)
EP (1) EP0779818B1 (en)
JP (1) JP3004729B2 (en)
KR (1) KR100370631B1 (en)
CN (1) CN1157572A (en)
AT (1) ATE246005T1 (en)
AU (1) AU700788B2 (en)
BR (1) BR9508821A (en)
CA (1) CA2197432C (en)
CZ (1) CZ285967B6 (en)
DE (1) DE69531400T2 (en)
DK (1) DK0779818T3 (en)
FI (1) FI970603A (en)
GB (1) GB9418092D0 (en)
HU (1) HU223668B1 (en)
IL (1) IL115226A (en)
MX (1) MX9701510A (en)
NO (1) NO971016D0 (en)
NZ (1) NZ292919A (en)
PL (1) PL182738B1 (en)
PT (1) PT779818E (en)
RO (1) RO118568B1 (en)
RU (1) RU2158605C2 (en)
SK (1) SK282332B6 (en)
TW (1) TW407056B (en)
WO (1) WO1996007429A1 (en)
ZA (1) ZA957583B (en)

Families Citing this family (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0827751B1 (en) * 1996-09-06 2003-02-26 Juridical Foundation The Chemo-Sero-Therapeutic Research Institute Medicinal composition containing tissue plasminogen activator and nicotinamide
GB9705810D0 (en) * 1997-03-20 1997-05-07 Common Services Agency Intravenous immune globulin
EP2275540B1 (en) 1999-04-09 2016-03-23 Kyowa Hakko Kirin Co., Ltd. Method for controlling the activity of immunologically functional molecule
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
BRPI0403964B8 (en) * 2003-04-04 2021-05-25 Genentech Inc stable liquid formulations, article of manufacture and use of these formulations for the treatment of ige-mediated dysfunction
DE10333317A1 (en) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulation for protein medicines without the addition of human serum albumin (HSA)
JP4219932B2 (en) 2003-10-01 2009-02-04 協和発酵キリン株式会社 Antibody stabilization method and stabilized solution antibody preparation
EP1532983A1 (en) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
CA2790018C (en) * 2006-12-21 2015-02-03 Amgen Inc. Formulations
AU2014201388C1 (en) * 2006-12-21 2017-02-02 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
JP5259710B2 (en) 2007-07-10 2013-08-07 メディ‐トックス、インク． Pharmaceutical liquid composition with improved stability of botulinum toxin
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 (en) 2008-03-17 2015-07-01 Baxter Healthcare Sa Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase
EP2403874A1 (en) * 2009-03-06 2012-01-11 Genentech, Inc. Antibody formulation
TWI445714B (en) 2009-05-27 2014-07-21 Baxter Int A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
IN2012DN03219A (en) 2009-09-17 2015-10-23 Baxter Healthcare Sa
AU2011212440B2 (en) 2010-02-04 2015-01-22 Csl Behring Ag Immunoglobulin preparation
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
SG10201502587SA (en) 2010-03-01 2015-06-29 Bayer Healthcare Llc Optimized monoclonal antibodies against tissue factor pathway inhibitor (tfpi)
FR2961107B1 (en) * 2010-06-15 2012-07-27 Lab Francais Du Fractionnement HUMAN IMMUNOGLOBULIN COMPOSITION STABILIZED
PL2616090T3 (en) 2010-09-17 2023-12-18 Takeda Pharmaceutical Company Limited Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph
EP2873422A4 (en) * 2012-07-10 2015-12-30 Takeda Pharmaceutical 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
EP3791862A1 (en) 2013-09-11 2021-03-17 Eagle Biologics, Inc. Liquid protein formulations containing viscosity-lowering agents
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
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
IL301681A (en) * 2020-09-27 2023-05-01 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 (en) * 1983-12-02 1985-06-28 Green Cross Corp:The Igg monomer
US4597966A (en) * 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
JPH0825902B2 (en) * 1985-02-21 1996-03-13 株式会社ミドリ十字 Method for heat treatment of γ-globulin
JPH0825903B2 (en) * 1985-05-16 1996-03-13 株式会社ミドリ十字 γ-globulin-containing aqueous solution
IL93986A0 (en) * 1989-04-04 1991-01-31 Lilly Co Eli Improvements in and relating to pharmaceutical formulations
JP2942412B2 (en) * 1991-12-26 1999-08-30 鐘紡株式会社 Cosmetics

Also Published As

Publication number Publication date
PL182738B1 (en) 2002-02-28
PT779818E (en) 2003-11-28
CZ285967B6 (en) 1999-12-15
PL318265A1 (en) 1997-05-26
DE69531400T2 (en) 2004-05-27
SK30097A3 (en) 1997-10-08
AU700788B2 (en) 1999-01-14
HU223668B1 (en) 2004-11-29
US5871736A (en) 1999-02-16
NO971016L (en) 1997-03-05
JP3004729B2 (en) 2000-01-31
EP0779818B1 (en) 2003-07-30
IL115226A (en) 1999-08-17
DK0779818T3 (en) 2003-11-24
IL115226A0 (en) 1995-12-31
AU3522995A (en) 1996-03-27
RU2158605C2 (en) 2000-11-10
JPH10502938A (en) 1998-03-17
EP0779818A1 (en) 1997-06-25
NO971016D0 (en) 1997-03-05
ATE246005T1 (en) 2003-08-15
SK282332B6 (en) 2002-01-07
FI970603A0 (en) 1997-02-12
GB9418092D0 (en) 1994-10-26
WO1996007429A1 (en) 1996-03-14
CZ68497A3 (en) 1997-06-11
FI970603A (en) 1997-02-12
TW407056B (en) 2000-10-01
BR9508821A (en) 1997-12-23
DE69531400D1 (en) 2003-09-04
CA2197432C (en) 2008-11-04
RO118568B1 (en) 2003-07-30
HUT77122A (en) 1998-03-02
KR100370631B1 (en) 2003-04-18
ZA957583B (en) 1997-03-10
MX9701510A (en) 1997-05-31
NZ292919A (en) 1998-12-23
CN1157572A (en) 1997-08-20

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Legal Events

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