WO2000067789A1 - Preparation a forte teneur en immunoglobuline et ses procedes de production - Google Patents

Preparation a forte teneur en immunoglobuline et ses procedes de production Download PDF

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Publication number
WO2000067789A1
WO2000067789A1 PCT/AU2000/000433 AU0000433W WO0067789A1 WO 2000067789 A1 WO2000067789 A1 WO 2000067789A1 AU 0000433 W AU0000433 W AU 0000433W WO 0067789 A1 WO0067789 A1 WO 0067789A1
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WO
WIPO (PCT)
Prior art keywords
immunoglobulin
preparation
concentration
aggregates
solution
Prior art date
Application number
PCT/AU2000/000433
Other languages
English (en)
Inventor
Germano Coppola
Joseph Bertolini
Original Assignee
Csl Limited
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 Csl Limited filed Critical Csl Limited
Priority to AU43855/00A priority Critical patent/AU4385500A/en
Priority to EP00924972A priority patent/EP1176979A4/fr
Publication of WO2000067789A1 publication Critical patent/WO2000067789A1/fr

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Classifications

    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

Definitions

  • the present invention relates to a stable, high concentration immunoglobulin preparation and to a method of producing such an immunoglobulin preparation.
  • These protein destabilizing conditions include the use of ethanol to isolate the product and heat to virally inactivate the isolated IgG. Once unfolded a subpopulation of the IgG molecules may refold to form various polymeric species including trimers, tetramers and aggregates. The formation of aggregated species appears to be cumulative with time. Thus it is imperative that IgG species which have aggregated or are prone to aggregate are removed prior to dispensing. This removal of aggregates typically occurs just prior to formulation so that aggregates formed throughout the process are removed.
  • the present inventors have now surprisingly found that if an immunoglobulin solution is exposed to conditions to deliberately enhance the formation of aggregates, and the aggregates are then removed, an immunoglobulin preparation is obtained which is stable at high concentrations for prolonged periods.
  • the present inventors have also made the observation that this clarification of the immunoglobulin solution to remove aggregates increases the stability and thus the clinical acceptability of the product.
  • the immunoglobulin solution prepared by this method is sufficiently stable that it may be formulated into a product which is room temperature stable and capable of being administered intramuscularly, intravenously or subcutaneously.
  • the present invention consists in a clinically acceptable immunoglobulin preparation, the preparation comprising about 5% to about 25% (w/v) immunoglobulin and an osmolality agent and /or a stabilizer and having a pH of about 5.0 to about 8.0, wherein the concentration of immunoglobulin aggregates present in the imiminoglobulin preparation after storage at 27°C for 3 months is less than 2% (w/v).
  • the present invention consists in a clinically acceptable imrmmoglobulin preparation, the preparation comprising about 5% to about 25% (w/v) immunoglobulin and an osmolality agent and /or a stabilizer and having a pH of about 4.0 to about 8.0, wherein the concentration of immunoglobulin aggregates present in the immunoglobulin preparation after storage at 4°C for 3 months is less than 1% (w/v).
  • the concentration of immunoglobulin is about 10% to about 25% (w/v), preferably about 20% (w/v) or about 25% (w/v).
  • the pH of the immunoglobulin preparation is about 5.0 to about 6.0, more preferably aboLit 5.5. This is particularly so when the immunoglobulin preparation is to be stored for prolonged periods at room temperature, eg 27°C.
  • the preparation of the present invention will include an osmolality agent such that the osmolality of preparation is suitable for administration.
  • This osmolality agent may also be a compound which stabilizes the imiminoglobulin.
  • Stabilizers are well known in the art and include saccharides, such as sucrose, maltose and glucose, sugar alcohols, S ich as sorbitol and mannitol, and amino acids.
  • the preparation further comprises glycine.
  • concentration of immunoglobulin aggregates present in the immunoglobulin preparation after storage at 27°C for 6 months is less than 2% [w/v), and more preferably the concentration of immunoglobulin aggregates present in the immunoglobulin preparation after storage at 27°C for 9 months is less than 2% (w/v).
  • the concentration of immunoglobulin aggregates present in the immunoglobulin preparation after storage at 27°C for 6 months is less than 1% (w/v).
  • the concentration of immunoglobulin aggregates present in the immunoglobulin preparation after storage at 4°C for 6 months is less than 1% (w/v), and preferably the concentration of immunoglobulin aggregates present in the immunoglobulin preparation after storage at 4°C for 9 months is less than 1% (w/v).
  • the present invention consists in a method for the production of a clinically acceptable immunoglobulin preparation, the method comprising the following steps ;-
  • step (2) comprises incubating the immunoglobulin solution at a pH of about 5.8 to about 8.0 at temperature of about 4° to about 27°C for at least about 6 hours. It is preferred that the immunoglobulin solution is incubated at a pH of about 6.8 for about 12 hours.
  • the aggregates are removed from the aggregate containing solution by filtration, precipitation or size exclusion chromatography.
  • the aggregates are removed from the aggregate containing solution by precipitation using a precipitation enhancing agent.
  • a preferred precipitation enhancing agent is polyethylene glycol.
  • the precipitation is performed at a protein concentration of about 2 to about 10% (w/v) and a polyethylene glycol concentration of about 6 to about 12% w/w and at a pH of about 6 to about 8.
  • the aggregates formed may be removed using any of a number of well known techniques, however it is presently preferred that the aggregates are removed by filtration or precipitation, optionally using a precipitation enhancing agent such as PEG.
  • the aggregates may be removed by membrane filtration using a filter of exclusion limits greater than 300,000 kDa.
  • the aggregates may be removed using size exclusion chromatography eg using a resin of exclusion limits of 10,000 - 1,5000,000.
  • the present invention will also have applicability for a range of protein preparations other than immv oglobulins, where the removal of protein aggregates is desirable.
  • the preparation of the present invention may be administered intravenously, intramuscularly or subcutaneously.
  • Example 1 Stability of 10% IgG prepara tions following aggrega te removal by membrane ⁇ ltra tion
  • IgG preparation produced by a combination of Cohn fractionation and chromatographic methods.
  • the preparation had been pasteurised in the presence of sucrose, followed by diafiltration against water, the final protein concentration being approximately 2% (w/v).
  • the solution was then adJ isted to pH 6.8 and maintained at this pH for 12hrs. Prior to membrane passage the solution was adjusted to pH 4.2.
  • the process has thus resulted in complete removal of aggregate IgG.
  • the filtered material was then diafiltered against PFW and concentrated to 10% w/v using a Amicon 30kDa membrane. Following concentration the solution was formulated to 10% w/v IgG containing 0.2 M glycine pH 5.5. Formulated samples were then incubated at various temperatures and stability was assessed over time by comparing protein composition with that of non-filtered solutions (Table 2).
  • Example 2 A similar procedure as described in Example 1 was used to prepare an aggregate depleted IgG solution. The solution was then concentrated and formulated to 16% w/v containing 0.25 Glycine pH 4.25 or 5.5. Samples of the final product were placed on stability trial and aggregate content determined (Tables 3a -3d.). Table 3a: 16% IgG, pH 4.25, 4 °C
  • Table 7a Determination of monomer, dimer, and aggregate content of PEG treated IgG 20% w/v, pH 5.5 following storage at 4°, 27°, 32° & 37°C for 1 month.
  • Table 7b Determination of monomer, dimer, and aggregate content of PEG treated IgG 25% w/v, pH 5.5 following storage at 4°, 27°, 32° & 37°C for 1 month.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

L'invention concerne des préparations d'immunoglobuline à administrer par voie intraveineuse qui sont stables pendant des périodes prolongées de stockage. L'invention concerne également un procédé de production d'une préparation d'immunoglobuline cliniquement acceptable. Ce procédé consiste 1) à obtenir une solution d'immunoglobuline; 2) à soumettre cette solution à des conditions qui augmentent la formation d'agrégats d'immunoglobulines pour former une solution contenant des agrégats d'immunoglobulines et 3) à séparer les agrégats d'immunoglobulines de la solution contenant les agrégats d'immunoglobulines afin d'obtenir une préparation d'immunoglobuline pratiquement exempte d'agrégats d'immunoglobulines.
PCT/AU2000/000433 1999-05-10 2000-05-10 Preparation a forte teneur en immunoglobuline et ses procedes de production WO2000067789A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU43855/00A AU4385500A (en) 1999-05-10 2000-05-10 High concentration immunoglobulin preparation and method for its production
EP00924972A EP1176979A4 (fr) 1999-05-10 2000-05-10 Preparation a forte teneur en immunoglobuline et ses procedes de production

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPQ0267A AUPQ026799A0 (en) 1999-05-10 1999-05-10 Method of increasing protein stability by removing immunoglobulin aggregates
AUPQ0267 1999-05-10

Publications (1)

Publication Number Publication Date
WO2000067789A1 true WO2000067789A1 (fr) 2000-11-16

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2000/000433 WO2000067789A1 (fr) 1999-05-10 2000-05-10 Preparation a forte teneur en immunoglobuline et ses procedes de production

Country Status (3)

Country Link
EP (1) EP1176979A4 (fr)
AU (1) AUPQ026799A0 (fr)
WO (1) WO2000067789A1 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007112757A2 (fr) * 2006-04-04 2007-10-11 Zymenex A/S Procédé de concentration d'un polypeptide
WO2010030222A1 (fr) * 2008-09-12 2010-03-18 Ge Healthcare Bio-Sciences Ab Séparation protéine-agrégat améliorée avec des échangeurs d'anions multimodaux en présence de zwitterions exclus de la protéine
EP2435474A2 (fr) * 2009-05-27 2012-04-04 Baxter International Inc Procédé de production d'une préparation d'immunoglobulines hautement concentrée et à usage sous-cutané
US8536315B2 (en) 2004-01-30 2013-09-17 Shire Pharmaceuticals Ireland Limited Production and purification of recombinant arylsulftase
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US8911741B2 (en) 2002-08-16 2014-12-16 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-alpha associated disorders
US8940873B2 (en) 2007-03-29 2015-01-27 Abbvie Inc. Crystalline anti-human IL-12 antibodies
US10155039B2 (en) 2012-09-07 2018-12-18 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
US10336992B2 (en) 2011-07-08 2019-07-02 Shire Human Genetic Therapies, Inc. Methods for purification of arylsulfatase A
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
US11407984B2 (en) 2013-01-09 2022-08-09 Takeda Pharmaceutical Company Limited Methods for purification of arysulfatase A

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EP0123029A1 (fr) * 1983-03-21 1984-10-31 Heilmittelwerke Wien Gesellschaft m.b.H. Procédé de production d'une solution d'IgG-immunoglobuline libre d'effet accessoire pour l'application intraveineuse
US4597966A (en) * 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
US4845199A (en) * 1986-07-09 1989-07-04 Green Cross Corporation Process for heat treating chemically unmodified gamma-globulin
US4880913A (en) * 1986-12-02 1989-11-14 Schwab & Co. Ges.M.B.H. Process for the preparation of an immunoglobulin which can be administered intravenously and is stable in liquid form
AU3429797A (en) * 1996-07-18 1998-02-10 Csl Limited Pasteurization of immunoglobulin solutions
WO1999064462A1 (fr) * 1998-06-09 1999-12-16 Statens Serum Institut Procede de production d'immunoglobulines destinees a une administration intraveineuse et d'autres produits d'immunoglobulines

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US5656730A (en) * 1995-04-07 1997-08-12 Enzon, Inc. Stabilized monomeric protein compositions
GB9705810D0 (en) * 1997-03-20 1997-05-07 Common Services Agency Intravenous immune globulin

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EP0123029A1 (fr) * 1983-03-21 1984-10-31 Heilmittelwerke Wien Gesellschaft m.b.H. Procédé de production d'une solution d'IgG-immunoglobuline libre d'effet accessoire pour l'application intraveineuse
US4597966A (en) * 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
US4845199A (en) * 1986-07-09 1989-07-04 Green Cross Corporation Process for heat treating chemically unmodified gamma-globulin
US4880913A (en) * 1986-12-02 1989-11-14 Schwab & Co. Ges.M.B.H. Process for the preparation of an immunoglobulin which can be administered intravenously and is stable in liquid form
AU3429797A (en) * 1996-07-18 1998-02-10 Csl Limited Pasteurization of immunoglobulin solutions
WO1999064462A1 (fr) * 1998-06-09 1999-12-16 Statens Serum Institut Procede de production d'immunoglobulines destinees a une administration intraveineuse et d'autres produits d'immunoglobulines

Non-Patent Citations (1)

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US9732152B2 (en) 2002-08-16 2017-08-15 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9738714B2 (en) 2002-08-16 2017-08-22 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9950066B2 (en) 2002-08-16 2018-04-24 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9750808B2 (en) 2002-08-16 2017-09-05 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-alpha associated disorders
US8932591B2 (en) 2002-08-16 2015-01-13 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US9327032B2 (en) 2002-08-16 2016-05-03 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9302011B2 (en) 2002-08-16 2016-04-05 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-α associated disorders
US9295725B2 (en) 2002-08-16 2016-03-29 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9289497B2 (en) 2002-08-16 2016-03-22 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9272041B2 (en) 2002-08-16 2016-03-01 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9272042B2 (en) 2002-08-16 2016-03-01 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9220781B2 (en) 2002-08-16 2015-12-29 Abbvie Biotechnology Ltd Formulation of human antibodies for treating TNF-alpha associated disorders
US9114166B2 (en) 2002-08-16 2015-08-25 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US8940305B2 (en) 2002-08-16 2015-01-27 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US8911741B2 (en) 2002-08-16 2014-12-16 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-alpha associated disorders
US8916157B2 (en) 2002-08-16 2014-12-23 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US8916158B2 (en) 2002-08-16 2014-12-23 Abbvie Biotechnology Ltd. Formulation of human antibodies for treating TNF-α associated disorders
US8536315B2 (en) 2004-01-30 2013-09-17 Shire Pharmaceuticals Ireland Limited Production and purification of recombinant arylsulftase
US9957489B2 (en) 2004-01-30 2018-05-01 Shire Pharmaceuticals Ireland Limited Production and purification of recombinant arylsulfatase A
EP2631242A3 (fr) * 2006-04-04 2013-10-02 Shire Pharmaceuticals Ireland Limited Procédé pour la concentration d'un polypeptide
JP2009532394A (ja) * 2006-04-04 2009-09-10 シャイア ファーマシューティカルズ アイルランド リミテッド ポリペプチドの濃縮方法
WO2007112757A2 (fr) * 2006-04-04 2007-10-11 Zymenex A/S Procédé de concentration d'un polypeptide
NO346368B1 (no) * 2006-04-04 2022-06-27 Chiesi Farm Spa En fremgangsmåte for konsentrasjon av alfa-mannosidase.
JP2014058521A (ja) * 2006-04-04 2014-04-03 Zymenex As ポリペプチドの濃縮方法
CN105233276A (zh) * 2006-04-04 2016-01-13 希尔制药爱尔兰有限责任公司 用于浓缩多肽的方法
EP2628746A3 (fr) * 2006-04-04 2014-03-19 Zymenex A/S Procédé pour la concentration d'un polypeptide
JP2013236633A (ja) * 2006-04-04 2013-11-28 Shire Pharmaceuticals Ireland Ltd ポリペプチドの濃縮方法
US8809055B2 (en) 2006-04-04 2014-08-19 Zymenex A/S Process for concentration of a polypeptide
EP2100898A1 (fr) * 2006-04-04 2009-09-16 Zymenex A/S Procédé de concentration d'un polypeptide
JP2009273469A (ja) * 2006-04-04 2009-11-26 Zymenex As ポリペプチドの濃縮方法
US9713634B2 (en) 2006-04-04 2017-07-25 Shire Pharmaceuticals Ireland Limited Process for concentration of a polypeptide
WO2007112757A3 (fr) * 2006-04-04 2008-02-28 Zymenex As Procédé de concentration d'un polypeptide
US8940873B2 (en) 2007-03-29 2015-01-27 Abbvie Inc. Crystalline anti-human IL-12 antibodies
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US9085619B2 (en) 2007-11-30 2015-07-21 Abbvie Biotechnology Ltd. Anti-TNF antibody formulations
US11167030B2 (en) 2007-11-30 2021-11-09 Abbvie Biotechnology Ltd Protein formulations and methods of making same
US11191834B2 (en) 2007-11-30 2021-12-07 Abbvie Biotechnology Ltd Protein formulations and methods of making same
WO2010030222A1 (fr) * 2008-09-12 2010-03-18 Ge Healthcare Bio-Sciences Ab Séparation protéine-agrégat améliorée avec des échangeurs d'anions multimodaux en présence de zwitterions exclus de la protéine
EP2435474A2 (fr) * 2009-05-27 2012-04-04 Baxter International Inc Procédé de production d'une préparation d'immunoglobulines hautement concentrée et à usage sous-cutané
US10125189B2 (en) 2009-05-27 2018-11-13 Baxalta Incorporated Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
AU2016203542B2 (en) * 2009-05-27 2018-02-15 Takeda Pharmaceutical Company Limited A Method To Produce A Highly Concentrated Immunoglobulin Preparation For Subcutaneous Use
US11242380B2 (en) 2009-05-27 2022-02-08 Takeda Pharmaceutical Company Limited Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
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US9175068B2 (en) 2009-05-27 2015-11-03 Baxalta Incorporated Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
US10336992B2 (en) 2011-07-08 2019-07-02 Shire Human Genetic Therapies, Inc. Methods for purification of arylsulfatase A
US10159733B2 (en) 2012-09-07 2018-12-25 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
US10786566B2 (en) 2012-09-07 2020-09-29 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
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US11884945B2 (en) 2013-01-09 2024-01-30 Takeda Pharmaceutical Company Limited Methods for purification of arylsulfatase A
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
US11576971B2 (en) 2016-04-20 2023-02-14 Coherus Biosciences, Inc. Method of filling a container with no headspace

Also Published As

Publication number Publication date
EP1176979A1 (fr) 2002-02-06
AUPQ026799A0 (en) 1999-06-03
EP1176979A4 (fr) 2005-05-04

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