WO2002013859A1 - Methode permettant d'inhiber la coagulation ou la turbidite d'une solution contenant des anticorps - Google Patents

Methode permettant d'inhiber la coagulation ou la turbidite d'une solution contenant des anticorps Download PDF

Info

Publication number
WO2002013859A1
WO2002013859A1 PCT/JP2001/006948 JP0106948W WO0213859A1 WO 2002013859 A1 WO2002013859 A1 WO 2002013859A1 JP 0106948 W JP0106948 W JP 0106948W WO 0213859 A1 WO0213859 A1 WO 0213859A1
Authority
WO
WIPO (PCT)
Prior art keywords
antibody
polysorbate
containing solution
surfactant
concentration
Prior art date
Application number
PCT/JP2001/006948
Other languages
English (en)
Japanese (ja)
Inventor
Masaya Kakuta
Toshiya Saijo
Hajime Moriya
Original Assignee
Chugai Seiyaku Kabushiki Kaisha
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 Chugai Seiyaku Kabushiki Kaisha filed Critical Chugai Seiyaku Kabushiki Kaisha
Priority to AU2001278716A priority Critical patent/AU2001278716A1/en
Priority to JP2002518998A priority patent/JP4812228B2/ja
Publication of WO2002013859A1 publication Critical patent/WO2002013859A1/fr

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers

Definitions

  • Antibodies are important and widely used as components of preventive or therapeutic agents for diseases or as components of diagnostic agents.
  • it may be necessary to ultrafiltrate the antibody-containing solution for various purposes, such as concentrating the antibody-containing solution. During these ultrafiltrations, aggregates or cloudiness may be formed in the antibody-containing solution. It is expected to be caused by insolubilization and aggregation of other contaminants.
  • the use of antibody proteins as therapeutic or diagnostic agents does not produce aggregates or cloudiness, particularly as injections.
  • Sepharose 4B (Pharmacia Fine Chemicals, Piscataway, Inc.) in which the anti-IL-16R antibody MT18 prepared by the method of Hirata et al. (J. Immunol., 143: 2900-2906, 1989) was activated by CNBr. NJ) and purified according to the attached procedure, and purified IL-6R (Yamasaki et al., Science 241: 825-828, 1988).
  • mice were immunized four times every 10 days with the above partially purified IL-6R obtained from 3 ⁇ 10 9 U266 cells, and then a hybridoma was prepared by a conventional method.
  • the hybridoma culture supernatant from the growth positive The binding activity to IL-16R was examined by the method. 5 ⁇ 10 7 U266 cells were labeled with 35 S-methionine (2.5 mCi) and solubilized with the above digitonin buffer.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

L'invention concerne une méthode permettant d'inhiber la coagulation ou la turbidité d'une solution contenant des anticorps au cours d'une ultrafiltration, consistant à ajouter à la solution contenant des anticorps un surfactant tel que le polysorbate. L'invention concerne également une composition contenant des anticorps stable par rapport aux contraintes physiques, contenant de 0,00025 à 0,5 % en poids de surfactant, par exemple du polysorbate, et ne contenant sensiblement pas de sels.
PCT/JP2001/006948 2000-08-10 2001-08-10 Methode permettant d'inhiber la coagulation ou la turbidite d'une solution contenant des anticorps WO2002013859A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2001278716A AU2001278716A1 (en) 2000-08-10 2001-08-10 Method of inhibiting antibody-containing solution from coagulating or becoming turbid
JP2002518998A JP4812228B2 (ja) 2000-08-10 2001-08-10 抗体含有溶液の凝集物生成または白濁抑制方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2000243363 2000-08-10
JP2000-243363 2000-08-10

Publications (1)

Publication Number Publication Date
WO2002013859A1 true WO2002013859A1 (fr) 2002-02-21

Family

ID=18734229

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2001/006948 WO2002013859A1 (fr) 2000-08-10 2001-08-10 Methode permettant d'inhiber la coagulation ou la turbidite d'une solution contenant des anticorps

Country Status (3)

Country Link
JP (1) JP4812228B2 (fr)
AU (1) AU2001278716A1 (fr)
WO (1) WO2002013859A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008156124A1 (fr) * 2007-06-19 2008-12-24 Asahi Kasei Kabushiki Kaisha Procédé de séparation d'un monomère d'immunoglobuline
US8398980B2 (en) 2004-03-24 2013-03-19 Chugai Seiyaku Kabushiki Kaisha Subtypes of humanized antibody against interleuken-6 receptor
US8568720B2 (en) 2007-12-27 2013-10-29 Chugai Seiyaku Kabushiki Kaisha High concentration antibody-containing liquid formulation
US8580264B2 (en) 2010-11-08 2013-11-12 Genentech, Inc. Subcutaneously administered anti-IL-6 receptor antibody
US8741600B2 (en) 2007-06-19 2014-06-03 Asahi Kasei Kabushiki Kaisha Method for separation of immunoglobulin monomers
WO2014115882A1 (fr) 2013-01-28 2014-07-31 国立大学法人 熊本大学 Préparation pharmaceutique sous forme de gel de protéine stabilisée
US8840884B2 (en) 2002-02-14 2014-09-23 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution pharmaceuticals
US20140309403A1 (en) * 2011-03-25 2014-10-16 Genentech, Inc. Novel protein purification methods
US9017677B2 (en) 1997-03-21 2015-04-28 Chugai Seiyaku Kabushiki Kaisha Methods of treating a disease mediated by sensitized T cells
US9255145B2 (en) 2001-04-02 2016-02-09 Chugai Seiyaku Kabushiki Kaisha Therapeutic agent for chronic arthritides diseases of childhood-related diseases
US10168326B2 (en) 2013-07-04 2019-01-01 F. Hoffmann-La Roche Inc. Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples
US10501769B2 (en) 2009-10-26 2019-12-10 Hoffmann-La Roche Inc. Method for the production of a glycosylated immunoglobulin
US10744201B2 (en) 2003-04-28 2020-08-18 Chugai Seiyaku Kabushiki Kaisha Method for treating rheumatoid arthritis with a human IL-6 receptor antibody and methotrexate

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997045140A1 (fr) * 1996-05-24 1997-12-04 Glaxo Group Limited Preparation d'anticorps concentree
EP0865793A1 (fr) * 1997-03-19 1998-09-23 The Green Cross Corporation Composition d'immunoglobulines et leur préparation
WO2000066160A1 (fr) * 1999-04-28 2000-11-09 Yamanouchi Pharmaceutical Co., Ltd. Composition medicamenteuse parenterale a fragment d'anticorps monoclonal humanise et procede de stabilisation

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10265406A (ja) * 1997-03-19 1998-10-06 Green Cross Corp:The 免疫グロブリン製剤

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997045140A1 (fr) * 1996-05-24 1997-12-04 Glaxo Group Limited Preparation d'anticorps concentree
EP0865793A1 (fr) * 1997-03-19 1998-09-23 The Green Cross Corporation Composition d'immunoglobulines et leur préparation
WO2000066160A1 (fr) * 1999-04-28 2000-11-09 Yamanouchi Pharmaceutical Co., Ltd. Composition medicamenteuse parenterale a fragment d'anticorps monoclonal humanise et procede de stabilisation

Cited By (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9017677B2 (en) 1997-03-21 2015-04-28 Chugai Seiyaku Kabushiki Kaisha Methods of treating a disease mediated by sensitized T cells
US9255145B2 (en) 2001-04-02 2016-02-09 Chugai Seiyaku Kabushiki Kaisha Therapeutic agent for chronic arthritides diseases of childhood-related diseases
US9051384B2 (en) 2002-02-14 2015-06-09 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution formulations
US8840884B2 (en) 2002-02-14 2014-09-23 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution pharmaceuticals
US10744201B2 (en) 2003-04-28 2020-08-18 Chugai Seiyaku Kabushiki Kaisha Method for treating rheumatoid arthritis with a human IL-6 receptor antibody and methotrexate
US8398980B2 (en) 2004-03-24 2013-03-19 Chugai Seiyaku Kabushiki Kaisha Subtypes of humanized antibody against interleuken-6 receptor
US8734800B2 (en) 2004-03-24 2014-05-27 Chugai Seiyaku Kabushiki Kaisha Subtypes of humanized antibody against interleukin-6 receptor
US9902777B2 (en) 2004-03-24 2018-02-27 Chugai Seiyaku Kabushiki Kaisha Methods for producing subtypes of humanized antibody against interleukin-6 receptor
JP5099930B2 (ja) * 2007-06-19 2012-12-19 旭化成株式会社 免疫グロブリン１量体の分離方法
WO2008156124A1 (fr) * 2007-06-19 2008-12-24 Asahi Kasei Kabushiki Kaisha Procédé de séparation d'un monomère d'immunoglobuline
US8741600B2 (en) 2007-06-19 2014-06-03 Asahi Kasei Kabushiki Kaisha Method for separation of immunoglobulin monomers
US11008394B2 (en) 2007-12-27 2021-05-18 Chugai Seiyaku Kabushiki Kaisha High concentration antibody-containing liquid formulation
US8568720B2 (en) 2007-12-27 2013-10-29 Chugai Seiyaku Kabushiki Kaisha High concentration antibody-containing liquid formulation
US11767363B2 (en) 2007-12-27 2023-09-26 Chugai Seiyaku Kabushiki Kaisha High concentration antibody-containing liquid formulation
US11584798B2 (en) 2007-12-27 2023-02-21 Hoffmann-La Roche Inc. High concentration antibody-containing liquid formulation
US11359026B2 (en) 2007-12-27 2022-06-14 Chugai Seiyaku Kabushiki Kaisha High concentration antibody-containing liquid formulation
US11377678B2 (en) 2009-10-26 2022-07-05 Hoffman-La Roche Inc. Method for the production of a glycosylated immunoglobulin
US11136610B2 (en) 2009-10-26 2021-10-05 Hoffmann-La Roche Inc. Method for the production of a glycosylated immunoglobulin
US11021728B2 (en) 2009-10-26 2021-06-01 Hoffmann-La Roche Inc. Method for the production of a glycosylated immunoglobulin
US10501769B2 (en) 2009-10-26 2019-12-10 Hoffmann-La Roche Inc. Method for the production of a glycosylated immunoglobulin
US10874677B2 (en) 2010-11-08 2020-12-29 Hoffmann-La Roche Inc. Subcutaneously administered anti-IL-6 receptor antibody
US8580264B2 (en) 2010-11-08 2013-11-12 Genentech, Inc. Subcutaneously administered anti-IL-6 receptor antibody
US10231981B2 (en) 2010-11-08 2019-03-19 Chugai Seiyaku Kabushiki Kaisha Subcutaneously administered anti-IL-6 receptor antibody for treatment of juvenile idiopathic arthritis
US9750752B2 (en) 2010-11-08 2017-09-05 Hoffmann-La Roche Inc. Subcutaneously administered anti-IL-6 receptor antibody
US11622969B2 (en) 2010-11-08 2023-04-11 Hoffmann-La Roche Inc. Subcutaneously administered anti-IL-6 receptor antibody
US11667720B1 (en) 2010-11-08 2023-06-06 Hoffmann-La Roche Inc. Subcutaneously administered anti-IL-6 receptor antibody
US9539263B2 (en) 2010-11-08 2017-01-10 Genentech, Inc. Subcutaneously administered anti-IL-6 receptor antibody for treatment of systemic sclerosis
US20140309403A1 (en) * 2011-03-25 2014-10-16 Genentech, Inc. Novel protein purification methods
US10906934B2 (en) * 2011-03-25 2021-02-02 Genentech, Inc. Protein purification methods
EP2697369B1 (fr) 2011-03-25 2018-06-27 F.Hoffmann-La Roche Ag Nouveaux procédés de purification de protéines
WO2014115882A1 (fr) 2013-01-28 2014-07-31 国立大学法人 熊本大学 Préparation pharmaceutique sous forme de gel de protéine stabilisée
US10761091B2 (en) 2013-07-04 2020-09-01 Hoffmann-La Roche, Inc. Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples
US10168326B2 (en) 2013-07-04 2019-01-01 F. Hoffmann-La Roche Inc. Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples

Also Published As

Publication number Publication date
AU2001278716A1 (en) 2002-02-25
JP4812228B2 (ja) 2011-11-09

Similar Documents

Publication Publication Date Title
EP4186926A1 (fr) Anticorps anti-ccr8 et application correspondante
KR101561314B1 (ko) 항ｉｌ－６ 수용체 항체
KR100996801B1 (ko) 항-ＭＡｄＣＡＭ 항체 조성물
JP5564049B2 (ja) 抗ｃｄ１４７抗体、方法及び使用
ES2444012T3 (es) Composiciones y metodos relacionados con anticuerpos de receptores de glucagón
AU2001295490B2 (en) Antibodies to human IL-1beta
US8940303B2 (en) CD127 binding proteins
JP2021526022A (ja) 抗インターロイキン１７ａ抗体、医薬組成物、およびその使用
US20110105724A1 (en) Novel compounds
CN110945026A (zh) 仅有重链的抗bcma抗体
WO2002013859A1 (fr) Methode permettant d'inhiber la coagulation ou la turbidite d'une solution contenant des anticorps
KR20230009441A (ko) 항-tigit 항체, 이의 제조 방법 및 용도
DK2542261T3 (en) ANTI-BINDING PROTEINS SPECIFIC TO SERUM AMYLOID-P COMPONENT
US20220411513A1 (en) Anti-pd-l1 antigen binding protein and application thereof
KR20210102946A (ko) 항il-17a 항체 및 이의 응용
EP4257603A1 (fr) Composition pharmaceutique comprenant un anticorps anti-facteur de croissance du tissu conjonctif
TW202229337A (zh) 犬抗體變異體
TW202233687A (zh) 貓抗體恆定區中之突變
KR20240049304A (ko) 융합 단백질을 함유하는 약학적 조성물
CN116102659A (zh) 一种抗il-17/vegf双功能融合蛋白及其用途
TW202313698A (zh) 抗ｍａｓｐ－２抗體及其用途
TW202409089A (zh) １型大麻素受體結合蛋白及其用途
TW202222830A (zh) 貓抗體變異體
CN116997357A (zh) 针对gdf-15的抗体
CN114591428A (zh) 抗Dsg1抗体及其应用

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
ENP Entry into the national phase

Ref country code: JP

Ref document number: 2002 518998

Kind code of ref document: A

Format of ref document f/p: F

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase