SG11201807765PA - Antibody-containing preparation - Google Patents

Antibody-containing preparation

Info

Publication number
SG11201807765PA
SG11201807765PA SG11201807765PA SG11201807765PA SG11201807765PA SG 11201807765P A SG11201807765P A SG 11201807765PA SG 11201807765P A SG11201807765P A SG 11201807765PA SG 11201807765P A SG11201807765P A SG 11201807765PA SG 11201807765P A SG11201807765P A SG 11201807765PA
Authority
SG
Singapore
Prior art keywords
antibody
containing preparation
relates
present
containing solution
Prior art date
Application number
SG11201807765PA
Inventor
Atsushi Saeki
Shaw Nishizawa
Hitoshi Sasaki
Chifumi Imai
Tomoyuki Igawa
Original Assignee
Chugai Pharmaceutical Co Ltd
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 Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Publication of SG11201807765PA publication Critical patent/SG11201807765PA/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/22—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
    • 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
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • A61K9/08—Solutions
    • 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
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

Abstract

ANTIBODY-CONTAINING PREPARATION The present invention relates to stable antibody-containing solution formulations in 5 which aggregate formation of Emicizumab (ACE910) which is a bispecific antibody functionally substituting for FVIII, is suppressed. Specifically, the present invention relates to the above-mentioned antibody-containing solution formulations of pH 4.5 to 6.5 that contain the aforementioned bispecific antibody at 20 to 180 mg/mL, 10 mM to 40 mM histidine-aspartate buffer, Poloxamer 188 at 0.2 to 1 mg/mL, and 100 mM to 300 mM arginine. 10 Figure 2
SG11201807765PA 2016-04-28 2017-04-27 Antibody-containing preparation SG11201807765PA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016090590 2016-04-28
PCT/JP2017/016658 WO2017188356A1 (en) 2016-04-28 2017-04-27 Antibody-containing preparation

Publications (1)

Publication Number Publication Date
SG11201807765PA true SG11201807765PA (en) 2018-10-30

Family

ID=60160798

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201807765PA SG11201807765PA (en) 2016-04-28 2017-04-27 Antibody-containing preparation

Country Status (21)

Country Link
US (1) US20210189006A1 (en)
EP (1) EP3449940A4 (en)
JP (3) JP7320943B2 (en)
KR (1) KR102456742B1 (en)
CN (2) CN108883178B (en)
AR (1) AR108240A1 (en)
AU (1) AU2017255077A1 (en)
BR (1) BR112018067792A2 (en)
CA (1) CA3016301A1 (en)
CL (1) CL2018003022A1 (en)
CR (1) CR20180554A (en)
HK (1) HK1257953A1 (en)
IL (1) IL262589A (en)
MA (1) MA44780A (en)
MX (1) MX2018012648A (en)
PE (1) PE20181889A1 (en)
RU (1) RU2748046C2 (en)
SG (1) SG11201807765PA (en)
TW (2) TW202402326A (en)
UA (1) UA126900C2 (en)
WO (1) WO2017188356A1 (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101198698B (en) 2005-03-31 2014-03-19 中外制药株式会社 Process for production of polypeptide by regulation of assembly
EP3345616A1 (en) 2006-03-31 2018-07-11 Chugai Seiyaku Kabushiki Kaisha Antibody modification method for purifying bispecific antibody
CA2647846C (en) 2006-03-31 2016-06-21 Chugai Seiyaku Kabushiki Kaisha Methods for controlling blood pharmacokinetics of antibodies
CN106519025B (en) 2007-09-26 2021-04-23 中外制药株式会社 Method for changing isoelectric point of antibody by using amino acid substitution of CDR
TWI505838B (en) 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody
WO2012067176A1 (en) 2010-11-17 2012-05-24 中外製薬株式会社 Multi-specific antigen-binding molecule having alternative function to function of blood coagulation factor viii
KR102441231B1 (en) 2013-09-27 2022-09-06 추가이 세이야쿠 가부시키가이샤 Method for producing polypeptide heteromultimer
TWI701435B (en) 2014-09-26 2020-08-11 日商中外製藥股份有限公司 Method to determine the reactivity of FVIII
TWI700300B (en) 2014-09-26 2020-08-01 日商中外製藥股份有限公司 Antibodies that neutralize substances with the function of FVIII coagulation factor (FVIII)
US11142587B2 (en) 2015-04-01 2021-10-12 Chugai Seiyaku Kabushiki Kaisha Method for producing polypeptide hetero-oligomer
EP3398965A4 (en) 2015-12-28 2019-09-18 Chugai Seiyaku Kabushiki Kaisha Method for promoting efficiency of purification of fc region-containing polypeptide
MA46200A (en) 2016-09-06 2019-07-17 Chugai Pharmaceutical Co Ltd METHODS FOR USING A BISPECIFIC ANTIBODY WHICH RECOGNIZES COAGULATION FACTOR IX AND / OR COAGULATION FACTOR IX ACTIVATED AND COAGULATION FACTOR X AND / OR COAGULATION FACTOR X ACTIVATED
AR113142A1 (en) 2017-09-29 2020-01-29 Chugai Pharmaceutical Co Ltd MULTISPECIFIC ANTIGEN BINDING MOLECULES THAT HAVE SUBSTITUTION ACTIVITY FOR THE COFACTOR FUNCTION OF BLOOD COAGULATION FACTOR VIII (FVIII), AND PHARMACEUTICAL FORMULATIONS CONTAINING SUCH ACTIVE MOLECULE AS INGREDIENT
FR3082427B1 (en) 2018-06-14 2020-09-25 Lab Francais Du Fractionnement COMBINATION OF FACTOR VII AND A BISPECIFIC ANTIBODY ANTI-FACTORS IX AND X
WO2020053301A1 (en) * 2018-09-11 2020-03-19 Ichnos Sciences S.A. Compositions comprising a bispecific antibody, bufffer and one or more stabilizing agents
CN111665352A (en) * 2020-06-23 2020-09-15 广州市丹蓝生物科技有限公司 Storage agent, antibody solution preparation prepared from storage agent and application of antibody solution preparation
WO2022166918A1 (en) * 2021-02-05 2022-08-11 百奥泰生物制药股份有限公司 Anti-il-5 antibody formulation, preparation method therefor and use thereof
WO2023058705A1 (en) * 2021-10-08 2023-04-13 中外製薬株式会社 Drug formulation of anti-hla-dq2.5 antibody
WO2023100975A1 (en) * 2021-12-01 2023-06-08 中外製薬株式会社 Method for preparing antibody-containing formulation
CN114544839A (en) * 2022-01-20 2022-05-27 未名生物医药有限公司 Charge variant detection method for anti-human nerve growth factor antibody

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4340062B2 (en) 2000-10-12 2009-10-07 ジェネンテック・インコーポレーテッド Concentrated protein preparation with reduced viscosity
AU2003271174A1 (en) 2003-10-10 2005-04-27 Chugai Seiyaku Kabushiki Kaisha Double specific antibodies substituting for functional protein
US20100003254A1 (en) 2005-04-08 2010-01-07 Chugai Seiyaku Kabushiki Kaisha Antibody Substituting for Function of Blood Coagulation Factor VIII
PE20091174A1 (en) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd LIQUID FORMULATION WITH HIGH CONCENTRATION OF ANTIBODY CONTENT
TWI505838B (en) 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody
WO2012067176A1 (en) 2010-11-17 2012-05-24 中外製薬株式会社 Multi-specific antigen-binding molecule having alternative function to function of blood coagulation factor viii
HUE028440T2 (en) 2012-03-08 2016-12-28 Hoffmann La Roche Abeta antibody formulation
TW201625299A (en) * 2014-06-20 2016-07-16 Chugai Pharmaceutical Co Ltd Pharmaceutical composition for use in prevention and/or treatment of disease that develops or progresses as a result of decrease or loss of activity of blood coagulation factor viii and/or activated blood coagulation factor viii

Also Published As

Publication number Publication date
KR102456742B1 (en) 2022-10-19
JP7320943B2 (en) 2023-08-04
CA3016301A1 (en) 2017-11-02
JP2023145766A (en) 2023-10-11
HK1257953A1 (en) 2019-11-01
TW201737942A (en) 2017-11-01
BR112018067792A2 (en) 2019-02-12
TWI820000B (en) 2023-11-01
IL262589A (en) 2018-12-31
CL2018003022A1 (en) 2019-01-18
AU2017255077A1 (en) 2018-10-04
RU2748046C2 (en) 2021-05-19
US20210189006A1 (en) 2021-06-24
MA44780A (en) 2019-03-06
UA126900C2 (en) 2023-02-22
CN116059353A (en) 2023-05-05
EP3449940A4 (en) 2020-01-22
PE20181889A1 (en) 2018-12-11
RU2018141173A3 (en) 2020-06-11
MX2018012648A (en) 2019-01-30
WO2017188356A1 (en) 2017-11-02
KR20190003596A (en) 2019-01-09
AR108240A1 (en) 2018-08-01
JP2022037069A (en) 2022-03-08
RU2018141173A (en) 2020-05-28
CN108883178B (en) 2023-03-14
TW202402326A (en) 2024-01-16
EP3449940A1 (en) 2019-03-06
CN108883178A (en) 2018-11-23
JPWO2017188356A1 (en) 2019-03-07
CR20180554A (en) 2019-01-10

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