CA2903611C - Formulation of an antibody and use thereof - Google Patents

Formulation of an antibody and use thereof Download PDF

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Publication number
CA2903611C
CA2903611C CA2903611A CA2903611A CA2903611C CA 2903611 C CA2903611 C CA 2903611C CA 2903611 A CA2903611 A CA 2903611A CA 2903611 A CA2903611 A CA 2903611A CA 2903611 C CA2903611 C CA 2903611C
Authority
CA
Canada
Prior art keywords
lymphoma
antibody
lyophilized formulation
cell
formulation
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.)
Active
Application number
CA2903611A
Other languages
English (en)
French (fr)
Other versions
CA2903611A1 (en
Inventor
Markus Rast
Wolfgang Ise
Gerhard Becker
Peter Skufca
Henning GIESELER
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.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda 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 Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Publication of CA2903611A1 publication Critical patent/CA2903611A1/en
Application granted granted Critical
Publication of CA2903611C publication Critical patent/CA2903611C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Communicable Diseases (AREA)
  • Rheumatology (AREA)
  • Epidemiology (AREA)
  • Biotechnology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
CA2903611A 2013-03-15 2014-03-17 Formulation of an antibody and use thereof Active CA2903611C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201361787225P 2013-03-15 2013-03-15
US61/787,225 2013-03-15
EP13159325.3 2013-03-15
EP13159325 2013-03-15
PCT/EP2014/055279 WO2014140361A1 (en) 2013-03-15 2014-03-17 Formulation of an antibody and use thereof

Publications (2)

Publication Number Publication Date
CA2903611A1 CA2903611A1 (en) 2014-09-18
CA2903611C true CA2903611C (en) 2023-11-07

Family

ID=47900830

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2903611A Active CA2903611C (en) 2013-03-15 2014-03-17 Formulation of an antibody and use thereof

Country Status (6)

Country Link
US (2) US11576863B2 (cg-RX-API-DMAC10.html)
EP (1) EP2970465B1 (cg-RX-API-DMAC10.html)
JP (1) JP6407174B2 (cg-RX-API-DMAC10.html)
CN (1) CN105189559B (cg-RX-API-DMAC10.html)
CA (1) CA2903611C (cg-RX-API-DMAC10.html)
WO (1) WO2014140361A1 (cg-RX-API-DMAC10.html)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6594272B2 (ja) * 2016-09-02 2019-10-23 株式会社東芝 半導体装置及びその製造方法
CN110022855B (zh) 2016-10-07 2024-07-16 瑞泽恩制药公司 室温稳定的冻干蛋白质
WO2020013126A1 (ja) * 2018-07-09 2020-01-16 国立大学法人 熊本大学 環状一本鎖抗体
MX2021007047A (es) * 2018-12-14 2021-10-26 Morphosys Ag Formulaciones de anticuerpos.
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
RU2754760C2 (ru) * 2019-04-02 2021-09-07 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция анти-il17a антитела и ее применение
CN114555117A (zh) * 2019-10-12 2022-05-27 百奥泰生物制药股份有限公司 抗cd20抗体制剂及抗cd20抗体在治疗cd20阳性疾病中的应用
CN112675126A (zh) * 2019-10-18 2021-04-20 百奥泰生物制药股份有限公司 抗cd20抗体制剂及其应用
CN113082203B (zh) * 2020-01-09 2023-10-20 鲁南制药集团股份有限公司 一种免疫抑制剂单克隆抗体的液体制剂
CN116782889A (zh) * 2020-11-16 2023-09-19 生物技术欧洲股份公司 增强的制剂稳定性和改善的冻干工艺
US20230414516A1 (en) * 2020-11-16 2023-12-28 BioNTech SE Enhanced formulation stabilization and improved lyophilization processes
CN113855798A (zh) * 2021-09-30 2021-12-31 佛山汉腾生物科技有限公司 抗cd20的抗体制剂

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
ATE454137T1 (de) 2001-07-25 2010-01-15 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
EP2377554A1 (en) 2005-07-22 2011-10-19 Amgen, Inc Concentrated protein lyophilates, methods and uses
US20090208492A1 (en) 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
JP2010531340A (ja) * 2007-07-10 2010-09-24 エフ．ホフマン−ラ ロシュ アーゲー 新規処方物
WO2009080541A1 (en) * 2007-12-21 2009-07-02 F. Hoffmann-La Roche Ag Antibody formulation
CN102159243B (zh) * 2008-07-21 2015-08-19 免疫医疗公司 用于改良的治疗特征的抗体的结构变体
JP5785077B2 (ja) 2008-08-05 2015-09-24 ワイス・エルエルシー 崩壊温度より高温での凍結乾燥
MX2011013722A (es) 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
WO2010148321A1 (en) * 2009-06-18 2010-12-23 Wyeth Llc Slow dissolution method for reconstitution of lyophilized material
WO2011017070A1 (en) 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
AR078161A1 (es) * 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
AU2012250924B2 (en) * 2011-05-02 2017-05-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
EP2727602A1 (en) * 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody

Also Published As

Publication number Publication date
EP2970465A1 (en) 2016-01-20
JP2016512218A (ja) 2016-04-25
JP6407174B2 (ja) 2018-10-17
US11576863B2 (en) 2023-02-14
WO2014140361A1 (en) 2014-09-18
CA2903611A1 (en) 2014-09-18
US11433029B2 (en) 2022-09-06
CN105189559A (zh) 2015-12-23
CN105189559B (zh) 2021-07-13
US20160022585A1 (en) 2016-01-28
EP2970465B1 (en) 2019-09-25
US20140271636A1 (en) 2014-09-18

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