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WO2026009179A1 - Procédé de bioréacteur défini par ph et température pour produire des anticorps d'eptinézumab - Google Patents

Procédé de bioréacteur défini par ph et température pour produire des anticorps d'eptinézumab

Info

Publication number
WO2026009179A1
WO2026009179A1 PCT/IB2025/056740 IB2025056740W WO2026009179A1 WO 2026009179 A1 WO2026009179 A1 WO 2026009179A1 IB 2025056740 W IB2025056740 W IB 2025056740W WO 2026009179 A1 WO2026009179 A1 WO 2026009179A1
Authority
WO
WIPO (PCT)
Prior art keywords
promoter
seq
cells
eptinezumab
temperature
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.)
Pending
Application number
PCT/IB2025/056740
Other languages
English (en)
Inventor
Patricia Dianne Mcneill
Kathy SNOW
Shaun Douglas BARNETT
Kristin Marie ZIEGLER
Barbara BENGTSSON
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.)
H Lundbeck AS
Original Assignee
H Lundbeck AS
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 H Lundbeck AS filed Critical H Lundbeck AS
Publication of WO2026009179A1 publication Critical patent/WO2026009179A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

L'invention concerne un procédé de culture pour la production d'Eptinézumab dans une culture de cellules de mammifère, comprenant la culture de cellules de mammifère, par exemple, des cellules CHO dans un bioréacteur, par exemple, un bioréacteur à alimentation discontinue, lesdites cellules de mammifère comprenant des séquences d'acide nucléique qui permettent l'expression d'Eptinézumab et la culture étant effectuée à une température comprise entre 33 °C et 38 °C et un pH d'environ 7 (par exemple, entre 6,85 et 7,05), par exemple, le pH étant maintenu à environ 7 pendant jusqu'à 14 jours, ou à 6,95.<sp /> Le procédé de culture de l'invention contrôle ou améliore le taux de croissance cellulaire, la viabilité cellulaire, la densité de cellules viables et/ou le titre en anticorps (Eptinézumab) des cellules de mammifère.
PCT/IB2025/056740 2024-07-03 2025-07-02 Procédé de bioréacteur défini par ph et température pour produire des anticorps d'eptinézumab Pending WO2026009179A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463667187P 2024-07-03 2024-07-03
US63/667,187 2024-07-03

Publications (1)

Publication Number Publication Date
WO2026009179A1 true WO2026009179A1 (fr) 2026-01-08

Family

ID=96431135

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2025/056740 Pending WO2026009179A1 (fr) 2024-07-03 2025-07-02 Procédé de bioréacteur défini par ph et température pour produire des anticorps d'eptinézumab

Country Status (1)

Country Link
WO (1) WO2026009179A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2532737A2 (fr) * 2006-09-13 2012-12-12 Abbott Laboratories Améliorations de culture cellulaire
US20150005475A1 (en) * 2012-02-03 2015-01-01 Medimmune Limited Process for reducing antibody aggregate levels and antibodies produced thereby
WO2020227121A1 (fr) * 2019-05-03 2020-11-12 Coherus Biosciences, Inc. Procédé de production d'une protéine recombinée
WO2023161885A1 (fr) * 2022-02-25 2023-08-31 Kashiv Biosciences, Llc Procédé d'amélioration de l'expression de polypeptides dans une culture cellulaire de mammifères
US20230399671A1 (en) * 2020-08-11 2023-12-14 University College Dublin, National University Of Ireland Beta-1,4 galactosylation of proteins

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2532737A2 (fr) * 2006-09-13 2012-12-12 Abbott Laboratories Améliorations de culture cellulaire
US20150005475A1 (en) * 2012-02-03 2015-01-01 Medimmune Limited Process for reducing antibody aggregate levels and antibodies produced thereby
WO2020227121A1 (fr) * 2019-05-03 2020-11-12 Coherus Biosciences, Inc. Procédé de production d'une protéine recombinée
US20230399671A1 (en) * 2020-08-11 2023-12-14 University College Dublin, National University Of Ireland Beta-1,4 galactosylation of proteins
WO2023161885A1 (fr) * 2022-02-25 2023-08-31 Kashiv Biosciences, Llc Procédé d'amélioration de l'expression de polypeptides dans une culture cellulaire de mammifères

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ZHANG JUN-HE ET AL: "Strategies and Considerations for Improving Recombinant Antibody Production and Quality in Chinese Hamster Ovary Cells", FRONTIERS IN BIOENGINEERING AND BIOTECHNOLOGY, vol. 10, 4 March 2022 (2022-03-04), XP055974060, Retrieved from the Internet <URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8934426/pdf/fbioe-10-856049.pdf> DOI: 10.3389/fbioe.2022.856049 *

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