CA2845579C - Multi-copy strategy for high-titer and high-purity production of multi-subunit proteins such as antibodies in transformed microbes such as pichia pastoris - Google Patents

Multi-copy strategy for high-titer and high-purity production of multi-subunit proteins such as antibodies in transformed microbes such as pichia pastoris Download PDF

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Publication number
CA2845579C
CA2845579C CA2845579A CA2845579A CA2845579C CA 2845579 C CA2845579 C CA 2845579C CA 2845579 A CA2845579 A CA 2845579A CA 2845579 A CA2845579 A CA 2845579A CA 2845579 C CA2845579 C CA 2845579C
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Canada
Prior art keywords
desired antibody
antibody
copies
pichia pastoris
subunit
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CA2845579A
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English (en)
French (fr)
Other versions
CA2845579A1 (en
Inventor
Danielle Marie MITCHELL
Leon F. Garcia-Martinez
Patricia Dianne Mcneill
Ethan Wayne OJALA
Mehmet Inan
John Latham
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H Lundbeck AS
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Alderbio Holdings LLC
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Priority claimed from US13/466,795 external-priority patent/US11214610B2/en
Application filed by Alderbio Holdings LLC filed Critical Alderbio Holdings LLC
Publication of CA2845579A1 publication Critical patent/CA2845579A1/en
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/14Fungi; Culture media therefor
    • C12N1/16Yeasts; Culture media therefor
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/80Vectors or expression systems specially adapted for eukaryotic hosts for fungi
    • C12N15/81Vectors or expression systems specially adapted for eukaryotic hosts for fungi for yeasts
    • C12N15/815Vectors or expression systems specially adapted for eukaryotic hosts for fungi for yeasts for yeasts other than Saccharomyces
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00Preparation of peptides or proteins
    • C12P21/005Glycopeptides, glycoproteins
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00Preparation of peptides or proteins
    • C12P21/02Preparation of peptides or proteins having a known sequence of two or more amino acids, e.g. glutathione
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/01Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/036Fusion polypeptide containing a localisation/targetting motif targeting to the medium outside of the cell, e.g. type III secretion
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/50Fusion polypeptide containing protease site

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Botany (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
CA2845579A 2011-08-19 2012-08-20 Multi-copy strategy for high-titer and high-purity production of multi-subunit proteins such as antibodies in transformed microbes such as pichia pastoris Active CA2845579C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161525307P 2011-08-19 2011-08-19
US61/525,307 2011-08-19
US13/466,795 US11214610B2 (en) 2010-12-01 2012-05-08 High-purity production of multi-subunit proteins such as antibodies in transformed microbes such as Pichia pastoris
US13/466,795 2012-05-08
PCT/US2012/051619 WO2013028635A1 (en) 2011-08-19 2012-08-20 Multi-copy strategy for high-titer and high-purity production of multi-subunit proteins such as a antibodies in transformed microbes such as pichia pastoris

Publications (2)

Publication Number Publication Date
CA2845579A1 CA2845579A1 (en) 2013-02-28
CA2845579C true CA2845579C (en) 2020-03-24

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2845579A Active CA2845579C (en) 2011-08-19 2012-08-20 Multi-copy strategy for high-titer and high-purity production of multi-subunit proteins such as antibodies in transformed microbes such as pichia pastoris

Country Status (14)

Country Link
EP (1) EP2744903B1 (OSRAM)
JP (1) JP6138788B2 (OSRAM)
KR (1) KR101978534B1 (OSRAM)
CN (1) CN103890178A (OSRAM)
AR (1) AR087612A1 (OSRAM)
AU (1) AU2012299035B2 (OSRAM)
BR (1) BR112014003841B1 (OSRAM)
CA (1) CA2845579C (OSRAM)
DK (1) DK2744903T3 (OSRAM)
IL (1) IL230978B (OSRAM)
MX (2) MX355890B (OSRAM)
SG (2) SG2014011878A (OSRAM)
TW (1) TWI666318B (OSRAM)
WO (1) WO2013028635A1 (OSRAM)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10202630B2 (en) 2013-03-15 2019-02-12 Alderbio Holdings Llc Temperature shift for high yield expression of polypeptides in yeast and other transformed cells
EP3754012A1 (en) 2013-03-15 2020-12-23 Alder Biopharmaceuticals, Inc. Antibody purification and purity monitoring
JP6412552B2 (ja) 2013-03-15 2018-10-24 アルダー・バイオファーマシューティカルズ・インコーポレーテッド 酵母及び他の形質転換細胞中のポリペプチドの高収率発現のための温度シフト
JP6206873B2 (ja) * 2013-09-30 2017-10-04 国立研究開発法人農業・食品産業技術総合研究機構 ニワトリリゾチーム由来の分泌シグナルペプチドを用いたブタリゾチームの製造方法
US10556945B2 (en) 2014-03-21 2020-02-11 Teva Pharmaceuticals International Gmbh Antagonist antibodies directed against calcitonin gene-related peptide and methods using same
HRP20240159T1 (hr) 2014-03-21 2024-04-12 Teva Pharmaceuticals International Gmbh Antagonistička protutijela usmjerena protiv peptida povezanog s genom kalcitonina i postupci koji ih koriste
WO2018055574A1 (en) 2016-09-23 2018-03-29 Teva Pharmaceuticals International Gmbh Treating refractory migraine
EP4202035A1 (en) 2021-12-22 2023-06-28 Gelita AG Improved expression of peptides
WO2025141786A1 (ja) * 2023-12-27 2025-07-03 中外製薬株式会社 抗体の製造方法

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4855231A (en) 1984-10-30 1989-08-08 Phillips Petroleum Company Regulatory region for heterologous gene expression in yeast
US4818700A (en) 1985-10-25 1989-04-04 Phillips Petroleum Company Pichia pastoris argininosuccinate lyase gene and uses thereof
US4812405A (en) 1986-02-18 1989-03-14 Phillips Petroleum Company Double auxotrophic mutants of Pichia pastoris and methods for preparation
US4929555A (en) 1987-10-19 1990-05-29 Phillips Petroleum Company Pichia transformation
WO1994021293A1 (en) 1993-03-19 1994-09-29 Duke University Method of treatment of tumors with an antibody binding to tenascin
WO1996004925A1 (en) 1994-08-12 1996-02-22 Immunomedics, Inc. Immunoconjugates and humanized antibodies specific for b-cell lymphoma and leukemia cells
US5955349A (en) 1996-08-26 1999-09-21 Zymogenetics, Inc. Compositions and methods for producing heterologous polypeptides in Pichia methanolica
US5736383A (en) 1996-08-26 1998-04-07 Zymogenetics, Inc. Preparation of Pichia methanolica auxotrophic mutants
US6730499B1 (en) 1998-07-03 2004-05-04 Research Corporation Technologies, Inc. Promoter for the Pichia pastoris formaldehyde dehydrogenase gene FLD1
AU1219000A (en) 1998-10-22 2000-05-08 Regents Of The University Of California, The Functionally assembled antigen-specific intact recombinant antibody and a methodfor production thereof
US6258559B1 (en) 1999-03-22 2001-07-10 Zymogenetics, Inc. Method for producing proteins in transformed Pichia
US6406863B1 (en) * 2000-06-23 2002-06-18 Genetastix Corporation High throughput generation and screening of fully human antibody repertoire in yeast
ES2630224T3 (es) 2003-10-22 2017-08-18 Keck Graduate Institute Métodos para sintetizar polipéptidos heteromultiméricos en levadura con el uso de una estrategia de apareamiento haploide
WO2008063302A2 (en) 2006-10-10 2008-05-29 Keck Graduate Institute Novel p. pastoris pastoris promoters, and the use thereof to direct expression of proteins in yeast, preferably using a haploid mating strategy
KR101829776B1 (ko) 2007-05-21 2018-02-19 앨더바이오 홀딩스 엘엘씨 Il-6에 대한 항체 및 이의 용도
TWI501976B (zh) 2007-05-21 2015-10-01 Alder Biopharmaceuticals Inc 抗TNF-α之抗體及其用途
US11214610B2 (en) 2010-12-01 2022-01-04 H. Lundbeck A/S High-purity production of multi-subunit proteins such as antibodies in transformed microbes such as Pichia pastoris

Also Published As

Publication number Publication date
TWI666318B (zh) 2019-07-21
KR20140057613A (ko) 2014-05-13
IL230978B (en) 2018-08-30
TW201313899A (zh) 2013-04-01
KR101978534B1 (ko) 2019-08-28
BR112014003841B1 (pt) 2022-02-15
SG2014011878A (en) 2014-04-28
EP2744903B1 (en) 2018-10-10
AU2012299035B2 (en) 2017-11-02
IL230978A0 (en) 2014-03-31
WO2013028635A9 (en) 2013-09-26
NZ721102A (en) 2020-01-31
SG10201609752YA (en) 2017-01-27
AU2012299035A1 (en) 2014-03-13
JP2014525247A (ja) 2014-09-29
EP2744903A1 (en) 2014-06-25
AR087612A1 (es) 2014-04-03
MX383145B (es) 2025-03-13
EP2744903A4 (en) 2014-12-31
DK2744903T3 (en) 2019-01-28
CA2845579A1 (en) 2013-02-28
MX355890B (es) 2018-05-03
JP6138788B2 (ja) 2017-05-31
MX2014001951A (es) 2016-02-05
CN103890178A (zh) 2014-06-25
NZ621199A (en) 2016-07-29
WO2013028635A1 (en) 2013-02-28
BR112014003841A2 (pt) 2017-03-14

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