DK3055409T3 - Metabolisk optimeret cellekultur - Google Patents

Metabolisk optimeret cellekultur Download PDF

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Publication number
DK3055409T3
DK3055409T3 DK14851841.8T DK14851841T DK3055409T3 DK 3055409 T3 DK3055409 T3 DK 3055409T3 DK 14851841 T DK14851841 T DK 14851841T DK 3055409 T3 DK3055409 T3 DK 3055409T3
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cells
cell culture
cell
lactate
culture
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DK14851841.8T
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Shawn Lawrence
Amy Johnson
Ann Kim
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Regeneron Pharma
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    • 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
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06Animal cells or tissues; Human cells or tissues
    • 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
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06Animal cells or tissues; Human cells or tissues
    • C12N5/0602Vertebrate cells
    • C12N5/0681Cells of the genital tract; Non-germinal cells from gonads
    • C12N5/0682Cells of the female genital tract, e.g. endometrium; Non-germinal cells from ovaries, e.g. ovarian follicle cells
    • 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
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10Cells modified by introduction of foreign genetic material
    • C12N5/12Fused cells, e.g. hybridomas
    • C12N5/16Animal cells
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], 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
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • 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
    • 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
    • C12N2500/00Specific components of cell culture medium
    • C12N2500/60Buffer, e.g. pH regulation, osmotic pressure
    • 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
    • C12N2511/00Cells for large scale production

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Reproductive Health (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Peptides Or Proteins (AREA)

Claims (17)

1. En metode til kultivering af celler, der omfatter: (a) kultivering af celler i en første cellekultur; (b) bestemmelse af at en stofskifteændring til laktatforbrug har fundet sted i den første cellekultur, og (c) overførsel af cellerne til en anden cellekultur efter at stofskifteændringen til laktatforbrug i cellerne har fundet sted, hvor laktatkoncentrationen i den anden cellekultur indikerer netto laktatforbrug.
2. Metoden i krav 1, hvor cellerne transficeres med DNA, hvorved en polypeptid af interesse indkodes, inden cellerne i en første cellekultur kultiveres, og omfattende opbevaring af en anden cellekultur under forhold, som tillader manifestation af polypeptiden af interesse, og høstning af polypeptiden af interesse fra den anden cellekultur.
3. Metoden i krav 1 eller 2, hvor stofskifteændring til laktatforbrug er påvist af pH, laktat eller basemålinger i den første cellekultur.
4. Metoden i ethvert af krav 1-3, hvor stofskifteændringen til laktatforbrug påvises, efter at pH stiger i det første cellekulturmedium uden tilsætning af base.
5. Metoden i ethvert af krav 1-4, hvor stofskifteændringen finder sted, når cellerne stammer fra eksponentiel fase eller har nået stationær fase i den første cellekultur.
6. Metoden i ethvert af krav 1-5, hvor stofskifteændringen finder sted, når laktatniveauerne stabiliseres i den første cellekultur
7. Metoden i ethvert af krav 1-6, hvor stofskifteændringen finder sted i den første cellekultur ved eller efter 3 dages cellevækst i den første cellekultur.
8. Metoden i ethvert af krav 1-7, hvor de overførte celler har en indpodningscelletæthed på mellem ca. 0,5 x 106 celler/ml til ca. 3,0 x 106 celler/ml i den anden cellekultur.
9. Metoden i ethvert af krav 1-8, hvor trinnet til bestemmelse af stofskifteændring omfatter: (a) måling af pH i den første cellekultur, (b) tilsætning af base for at opretholde pH over en forudbestemt laveste grænse, (c) bestemmelse af at pH er over den forudbestemte laveste grænse i på hinanden følgende intervaller, og (d) ophør af tilsætning af base, derved bestemmes at stofskifteændringen til laktatforbrug har fundet sted i den første cellekultur.
10. Metoden i ethvert af krav 1-9, hvor den første cellekultur er en inokulum celledannelseskultur.
11. Metoden i ethvert af krav 1-10, hvor den anden cellekultur er en produktionskultur.
12. Metoden i ethvert af krav 1-11, hvor overførsel af celler til en anden cellekultur omfatter overførsel af celler til en produktionsbioreaktor.
13. Metoden i ethvert af krav 2-12, hvor polypeptiden af interesse er udvalgt fra gruppen bestående af et antistof, et antigenbindende protein, og et fusionsprotein.
14. Metoden i ethvert af krav 1-12, hvor en eller flere nukleinsyresekvenser er stabilt integrerede i cellernes cellegenom, og hvor nukleinsyresekvensen indkoder en polypeptid af interesse.
15. Metoden i ethvert af krav 1 eller 3-12, hvor cellerne omfatter en eller flere udtryksvektorer, der indkoder en polypeptid af interesse
16. Metoden i ethvert af krav 14 eller krav 15, hvor polypeptiden af interesse er udvalgt fra gruppen bestående af et antistof, et antigenbindende protein og et fusionsprotein.
17. Metoden i ethvert af krav 1-16, hvor cellerne er udvalgt fra gruppen bestående af CHO, COS, retinal, Vero, CV1, HEK293, 293 EBNA, MSR 293, MDCK, HaK, BHK21, HeLa, HepG2, WI38, MRC 5, Colo25, HB 8065, HL-60, Jurkat, Daudi, A431, CV-1, U937, 3T3, L-celle, C127 celle, SP2/0, NS-O, MMT, PER.C6, murinlymfoid og murinhybridomeceller.
DK14851841.8T 2013-10-11 2014-10-10 Metabolisk optimeret cellekultur DK3055409T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361889815P 2013-10-11 2013-10-11
PCT/US2014/059993 WO2015054554A1 (en) 2013-10-11 2014-10-10 Metabolically optimized cell culture

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DK3055409T3 true DK3055409T3 (da) 2018-07-30

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ID=52813657

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DK18161278.9T DK3351620T3 (da) 2013-10-11 2014-10-10 Metabolsk optimeret cellekultur
DK14851841.8T DK3055409T3 (da) 2013-10-11 2014-10-10 Metabolisk optimeret cellekultur
DK20193898.2T DK3812453T3 (da) 2013-10-11 2014-10-10 Metabolisk optimeret cellkultur

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US (2) US20160244725A1 (da)
EP (3) EP3351620B1 (da)
JP (3) JP6663854B2 (da)
KR (4) KR102243980B1 (da)
CN (2) CN105637085A (da)
AU (2) AU2014331776B2 (da)
CA (1) CA2926049C (da)
DK (3) DK3351620T3 (da)
EA (2) EA033783B1 (da)
ES (2) ES2833471T3 (da)
HU (2) HUE039551T2 (da)
IL (2) IL244511A0 (da)
MX (2) MX384960B (da)
PL (2) PL3351620T3 (da)
SG (2) SG10201800772TA (da)
WO (1) WO2015054554A1 (da)
ZA (1) ZA201601550B (da)

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EP3812453A1 (en) 2021-04-28
JP2016532457A (ja) 2016-10-20
SG11201601681QA (en) 2016-04-28
KR20210046835A (ko) 2021-04-28
WO2015054554A1 (en) 2015-04-16
PL3351620T3 (pl) 2021-03-08
ZA201601550B (en) 2023-05-31
DK3351620T3 (da) 2020-10-26
CN114717196A (zh) 2022-07-08
JP6663854B2 (ja) 2020-03-13
CN105637085A (zh) 2016-06-01
ES2833471T3 (es) 2021-06-15
IL262833A (en) 2018-12-31
HK1253275A1 (en) 2019-06-14
JP6967620B2 (ja) 2021-11-17
MX384960B (es) 2025-03-14
JP2020072760A (ja) 2020-05-14
CA2926049C (en) 2023-09-05
KR20230038324A (ko) 2023-03-17
KR20220020415A (ko) 2022-02-18
SG10201800772TA (en) 2018-03-28
EP3812453B1 (en) 2026-03-25
KR20160062032A (ko) 2016-06-01
EP3351620A1 (en) 2018-07-25
EP3351620B1 (en) 2020-09-02
AU2021200193A1 (en) 2021-03-18
HUE039551T2 (hu) 2019-01-28
US20160244725A1 (en) 2016-08-25
CA2926049A1 (en) 2015-04-16
US20210087535A1 (en) 2021-03-25
IL244511A0 (en) 2016-04-21
JP2022009453A (ja) 2022-01-14
EA201690600A1 (ru) 2016-09-30
KR102358807B1 (ko) 2022-02-08
AU2014331776B2 (en) 2020-10-22
ES2678945T3 (es) 2018-08-21
EA033783B1 (ru) 2019-11-25
HK1223122A1 (en) 2017-07-21
EP3055409A1 (en) 2016-08-17
EP3055409B1 (en) 2018-04-25
JP7377243B2 (ja) 2023-11-09
KR102243980B1 (ko) 2021-04-26
EP3055409A4 (en) 2016-09-28
AU2021200193B2 (en) 2023-08-24
MX2020011334A (es) 2021-07-30
KR102610425B1 (ko) 2023-12-06
DK3812453T3 (da) 2026-04-13
EA201991976A1 (ru) 2020-04-02
MX376623B (es) 2025-03-07
HUE051049T2 (hu) 2021-01-28
MX2016004564A (es) 2016-07-12
AU2014331776A1 (en) 2016-03-24
PL3055409T3 (pl) 2018-10-31
KR102510238B1 (ko) 2023-03-16

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