DK3152317T3 - Fremgangsmåder til at høste pattedyrscellekulturer - Google Patents
Fremgangsmåder til at høste pattedyrscellekulturer Download PDFInfo
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- DK3152317T3 DK3152317T3 DK15730015.3T DK15730015T DK3152317T3 DK 3152317 T3 DK3152317 T3 DK 3152317T3 DK 15730015 T DK15730015 T DK 15730015T DK 3152317 T3 DK3152317 T3 DK 3152317T3
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- cell culture
- cells
- bioreactor
- cell
- recombinant protein
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M1/00—Apparatus for enzymology or microbiology
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
- C12M29/10—Perfusion
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
- C12M29/04—Filters; Permeable or porous membranes or plates, e.g. dialysis
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
- C12M29/16—Hollow fibers
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M33/00—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus
- C12M33/14—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus with filters, sieves or membranes
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/48—Automatic or computerized control
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M47/00—Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
- C12M47/02—Separating microorganisms from the culture medium; Concentration of biomass
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M47/00—Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
- C12M47/12—Purification
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/0018—Culture media for cell or tissue culture
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
- C12P21/00—Preparation of peptides or proteins
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- 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
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2510/00—Genetically modified cells
- C12N2510/02—Cells for production
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2511/00—Cells for large scale production
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2523/00—Culture process characterised by temperature
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biotechnology (AREA)
- Genetics & Genomics (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- Sustainable Development (AREA)
- Molecular Biology (AREA)
- Cell Biology (AREA)
- Analytical Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Immunology (AREA)
- Computer Hardware Design (AREA)
- Water Supply & Treatment (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
Claims (15)
1. Fremgangsmåde til at høste et rekombinant protein, omfattende: i. at etablere en cellekultur ved at inokulere en bioreaktor med pattedyrsceller, som udtrykker et rekombinant protein, ii. at vedligeholde cellekulturen ved perfusion af cellekulturen med friske cellekulturmedium, som er formuleret eller suppleret for at opnå en koncentration på mindst 5 g/L af en ikke-ionisk blokcopolymer, iii. at lade cellekulturen passere gennem et filter af hule fibre, som har en porestørrelse eller molekylevægtgrænse, der ikke tilbageholder det rekombinante protein i bioreaktoren, og iv. at opsamle et permeat, som indeholder det rekombinante protein.
2. Fremgangsmåde til at høste et rekombinant protein omfattende i. at etablere en cellekultur ved at inokulere en bioreaktor med pattedyrsceller, som udtrykker et rekombinant protein, ii. at vedligeholde cellekulturen ved perfusion af cellekulturen med friske cellekulturmedier, som er formuleret eller suppleret for at opnå en koncentration på mindst 1 g/L af en ikke-ionisk blokcopolymer og at lade cellekulturen passere gennem et filter af hule fibre, som har en porestørrelse eller molekylevægtgrænse, der tilbageholder det rekombinante protein i bioreaktoren, og at opsamle et permeat, iii. når et forudbestemt parameter er nået, perfusion af cellekulturen med frisk cellekulturmedium, som er formuleret eller suppleret for at opnå en koncentration på mindst 5 g/L af en ikke-ionisk blokcopolymer og at lade cellekulturen passere gennem et filter af hule fibre, som har en porestørrelse eller molekylevægtgrænse, der ikke tilbageholder det rekombinante protein i bioreaktoren og iv. at opsamle et permeat, som indeholde det rekombinante protein.
3. Fremgangsmåde ifølge krav 2, hvor filteret af hule fibre, som har en porestørrelse eller molekylevægtgrænse, der tilbageholder det rekombinante protein i bioreaktoren og filteret af hule fibre, som har en porestørrelse eller molekylevægtgrænse, der ikke tilbageholder det rekombinante protein i bioreaktoren er komponenter af et enkeltenhedsfiltersystem.
4. Fremgangsmåde ifølge kravene 1 -3, hvor filteret af hule fibre, som har en porestørrelse eller molekylevægtgrænse, der ikke tilbageholder det rekombinante protein i bioreaktoren er et mikrofilter.
5. Fremgangsmåde ifølge krav 4, hvor molekylevægtgrænsen for mikrofilteret er mindst 500 kDa.
6. Fremgangsmåde ifølge krav 4, hvor molekylevægtgrænsen for mikrofilteret er 750 kDa.
7. Fremgangsmåde ifølge krav 4, hvor porestørrelsen på mikrofilteret er 0,1 mikrometer til 10 mikrometer.
8. Fremgangsmåde ifølge kravene 2-3, hvor filteret af hule fibre, som har en porestørrelse eller molekylevægtgrænse, der tilbageholder det rekombinante protein i bioreaktoren er et ultrafilter.
9. Fremgangsmåde ifølge krav 8, hvor molekylevægtgrænsen for ultrafilteret er 300 kDa eller mindre.
10. Fremgangsmåde ifølge krav 8, hvor molekylevægtgrænsen for ultrafilteret er 30 kDa.
11. Fremgangsmåde ifølge krav 8, hvor porestørrelsen på ultrafilteret er 0,01 mikrometer til 0,1 mikrometer.
12. Fremgangsmåde ifølge krav 3, hvor enkeltenhedsfiltersystemet er indeholdt i et hus.
13. Fremgangsmåde ifølge krav 3, hvor enkeltenhedsfiltersystemet yderligere omfatter et afstandsstykke mellem mindst to af filterkomponenterne af hule fibre.
14. Fremgangsmåde ifølge kravene 1-3, hvor den ikke-ioniske blokcopolymer er en polyoxypropylen-polyoxyethylen blokcopolymer.
15. Fremgangsmåde ifølge kravene 1-3, hvor den ikke-ioniske blokcopolymer er poloxamer 188.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462007588P | 2014-06-04 | 2014-06-04 | |
PCT/US2015/034297 WO2015188009A1 (en) | 2014-06-04 | 2015-06-04 | Methods for harvesting mammalian cell cultures |
Publications (1)
Publication Number | Publication Date |
---|---|
DK3152317T3 true DK3152317T3 (da) | 2019-04-08 |
Family
ID=53433304
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK15730015.3T DK3152317T3 (da) | 2014-06-04 | 2015-06-04 | Fremgangsmåder til at høste pattedyrscellekulturer |
DK21179944.0T DK3926051T3 (da) | 2014-06-04 | 2015-06-04 | Fremgangsmåder til høst af pattedyrecellekulturer |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK21179944.0T DK3926051T3 (da) | 2014-06-04 | 2015-06-04 | Fremgangsmåder til høst af pattedyrecellekulturer |
Country Status (25)
Country | Link |
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US (3) | US11384378B2 (da) |
EP (4) | EP3926051B1 (da) |
JP (3) | JP6695814B2 (da) |
KR (2) | KR102598799B1 (da) |
CN (1) | CN106687575B (da) |
AU (5) | AU2015269365A1 (da) |
BR (2) | BR112016028285B1 (da) |
CA (2) | CA3195249A1 (da) |
CL (2) | CL2016003096A1 (da) |
CY (1) | CY1121217T1 (da) |
DK (2) | DK3152317T3 (da) |
EA (2) | EA039148B1 (da) |
ES (3) | ES2980493T3 (da) |
FI (1) | FI3926051T3 (da) |
HU (2) | HUE042277T2 (da) |
IL (2) | IL249150B (da) |
LT (2) | LT3152317T (da) |
MX (3) | MX2016015944A (da) |
PL (2) | PL3926051T3 (da) |
PT (2) | PT3152317T (da) |
SG (2) | SG10202113019XA (da) |
SI (2) | SI3926051T1 (da) |
TR (1) | TR201900776T4 (da) |
WO (1) | WO2015188009A1 (da) |
ZA (1) | ZA201608303B (da) |
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