DK1807101T3 - Indretninger og fremgangsmåder til integreret kontinuerlig fremstilling af biologiske molekyler - Google Patents
Indretninger og fremgangsmåder til integreret kontinuerlig fremstilling af biologiske molekyler Download PDFInfo
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- DK1807101T3 DK1807101T3 DK05800224.7T DK05800224T DK1807101T3 DK 1807101 T3 DK1807101 T3 DK 1807101T3 DK 05800224 T DK05800224 T DK 05800224T DK 1807101 T3 DK1807101 T3 DK 1807101T3
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- continuous
- tissue culture
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Classifications
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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
- C12P21/06—Preparation of peptides or proteins produced by the hydrolysis of a peptide bond, e.g. hydrolysate products
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
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- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/145—Ultrafiltration
-
- 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
-
- 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
- C07K1/145—Extraction; Separation; Purification by extraction or solubilisation
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
-
- 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
-
- 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
- C12M1/24—Apparatus for enzymology or microbiology tube or bottle type
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/14—Pressure control
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/16—Flow or flux control
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/10—Specific supply elements
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/10—Specific supply elements
- B01D2313/105—Supply manifolds
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/18—Specific valves
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2317/00—Membrane module arrangements within a plant or an apparatus
- B01D2317/04—Elements in parallel
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- General Health & Medical Sciences (AREA)
- Zoology (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Wood Science & Technology (AREA)
- Biotechnology (AREA)
- Water Supply & Treatment (AREA)
- Analytical Chemistry (AREA)
- General Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Sustainable Development (AREA)
- Biomedical Technology (AREA)
- Gastroenterology & Hepatology (AREA)
- Toxicology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- General Chemical & Material Sciences (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Treatment Of Liquids With Adsorbents In General (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Filtration Of Liquid (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Claims (9)
1. Fremgangsmåde til oprensning af et protein af interesse fra en heterogen vævskultur-fluidblanding, omfattende: (a) at fremstille med en kontinuerlig perfusionsfermenteringsfremgangsmåde en heterogen vævskultur-fluidblanding indeholdende et protein af interesse; (b) at overføre vævskultur-fluidblandingen til en kontinuerlig partikelfjernelsesfremgangsmåde integreret med den kontinuerlige perfusionsfermenteringsfremgangsmåde; (c) at fjerne partikelformige kontaminanter fra vævskulturfluiden i den kontinuerlige partikelfjernelsesfremgangsmåde for at fremstille en klaret vævskulturfluid indeholdende proteinet af interesse; (d) at overføre den klarede vævskulturfluid til en kontinuerlig oprensningsfremgangsmåde integreret med den kontinuerlige partikelfjernelsesfremgangsmåde, hvor den kontinuerlige oprensningsfremgangsmåde er ultrafiltrering og den klarede vævskulturfluid filtreres ved en specifik strømningshastighed som frembringer en vægkoncentration mindre end 20% større end en retentatkoncentration; og (e) at oprense proteinet af interesse fra den klarede vævskulturfluid i den kontinuerlige oprensningsfremgangsmåde; hvor den specifikke strømningshastighed af blandingen igennem den kontinuerlige perfusionsfermenteringsfremgangsmåde, den kontinuerlige partikelfjernelsesfremgangsmåde, og den kontinuerlige oprensningsfremgangsmåde opretholdes i alt væsentligt konstant.
2. Fremgangsmåden ifølge krav 1, hvor den klarede vævskulturblanding filtreres ved en specifik strømningshastighed således at en vægkoncentration mindre end 15% større end retentatkoncentrationen frembringes.
3. Fremgangsmåden ifølge krav 1, hvor den klarede vævskulturblanding filtreres ved en specifik strømningshastighed således at en vægkoncentration mindre end 10% større end retentatkoncentrationen frembringes.
4. Fremgangsmåden ifølge krav 1, hvor den klarede vævskulturblanding filtreres igennem en ultrafiltreringsmembran med et areal i kvadratmeter mellem 0,1 til 2 gange den volumetriske strømningshastighed af den kontinuerlige perfusionsfermentering i liter/time.
5. Fremgangsmåden ifølge krav 1, hvor den klarede vævskulturblanding filtreres igennem en ultrafiltreringsmembran med et areal i kvadratmeter mellem 0,3 til 1 gange den volumetriske strømningshastighed af den kontinuerlige perfusionsfermentering i liter/time.
6. Apparat til at separere et protein af interesse fra en heterogen vævskultur-fluidblanding, omfattende: (a) et kontinuerligt perfusionsfermenteringssystem; (b) et kontinuerligt partikelfjernelsessystem integreret med perfusionsfermenteringssystemet; og (c) et kontinuerligt oprensningssystem som er ultrafiltrering integreret med partikelfjernelsessystemet; hvor apparatet er holdt under sterile forhold.
7. Apparatet ifølge krav 6, omfattende: (a) et kontinuerligt perfusionsfermenteringssystem indrettet til kontinuerligt at fremstille en vævskulturfluid indeholdende et protein af interesse ved en i alt væsentligt konstant volumetrisk strømningshastighed; (b) et kontinuerligt partikelfjernelsessystem integreret med og indrettet til kontinuerligt at modtage vævskulturfluiden fra perfusionsfermenteringssystemet og kontinuerligt fremstille en klaret vævskulturfluid; og (c) et kontinuerligt oprensningssystem som er ultrafiltrering integreret med og indrettet til kontinuerligt at modtage den klarede vævskulturfluid fra partikelfjernelsessystemet og kontinuerligt fremstille et produktisolat indeholdende proteinet af interesse; hvor apparatet er holdt under sterile forhold.
8. Apparatet ifølge krav 7, hvor ultrafiltreringssystemet omfatter en ultrafiltreringsmembran med et areal i kvadratmeter mellem 0,1 til 2 gange den volumetriske strømningshastighed af den kontinuerlige perfusionsfermentering i liter/time.
9. Apparatet ifølge krav 7, hvor ultrafiltreringssystemet omfatter en ultrafiltreringsmembran med et areal i kvadratmeter mellem 0,3 til 1 gange den volumetriske strømningshastighed af den kontinuerlige perfusionsfermentering i liter/time.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US61499504P | 2004-09-30 | 2004-09-30 | |
| PCT/US2005/035364 WO2006039588A2 (en) | 2004-09-30 | 2005-09-30 | Devices and methods for integrated continuous manufacturing of biological molecules |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1807101T3 true DK1807101T3 (da) | 2016-05-23 |
Family
ID=36143124
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK05800224.7T DK1807101T3 (da) | 2004-09-30 | 2005-09-30 | Indretninger og fremgangsmåder til integreret kontinuerlig fremstilling af biologiske molekyler |
| DK12179336.8T DK2550971T3 (da) | 2004-09-30 | 2005-09-30 | Indretninger og fremgangsmåder til integreret kontinuerlig fremstilling af biologiske molekyler |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK12179336.8T DK2550971T3 (da) | 2004-09-30 | 2005-09-30 | Indretninger og fremgangsmåder til integreret kontinuerlig fremstilling af biologiske molekyler |
Country Status (24)
| Country | Link |
|---|---|
| US (3) | US9045725B2 (da) |
| EP (2) | EP1807101B1 (da) |
| JP (2) | JP5579966B2 (da) |
| KR (2) | KR101238798B1 (da) |
| CN (2) | CN101076347B (da) |
| AU (1) | AU2005292358B2 (da) |
| BR (1) | BRPI0515849B1 (da) |
| CA (1) | CA2579845C (da) |
| CY (1) | CY1117699T1 (da) |
| DK (2) | DK1807101T3 (da) |
| ES (2) | ES2634323T3 (da) |
| HR (1) | HRP20070097B1 (da) |
| HU (2) | HUE032538T2 (da) |
| IL (5) | IL181775A (da) |
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