CA2984981A1 - Modular system and method for continuously producing and/or preparing a product in a disinfected manner - Google Patents
Modular system and method for continuously producing and/or preparing a product in a disinfected manner Download PDFInfo
- Publication number
- CA2984981A1 CA2984981A1 CA2984981A CA2984981A CA2984981A1 CA 2984981 A1 CA2984981 A1 CA 2984981A1 CA 2984981 A CA2984981 A CA 2984981A CA 2984981 A CA2984981 A CA 2984981A CA 2984981 A1 CA2984981 A1 CA 2984981A1
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- Prior art keywords
- product
- microbe
- filter
- steps
- protein
- 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.)
- Abandoned
Links
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- 239000000047 product Substances 0.000 claims abstract description 105
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- 238000004587 chromatography analysis Methods 0.000 claims abstract description 44
- 238000001914 filtration Methods 0.000 claims abstract description 44
- 239000012530 fluid Substances 0.000 claims abstract description 33
- 239000012528 membrane Substances 0.000 claims abstract description 27
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- 229960000074 biopharmaceutical Drugs 0.000 claims abstract description 15
- 239000000203 mixture Substances 0.000 claims abstract description 15
- 238000000108 ultra-filtration Methods 0.000 claims abstract description 14
- 238000011026 diafiltration Methods 0.000 claims abstract description 9
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- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims description 16
- 230000002209 hydrophobic effect Effects 0.000 claims description 14
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- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 9
- RAXXELZNTBOGNW-UHFFFAOYSA-N imidazole Natural products C1=CNC=N1 RAXXELZNTBOGNW-UHFFFAOYSA-N 0.000 claims description 9
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- XBDQKXXYIPTUBI-UHFFFAOYSA-N dimethylselenoniopropionate Natural products CCC(O)=O XBDQKXXYIPTUBI-UHFFFAOYSA-N 0.000 claims description 7
- 239000007789 gas Substances 0.000 claims description 7
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 claims description 6
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- 102000007056 Recombinant Fusion Proteins Human genes 0.000 claims description 6
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- LLEMOWNGBBNAJR-UHFFFAOYSA-N biphenyl-2-ol Chemical compound OC1=CC=CC=C1C1=CC=CC=C1 LLEMOWNGBBNAJR-UHFFFAOYSA-N 0.000 claims description 6
- VKYKSIONXSXAKP-UHFFFAOYSA-N hexamethylenetetramine Chemical compound C1N(C2)CN3CN1CN2C3 VKYKSIONXSXAKP-UHFFFAOYSA-N 0.000 claims description 6
- 239000003446 ligand Substances 0.000 claims description 6
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- 230000008859 change Effects 0.000 claims description 4
- 235000010300 dimethyl dicarbonate Nutrition 0.000 claims description 4
- 239000004316 dimethyl dicarbonate Substances 0.000 claims description 4
- 235000010350 erythorbic acid Nutrition 0.000 claims description 4
- 235000010299 hexamethylene tetramine Nutrition 0.000 claims description 4
- 239000004312 hexamethylene tetramine Substances 0.000 claims description 4
- 229910052751 metal Inorganic materials 0.000 claims description 4
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- 235000010292 orthophenyl phenol Nutrition 0.000 claims description 4
- 239000004306 orthophenyl phenol Substances 0.000 claims description 4
- 235000019260 propionic acid Nutrition 0.000 claims description 4
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- 239000004334 sorbic acid Substances 0.000 claims description 4
- 230000001954 sterilising effect Effects 0.000 claims description 4
- CIWBSHSKHKDKBQ-DUZGATOHSA-N D-isoascorbic acid Chemical compound OC[C@@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-DUZGATOHSA-N 0.000 claims description 3
- GZDFHIJNHHMENY-UHFFFAOYSA-N Dimethyl dicarbonate Chemical compound COC(=O)OC(=O)OC GZDFHIJNHHMENY-UHFFFAOYSA-N 0.000 claims description 3
- 102000016943 Muramidase Human genes 0.000 claims description 3
- 108010014251 Muramidase Proteins 0.000 claims description 3
- 108010062010 N-Acetylmuramoyl-L-alanine Amidase Proteins 0.000 claims description 3
- NVNLLIYOARQCIX-MSHCCFNRSA-N Nisin Chemical compound N1C(=O)[C@@H](CC(C)C)NC(=O)C(=C)NC(=O)[C@@H]([C@H](C)CC)NC(=O)[C@@H](NC(=O)C(=C/C)/NC(=O)[C@H](N)[C@H](C)CC)CSC[C@@H]1C(=O)N[C@@H]1C(=O)N2CCC[C@@H]2C(=O)NCC(=O)N[C@@H](C(=O)N[C@H](CCCCN)C(=O)N[C@@H]2C(NCC(=O)N[C@H](C)C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCSC)C(=O)NCC(=O)N[C@H](CS[C@@H]2C)C(=O)N[C@H](CC(N)=O)C(=O)N[C@H](CCSC)C(=O)N[C@H](CCCCN)C(=O)N[C@@H]2C(N[C@H](C)C(=O)N[C@@H]3C(=O)N[C@@H](C(N[C@H](CC=4NC=NC=4)C(=O)N[C@H](CS[C@@H]3C)C(=O)N[C@H](CO)C(=O)N[C@H]([C@H](C)CC)C(=O)N[C@H](CC=3NC=NC=3)C(=O)N[C@H](C(C)C)C(=O)NC(=C)C(=O)N[C@H](CCCCN)C(O)=O)=O)CS[C@@H]2C)=O)=O)CS[C@@H]1C NVNLLIYOARQCIX-MSHCCFNRSA-N 0.000 claims description 3
- 108010053775 Nisin Proteins 0.000 claims description 3
- LSNNMFCWUKXFEE-UHFFFAOYSA-N Sulfurous acid Chemical class OS(O)=O LSNNMFCWUKXFEE-UHFFFAOYSA-N 0.000 claims description 3
- 238000005411 Van der Waals force Methods 0.000 claims description 3
- 229960000583 acetic acid Drugs 0.000 claims description 3
- 229960005070 ascorbic acid Drugs 0.000 claims description 3
- 150000001540 azides Chemical class 0.000 claims description 3
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 3
- 239000013522 chelant Substances 0.000 claims description 3
- 150000002148 esters Chemical class 0.000 claims description 3
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 3
- 229940026239 isoascorbic acid Drugs 0.000 claims description 3
- 235000010335 lysozyme Nutrition 0.000 claims description 3
- 239000004325 lysozyme Substances 0.000 claims description 3
- 229960000274 lysozyme Drugs 0.000 claims description 3
- 235000010298 natamycin Nutrition 0.000 claims description 3
- 239000004311 natamycin Substances 0.000 claims description 3
- 150000002823 nitrates Chemical class 0.000 claims description 3
- 150000002826 nitrites Chemical class 0.000 claims description 3
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 3
- IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 claims description 3
- 229940075582 sorbic acid Drugs 0.000 claims description 3
- 238000004659 sterilization and disinfection Methods 0.000 claims description 3
- CSABAZBYIWDIDE-UHFFFAOYSA-N sulfino hydrogen sulfite Chemical class OS(=O)OS(O)=O CSABAZBYIWDIDE-UHFFFAOYSA-N 0.000 claims description 3
- 108010041986 DNA Vaccines Proteins 0.000 claims description 2
- 229940021995 DNA vaccine Drugs 0.000 claims description 2
- 229940022005 RNA vaccine Drugs 0.000 claims description 2
- 239000001307 helium Substances 0.000 claims description 2
- 229910052734 helium Inorganic materials 0.000 claims description 2
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 claims description 2
- 108700021021 mRNA Vaccine Proteins 0.000 claims description 2
- NCXMLFZGDNKEPB-FFPOYIOWSA-N natamycin Chemical compound O[C@H]1[C@@H](N)[C@H](O)[C@@H](C)O[C@H]1O[C@H]1/C=C/C=C/C=C/C=C/C[C@@H](C)OC(=O)/C=C/[C@H]2O[C@@H]2C[C@H](O)C[C@](O)(C[C@H](O)[C@H]2C(O)=O)O[C@H]2C1 NCXMLFZGDNKEPB-FFPOYIOWSA-N 0.000 claims description 2
- 229960003255 natamycin Drugs 0.000 claims description 2
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- 238000002604 ultrasonography Methods 0.000 claims description 2
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- 238000004140 cleaning Methods 0.000 abstract description 6
- 238000004113 cell culture Methods 0.000 abstract description 5
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 15
- 238000010924 continuous production Methods 0.000 description 9
- 230000010412 perfusion Effects 0.000 description 8
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- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 description 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 2
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- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 2
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- SCVFZCLFOSHCOH-UHFFFAOYSA-M potassium acetate Substances [K+].CC([O-])=O SCVFZCLFOSHCOH-UHFFFAOYSA-M 0.000 description 1
- 235000011056 potassium acetate Nutrition 0.000 description 1
- 239000004293 potassium hydrogen sulphite Substances 0.000 description 1
- 235000010259 potassium hydrogen sulphite Nutrition 0.000 description 1
- 239000004304 potassium nitrite Substances 0.000 description 1
- 235000010289 potassium nitrite Nutrition 0.000 description 1
- 239000004331 potassium propionate Substances 0.000 description 1
- 235000010332 potassium propionate Nutrition 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 1
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- 239000011347 resin Substances 0.000 description 1
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- 239000004290 sodium methyl p-hydroxybenzoate Substances 0.000 description 1
- 235000010268 sodium methyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004307 sodium orthophenyl phenol Substances 0.000 description 1
- 235000010294 sodium orthophenyl phenol Nutrition 0.000 description 1
- 239000004328 sodium tetraborate Substances 0.000 description 1
- 235000010339 sodium tetraborate Nutrition 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
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- 239000000126 substance Substances 0.000 description 1
- 239000004291 sulphur dioxide Substances 0.000 description 1
- 235000010269 sulphur dioxide Nutrition 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
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- 238000012546 transfer Methods 0.000 description 1
- 238000009281 ultraviolet germicidal irradiation Methods 0.000 description 1
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Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/24—Dialysis ; Membrane extraction
- B01D61/243—Dialysis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
- B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
- B01D15/1864—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D19/00—Degasification of liquids
- B01D19/0031—Degasification of liquids by filtration
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/145—Ultrafiltration
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/58—Multistep processes
-
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
-
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- 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
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- 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
- C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
-
- 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
-
- 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
- C12M47/16—Sterilization
-
- 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
- B01D2311/12—Addition of chemical agents
-
- 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
- B01D2311/26—Further operations combined with membrane separation processes
- B01D2311/2626—Absorption or adsorption
-
- 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
- B01D2311/26—Further operations combined with membrane separation processes
- B01D2311/2649—Filtration
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2315/00—Details relating to the membrane module operation
- B01D2315/16—Diafiltration
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
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- Genetics & Genomics (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
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- Analytical Chemistry (AREA)
- Water Supply & Treatment (AREA)
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- Medicinal Chemistry (AREA)
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- Sustainable Development (AREA)
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- General Engineering & Computer Science (AREA)
- Urology & Nephrology (AREA)
- Immunology (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
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| EP15166686.4A EP3015542A1 (de) | 2015-05-07 | 2015-05-07 | Modulare anlage und verfahren zur kontinuierlichen, keimreduzierten produktion und/oder aufbereitung eines produktes |
| EP15166686.4 | 2015-05-07 | ||
| PCT/EP2016/059700 WO2016177650A1 (de) | 2015-05-07 | 2016-04-29 | Modulare anlage und verfahren zur kontinuierlichen, keimreduzierten produktion und/oder aufbereitung eines produktes |
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| CA2984981A1 true CA2984981A1 (en) | 2016-11-10 |
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| CA2984981A Abandoned CA2984981A1 (en) | 2015-05-07 | 2016-04-29 | Modular system and method for continuously producing and/or preparing a product in a disinfected manner |
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Families Citing this family (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9950282B2 (en) | 2012-03-15 | 2018-04-24 | Flodesign Sonics, Inc. | Electronic configuration and control for acoustic standing wave generation |
| US10967298B2 (en) | 2012-03-15 | 2021-04-06 | Flodesign Sonics, Inc. | Driver and control for variable impedence load |
| US9458450B2 (en) | 2012-03-15 | 2016-10-04 | Flodesign Sonics, Inc. | Acoustophoretic separation technology using multi-dimensional standing waves |
| US10704021B2 (en) | 2012-03-15 | 2020-07-07 | Flodesign Sonics, Inc. | Acoustic perfusion devices |
| CA2935960C (en) | 2014-01-08 | 2023-01-10 | Bart Lipkens | Acoustophoresis device with dual acoustophoretic chamber |
| US11377651B2 (en) | 2016-10-19 | 2022-07-05 | Flodesign Sonics, Inc. | Cell therapy processes utilizing acoustophoresis |
| US11708572B2 (en) | 2015-04-29 | 2023-07-25 | Flodesign Sonics, Inc. | Acoustic cell separation techniques and processes |
| US11021699B2 (en) | 2015-04-29 | 2021-06-01 | FioDesign Sonics, Inc. | Separation using angled acoustic waves |
| US11474085B2 (en) | 2015-07-28 | 2022-10-18 | Flodesign Sonics, Inc. | Expanded bed affinity selection |
| US11459540B2 (en) | 2015-07-28 | 2022-10-04 | Flodesign Sonics, Inc. | Expanded bed affinity selection |
| US11085035B2 (en) | 2016-05-03 | 2021-08-10 | Flodesign Sonics, Inc. | Therapeutic cell washing, concentration, and separation utilizing acoustophoresis |
| US11214789B2 (en) | 2016-05-03 | 2022-01-04 | Flodesign Sonics, Inc. | Concentration and washing of particles with acoustics |
| CN110494543A (zh) | 2016-10-19 | 2019-11-22 | 弗洛设计声能学公司 | 通过声学的亲和细胞提取 |
| AU2017358509A1 (en) * | 2016-11-11 | 2019-05-09 | Bayer Aktiengesellschaft | Method for sampling fluid streams for monitoring contaminants in a continuous flow |
| EP3141594A3 (en) * | 2016-11-11 | 2017-06-14 | Bayer Pharma Aktiengesellschaft | Method for sampling fluid streams for monitoring contaminants in a continuous flow |
| CN106474466B (zh) * | 2016-12-07 | 2018-04-13 | 申联生物医药(上海)股份有限公司 | 一种口蹄疫疫苗的制备方法 |
| US20200038778A1 (en) | 2017-02-17 | 2020-02-06 | Bayer Aktiengesellschaft | Degassing in methods for continuous processing of a healthcare product |
| EP3363517A1 (en) | 2017-02-17 | 2018-08-22 | Bayer Healthcare LLC | Degassing in methods for continuous production of a healthcare product |
| CN107286226A (zh) * | 2017-06-28 | 2017-10-24 | 浙江新银象生物工程有限公司 | 高清澈度和高效价乳酸链球菌素水溶液的制备方法 |
| EP3431168A1 (en) * | 2017-07-19 | 2019-01-23 | Bayer Aktiengesellschaft | Élimination de médicament non lié après couplage conjugué anticorps-médicament |
| DE102017127020A1 (de) * | 2017-11-16 | 2019-05-16 | Sartorius Stedim Biotech Gmbh | Verfahren zum Filtrieren eines großen Volumens eines Mediums mit einer vorsterilisierbaren, wenigstens teilautomatisierten Einweg-Filtrationsvorrichtung |
| DE102017127017A1 (de) * | 2017-11-16 | 2019-05-16 | Sartorius Stedim Biotech Gmbh | Automatisierte Einweg-Filtrationsvorrichtung und Verfahren zur Steuerung einer automatisierten Einweg-Filtrationsvorrichtung |
| KR20220066413A (ko) | 2017-12-14 | 2022-05-24 | 프로디자인 소닉스, 인크. | 음향 트랜스듀서 구동기 및 제어기 |
| US10792618B2 (en) * | 2018-06-19 | 2020-10-06 | Sartorius Stedim Biotech Gmbh | Particle separation and/or purification of a fluid |
| US11028359B2 (en) * | 2018-09-11 | 2021-06-08 | Global Life Sciences Solutions Usa Llc | Separation devices, associated methods, and systems |
| US20210355428A1 (en) * | 2018-10-19 | 2021-11-18 | Univercells Technologies S.A. | Method for decontaminating a biomolecule production system and a system suitable for decontamination |
| US11433332B2 (en) | 2018-11-05 | 2022-09-06 | Hollingsworth & Vose Company | Filter media with irregular structure |
| US11420143B2 (en) * | 2018-11-05 | 2022-08-23 | Hollingsworth & Vose Company | Filter media with irregular structure and/or reversibly stretchable layers |
| EP3663623A1 (en) * | 2018-12-05 | 2020-06-10 | Bayer AG | Pressure stabilizer |
| CN109603201B (zh) * | 2018-12-28 | 2021-07-16 | 晨光生物科技集团股份有限公司 | 辣椒提取物中苯甲酸的去除方法 |
| JP7231419B2 (ja) * | 2019-01-22 | 2023-03-01 | 日東電工株式会社 | 分離膜モジュール及びそれを用いた液体処理システム |
| CN110776138B (zh) * | 2019-10-31 | 2021-12-24 | 南京工大膜应用技术研究所有限公司 | 一种钢铁酸洗废水膜法处理装置及方法 |
| DE102020103925A1 (de) * | 2020-02-14 | 2021-08-19 | Sartorius Stedim Biotech Gmbh | Einweg-Vorrichtung zur Separation oder Aufreinigung eines großen Volumens eines Stoffgemischs |
| JPWO2022196698A1 (enExample) * | 2021-03-15 | 2022-09-22 | ||
| JPWO2022215495A1 (enExample) * | 2021-04-08 | 2022-10-13 | ||
| TWI788850B (zh) * | 2021-05-17 | 2023-01-01 | 張勝致 | 生物力學測試系統及其反應器模組 |
| CN118973592A (zh) | 2022-03-30 | 2024-11-15 | 富士胶片株式会社 | 生物制药的原料药的制造方法、生物制药的原料药的制造系统及生物制药的原料药 |
| CN118984710A (zh) * | 2022-03-30 | 2024-11-19 | 富士胶片株式会社 | 生物制药的原料药的制造方法、生物制药的原料药的制造系统及生物制药的原料药 |
| KR102853272B1 (ko) * | 2022-12-27 | 2025-09-01 | 삼성바이오로직스 주식회사 | 분리된 정제구획을 포함하는 생물학적 물질의 정제 시스템 |
| CN115645996B (zh) * | 2022-12-28 | 2023-04-11 | 威县双赢化工有限公司 | 一种用于乳液输出的除气泡装置 |
| WO2025078462A1 (de) * | 2023-10-12 | 2025-04-17 | KyooBe Tech GmbH | Modul für die förderung eines fluids |
| JP7751674B2 (ja) * | 2024-02-06 | 2025-10-08 | オルガノ株式会社 | 水処理装置およびその運転方法 |
| WO2025217607A1 (en) * | 2024-04-12 | 2025-10-16 | Sartorius Bioanalytical Instruments, Inc. | Cell culture systems and methods |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS62298536A (ja) * | 1986-06-17 | 1987-12-25 | Green Cross Corp:The | 生理活性物質の自動精製方法および自動精製装置 |
| US6359114B1 (en) * | 1995-06-07 | 2002-03-19 | Aphton Corp. | System for method for the modification and purification of proteins |
| US6773613B1 (en) * | 1998-10-15 | 2004-08-10 | Sangart, Inc. | Method for production of stroma-free hemoglobin |
| JP2000202239A (ja) * | 1999-01-13 | 2000-07-25 | Canon Inc | バイオリアクタ―及びそれを用いた微生物分解方法 |
| US20060246537A1 (en) * | 2005-04-29 | 2006-11-02 | Jenkins Lauri L | Multi-step process for the manufacture of therapeutic protein |
| GB2452301A (en) | 2007-08-30 | 2009-03-04 | Ge Healthcare Bio Sciences Ab | Sterilization Method |
| US8109284B2 (en) * | 2007-09-29 | 2012-02-07 | Pendotech | Bubble trap assembly for critical bioprocess applications |
| US8707760B2 (en) * | 2009-07-31 | 2014-04-29 | Tricorntech Corporation | Gas collection and analysis system with front-end and back-end pre-concentrators and moisture removal |
| CA2776957A1 (en) * | 2009-10-08 | 2011-04-14 | Daniel Roland Manser | Portioned system for preparing a nutritional product |
| US10589239B2 (en) * | 2010-07-07 | 2020-03-17 | Ge Healthcare Bio-Sciences Ab | Fluid mixing in a disposable fluid processing system |
| SG10201508401TA (en) * | 2010-10-11 | 2015-11-27 | Abbvie Bahamas Ltd | Processes for purification of proteins |
| US20140284271A1 (en) * | 2010-10-31 | 2014-09-25 | Algaeon, Inc. | Photobioreactor system and method of using the same |
| JP2013544524A (ja) | 2010-12-06 | 2013-12-19 | ターポン バイオシステムズ,インコーポレイテッド | 生物学的生成物の連続プロセス法 |
| KR101902225B1 (ko) * | 2011-07-08 | 2018-09-28 | 이엠디 밀리포어 코포레이션 | 일회용 생명공학적 공정용의 개선된 심층 필터 |
| RU2014150071A (ru) * | 2012-05-11 | 2016-07-10 | Новартис Аг | Способы кристаллизации для очистки моноклональных антител |
| MY195362A (en) * | 2012-06-21 | 2023-01-16 | Baxalta Inc | Virus Filtration of Cell Culture Media |
| EP2682168A1 (en) * | 2012-07-02 | 2014-01-08 | Millipore Corporation | Purification of biological molecules |
| RU2493872C1 (ru) * | 2012-08-08 | 2013-09-27 | Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации ( ФГУП "НПО "Микроген" Минздрава России) | Способ очистки вируса гриппа |
| HK1219964A1 (zh) | 2013-03-08 | 2017-04-21 | Genzyme Corporation | 治疗性蛋白药物物质的整合连续制造 |
| HUE038741T2 (hu) * | 2013-05-06 | 2018-11-28 | Sanofi Sa | Folyamatos többlépéses eljárás antitestek tisztítására |
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2015
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2016
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- 2016-04-29 HK HK18114001.8A patent/HK1254902A1/zh unknown
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- 2016-04-29 RU RU2017142617A patent/RU2721535C2/ru active
- 2016-04-29 MX MX2017014278A patent/MX383628B/es unknown
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- 2016-04-29 CN CN201680039860.3A patent/CN107995924B/zh not_active Expired - Fee Related
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| RU2721535C2 (ru) | 2020-05-19 |
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| JP6794372B2 (ja) | 2020-12-02 |
| CN107995924A (zh) | 2018-05-04 |
| MX2017014278A (es) | 2018-03-07 |
| US20180135006A1 (en) | 2018-05-17 |
| CN107995924B (zh) | 2021-09-07 |
| TW201706403A (zh) | 2017-02-16 |
| EP3292195A1 (de) | 2018-03-14 |
| JP2018518161A (ja) | 2018-07-12 |
| EP3015542A1 (de) | 2016-05-04 |
| IL255383A0 (en) | 2017-12-31 |
| MX383628B (es) | 2025-03-14 |
| KR20180002783A (ko) | 2018-01-08 |
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| RU2017142617A3 (enExample) | 2019-10-04 |
| US10696940B2 (en) | 2020-06-30 |
| RU2017142617A (ru) | 2019-06-10 |
| TWI696696B (zh) | 2020-06-21 |
| SA517390299B1 (ar) | 2021-03-02 |
| WO2016177650A1 (de) | 2016-11-10 |
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