HK1258253A1 - 一種用於生產生物藥品的生產設施 - Google Patents
一種用於生產生物藥品的生產設施Info
- Publication number
- HK1258253A1 HK1258253A1 HK19100617.2A HK19100617A HK1258253A1 HK 1258253 A1 HK1258253 A1 HK 1258253A1 HK 19100617 A HK19100617 A HK 19100617A HK 1258253 A1 HK1258253 A1 HK 1258253A1
- Authority
- HK
- Hong Kong
- Prior art keywords
- biopharmaceuticals
- production
- manufacturing facility
- facility
- manufacturing
- Prior art date
Links
- 238000004519 manufacturing process Methods 0.000 title 2
- 229960000074 biopharmaceutical Drugs 0.000 title 1
Classifications
-
- 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
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/58—Reaction vessels connected in series or in parallel
-
- 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
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
- B01D15/361—Ion-exchange
- B01D15/362—Cation-exchange
-
- 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
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/18—Apparatus therefor
-
- 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
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- 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
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/28—Constructional details, e.g. recesses, hinges disposable or single use
-
- 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
-
- 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
-
- 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
-
- 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
- C12M47/04—Cell isolation or sorting
-
- 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
- B01D2311/2623—Ion-Exchange
-
- 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
- B01D2311/2688—Biological processes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2313/00—Details relating to membrane modules or apparatus
- B01D2313/13—Specific connectors
-
- 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
Landscapes
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Biotechnology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Sustainable Development (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Analytical Chemistry (AREA)
- Water Supply & Treatment (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Clinical Laboratory Science (AREA)
- Molecular Biology (AREA)
- Cell Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Chemistry (AREA)
- Computer Hardware Design (AREA)
- Urology & Nephrology (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Materials For Medical Uses (AREA)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562246478P | 2015-10-26 | 2015-10-26 | |
US201662299930P | 2016-02-25 | 2016-02-25 | |
PCT/EP2016/075869 WO2017072201A2 (en) | 2015-10-26 | 2016-10-26 | A manufacturing facility for the production of biopharmaceuticals |
Publications (1)
Publication Number | Publication Date |
---|---|
HK1258253A1 true HK1258253A1 (zh) | 2019-11-08 |
Family
ID=57241063
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HK19100617.2A HK1258253A1 (zh) | 2015-10-26 | 2019-01-15 | 一種用於生產生物藥品的生產設施 |
Country Status (11)
Country | Link |
---|---|
US (1) | US11008540B2 (zh) |
EP (1) | EP3368176A2 (zh) |
JP (1) | JP2018532429A (zh) |
KR (1) | KR20180074775A (zh) |
CN (1) | CN108348817A (zh) |
AU (1) | AU2016347484A1 (zh) |
CA (1) | CA3001761A1 (zh) |
HK (1) | HK1258253A1 (zh) |
IL (1) | IL258733A (zh) |
SG (1) | SG11201803013YA (zh) |
WO (1) | WO2017072201A2 (zh) |
Families Citing this family (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9677042B2 (en) | 2010-10-08 | 2017-06-13 | Terumo Bct, Inc. | Customizable methods and systems of growing and harvesting cells in a hollow fiber bioreactor system |
US9617506B2 (en) | 2013-11-16 | 2017-04-11 | Terumo Bct, Inc. | Expanding cells in a bioreactor |
EP3613841B1 (en) | 2014-03-25 | 2022-04-20 | Terumo BCT, Inc. | Passive replacement of media |
EP3198006B1 (en) | 2014-09-26 | 2021-03-24 | Terumo BCT, Inc. | Scheduled feed |
WO2017004592A1 (en) | 2015-07-02 | 2017-01-05 | Terumo Bct, Inc. | Cell growth with mechanical stimuli |
US11965175B2 (en) | 2016-05-25 | 2024-04-23 | Terumo Bct, Inc. | Cell expansion |
KR102398310B1 (ko) | 2016-06-03 | 2022-05-16 | 론자 리미티드 | 일회용 생물반응기 |
US11685883B2 (en) | 2016-06-07 | 2023-06-27 | Terumo Bct, Inc. | Methods and systems for coating a cell growth surface |
US11104874B2 (en) | 2016-06-07 | 2021-08-31 | Terumo Bct, Inc. | Coating a bioreactor |
EP3475410A4 (en) | 2016-06-24 | 2020-02-12 | Lonza Ltd | VARIABLE DIAMETER BIOREACTORS |
EP3656842A1 (en) | 2017-03-31 | 2020-05-27 | Terumo BCT, Inc. | Cell expansion |
US11624046B2 (en) | 2017-03-31 | 2023-04-11 | Terumo Bct, Inc. | Cell expansion |
US11231360B2 (en) * | 2017-06-29 | 2022-01-25 | Hydrite Chemical Co. | Automatic titration device |
EA202091422A1 (ru) * | 2017-12-11 | 2020-08-28 | Эмджен Инк. | Способ непрерывного производства продуктов на основе биспецифических антител |
CN113039497A (zh) * | 2018-08-24 | 2021-06-25 | 思拓凡瑞典有限公司 | 用于生物制药产品的监测系统和方法 |
TW202043253A (zh) * | 2019-01-28 | 2020-12-01 | 美商安進公司 | 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程 |
CN114901794A (zh) * | 2019-11-15 | 2022-08-12 | 隆萨有限公司 | 用于生产接种物的过程和系统 |
Family Cites Families (25)
Publication number | Priority date | Publication date | Assignee | Title |
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US4722902A (en) * | 1985-11-04 | 1988-02-02 | Endotronics, Inc. | Apparatus and method for culturing cells, removing waste and concentrating product |
IT1258959B (it) | 1992-06-09 | 1996-03-11 | Impianto a moduli mobili per lo sviluppo e la produzione di prodotti biotecnologici su scala pilota | |
JPH07318694A (ja) * | 1994-05-24 | 1995-12-08 | Seitai Kinou Kenkyusho:Kk | 11c標識メチル化合物の注射製剤の自動合成装置および自動合成方法 |
CA2379823A1 (en) * | 1999-07-16 | 2001-01-25 | Human Genome Sciences, Inc. | Real-time, in situ biomanufacturing process monitoring and control in response to ir spectroscopy |
NZ539297A (en) * | 2002-09-13 | 2008-04-30 | Biogen Idec Inc | Method of purifying polypeptides by simulated moving bed chromatography |
CA2554941A1 (en) | 2004-02-03 | 2005-08-18 | Xcellerex, Llc | System and method for manufacturing |
US7444197B2 (en) | 2004-05-06 | 2008-10-28 | Smp Logic Systems Llc | Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes |
US7799273B2 (en) | 2004-05-06 | 2010-09-21 | Smp Logic Systems Llc | Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes |
EP1773976B2 (en) | 2004-06-04 | 2020-01-01 | Global Life Sciences Solutions USA LLC | Disposable bioreactor systems and methods |
EP2004798A4 (en) | 2005-12-05 | 2010-11-24 | Ernest G Hope | PREVALIDED, MODULAR GOODS MANUFACTURING PRACTICE CORRESPONDING ESTABLISHMENT |
RU2009141965A (ru) | 2007-04-16 | 2011-05-27 | Момента Фармасьютикалз, Инк. (Us) | Определенные продукты гликопротеина и способы их производства |
US8771635B2 (en) | 2010-04-26 | 2014-07-08 | Toyota Motor Engineering & Manufacturing North America, Inc. | Hydrogen release from complex metal hydrides by solvation in ionic liquids |
US10371394B2 (en) | 2010-09-20 | 2019-08-06 | Biologics Modular Llc | Mobile, modular cleanroom facility |
US20120077232A1 (en) * | 2010-09-23 | 2012-03-29 | Rockwell Automation Technologies, Inc. | System and method for controlling a fermentation process |
WO2012104667A1 (en) * | 2011-02-04 | 2012-08-09 | Krisada Kampanatsanyakorn | Eukaryotic algae farming continuous mode process and related photo-bio-reactor system |
US9388373B2 (en) | 2011-03-08 | 2016-07-12 | University Of Maryland Baltimore County | Microscale bioprocessing system and method for protein manufacturing |
US9725688B2 (en) * | 2011-06-30 | 2017-08-08 | Peter Simpson Bell | Bioreactor for syngas fermentation |
DE102011106165B4 (de) * | 2011-06-30 | 2015-07-02 | Sartorius Stedim Biotech Gmbh | Prüfverfahren und -vorrichtung für Bioreaktorbehälter sowie Verwendung |
WO2014137903A2 (en) * | 2013-03-08 | 2014-09-12 | Genzyme Corporation | Integrated continuous manufacturing of therapeutic protein drug substances |
WO2015003012A2 (en) * | 2013-07-01 | 2015-01-08 | Olivier Berteau | Distributed perfusion bioreactor system for continuous culture of biological cells |
WO2015166083A1 (en) * | 2014-05-02 | 2015-11-05 | Novo Nordisk A/S | Integrated continuous biomanufacturing process |
TW202246486A (zh) * | 2014-06-09 | 2022-12-01 | 美商健臻公司 | 種子罐培養法(seed train processes)及其用途 |
US10883121B2 (en) * | 2015-05-09 | 2021-01-05 | String Bio Private Limited | Processes for fermentation and purification of value added products from gaseous substrates |
CA3001916A1 (en) | 2015-10-16 | 2017-04-20 | Lonza Ltd. | System and method for regulating cell culture based production of biologics |
US11958050B2 (en) * | 2018-05-24 | 2024-04-16 | John Collins | Fluidic devices for closed cell culture applications under current good manufacturing practice |
-
2016
- 2016-10-26 EP EP16791347.4A patent/EP3368176A2/en not_active Ceased
- 2016-10-26 WO PCT/EP2016/075869 patent/WO2017072201A2/en active Application Filing
- 2016-10-26 CN CN201680062877.0A patent/CN108348817A/zh active Pending
- 2016-10-26 SG SG11201803013YA patent/SG11201803013YA/en unknown
- 2016-10-26 AU AU2016347484A patent/AU2016347484A1/en not_active Abandoned
- 2016-10-26 JP JP2018540219A patent/JP2018532429A/ja active Pending
- 2016-10-26 US US15/771,053 patent/US11008540B2/en active Active
- 2016-10-26 CA CA3001761A patent/CA3001761A1/en not_active Abandoned
- 2016-10-26 KR KR1020187014934A patent/KR20180074775A/ko unknown
-
2018
- 2018-04-16 IL IL258733A patent/IL258733A/en unknown
-
2019
- 2019-01-15 HK HK19100617.2A patent/HK1258253A1/zh unknown
Also Published As
Publication number | Publication date |
---|---|
EP3368176A2 (en) | 2018-09-05 |
US20190055508A1 (en) | 2019-02-21 |
CA3001761A1 (en) | 2017-05-04 |
CN108348817A (zh) | 2018-07-31 |
WO2017072201A3 (en) | 2017-06-08 |
US11008540B2 (en) | 2021-05-18 |
IL258733A (en) | 2018-06-28 |
KR20180074775A (ko) | 2018-07-03 |
WO2017072201A2 (en) | 2017-05-04 |
JP2018532429A (ja) | 2018-11-08 |
SG11201803013YA (en) | 2018-05-30 |
AU2016347484A1 (en) | 2018-05-10 |
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