MX2017014278A - Sistema modular y proceso para la produccion continua reducida respecto del contenido de microbios y/o procesamiento de un producto. - Google Patents
Sistema modular y proceso para la produccion continua reducida respecto del contenido de microbios y/o procesamiento de un producto.Info
- Publication number
- MX2017014278A MX2017014278A MX2017014278A MX2017014278A MX2017014278A MX 2017014278 A MX2017014278 A MX 2017014278A MX 2017014278 A MX2017014278 A MX 2017014278A MX 2017014278 A MX2017014278 A MX 2017014278A MX 2017014278 A MX2017014278 A MX 2017014278A
- Authority
- MX
- Mexico
- Prior art keywords
- product
- carrying
- manner
- disinfected
- preparing
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 9
- 239000000047 product Substances 0.000 abstract 5
- 239000012530 fluid Substances 0.000 abstract 4
- 238000004113 cell culture Methods 0.000 abstract 2
- 238000011210 chromatographic step Methods 0.000 abstract 2
- 238000004140 cleaning Methods 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 229960000074 biopharmaceutical Drugs 0.000 abstract 1
- 238000004587 chromatography analysis Methods 0.000 abstract 1
- 238000011026 diafiltration Methods 0.000 abstract 1
- 239000000706 filtrate Substances 0.000 abstract 1
- 238000001914 filtration Methods 0.000 abstract 1
- 239000012528 membrane Substances 0.000 abstract 1
- 238000000108 ultra-filtration Methods 0.000 abstract 1
Classifications
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- 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
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- 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
- B01D61/146—Ultrafiltration comprising multiple ultrafiltration steps
-
- 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
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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
- C07K1/16—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
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biotechnology (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Analytical Chemistry (AREA)
- Water Supply & Treatment (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biomedical Technology (AREA)
- Microbiology (AREA)
- Sustainable Development (AREA)
- General Engineering & Computer Science (AREA)
- Immunology (AREA)
- Urology & Nephrology (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Separation Using Semi-Permeable Membranes (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)
Abstract
La invención provee un método para el procesamiento y/o la producción continua reducida en cuanto al contenido de microbios de un producto macromolecular biológico biofarmacéutico de una mezcla heterogénea de fluido-cultivo celular, que comprende los siguientes pasos: (a) proveer un fluido libre de partículas de una mezcla heterogénea de fluidos-cultivo celular que contiene el producto, en forma de una corriente de producto, (b) al menos una filtración, que provee un filtrado, (c) al menos dos pasos de cromatografía para purificar el producto, (d) al menos un agotamiento de virus, (e) al menos una ultrafiltración y/o al menos una diafiltración de la corriente de producto de los pasos (b), (c) y/o (d), caracterizado porque los al menos dos pasos cromatografía de (c) comprenden una purificación mediante al menos dos columnas de cromatografía y/o adsorbentes de membrana en cada caso y que el proceso se realiza de manera cerrada y modular. La invención además provee un sistema modular correspondiente para realizar dicho método.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP15166686.4A EP3015542A1 (de) | 2015-05-07 | 2015-05-07 | Modulare anlage und verfahren zur kontinuierlichen, keimreduzierten produktion und/oder aufbereitung eines produktes |
PCT/EP2016/059700 WO2016177650A1 (de) | 2015-05-07 | 2016-04-29 | Modulare anlage und verfahren zur kontinuierlichen, keimreduzierten produktion und/oder aufbereitung eines produktes |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2017014278A true MX2017014278A (es) | 2018-03-07 |
Family
ID=53177140
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2017014278A MX2017014278A (es) | 2015-05-07 | 2016-04-29 | Sistema modular y proceso para la produccion continua reducida respecto del contenido de microbios y/o procesamiento de un producto. |
Country Status (18)
Country | Link |
---|---|
US (1) | US10696940B2 (es) |
EP (2) | EP3015542A1 (es) |
JP (1) | JP6794372B2 (es) |
KR (1) | KR20180002783A (es) |
CN (1) | CN107995924B (es) |
AR (1) | AR104523A1 (es) |
AU (1) | AU2016257253B2 (es) |
BR (1) | BR112017023912A2 (es) |
CA (1) | CA2984981A1 (es) |
HK (1) | HK1254902A1 (es) |
IL (1) | IL255383B (es) |
MX (1) | MX2017014278A (es) |
RU (1) | RU2721535C2 (es) |
SA (1) | SA517390299B1 (es) |
SG (1) | SG11201709094WA (es) |
TW (1) | TWI696696B (es) |
WO (1) | WO2016177650A1 (es) |
ZA (1) | ZA201708284B (es) |
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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 |
US10967298B2 (en) | 2012-03-15 | 2021-04-06 | Flodesign Sonics, Inc. | Driver and control for variable impedence load |
US9950282B2 (en) | 2012-03-15 | 2018-04-24 | Flodesign Sonics, Inc. | Electronic configuration and control for acoustic standing wave generation |
WO2015105955A1 (en) | 2014-01-08 | 2015-07-16 | Flodesign Sonics, Inc. | Acoustophoresis device with dual acoustophoretic chamber |
US11021699B2 (en) | 2015-04-29 | 2021-06-01 | FioDesign Sonics, Inc. | Separation using angled acoustic waves |
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 |
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 |
JP2020513248A (ja) | 2016-10-19 | 2020-05-14 | フロデザイン ソニックス, インク.Flodesign Sonics, Inc. | 音響による親和性細胞抽出 |
EP3141594A3 (en) * | 2016-11-11 | 2017-06-14 | Bayer Pharma Aktiengesellschaft | Method for sampling fluid streams for monitoring contaminants in a continuous flow |
US20190359930A1 (en) * | 2016-11-11 | 2019-11-28 | Bayer 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 |
EP3363517A1 (en) | 2017-02-17 | 2018-08-22 | Bayer Healthcare LLC | Degassing in methods for continuous production of a healthcare product |
AU2018221143A1 (en) | 2017-02-17 | 2019-07-25 | Bayer Aktiengesellschaft | Degassing in methods for continuous processing 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 |
CA3085784A1 (en) | 2017-12-14 | 2019-06-20 | Flodesign Sonics, Inc. | Acoustic transducer driver and controller |
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 |
US11420143B2 (en) * | 2018-11-05 | 2022-08-23 | Hollingsworth & Vose Company | Filter media with irregular structure and/or reversibly stretchable layers |
US11433332B2 (en) * | 2018-11-05 | 2022-09-06 | Hollingsworth & Vose Company | Filter media with irregular structure |
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 |
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 |
JPWO2022215495A1 (es) * | 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 |
WO2023191009A1 (ja) * | 2022-03-30 | 2023-10-05 | 富士フイルム株式会社 | バイオ医薬品の原薬の製造方法、バイオ医薬品の原薬の製造システム、およびバイオ医薬品の原薬 |
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 |
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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 |
MX2015012114A (es) | 2013-03-08 | 2016-01-12 | Genzyme Corp | Fabricacion continua integrada de principios activos proteinicos terapeuticos. |
DK3301115T3 (da) * | 2013-05-06 | 2022-01-31 | Sanofi Sa | Kontinuerlig flertrinsfremgangsmåde til oprensning af antistoffer |
-
2015
- 2015-05-07 EP EP15166686.4A patent/EP3015542A1/de not_active Withdrawn
-
2016
- 2016-04-29 RU RU2017142617A patent/RU2721535C2/ru active
- 2016-04-29 AU AU2016257253A patent/AU2016257253B2/en not_active Ceased
- 2016-04-29 US US15/571,754 patent/US10696940B2/en active Active
- 2016-04-29 WO PCT/EP2016/059700 patent/WO2016177650A1/de active Application Filing
- 2016-04-29 BR BR112017023912-4A patent/BR112017023912A2/pt not_active Application Discontinuation
- 2016-04-29 CN CN201680039860.3A patent/CN107995924B/zh not_active Expired - Fee Related
- 2016-04-29 SG SG11201709094WA patent/SG11201709094WA/en unknown
- 2016-04-29 EP EP16722580.4A patent/EP3292195A1/de not_active Withdrawn
- 2016-04-29 KR KR1020177034919A patent/KR20180002783A/ko not_active Application Discontinuation
- 2016-04-29 MX MX2017014278A patent/MX2017014278A/es unknown
- 2016-04-29 CA CA2984981A patent/CA2984981A1/en not_active Abandoned
- 2016-04-29 JP JP2017557944A patent/JP6794372B2/ja active Active
- 2016-05-04 AR ARP160101271A patent/AR104523A1/es active IP Right Grant
- 2016-05-05 TW TW105113911A patent/TWI696696B/zh not_active IP Right Cessation
-
2017
- 2017-11-01 IL IL255383A patent/IL255383B/en unknown
- 2017-11-07 SA SA517390299A patent/SA517390299B1/ar unknown
- 2017-12-06 ZA ZA2017/08284A patent/ZA201708284B/en unknown
-
2018
- 2018-11-02 HK HK18114001.8A patent/HK1254902A1/zh unknown
Also Published As
Publication number | Publication date |
---|---|
RU2017142617A (ru) | 2019-06-10 |
JP6794372B2 (ja) | 2020-12-02 |
WO2016177650A1 (de) | 2016-11-10 |
RU2721535C2 (ru) | 2020-05-19 |
CN107995924B (zh) | 2021-09-07 |
AU2016257253A1 (en) | 2017-11-30 |
CA2984981A1 (en) | 2016-11-10 |
TW201706403A (zh) | 2017-02-16 |
EP3292195A1 (de) | 2018-03-14 |
IL255383A0 (en) | 2017-12-31 |
EP3015542A1 (de) | 2016-05-04 |
RU2017142617A3 (es) | 2019-10-04 |
BR112017023912A2 (pt) | 2018-07-17 |
SG11201709094WA (en) | 2017-12-28 |
CN107995924A (zh) | 2018-05-04 |
AU2016257253B2 (en) | 2020-06-18 |
SA517390299B1 (ar) | 2021-03-02 |
JP2018518161A (ja) | 2018-07-12 |
ZA201708284B (en) | 2021-05-26 |
US10696940B2 (en) | 2020-06-30 |
KR20180002783A (ko) | 2018-01-08 |
IL255383B (en) | 2021-09-30 |
AR104523A1 (es) | 2017-07-26 |
TWI696696B (zh) | 2020-06-21 |
HK1254902A1 (zh) | 2019-08-02 |
US20180135006A1 (en) | 2018-05-17 |
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