MX2015005178A - Purificacion de polipeptidos usando ultrafiltracion de flujo tangencial de etapa doble. - Google Patents

Purificacion de polipeptidos usando ultrafiltracion de flujo tangencial de etapa doble.

Info

Publication number
MX2015005178A
MX2015005178A MX2015005178A MX2015005178A MX2015005178A MX 2015005178 A MX2015005178 A MX 2015005178A MX 2015005178 A MX2015005178 A MX 2015005178A MX 2015005178 A MX2015005178 A MX 2015005178A MX 2015005178 A MX2015005178 A MX 2015005178A
Authority
MX
Mexico
Prior art keywords
processes
unit operations
purification
dual stage
methods
Prior art date
Application number
MX2015005178A
Other languages
English (en)
Inventor
Peter Becker
Sebastian Neumann
Original Assignee
Hoffmann La Roche
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of MX2015005178A publication Critical patent/MX2015005178A/es

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361Ion-exchange
    • B01D15/362Cation-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361Ion-exchange
    • B01D15/363Anion-exchange
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12MAPPARATUS 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
    • C12M47/00Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
    • C12M47/10Separation or concentration of fermentation products
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12MAPPARATUS 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
    • C12M47/00Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
    • C12M47/12Purification
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2315/00Details relating to the membrane module operation
    • B01D2315/10Cross-flow filtration
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2317/00Membrane module arrangements within a plant or an apparatus
    • B01D2317/02Elements in series
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14Ultrafiltration; Microfiltration
    • B01D61/145Ultrafiltration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/34Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types

Landscapes

  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Biotechnology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Water Supply & Treatment (AREA)
  • General Engineering & Computer Science (AREA)
  • Sustainable Development (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

La presente invención está dirigida a métodos para la separación de una molécula de interés desde una solución que contiene la molécula utilizando la ultrafiltración de flujo tangencial de doble etapa ("TFF"). En particular, los métodos de la invención están dirigidos al procesamiento de las corrientes de alimentación crudas tales como el sobrenadante del cultivo celular acondicionado para reducir notablemente los niveles de los contaminantes y/o las impurezas previo a las operaciones unitarias de refinación subsiguientes, es decir corriente abajo. Los métodos de la invención pueden ser utilizados en el procesamiento de una corriente de alimentación cruda desde los sistemas de producción biológica tales como la fermentación u otro proceso de cultivo celular, y puede eliminar además la necesidad de los procesos de precipitación de las impurezas (por ejemplo, impulsado por el pH) y/o la filtración del precipitado, que consumen mucho tiempo, previo a los procesos corriente abajo que son sensibles a cargas de impurezas elevadas tales como las operaciones unitarias cromatográficas. El proceso de TFF de doble etapa descrito combina al menos dos operaciones unitarias de TFF que pueden ser llevadas a cabo ventajosamente a un pH que corresponde a, o que es aproximadamente aquel del pH de la corriente de alimentación, por ejemplo, un sobrenadante del cultivo celular, típicamente un pH de 7.5 - 1.0. El uso de las operaciones unitarias de TFF para suplementar, mejorar o reemplazar los procesos tradicionales para la purificación de las proteínas de interés para una corriente de alimentación puede representar ahorros significativos en los costos de procesamiento tanto directos como indirectos. Por ejemplo, además de los ahorros indirectos por la eliminación de los procesos de precipitación y de filtración del precipitado, la reducción en las cargas de las impurezas efectuadas por las operaciones unitarias de TFF de doble etapa puede conducir a ahorros indirectos por la mejora del funcionamiento de la columna corriente abajo, por ejemplo, de la separación cromatográfica, de la capacidad de aglutinación dinámica, del tiempo de vida útil opeativa y/o una reducción del tamaño de columna requerido. En las modalidades particulares, los métodos de la invención son utilizados en los procesos para la purificación de moléculas de inmunoglobulina, por ejemplos, los anticuerpos, tales procesos están desprovistos de etapas de purificación por afinidad, por ejemplo la purificación por cromatografía de afinidad con proteína A.
MX2015005178A 2012-10-30 2013-10-28 Purificacion de polipeptidos usando ultrafiltracion de flujo tangencial de etapa doble. MX2015005178A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP12190682 2012-10-30
PCT/EP2013/072511 WO2014067898A1 (en) 2012-10-30 2013-10-28 Purification of polypeptides using dual stage tangential-flow ultrafiltration

Publications (1)

Publication Number Publication Date
MX2015005178A true MX2015005178A (es) 2015-09-07

Family

ID=47115562

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015005178A MX2015005178A (es) 2012-10-30 2013-10-28 Purificacion de polipeptidos usando ultrafiltracion de flujo tangencial de etapa doble.

Country Status (15)

Country Link
US (2) US20150274773A1 (es)
EP (1) EP2914612B1 (es)
JP (1) JP6345184B2 (es)
KR (1) KR20150079830A (es)
CN (1) CN104755489B (es)
BR (1) BR112015009553A2 (es)
CA (1) CA2887684A1 (es)
ES (1) ES2706190T3 (es)
HK (1) HK1208872A1 (es)
HR (1) HRP20190043T1 (es)
MX (1) MX2015005178A (es)
PL (1) PL2914612T3 (es)
RU (1) RU2632568C2 (es)
SI (1) SI2914612T1 (es)
WO (1) WO2014067898A1 (es)

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DK2483305T3 (en) * 2009-10-01 2016-10-24 Hoffmann La Roche MULTI-STEP-END FILTERING Immunoglobulin
US10550148B2 (en) * 2014-06-16 2020-02-04 Emd Millipore Corporation Methods for increasing the capacity of flow-through processes
US10207225B2 (en) 2014-06-16 2019-02-19 Emd Millipore Corporation Single-pass filtration systems and processes
EP2986361B1 (en) 2014-06-25 2019-06-12 EMD Millipore Corporation Compact spiral-wound membrane filter elements
KR102061553B1 (ko) 2014-08-29 2020-02-11 이엠디 밀리포어 코포레이션 잔류물의 재순환에 의한 싱글 패스 접선 유동 여과 시스템 및 접선 유동 여과 시스템을 사용하여 액체를 여과하는 공정
CN105745009B (zh) 2014-08-29 2018-09-28 Emd 密理博公司 单程切向流过滤系统和具有渗余物的再循环的切向流过滤系统
CN104845956A (zh) * 2015-06-11 2015-08-19 山东农业大学 一种切向流超滤技术提取生姜蛋白酶的方法
EP3443348A1 (en) * 2016-04-14 2019-02-20 Lonza Ltd Compositions and methods for the detection of host cell proteins
TWI767930B (zh) * 2016-08-16 2022-06-21 美商健臻公司 處理包括重組治療性蛋白之流體的方法及其用途
EP3500588A1 (en) * 2016-08-17 2019-06-26 Boehringer Ingelheim International GmbH Process for the preparation of highly concentrated liquid formulations containing biomolecules
AU2017347809A1 (en) * 2016-10-28 2019-05-09 Merck Sharp & Dohme Llc Purification process for removal of tyrosine sulfation antibody variants; purified compositions
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
CN110241012B (zh) * 2018-03-09 2022-11-01 嘉和生物药业有限公司 一种生物大分子上游分阶段截留的生产方法、生产模块及在生产中的应用
US11028124B2 (en) * 2018-05-07 2021-06-08 Repligen Corporation Methods, devices and systems for 3-stage filtration
WO2019236811A1 (en) * 2018-06-08 2019-12-12 Bristol-Myers Squibb Company Single pass tangential flow filtration hybrid configurations for enhancing concentration of macromolecule solutions
CN114750976B (zh) * 2022-06-15 2022-11-01 成都凯天电子股份有限公司 一种直升机自适应供油系统性能地面测试系统及方法

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Also Published As

Publication number Publication date
US20200291064A1 (en) 2020-09-17
WO2014067898A1 (en) 2014-05-08
JP2015533378A (ja) 2015-11-24
EP2914612B1 (en) 2018-11-14
CN104755489B (zh) 2019-01-15
SI2914612T1 (sl) 2019-03-29
CA2887684A1 (en) 2014-05-08
RU2632568C2 (ru) 2017-10-05
HK1208872A1 (en) 2016-03-18
US20150274773A1 (en) 2015-10-01
RU2015120458A (ru) 2016-12-20
BR112015009553A2 (pt) 2017-10-03
ES2706190T3 (es) 2019-03-27
EP2914612A1 (en) 2015-09-09
HRP20190043T1 (hr) 2019-02-22
CN104755489A (zh) 2015-07-01
KR20150079830A (ko) 2015-07-08
JP6345184B2 (ja) 2018-06-20
PL2914612T3 (pl) 2019-04-30

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