MX370179B - Resina de cromatografía estéril y uso de la misma en procesos de fabricación. - Google Patents
Resina de cromatografía estéril y uso de la misma en procesos de fabricación.Info
- Publication number
- MX370179B MX370179B MX2016009296A MX2016009296A MX370179B MX 370179 B MX370179 B MX 370179B MX 2016009296 A MX2016009296 A MX 2016009296A MX 2016009296 A MX2016009296 A MX 2016009296A MX 370179 B MX370179 B MX 370179B
- Authority
- MX
- Mexico
- Prior art keywords
- chromatography resin
- chromatography
- bioburden
- chelator
- reduced bioburden
- Prior art date
Links
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/30—Processes for preparing, regenerating, or reactivating
- B01J20/34—Regenerating or reactivating
- B01J20/3441—Regeneration or reactivation by electric current, ultrasound or irradiation, e.g. electromagnetic radiation such as X-rays, UV, light, microwaves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
- A61L2/08—Radiation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
- A61L2/08—Radiation
- A61L2/081—Gamma radiation
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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
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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
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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
- B01D15/20—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
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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
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/32—Bonded phase chromatography
- B01D15/325—Reversed phase
- B01D15/327—Reversed phase with hydrophobic interaction
-
- 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
- B01D15/34—Size-selective separation, e.g. size-exclusion chromatography; Gel filtration; Permeation
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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
- B01D15/26—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, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
- B01D15/361—Ion-exchange
- B01D15/362—Cation-exchange
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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
- B01D15/26—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, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
- B01D15/361—Ion-exchange
- B01D15/363—Anion-exchange
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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
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
- B01D15/3804—Affinity chromatography
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/22—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising organic material
- B01J20/26—Synthetic macromolecular compounds
- B01J20/265—Synthetic macromolecular compounds modified or post-treated polymers
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J39/00—Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
- B01J39/26—Cation exchangers for chromatographic processes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J41/00—Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
- B01J41/08—Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
- B01J41/12—Macromolecular compounds
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J41/00—Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
- B01J41/20—Anion exchangers for chromatographic 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
-
- 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
- C07K1/18—Ion-exchange 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
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Landscapes
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Physics & Mathematics (AREA)
- Electromagnetism (AREA)
- Toxicology (AREA)
- Treatment Of Liquids With Adsorbents In General (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
- Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
En la presente memoria se proporcionan métodos para reducir la carga biológica (por ejemplo, esterilización) de una resina de cromatografía, que incluyen exponer un recipiente que incluye una composición que incluye una resina de cromatografía y al menos un agente antioxidante y/o un quelante, a una dosis de irradiación gamma suficiente para reducir la carga biológica del recipiente y de la resina de cromatografía, en donde al menos un agente antioxidante y/o quelante están presentes en una cantidad suficiente para mejorar la pérdida de capacidad de unión de la resina de cromatografía después/tras la exposición a la dosis irradiación gamma. También se proporcionan columnas de cromatografía con carga biológica reducida que incluyen la resina de cromatografía con carga biológica reducida, composiciones que incluyen una resina de cromatografía y al menos un quelante y/o agente antioxidante, métodos para realizar cromatografía en columna con carga biológica reducida usando al menos una de estas columnas de cromatografía con carga biológica reducida, y procesos integrados, cerrados y continuos para la fabricación de una proteína recombinante purificada con carga biológica reducida.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461928929P | 2014-01-17 | 2014-01-17 | |
| US201462001498P | 2014-05-21 | 2014-05-21 | |
| PCT/US2015/011705 WO2015109151A1 (en) | 2014-01-17 | 2015-01-16 | Sterile chromatography resin and use thereof in manufacturing processes |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2016009296A MX2016009296A (es) | 2016-11-11 |
| MX370179B true MX370179B (es) | 2019-12-04 |
Family
ID=52440888
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019014428A MX381357B (es) | 2014-01-17 | 2015-01-16 | Resina de cromatografia esteril y uso de la misma en procesos de fabricacion. |
| MX2016009296A MX370179B (es) | 2014-01-17 | 2015-01-16 | Resina de cromatografía estéril y uso de la misma en procesos de fabricación. |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019014428A MX381357B (es) | 2014-01-17 | 2015-01-16 | Resina de cromatografia esteril y uso de la misma en procesos de fabricacion. |
Country Status (18)
| Country | Link |
|---|---|
| US (4) | US10071364B2 (es) |
| EP (1) | EP3094392B1 (es) |
| JP (2) | JP6560236B2 (es) |
| KR (1) | KR102306419B1 (es) |
| CN (2) | CN106068150B (es) |
| AU (2) | AU2015206341B2 (es) |
| BR (1) | BR112016016332B1 (es) |
| CA (1) | CA2936969C (es) |
| DK (1) | DK3094392T3 (es) |
| ES (1) | ES2982088T3 (es) |
| HU (1) | HUE067110T2 (es) |
| IL (2) | IL246775B (es) |
| MX (2) | MX381357B (es) |
| PL (1) | PL3094392T3 (es) |
| RU (1) | RU2679134C2 (es) |
| SG (2) | SG10201804483PA (es) |
| TW (1) | TWI709569B (es) |
| WO (1) | WO2015109151A1 (es) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2958988A2 (en) | 2013-02-22 | 2015-12-30 | Genzyme Corporation | Microcarrier perfusion culturing methods and uses thereof |
| CN105143443A (zh) | 2013-02-22 | 2015-12-09 | 建新公司 | 微载体灌注培养方法及其用途 |
| SG10201709131UA (en) | 2013-03-08 | 2017-12-28 | Genzyme Corp | Continuous purification of therapeutic proteins |
| TWI709569B (zh) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析樹脂及其用於製造方法的用途 |
| TWI671312B (zh) | 2014-01-17 | 2019-09-11 | 美商健臻公司 | 無菌層析法及製法 |
| TW202204596A (zh) | 2014-06-06 | 2022-02-01 | 美商健臻公司 | 灌注培養方法及其用途 |
| TWI776235B (zh) | 2014-06-09 | 2022-09-01 | 美商健臻公司 | 種子罐培養法(seed train processes)及其用途 |
| KR20250025516A (ko) | 2014-12-22 | 2025-02-21 | 젠자임 코포레이션 | 포유류 세포의 배양 방법 |
| JP7811061B2 (ja) * | 2017-11-30 | 2026-02-04 | コーニング インコーポレイテッド | バッチクロマトグラフィー用のパッケージ |
| CN108776190B (zh) * | 2018-04-19 | 2020-08-07 | 中国林业科学研究院林业研究所 | 沙棘中酚类物质定量检测方法 |
| HK40046210A (en) * | 2018-08-31 | 2021-10-29 | Genzyme Corporation | Sterile chromatography resin and use thereof in manufacturing processes |
| TW202534309A (zh) | 2019-10-22 | 2025-09-01 | 美商健臻公司 | 整合式連續生物製造中的線上產物監測 |
| WO2022261050A1 (en) * | 2021-06-07 | 2022-12-15 | The University Of Massachusetts | Apparatus and method for continuous production of rna |
| CA3247416A1 (en) * | 2022-04-08 | 2023-10-12 | Csl Behring Ag | Methods of sanitizing and/or regenerating a chromatography medium |
| GB2626063A (en) * | 2023-01-06 | 2024-07-10 | Micronclean Ltd | Disinfectant formulation |
| WO2024155768A1 (en) * | 2023-01-18 | 2024-07-25 | President And Fellows Of Harvard College | Devices, chromatography columns, methods for automated chromatography in parallel and methods for purification of extracellular vesicles |
| WO2025059162A1 (en) | 2023-09-11 | 2025-03-20 | Dana-Farber Cancer Institute, Inc. | Car-engager containing il-2 variants to enhance the functionality of car t cells |
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