JP5749270B2 - 分離システム及び方法 - Google Patents
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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
- B01D15/1871—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in series
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/38—Flow patterns
- G01N30/46—Flow patterns using more than one column
- G01N30/461—Flow patterns using more than one column with serial coupling of separation columns
- G01N30/465—Flow patterns using more than one column with serial coupling of separation columns with specially adapted interfaces between the columns
-
- 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
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/24—Automatic injection systems
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
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- Immunology (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Peptides Or Proteins (AREA)
- Treatment Of Liquids With Adsorbents In General (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
Description
1.第1のカラム(21)が結合・溶出方式、最後がウイルス濾過(23)の場合。
2.第1のカラム(21)が結合・溶出方式、第2のカラム(22)が捕獲方式(フロースルー)、最後がウイルス濾過(23)の場合。
3.第1のカラム(21)が結合・溶出方式、第2のカラム(22)が結合・溶出方式、最後がウイルス濾過(23)の場合。
第1のカラム21は、予め調製された溶液、或いは、前述の同時係属中の出願「Method and system for preparation of liquid mixtures(液体混合物の調製のための方法及びシステム)」に開示されたのもの等インライン緩衝液調製ユニット又は構造を使用してリアルタイムで調製された緩衝液のいずれかと平衡になっている。次に、サンプルは、直接、或いは、ポンプ33及び制御回路38、39、40を介した導電率又はpHの調節を伴って、カラム21にローディングされる。サンプルが結合し、非結合のサンプルの洗浄が完了した後、タンパク質が溶出される。
第1と第2のカラム21、22は、予め調製された溶液又は(そのように装備されている場合は)システムのインライン緩衝液調製機能を使用してリアルタイムで調製された緩衝液のいずれかと平衡になっている。この平衡溶液が2つのカラムに対して同一の場合は、これを一緒に実施してもよいが、別のカラムをバイパスして平衡化を順次実施してもよい。
第1と第2のカラム21、22は、予め調製された溶液又は(装備されている場合は)システムのインライン緩衝液調製機能を使用してリアルタイムで調製された緩衝液と平衡になっている。平衡溶液が2つのカラムに対して同一の場合、インラインで一緒これを実施してもよいが、別のカラムをバイパスして順番に平衡化を実施してもよい。この時点では、フィルタ23はインラインでない。
図3は、第1のモデルのモノクローナル抗体のDPC(直接生成物捕獲)生成物に使用される、第1の試験用プラットフォーム用のクロマトグラフィーシステムの構成を示し、以下では「Mab1」と称する。
実際のタンパク質での全ての動作実施に先立ち、緩衝液だけで一連の動作を行い、システムに組み込まれた制御ループの動作の検証と、過渡及び定常状態における、導電率、pH及びUV(タンパク質濃度)の制御機能のプロファイリングを行った。各制御回路を使用し、プロセスの流れを設定値で制御した。
次に、(i)目標の導電率に対するローディング中のサンプルのインライン希釈の実証、(ii)溶出中のカラム後pH調節の実証、及び(iii)溶出中のカラム後タンパク質濃度(UV)調節の実証を目標として、Mab1モノクローナル抗体生成物で実験を行った。
図4は、第2のモデルのモノクローナル抗体のDPC(直接生成物捕獲)生成物に使用される、第2の試験用プラットフォーム用のクロマトグラフィーシステム構成を示しており、以下ではこれを「Mab2」と称する。
次に、(i)サンプルローディング中のカラム前インラインpH(下降)調節の実証、及び(ii)溶出中のカラム後タンパク質濃度(UV)調節の実証を目標として、Mab2モノクローナル抗体生成物で実験を行った。
緩衝液動作では、ポンプが自身の直線的動作範囲で動作していれば、多くの動的な条件にシステムが応答可能であることがわかった。
Claims (14)
- タンパク質の下流精製のためのストレートスルー・プロセッシング分離システムであって、
各々流体入口と流体出口とを含む2以上の分離ユニットであって、分離ユニットの出口と入口とが直列に接続されて分離ユニット列を形成している2以上の分離ユニットと、
各分離ユニット間にインラインで設けられた検知・調節手段であって、分離ユニット列のうち1つの分離ユニットから次の分離ユニットに流れる流体の1以上の環境特性パラメータを連続的に監視及び調節する検知・調節手段と
を備えており、検知・調節手段が、流体送達装置と閉ループで接続された制御装置及びインラインセンサを含んでいる、分離システム。 - 3以上の分離ユニットを含む、請求項1記載の分離システム。
- 分離ユニットがカラム及びフィルタから選択される、請求項1記載の分離システム。
- 流体送達装置が1以上のポンプを含む、請求項1記載の分離システム。
- 2以上のクロマトグラフィーカラムを含む、請求項3記載の分離システム。
- 1以上の環境特性パラメータが、pH、導電率、化学種の濃度から選択される、請求項1記載の分離システム。
- 化学種の濃度を監視及び調節するための検知・調節手段が、UVセンサを含む、請求項6記載の分離システム。
- 2つのクロマトグラフィーカラムとウイルス除去フィルタとを含む、タンパク質精製のための請求項3記載の分離システム。
- クロマトグラフィーカラムが、カチオン交換カラム及びアニオン交換カラムを含む、請求項8記載の分離システム。
- カチオン交換カラムとアニオン交換カラムとの間に設けられる検知・調節手段が、導電率とpHのうち少なくとも1つを監視及び調節するための検知・調節手段を含む、請求項9記載の分離システム。
- アニオン交換カラムとウイルス除去フィルタとの間に設けられる検知・調節手段が、UV吸光度を監視及び調節するための検知・調節手段を含む、請求項9記載の分離システム。
- 分離システムを操作するためのコンピュータ制御及びデータ解析システムを含む、請求項1記載の分離システム。
- 1種以上の所望のタンパク質を含有する液体からタンパク質を下流精製するためのストレートスルー・プロセッシング方法であって、
液体を第1の分離ユニットにローディングし、そこから所望のタンパク質を含有する精製後の流体流出物を得るステップと、
流体送達装置と閉ループで接続された制御装置及びインラインセンサを用いて、流体流出物の1以上の環境特性パラメータを、オンラインで監視して所望の値に調節するステップと、
流出物を第2の分離ユニットに導き、そこから所望のタンパク質を含有する精製後の流体流出物を得るステップと、
所望のタンパク質を含有する精製後の流出物を回収するステップと
を含む方法。 - 第2の分離ユニットからの流出物を、1以上の追加の分離ユニットにかけるステップを含み、各々の追加の分離ユニットへの流体の入口流れの1以上の環境特性パラメータを監視して所望の値に調節する、請求項13記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/566,701 US9527010B2 (en) | 2009-09-25 | 2009-09-25 | Separation system and method |
US12/566,701 | 2009-09-25 | ||
PCT/SE2010/051003 WO2011037522A1 (en) | 2009-09-25 | 2010-09-20 | Separation system and method |
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JP2013506127A JP2013506127A (ja) | 2013-02-21 |
JP5749270B2 true JP5749270B2 (ja) | 2015-07-15 |
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US (1) | US9527010B2 (ja) |
EP (1) | EP2480305B1 (ja) |
JP (1) | JP5749270B2 (ja) |
CN (1) | CN102574026B (ja) |
AU (1) | AU2010298768B2 (ja) |
IN (1) | IN2012DN01850A (ja) |
WO (1) | WO2011037522A1 (ja) |
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9327212B2 (en) * | 2009-09-25 | 2016-05-03 | Ge Healthcare Bio-Sciences Ab | Method and system for preparation of liquid mixtures |
EA201201132A1 (ru) * | 2010-02-12 | 2013-03-29 | ДСМ АйПи АССЕТС Б.В. | Очистка антител с помощью единого функционального блока |
US9428546B2 (en) * | 2010-07-30 | 2016-08-30 | Pfizer Inc. | Tandem purification of proteins |
JP2012068244A (ja) * | 2010-09-20 | 2012-04-05 | Asahi Kasei Bioprocess Inc | タンパク質の分離及び精製のための液体クロマトグラフィーのシステム及び方法 |
JP2013540787A (ja) * | 2010-11-01 | 2013-11-07 | ディーエスエム アイピー アセッツ ビー.ブイ. | 単一ユニットイオン交換クロマトグラフィー抗体精製 |
AU2012269240B2 (en) * | 2011-06-16 | 2016-01-21 | Dpx Holdings B.V. | Single unit chromatography antibody purification |
US9096648B2 (en) | 2011-08-19 | 2015-08-04 | Emd Millipore Corporation | Methods of reducing level of one or more impurities in a sample during protein purification |
EP2578286A1 (en) | 2011-10-04 | 2013-04-10 | Merck Patent GmbH | Method and apparatus for chromatographic purification |
EP2776825B1 (en) | 2011-11-10 | 2024-06-19 | F. Hoffmann-La Roche AG | Preparative column chromatography system |
WO2013075740A1 (en) | 2011-11-23 | 2013-05-30 | Sanofi | Antibody purification method |
WO2014004103A1 (en) * | 2012-06-29 | 2014-01-03 | Emd Millipore Corporation | Methods for inactivating viruses during a protein purification process |
EP2994485B1 (en) * | 2013-05-06 | 2018-01-10 | Sanofi | Continuous multistep process for purifying antibodies |
CN103439433B (zh) * | 2013-09-11 | 2015-06-10 | 青岛普仁仪器有限公司 | 免稀释作线性曲线的色谱仪及线性曲线测量方法 |
WO2015041218A1 (ja) * | 2013-09-17 | 2015-03-26 | 株式会社カネカ | 新規抗体精製方法及びそれから得られる抗体(Novel Antibody Purification Method and Antibody obtained therefrom)、並びに陽イオン交換基を用いた新規抗体精製法及びそれから得られる抗体(Novel Antibody Purification method using Cation Exchanger and Antibody obtained therefrom) |
US11267869B2 (en) * | 2014-02-07 | 2022-03-08 | Cmc Biologics A/S | Chromatography system and method for capturing a biopolymer |
JP6612242B2 (ja) | 2014-02-14 | 2019-11-27 | ジーイー・ヘルスケア・バイオサイエンス・アクチボラグ | 自動化された多段階精製システム及び多段階クロマトグラフィー精製方法 |
JP6331485B2 (ja) * | 2014-03-04 | 2018-05-30 | 株式会社島津製作所 | 液体クロマトグラフ及び液体クロマトグラフ分析方法 |
EP3137484A1 (en) * | 2014-05-02 | 2017-03-08 | Novo Nordisk A/S | Integrated continuous biomanufacturing process |
US11835501B2 (en) | 2015-07-13 | 2023-12-05 | Sartorius Stedim Chromatography Systems Ltd. | Optimizing operating binding capacity for a multiple column chromatography process |
JP6579515B2 (ja) * | 2015-08-10 | 2019-09-25 | 国立大学法人 岡山大学 | アポe含有hdlの測定方法及び測定装置 |
EP3440518A1 (en) * | 2016-04-04 | 2019-02-13 | Boehringer Ingelheim RCV GmbH & Co KG | Real time monitoring of product purification |
GB201622343D0 (en) * | 2016-12-29 | 2017-02-15 | Ge Healthcare Bio Sciences Ab | Method in bioprocess purification system |
WO2018140485A1 (en) * | 2017-01-26 | 2018-08-02 | Counsyl, Inc. | Reagent delivery and waste management system |
US11185830B2 (en) | 2017-09-06 | 2021-11-30 | Waters Technologies Corporation | Fluid mixer |
FR3073424B1 (fr) | 2017-11-16 | 2022-03-25 | Novasep Process | Procede regule de separation d’un melange |
GB201802593D0 (en) * | 2018-02-16 | 2018-04-04 | Fujifilm Diosynth Biotechnologies Uk Ltd | Rig |
JP2021519298A (ja) * | 2018-03-27 | 2021-08-10 | ブリストル−マイヤーズ スクイブ カンパニーBristol−Myers Squibb Company | 紫外線シグナルを使用した力価のリアルタイムモニタリング |
CN109453545A (zh) * | 2018-12-20 | 2019-03-12 | 上海兆维科技发展有限公司 | 层析柱洗脱液的配液装置 |
AU2020223413A1 (en) * | 2019-02-11 | 2021-07-22 | Bayer Aktiengesellschaft | Influencing a sequential chromatography in real-time |
EP3763429A1 (en) * | 2019-07-08 | 2021-01-13 | Bayer Aktiengesellschaft | Influencing a sequential chromatography in real-time |
EP3693732A1 (en) * | 2019-02-11 | 2020-08-12 | Bayer Aktiengesellschaft | Influencing a sequential chromatography in real-time |
EP3699697A1 (en) * | 2019-02-25 | 2020-08-26 | Bayer Aktiengesellschaft | Automated simultaneous process control |
FR3099066B1 (fr) | 2019-07-26 | 2021-08-13 | Novasep Process | Procédé de purification d’une substance cible avec inactivation virale |
CN114207433A (zh) | 2019-08-12 | 2022-03-18 | 沃特世科技公司 | 用于色谱系统的混合器 |
GB201911686D0 (en) * | 2019-08-15 | 2019-10-02 | Fujifilm Diosynth Biotechnologies Uk Ltd | Process for purifying target substances |
GB201911685D0 (en) * | 2019-08-15 | 2019-10-02 | Fujifilm Diosynth Biotechnologies Uk Ltd | Process for purifying monoclonal antibodies |
KR20220069053A (ko) * | 2019-09-23 | 2022-05-26 | 젠자임 코포레이션 | 제품 품질 특성 측정 |
JP7388206B2 (ja) * | 2020-01-22 | 2023-11-29 | 株式会社島津製作所 | 液体クロマトグラフおよび分析方法 |
EP4179311A1 (en) | 2020-07-07 | 2023-05-17 | Waters Technologies Corporation | Combination mixer arrangement for noise reduction in fluid chromatography |
EP4179310A1 (en) | 2020-07-07 | 2023-05-17 | Waters Technologies Corporation | Mixer for liquid chromatography |
CN116194767A (zh) | 2020-09-22 | 2023-05-30 | 沃特世科技公司 | 连续流混合器 |
WO2023165947A1 (en) * | 2022-03-03 | 2023-09-07 | Chromacon Ag | Chromatographic purification method and uses thereof |
Family Cites Families (34)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3918907A (en) * | 1973-10-29 | 1975-11-11 | Beckman Instruments Inc | Micro automatic amino acid analysis process and system |
US4246101A (en) * | 1978-12-28 | 1981-01-20 | Pure Cycle Corporation | Water recycling system |
US4762796A (en) | 1981-10-05 | 1988-08-09 | Exxon Research And Engineering Company | pH control of a process stream |
JPS62255865A (ja) | 1986-04-28 | 1987-11-07 | Hitachi Ltd | 液体クロマトグラフ |
US4840730A (en) * | 1986-07-25 | 1989-06-20 | Sepragen Corporation | Chromatography system using horizontal flow columns |
JP2581568B2 (ja) | 1987-10-08 | 1997-02-12 | 株式会社日立製作所 | イオンクロマトグラフイ装置 |
US5114576A (en) * | 1990-02-15 | 1992-05-19 | Trineos | Prevention of contaminants buildup in captured and recirculated water systems |
WO1992017259A1 (en) * | 1991-03-28 | 1992-10-15 | Perseptive Biosystems, Inc. | On-line product identification in a chromatography effluent by subtraction |
US5792371A (en) | 1996-08-22 | 1998-08-11 | Iosolutions Incorporated | Method of disinfecting water with iodine species |
US6799883B1 (en) | 1999-12-20 | 2004-10-05 | Air Liquide America L.P. | Method for continuously blending chemical solutions |
CA2460819A1 (en) * | 2001-09-18 | 2003-03-27 | Affinium Pharmaceuticals, Inc. | Methods and apparatuses for purification |
EP1488226B1 (de) | 2002-03-28 | 2012-08-29 | Siemens Aktiengesellschaft | Gaschromatograph zur analyse von erdgas |
JP2004077329A (ja) | 2002-08-20 | 2004-03-11 | Japan Organo Co Ltd | クロマト分離装置 |
US6972415B2 (en) * | 2002-09-26 | 2005-12-06 | R-Can Environmental Inc. | Fluid treatment system with UV sensor and intelligent driver |
US20040124253A1 (en) * | 2002-10-17 | 2004-07-01 | Bergwin Gregory A. | Injection apparatus for irrigation system |
AU2003295584A1 (en) | 2002-11-18 | 2004-06-15 | Taurus Hsa Llc | Method for continuous, automated blending of solutions from acids and bases |
JP2007500852A (ja) * | 2003-05-16 | 2007-01-18 | クリオバイオフィジカ, インコーポレイテッド | 外部勾配クロマトフォーカシング |
US7632410B2 (en) * | 2003-08-21 | 2009-12-15 | Christopher Heiss | Universal water purification system |
WO2005040787A1 (en) | 2003-10-17 | 2005-05-06 | Ge Healthcare Bio-Sciences Ab | Chromatography system, method and software for the separation of biomolecules |
US8271139B2 (en) | 2003-10-17 | 2012-09-18 | Asahi Kasei Bioprocess, Inc. | Multi-stage accurate blending system and method |
US7072742B1 (en) | 2003-10-17 | 2006-07-04 | Technikrom, Inc. | Accurate blending module and method |
AU2005242998B2 (en) * | 2004-05-17 | 2010-05-27 | Firmenich Sa | New multidimensional gas chromatography apparatus and analyte transfer procedure using a multiple-cool strand interface |
JP4959565B2 (ja) * | 2004-05-21 | 2012-06-27 | ウオーターズ・テクノロジーズ・コーポレイシヨン | 低流量動作を可能にするためのhplc定流量ポンプの閉ループ流量制御 |
US7642306B2 (en) | 2004-06-25 | 2010-01-05 | Johns Manville | Control of pH in formaldehyde-free binder systems |
CN101076347B (zh) | 2004-09-30 | 2012-09-26 | 拜耳医药保健有限公司 | 用于集成连续生产生物分子的装置和方法 |
EP1871503B1 (en) * | 2005-01-20 | 2014-03-12 | Waters Technologies Corporation | Methods for separating compounds |
EP1716900A1 (en) * | 2005-04-29 | 2006-11-02 | Eidgenössische Technische Hochschule Zürich | Method and device for chromatographic purification |
EP1775001A1 (en) | 2005-10-13 | 2007-04-18 | Xendo Holding B.V. | Device for chromatographic separations |
JP4939910B2 (ja) * | 2006-11-29 | 2012-05-30 | 株式会社東芝 | マイクロ化学分析システム及びマイクロ化学分析装置 |
US9012212B2 (en) | 2007-04-17 | 2015-04-21 | Xendo Holding B.V. | Method and device for continuous membrane adsorption |
GB0709109D0 (en) | 2007-05-11 | 2007-06-20 | Enpar Technologies Inc | Wastewater ammonium extraction and electrolytic conversion to nitrogen gas |
US20090149638A1 (en) * | 2007-10-03 | 2009-06-11 | Ley Arthur C | Systems and methods for purifying proteins |
CN102027010A (zh) | 2008-05-15 | 2011-04-20 | 诺沃-诺迪斯克有限公司 | 抗体纯化方法 |
WO2010124159A1 (en) | 2009-04-23 | 2010-10-28 | Xcellerex, Inc. | System and method for variable speed feedback control chromatography loading |
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