JP6676073B2 - クロマトグラフィーカラムからプロダクトを連続的に溶出する方法 - Google Patents
クロマトグラフィーカラムからプロダクトを連続的に溶出する方法 Download PDFInfo
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Classifications
-
- 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
- B01D15/16—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
-
- 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
-
- 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 - B01D15/36
- B01D15/3804—Affinity chromatography
-
- 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
- B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
- B01D15/424—Elution mode
-
- 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
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/10—Processes for the isolation, preparation or purification of DNA or RNA
- C12N15/1003—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor
- C12N15/1006—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor by means of a solid support carrier, e.g. particles, polymers
- C12N15/101—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor by means of a solid support carrier, e.g. particles, polymers by chromatography, e.g. electrophoresis, ion-exchange, reverse phase
-
- 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
-
- 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
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- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Physics & Mathematics (AREA)
- Wood Science & Technology (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Microbiology (AREA)
- Plant Pathology (AREA)
- Crystallography & Structural Chemistry (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Treatment Of Liquids With Adsorbents In General (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Description
1 灌流培養
2 細胞保持システム、
工程1および2の代わりとして、流加培養も想定することができる。
3 細胞除去
4 バッファーまたは培地交換、好ましくは、濃縮とともに交換
5 バイオバーデンを減らすこと、好ましくは、滅菌濾過による
6 キャプチャークロマトグラフィー
7 ウイルス不活性化
8 中和、および
9 随意にさらなる深層濾過、バイオバーデンを減らすこと(滅菌濾過)
10 クロマトグラフィー中間物および高品質精製
11 バイオバーデンを減らすこと、例えば、滅菌濾過
12 ウイルス濾過
13 バッファー交換および好ましくは、濃縮、ならびに
14 滅菌濾過
(a) インレットを通してプロダクトストリームを供給する工程と、
(b) ローディングゾーンにおいてプロダクトストリームによりn本のフロントクロマトグラフィーカラムをローディング時間tBで同時にロードし、n本のフロントクロマトグラフィーカラムのアウトレットストリームは、回収ゾーンにある少なくともn−1本の回収クロマトグラフィーカラムに同時に分配され、
nは1〜5であり、
所与の時点におけるn本のフロントクロマトグラフィーカラムは、0〜L1の間、L1〜L2の間、および最大でLn−1〜Lnの間で変動するローディング時間tBを有し、
各フロントクロマトグラフィーカラムは、Lnの総ローディング時間を有し、
Ln〜Ln−1の一定の切換時間tS後に周期的に、フロントクロマトグラフィーカラムnはローディングゾーンから出て、回収ゾーンからの回収クロマトグラフィーカラムはローディングゾーンに入ることを特徴とする工程と、
(c) 工程(b)からのプロダクトをロードしたカラムを少なくとも1つの洗浄バッファーで洗う工程と、
(d) 切換時間tSの80%以上である溶出時間tEで、工程(c)からの洗浄済みカラムからプロダクトを溶出する工程とを含み、
総実行時間tGの80%超にわたって、少なくとも1つのクロマトグラフィーカラムが連続的に溶出工程(d)にある。
以下を示す。
実施例1ではIgG1モノクローナル抗体を使用した。発酵槽培養液を流加回分法によって調製した。供給濃度は0.8〜1.5g/l相当であった。使用したクロマトグラフィーシステムはTarponシステムであった。該システムでは内径が16mmのカラムが12本使用された。カラムをGE社のプロテインA樹脂、Mabselect Sureで充填した。製造業者の仕様書に従ってカラムは体積16.1mlで高さ8cmに充填した。
Tarponシステムには8本のインレットがあった。インレットの構成は次の通りであった。
インレット1:フロントカラムのアウトレットとの接続
インレット2:発酵槽培養液供給
インレット3:洗浄1バッファー
インレット4:洗浄2バッファー
インレット5:溶出バッファー
インレット6:再生バッファー
インレット7:定置洗浄(CIP)
インレット8:平衡化バッファーまたは洗浄3バッファー
アウトレット1:洗浄ストリーム
アウトレット2:閉鎖
アウトレット3:溶出
アウトレット4:洗浄廃液
アウトレット5:回収ゾーンからの通過画分廃液
アウトレット6:インレット1につなげられたフロントカラムのアウトレット
バッファー系は次のように構成した。
洗浄1:50mM トリス、2.5M NaCl、pH7
洗浄2:50mM NaAc、1M NaCl、pH5
溶出バッファー:100mM 酢酸ナトリウム、50mM NaCl、pH5
再生バッファー:50mM 酢酸ナトリウム、500mM NaCl、pH2.7
洗浄3/平衡化バッファー:50mM トリス/50mM NaCl、pH7
CIP:0.5M NaOH
Claims (2)
- 複数のクロマトグラフィーカラムからバイオ医薬プロダクト、生物学的プロダクト、高分子プロダクトを連続的に溶出する方法であって、
(a) インレットを通してプロダクトストリームを供給する工程と、
(b) ローディングゾーンにおいて前記プロダクトストリームによりn本のフロントクロマトグラフィーカラムをローディング時間tBで同時にロードし、前記n本のフロントクロマトグラフィーカラムのアウトレットストリームは、回収ゾーンにある少なくともn−1本の回収クロマトグラフィーカラムに同時に分配され、
nは1〜5であり、
所与の時点における前記n本のフロントクロマトグラフィーカラムは、0〜L1の間、L1〜L2の間、および最大でLn−1〜Lnの間で変動するローディング時間tBを有し、
各フロントクロマトグラフィーカラムは、Lnの総ローディング時間を有し、
Ln〜Ln−1の一定の切換時間tS後に周期的に、前記フロントクロマトグラフィーカラムnは前記ローディングゾーンから出て、前記回収ゾーンからの回収クロマトグラフィーカラムは前記ローディングゾーンに入ることを特徴とする工程と、
(c) 工程(b)からのプロダクトをロードしたカラムを少なくとも1つの洗浄バッファーで洗う工程と、
(d) 前記切換時間tSの80%以上である溶出時間tEで、工程(c)からの洗浄済みカラムから前記プロダクトを溶出する工程とを含み、
総実行時間tGの80%超にわたって、少なくとも1つのクロマトグラフィーカラムが連続的に溶出工程(d)にあり、
溶出工程(d)後において、溶出されたプロダクトは、ホモジナイゼーション工程(e)によって、リサイクリングタンクを備えるリサイクリングループによって、またはリサイクリングタンクのないリサイクリングループによって、または使い捨てスタティックミキサーによって混合される、
方法。 - (f) 工程(d)からの溶出済みカラムを再生する工程、
をさらに含むことを特徴とする、請求項1に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP15167518.8 | 2015-05-13 | ||
EP15167518.8A EP3037513A1 (de) | 2015-05-13 | 2015-05-13 | Verfahren zur kontinuierlichen elution eines produktes von chromatographiesäulen |
PCT/EP2016/060368 WO2016180797A1 (de) | 2015-05-13 | 2016-05-10 | Verfahren zur kontinuierlichen elution eines produktes von chromatographiesäulen |
Publications (3)
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JP2018524146A JP2018524146A (ja) | 2018-08-30 |
JP2018524146A5 JP2018524146A5 (ja) | 2019-01-17 |
JP6676073B2 true JP6676073B2 (ja) | 2020-04-08 |
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Country Status (16)
Country | Link |
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US (1) | US20180117495A1 (ja) |
EP (2) | EP3037513A1 (ja) |
JP (1) | JP6676073B2 (ja) |
KR (1) | KR20180004726A (ja) |
CN (1) | CN107683285A (ja) |
AR (1) | AR104573A1 (ja) |
AU (1) | AU2016259745B2 (ja) |
BR (1) | BR112017024339A2 (ja) |
CA (1) | CA2985679A1 (ja) |
HK (1) | HK1244822A1 (ja) |
IL (1) | IL255434A0 (ja) |
MX (1) | MX2017014516A (ja) |
RU (1) | RU2017143436A (ja) |
SG (1) | SG11201709192RA (ja) |
TW (1) | TWI679053B (ja) |
WO (1) | WO2016180797A1 (ja) |
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US9950282B2 (en) | 2012-03-15 | 2018-04-24 | Flodesign Sonics, Inc. | Electronic configuration and control for acoustic standing wave generation |
US9458450B2 (en) | 2012-03-15 | 2016-10-04 | Flodesign Sonics, Inc. | Acoustophoretic separation technology using multi-dimensional standing waves |
US10967298B2 (en) | 2012-03-15 | 2021-04-06 | Flodesign Sonics, Inc. | Driver and control for variable impedence load |
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RU2017143436A (ru) | 2019-06-17 |
MX2017014516A (es) | 2018-03-15 |
AR104573A1 (es) | 2017-08-02 |
AU2016259745A1 (en) | 2017-11-30 |
CA2985679A1 (en) | 2016-11-17 |
TWI679053B (zh) | 2019-12-11 |
RU2017143436A3 (ja) | 2019-11-28 |
SG11201709192RA (en) | 2017-12-28 |
HK1244822A1 (zh) | 2018-08-17 |
EP3294857A1 (de) | 2018-03-21 |
TW201709962A (zh) | 2017-03-16 |
CN107683285A (zh) | 2018-02-09 |
EP3037513A1 (de) | 2016-06-29 |
BR112017024339A2 (pt) | 2018-07-31 |
KR20180004726A (ko) | 2018-01-12 |
US20180117495A1 (en) | 2018-05-03 |
JP2018524146A (ja) | 2018-08-30 |
AU2016259745B2 (en) | 2020-08-06 |
IL255434A0 (en) | 2017-12-31 |
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