JP7075359B2 - オリゴヌクレオチドの精製のための疎水性相互作用クロマトグラフィー - Google Patents

オリゴヌクレオチドの精製のための疎水性相互作用クロマトグラフィー Download PDF

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JP7075359B2
JP7075359B2 JP2018565677A JP2018565677A JP7075359B2 JP 7075359 B2 JP7075359 B2 JP 7075359B2 JP 2018565677 A JP2018565677 A JP 2018565677A JP 2018565677 A JP2018565677 A JP 2018565677A JP 7075359 B2 JP7075359 B2 JP 7075359B2
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target oligonucleotide
product
impurity
impurities
mixture
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JP2019518759A (ja
JP2019518759A5 (enExample
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グロンケ,ロバート・エス
ジョシ,ラトネッシュ・エス
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Biogen MA Inc
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H1/00Processes for the preparation of sugar derivatives
    • 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
    • B01D15/30Partition chromatography
    • B01D15/305Hydrophilic interaction chromatography [HILIC]
    • 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
    • B01D15/32Bonded phase chromatography
    • B01D15/325Reversed phase
    • B01D15/327Reversed phase with hydrophobic interaction
    • 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
    • B01D15/42Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424Elution mode
    • B01D15/426Specific type of solvent
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H1/00Processes for the preparation of sugar derivatives
    • C07H1/06Separation; Purification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H21/00Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H21/00Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
    • C07H21/02Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with ribosyl as saccharide radical
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H21/00Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
    • C07H21/04Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Saccharide Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2018565677A 2016-06-14 2017-06-13 オリゴヌクレオチドの精製のための疎水性相互作用クロマトグラフィー Active JP7075359B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662349970P 2016-06-14 2016-06-14
US62/349,970 2016-06-14
US201762492402P 2017-05-01 2017-05-01
US62/492,402 2017-05-01
PCT/US2017/037126 WO2017218454A1 (en) 2016-06-14 2017-06-13 Hydrophobic interaction chromatography for purification of oligonucleotides

Publications (3)

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JP2019518759A JP2019518759A (ja) 2019-07-04
JP2019518759A5 JP2019518759A5 (enExample) 2022-04-07
JP7075359B2 true JP7075359B2 (ja) 2022-05-25

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JP2018565677A Active JP7075359B2 (ja) 2016-06-14 2017-06-13 オリゴヌクレオチドの精製のための疎水性相互作用クロマトグラフィー

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US (3) US10947262B2 (enExample)
EP (1) EP3468981B1 (enExample)
JP (1) JP7075359B2 (enExample)
KR (1) KR102461234B1 (enExample)
CN (1) CN109641928B (enExample)
AU (1) AU2017284202B2 (enExample)
BR (1) BR112018075667B1 (enExample)
ES (1) ES2988362T3 (enExample)
IL (1) IL263639B (enExample)
MX (1) MX2018015654A (enExample)
NZ (1) NZ749360A (enExample)
WO (1) WO2017218454A1 (enExample)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10436802B2 (en) 2014-09-12 2019-10-08 Biogen Ma Inc. Methods for treating spinal muscular atrophy
AR102198A1 (es) 2014-10-09 2017-02-08 Regeneron Pharma Proceso para reducir partículas subvisibles en una formulación farmacéutica
US11020686B2 (en) 2016-08-16 2021-06-01 Regeneron Pharmaceuticals, Inc. Methods for quantitating individual antibodies from a mixture
JP7102401B2 (ja) 2016-10-25 2022-07-19 リジェネロン・ファーマシューティカルズ・インコーポレイテッド クロマトグラフィーデータ解析のための方法およびシステム
CA3073935A1 (en) 2017-09-19 2019-03-28 Regeneron Pharmaceuticals, Inc. Methods of reducing particle formation and compositions formed thereby
TWI853823B (zh) 2018-07-02 2024-09-01 美商里珍納龍藥品有限公司 自混合物製備多肽之系統及方法
WO2020072062A1 (en) * 2018-10-04 2020-04-09 Gsw Creative Corporation Portable charging case
EA202192422A1 (ru) 2019-03-05 2021-12-09 Ридженерон Фармасьютикалз, Инк. Человеческий сывороточный альбумин в составах
CN110066789B (zh) * 2019-05-17 2021-04-20 通用生物系统(安徽)有限公司 一种长链dna引物的hplc纯化改进的方法
CN119874910A (zh) * 2019-06-07 2025-04-25 达因疗法公司 制备蛋白质-寡核苷酸复合物的方法
CN120505310A (zh) 2020-02-28 2025-08-19 Ionis制药公司 用于调节smn2的化合物和方法
EP4301766A4 (en) * 2021-03-02 2024-12-25 Ionis Pharmaceuticals, Inc. PURIFICATION PROCESSES FOR OLIGOMERIC COMPOUNDS
CN119855824A (zh) 2022-09-07 2025-04-18 株式会社日本触媒 核酸的制造方法、杂质的去除方法以及杂质少的核酸
CN117050120A (zh) * 2022-12-09 2023-11-14 苏州赛分科技股份有限公司 一种纯化小干扰rna的柱层析法
WO2024175051A1 (zh) * 2023-02-23 2024-08-29 奥安医药(苏州)有限公司 一种疏水层析制备寡核苷酸的方法
WO2025149349A1 (en) 2024-01-09 2025-07-17 Cytiva Bioprocess R&D Ab Method for separating nucleic acid molecules
WO2025234897A1 (ru) * 2024-05-07 2025-11-13 Акционерное общество "ГЕНЕРИУМ" Способ получения тиофосфатных олигонуклеотидов для терапевтического применения

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002004027A1 (en) 2000-07-10 2002-01-17 Instituto Superior Tecnico Purification of plasmid dna by hydrophobic interaction chromatography
JP2006501250A (ja) 2002-08-28 2006-01-12 キアテック アクチボラゲット オリゴヌクレオチドの分離及び脱保護方法

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS60104097A (ja) * 1983-11-08 1985-06-08 Sagami Chem Res Center Dνaの精製方法
DE3433649A1 (de) * 1984-09-13 1986-03-20 Gesellschaft für Biotechnologische Forschung mbH (GBF), 3300 Braunschweig Verfahren zur aufreinigung synthetischer oligonucleotide
US6087491A (en) * 1993-01-08 2000-07-11 Hybridon, Inc. Extremely high purity oligonucleotides and methods of synthesizing them using dimer blocks
CN1155887A (zh) * 1994-07-05 1997-07-30 海布里顿公司 用deae-5pw阴离子-离子交换色谱和疏水作用色谱纯化硫代磷酸寡脱氧核苷酸
CA2194350A1 (en) 1994-07-05 1996-01-18 Hybridon, Inc. Purification of oligodeoxynucleotide phosphorothioates using deae 5pw anion ion-exchange chromatography and hydrophobic interaction chromatography
JP2001520660A (ja) * 1997-04-21 2001-10-30 プロリゴ・エルエルシー オリゴヌクレオチドの溶液相合成方法
JP2000035423A (ja) 1998-05-11 2000-02-02 Tosoh Corp 液体クロマトグラフィ―による核酸の分離法
RU2001135838A (ru) * 1999-05-28 2004-01-20 Камбрекс Байо Сайенс Инк. (Us) Способы очистки ДНК и очищенная ДНК
WO2004041889A2 (en) 2002-11-05 2004-05-21 Isis Pharmaceuticals, Inc. Polycyclic sugar surrogate-containing oligomeric compounds and compositions for use in gene modulation
US20050019951A1 (en) * 2003-07-14 2005-01-27 Gjerde Douglas T. Method and device for extracting an analyte
EP1661905B9 (en) 2003-08-28 2012-12-19 IMANISHI, Takeshi Novel artificial nucleic acids of n-o bond crosslinkage type
NZ549835A (en) * 2004-04-19 2008-12-24 Centelion Method for purifying plasmid DNA
EP3470072A1 (en) 2005-06-23 2019-04-17 Biogen MA Inc. Compositions and methods for modulation of smn2 splicing
WO2007090071A2 (en) 2006-01-27 2007-08-09 Isis Pharmaceuticals, Inc. 6-modified bicyclic nucleic acid analogs
US8969068B2 (en) * 2008-04-30 2015-03-03 Gradalis, Inc. Processes for the preparation of highly pure plasmid compositions by enzymatic digestion of colanic acid
ES2699827T3 (es) 2009-06-17 2019-02-13 Biogen Ma Inc Composiciones y métodos para la modulación de corte y empalme de SMN2 en un sujeto
HUE050704T2 (hu) 2014-04-01 2020-12-28 Biogen Ma Inc Összetételek a SOD-1 expressziójának modulálására

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002004027A1 (en) 2000-07-10 2002-01-17 Instituto Superior Tecnico Purification of plasmid dna by hydrophobic interaction chromatography
JP2006501250A (ja) 2002-08-28 2006-01-12 キアテック アクチボラゲット オリゴヌクレオチドの分離及び脱保護方法

Also Published As

Publication number Publication date
KR102461234B1 (ko) 2022-10-28
NZ749360A (en) 2025-11-28
ES2988362T3 (es) 2024-11-20
EP3468981B1 (en) 2024-07-24
CN109641928B (zh) 2022-08-30
KR20190018467A (ko) 2019-02-22
IL263639B (en) 2021-09-30
JP2019518759A (ja) 2019-07-04
MX2018015654A (es) 2019-06-10
IL263639A (en) 2019-01-31
US10947262B2 (en) 2021-03-16
US20190248823A1 (en) 2019-08-15
BR112018075667A2 (pt) 2019-04-09
EP3468981A1 (en) 2019-04-17
BR112018075667B1 (pt) 2024-02-20
CA3027288A1 (en) 2017-12-21
CN109641928A (zh) 2019-04-16
AU2017284202B2 (en) 2021-11-04
US20250011357A1 (en) 2025-01-09
US20210269467A1 (en) 2021-09-02
WO2017218454A1 (en) 2017-12-21
AU2017284202A1 (en) 2019-01-17

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