BR112018075667B1 - Métodos para separar um oligonucleotídeo alvo de uma mistura contendo o oligonucleotídeo alvo e uma impureza relacionada com o produto - Google Patents

Métodos para separar um oligonucleotídeo alvo de uma mistura contendo o oligonucleotídeo alvo e uma impureza relacionada com o produto Download PDF

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Publication number
BR112018075667B1
BR112018075667B1 BR112018075667-9A BR112018075667A BR112018075667B1 BR 112018075667 B1 BR112018075667 B1 BR 112018075667B1 BR 112018075667 A BR112018075667 A BR 112018075667A BR 112018075667 B1 BR112018075667 B1 BR 112018075667B1
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BR
Brazil
Prior art keywords
impurity
target oligonucleotide
product
approximately
oligonucleotide
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Application number
BR112018075667-9A
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English (en)
Portuguese (pt)
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BR112018075667A2 (pt
Inventor
Robert S. Gronke
Ratnesh S. Joshi
Original Assignee
Biogen Ma, Inc
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Publication date
Application filed by Biogen Ma, Inc filed Critical Biogen Ma, Inc
Publication of BR112018075667A2 publication Critical patent/BR112018075667A2/pt
Publication of BR112018075667B1 publication Critical patent/BR112018075667B1/pt

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    • 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H1/00Processes for the preparation of sugar derivatives
    • C07H1/06Separation; Purification

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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)
BR112018075667-9A 2016-06-14 2017-06-13 Métodos para separar um oligonucleotídeo alvo de uma mistura contendo o oligonucleotídeo alvo e uma impureza relacionada com o produto BR112018075667B1 (pt)

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 (2)

Publication Number Publication Date
BR112018075667A2 BR112018075667A2 (pt) 2019-04-09
BR112018075667B1 true BR112018075667B1 (pt) 2024-02-20

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BR112018075667-9A BR112018075667B1 (pt) 2016-06-14 2017-06-13 Métodos para separar um oligonucleotídeo alvo de uma mistura contendo o oligonucleotídeo alvo e uma impureza relacionada com o produto

Country Status (12)

Country Link
US (3) US10947262B2 (cg-RX-API-DMAC7.html)
EP (1) EP3468981B1 (cg-RX-API-DMAC7.html)
JP (1) JP7075359B2 (cg-RX-API-DMAC7.html)
KR (1) KR102461234B1 (cg-RX-API-DMAC7.html)
CN (1) CN109641928B (cg-RX-API-DMAC7.html)
AU (1) AU2017284202B2 (cg-RX-API-DMAC7.html)
BR (1) BR112018075667B1 (cg-RX-API-DMAC7.html)
ES (1) ES2988362T3 (cg-RX-API-DMAC7.html)
IL (1) IL263639B (cg-RX-API-DMAC7.html)
MX (1) MX2018015654A (cg-RX-API-DMAC7.html)
NZ (1) NZ749360A (cg-RX-API-DMAC7.html)
WO (1) WO2017218454A1 (cg-RX-API-DMAC7.html)

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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

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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
JP7075359B2 (ja) 2022-05-25
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
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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B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B15K Others concerning applications: alteration of classification

Free format text: A CLASSIFICACAO ANTERIOR ERA: C07H 1/00

Ipc: B01D 15/30 (2006.01), B01D 15/32 (2006.01), B01D 1

B09A Decision: intention to grant [chapter 9.1 patent gazette]
B09X Republication of the decision to grant [chapter 9.1.3 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/06/2017, OBSERVADAS AS CONDICOES LEGAIS