DK2970948T3 - Fremgangsmåder til rna-oprensning - Google Patents

Fremgangsmåder til rna-oprensning Download PDF

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Publication number
DK2970948T3
DK2970948T3 DK14709704.2T DK14709704T DK2970948T3 DK 2970948 T3 DK2970948 T3 DK 2970948T3 DK 14709704 T DK14709704 T DK 14709704T DK 2970948 T3 DK2970948 T3 DK 2970948T3
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rna
sample
buffer
purification
chromatography
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DK14709704.2T
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English (en)
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Scorza Francesco Berlanda
Yingxia Wen
Andrew Geall
Frederick Porter
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Glaxosmithkline Biologicals Sa
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H21/00—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
    • C07H21/02—Compounds 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • 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
    • 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
    • B01D15/3847—Multimodal interactions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H1/00—Processes for the preparation of sugar derivatives
    • C07H1/06—Separation; Purification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H21/00—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H21/00—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
    • C07H21/04—Compounds 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
    • 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
    • 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
    • C12N15/1017—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor by filtration, e.g. using filters, frits, membranes
    • 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
    • B01D2015/3838—Ligand exchange chromatography, e.g. complexation chromatography, chelation chromatography, metal interaction chromatography

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • General Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Water Supply & Treatment (AREA)
  • Microbiology (AREA)
  • Plant Pathology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Saccharide Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (13)

1. Fremgangsmåde til oprensning af RNA fra en in w'fro-transskription-(IVT)-reaktionsprøve omfattende et første trin af core-bead-flow-through-kromatografi under tilstedeværelse af en buffer indeholdende et kaliumsalt, hvor fremgangsmåden yderligere omfatter, i et eller flere trin, udskiftning af buffer omfattende tangentialstrømsfiltrering.
2. Fremgangsmåde ifølge krav 1, hvor kaliumsaltet er kaliumfosfat eller kaliumklorid.
3. Fremgangsmåde ifølge krav 2, hvor kaliumsaltet er kaliumklorid i en koncentration på 100-500 mM.
4. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor RNA'et oprenses i præparativ skala.
5. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor fremgangsmåden ikke omfatter anvendelsen af litiumklorid, organiske opløsningsmidler, temperaturer højere end 70°C og/eller enzymatisk nedbrydning af DNA.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor fremgangsmåden indbefatter kassering af materialer, der ikke indeholder RNA eller den ønskede slags RNA, og at bevare materialer, der indeholder RNA eller det ønskede RNA.
7. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor prøven indeholder RNA og et eller flere af: plasmid-DNA, deoxyoligonukleotider, deoxynucleosidmonofosfater, ribonucleosidtrifosfater og protein.
8. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor prøven indeholder RNA og ikke mere end fire af: plasmid-DNA, deoxyoligonukleotider, deoxynucleosidmonofosfater, ribonucleosidtrifosfater og protein; og eventuelt hvor prøven ikke indeholder genomisk DNA og/eller en cellemembran eller fragmenter deraf.
9. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor RNA'et er et enkeltstrenget RNA, som for eksempel et mRNA.
10. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor RNA'et omfatter en lineær sekvens på mindst 1.000 nukleotider, f.eks. mindst 5.000 nukleotider.
11. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor fremgangsmåden anvender en hydrofil stationær fase og/eller en hydrofil membran.
12. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor fremgangsmåden yderligere omfatter et trin med RNA-fremstilling, for eksempel ved anvendelse af in v/'tro-transskription af RNA.
13. Fremgangsmåde til fremstilling af en farmaceutisk sammensætning omfattende trinnene: (a) at oprense RNA ifølge en fremgangsmåde ifølge et hvilket som helst af kravene 1-12; og (b) at formulere det oprensede RNA som en farmaceutisk sammensætning.
DK14709704.2T 2013-03-15 2014-03-13 Fremgangsmåder til rna-oprensning DK2970948T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361799705P 2013-03-15 2013-03-15
PCT/EP2014/055014 WO2014140211A1 (en) 2013-03-15 2014-03-13 Rna purification methods

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DK2970948T3 true DK2970948T3 (da) 2019-04-08

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US (2) US11155572B2 (da)
EP (2) EP3521429B1 (da)
JP (1) JP6461830B2 (da)
CN (1) CN105283548A (da)
BR (1) BR112015023513A2 (da)
CA (1) CA2906281A1 (da)
CY (1) CY1121478T1 (da)
DK (1) DK2970948T3 (da)
ES (2) ES2720200T3 (da)
HR (1) HRP20190197T1 (da)
HU (1) HUE042072T2 (da)
LT (1) LT2970948T (da)
PL (1) PL2970948T3 (da)
PT (1) PT2970948T (da)
SI (1) SI2970948T1 (da)
TR (1) TR201903248T4 (da)
WO (1) WO2014140211A1 (da)

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Publication number Publication date
EP3521429B1 (en) 2022-05-04
ES2720200T3 (es) 2019-07-18
SI2970948T1 (sl) 2019-04-30
HRP20190197T1 (hr) 2019-04-05
PL2970948T3 (pl) 2019-06-28
US12018044B2 (en) 2024-06-25
TR201903248T4 (tr) 2019-03-21
EP3521429A1 (en) 2019-08-07
LT2970948T (lt) 2019-03-25
PT2970948T (pt) 2019-03-20
BR112015023513A2 (pt) 2017-07-18
CN105283548A (zh) 2016-01-27
ES2923018T3 (es) 2022-09-22
EP2970948B1 (en) 2018-12-26
JP6461830B2 (ja) 2019-01-30
JP2016512212A (ja) 2016-04-25
WO2014140211A1 (en) 2014-09-18
CY1121478T1 (el) 2020-05-29
US20160024139A1 (en) 2016-01-28
HUE042072T2 (hu) 2019-06-28
CA2906281A1 (en) 2014-09-18
EP2970948A1 (en) 2016-01-20
US20210214388A1 (en) 2021-07-15
US11155572B2 (en) 2021-10-26

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