DK3102637T3 - Fremgangsmåde til oprensning af antistoffer, antistoffragmenter eller manipulerede varianter deraf ved anvendelse af specifikke anthraquinonfarvestofligand-strukturer - Google Patents

Fremgangsmåde til oprensning af antistoffer, antistoffragmenter eller manipulerede varianter deraf ved anvendelse af specifikke anthraquinonfarvestofligand-strukturer Download PDF

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DK3102637T3
DK3102637T3 DK15704492.6T DK15704492T DK3102637T3 DK 3102637 T3 DK3102637 T3 DK 3102637T3 DK 15704492 T DK15704492 T DK 15704492T DK 3102637 T3 DK3102637 T3 DK 3102637T3
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absorbent
alkyl
dye
formula
adsorbent
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DK15704492.6T
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Max Fabian Felle
Mari Granström
David Linder
Shilpa S Korde
Amarish Samel
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Basf Se
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Priority claimed from EP14159349.1A external-priority patent/EP2918641A1/en
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Priority claimed from IN324DE2014 external-priority patent/IN2014DE00324A/en
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Publication of DK3102637T3 publication Critical patent/DK3102637T3/da

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/281Sorbents specially adapted for preparative, analytical or investigative chromatography
    • B01J20/286Phases chemically bonded to a substrate, e.g. to silica or to polymers
    • B01J20/288Polar phases
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/281Sorbents specially adapted for preparative, analytical or investigative chromatography
    • B01J20/286Phases chemically bonded to a substrate, e.g. to silica or to polymers
    • B01J20/289Phases chemically bonded to a substrate, e.g. to silica or to polymers bonded via a spacer
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30Processes for preparing, regenerating, or reactivating
    • B01J20/3085Chemical treatments not covered by groups B01J20/3007 - B01J20/3078
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30Processes for preparing, regenerating, or reactivating
    • B01J20/32Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3202Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the carrier, support or substrate used for impregnation or coating
    • B01J20/3204Inorganic carriers, supports or substrates
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30Processes for preparing, regenerating, or reactivating
    • B01J20/32Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3202Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the carrier, support or substrate used for impregnation or coating
    • B01J20/3206Organic carriers, supports or substrates
    • B01J20/3208Polymeric carriers, supports or substrates
    • B01J20/321Polymeric carriers, supports or substrates consisting of a polymer obtained by reactions involving only carbon to carbon unsaturated bonds
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30Processes for preparing, regenerating, or reactivating
    • B01J20/32Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3202Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the carrier, support or substrate used for impregnation or coating
    • B01J20/3206Organic carriers, supports or substrates
    • B01J20/3208Polymeric carriers, supports or substrates
    • B01J20/3212Polymeric carriers, supports or substrates consisting of a polymer obtained by reactions otherwise than involving only carbon to carbon unsaturated bonds
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30Processes for preparing, regenerating, or reactivating
    • B01J20/32Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3214Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the method for obtaining this coating or impregnating
    • B01J20/3217Resulting in a chemical bond between the coating or impregnating layer and the carrier, support or substrate, e.g. a covalent bond
    • B01J20/3219Resulting in a chemical bond between the coating or impregnating layer and the carrier, support or substrate, e.g. a covalent bond involving a particular spacer or linking group, e.g. for attaching an active group
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30Processes for preparing, regenerating, or reactivating
    • B01J20/32Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3231Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the coating or impregnating layer
    • B01J20/3242Layers with a functional group, e.g. an affinity material, a ligand, a reactant or a complexing group
    • B01J20/3244Non-macromolecular compounds
    • B01J20/3246Non-macromolecular compounds having a well defined chemical structure
    • B01J20/3257Non-macromolecular compounds having a well defined chemical structure the functional group or the linking, spacer or anchoring group as a whole comprising at least one of the heteroatoms nitrogen, oxygen or sulfur together with at least one silicon atom, these atoms not being part of the carrier as such
    • B01J20/3261Non-macromolecular compounds having a well defined chemical structure the functional group or the linking, spacer or anchoring group as a whole comprising at least one of the heteroatoms nitrogen, oxygen or sulfur together with at least one silicon atom, these atoms not being part of the carrier as such comprising a cyclic structure not containing any of the heteroatoms nitrogen, oxygen or sulfur, e.g. aromatic structures
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09BORGANIC DYES OR CLOSELY-RELATED COMPOUNDS FOR PRODUCING DYES, e.g. PIGMENTS; MORDANTS; LAKES
    • C09B67/00Influencing the physical, e.g. the dyeing or printing properties of dyestuffs without chemical reactions, e.g. by treating with solvents grinding or grinding assistants, coating of pigments or dyes; Process features in the making of dyestuff preparations; Dyestuff preparations of a special physical nature, e.g. tablets, films
    • C09B67/0097Dye preparations of special physical nature; Tablets, films, extrusion, microcapsules, sheets, pads, bags with dyes
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09BORGANIC DYES OR CLOSELY-RELATED COMPOUNDS FOR PRODUCING DYES, e.g. PIGMENTS; MORDANTS; LAKES
    • C09B69/00Dyes not provided for by a single group of this subclass
    • C09B69/10Polymeric dyes; Reaction products of dyes with monomers or with macromolecular compounds
    • C09B69/101Polymeric dyes; Reaction products of dyes with monomers or with macromolecular compounds containing an anthracene dye
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/58Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G01N33/583Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with non-fluorescent dye label
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • G01N33/6857Antibody fragments
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2220/00Aspects relating to sorbent materials
    • B01J2220/40Aspects relating to the composition of sorbent or filter aid materials
    • B01J2220/49Materials comprising an indicator, e.g. colour indicator, pH-indicator

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biotechnology (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • Peptides Or Proteins (AREA)

Claims (15)

1. Adsorptionsmiddel til kromatografisk oprensing af immunoglobulinmolekyler, hvilket absorptionsmiddel omfatter en bærematrix, hvortil en farvestofligand er kovalent bundet, hvor farvestofliganden er valgt blandt anthraquinonfarvestoffer, og hvor liganddensiteten på absorptionsmidlet er mere end 150 pmol/g tørt absorptionsmiddel.
2. Absorptionsmiddel ifølge krav 1, hvor liganddensiteten på absorptionsmidlet er 160 til 500 pmol/g tørt absorptionsmiddel, fortrinsvis 200 til 350 pmol/g tørt absorptionsmiddel.
3. Absorptionsmiddel ifølge krav 1 eller 2, hvor absorptionsmidlet omfatter reaktionsproduktet af bærematrixen, eventuelt et linkermolekyle og en anthraquinonforbindelse med den generelle formel 1
(1) hvor X er halogen; k og m uafhængigt af hinanden er 0 eller 1, og summen af k+m er 1 eller 2; B er et aromatisk radikal, der omfatter en eller flere, kondenserede eller ikke-kondenserede, eventuelt mono- eller polysubstituerede aromatiske ringe; V er en substituent med formlen
(2a) eller
(2b) hvor n hver er O eller 1; med det forbehold at begge n ikke samtidigt er 0; R er ens eller forskellige og valgt blandt H, alkyl, NH2, NH-alkyl, NH-aryl, N(alkyl)2, NO2, OH, O-alkyl, CN, C(O)alkyl, C(O)aryl, C(O)NH2, C (O) N (H) alkyl, C (O) N (alkyl) 2, C (O) N (H) aryl, halogen; Ri er hydrogen eller eventuelt substitueret Ci-C4alkyl; Z er valgt blandt en kemisk binding, - (CH2)ni-, hvor ni er et helt tal fra 1 til 4, arylen, -CH2-arylen-, -SO2-arylen-, -C(O)N(H)arylen-, -SO2N(H)arylen-, -CH=CH-, -SO2-CH2-CH2-; -C (O) NH-(CH2) n2~, hvor n2 er et helt tal fra 1 til 4; og Y er ens eller forskellige polære funktionelle grupper valgt blandt -SO3H, -OSO3H, -CO2H, -P(O)(OH)2, -OP (O) (OH) 2, OH og SH.
4. Absorptionsmiddel ifølge et hvilket som helst af ovennævnte krav, hvor B er en substituent med formlen
Y er som defineret ovenfor, n er O eller 1, n3 er O, 1, 2, 3 eller 4, Yi er ens eller forskellige og valgt blandt halogen, alkyl, alkoxy, NO2 eller Y, hvor Y er som defineret ovenfor; W er en kemisk binding eller valgt blandt -C(O)N(H)-, -SO2N(H)-, -SO2- eller -N(H)-; og R2 er valgt blandt H eller alkyl.
5. Absorptionsmiddel ifølge et hvilket som helst af ovennævnte krav, hvor B er et aromatisk radikal med formel 3a, og/eller hvor V er en substituent til formel 2a.
6. Absorptionsmiddel ifølge krav 5, hvor B er et aromatisk radikal med formel 3a, hvor n3 er 0, 1, 2, 3 eller 4, og Yi uafhængigt er alkyl eller Y.
7. Absorptionsmiddel ifølge krav 5, hvor V er en substituent til formel 2a, hvor R er H, og Z er valgt blandt en kemisk binding eller -SO2-CH2-CH2-.
8. Absorptionsmiddel ifølge et hvilket som helst af ovennævnte krav, hvor k er 0, og m er 1.
9. Absorptionsmiddel ifølge et hvilket som helst af kravene 1 til 8, der har en gennemsnitlig partikelstørrelse i intervallet fra 10 til 200, såsom 20 til 180 eller 45 til 165 eller 80 til 120 eller 90 til 110 pm.
10. Fremgangsmåde til kromatografisk oprensning af immunoglobulinmolekyler, hvilken fremgangsmåde omfatter etablering af kontakt mellem en prøve, der indeholder mindst én ønsket type af immunoglobulinmolekyler i en blanding med kontaminerende uorganiske og/eller organiske stoffer, og et absorptionsmiddel ifølge et hvilket som helst af kravene 1 til 9, adsorbering af den ønskede type af immunoglobulinmolekyler på absorptionsmidlet, eventuelt vask af absorptionsmidlet med en vaskevæske og efterfølgende eluering af det adsorberede materiale til opnåelse af et eluat, der indeholder de ønskede immunoglobulinmolekyler i beriget form; eller hvilken fremgangsmåde omfatter etablering af kontakt mellem en prøve, der indeholder mindst én ønsket type af immunoglobulinmolekyler i en blanding med kontaminerende uorganiske og/eller organiske stoffer, og et absorptionsmiddel ifølge et hvilket som helst af kravene 1 til 9, adsorbering af de kontaminerende uorganiske og/eller organiske stoffer, opnåelse af et gennemstrømningsmateriale, der indeholder de ønskede immunoglobulinmolekyler i en mere ren form.
11. Fremgangsmåde ifølge krav 10, hvor den ønskede type af immunoglobulinmolekyle er et funktionelt antistof (Ab) eller fragmentantistof (fAb).
12. Fremgangsmåde ifølge et af kravene 10 og 11, hvor den immunoglobulinholdige prøve, der skal oprenses, er kontamineret med denaturerede og/eller agglomererede/multimeriserede immunoglobuliner.
13. Anvendelse af en forbindelse ifølge et hvilket som helst af kravene 1 til 8 til separering af immunoglobulinmolekyler, især Ab'er og fAb'er.
14. Præparativt eller analytisk kit, der omfatter mindst ét absorptionsmiddel, der bærer en anthraquinonforbindelse ifølge et hvilket som helst af kravene 1 til 9, og yderligere materiale til identificering af mindst ét separeret fAb.
15. Fremgangsmåde til fremstilling af et absorptionsmiddel ifølge et af kravene 1 til 9, hvilken fremgangsmåde omfatter reaktion af et eventuelt aktiveret bæremiddel med en egnet linker som for eksempel tri-2'-aminoethylamin (TREN), efterfulgt af reaktion af det således opnåede funktionaliserede absorptionsmiddel med en anthraquinonforbindelse ifølge krav 1 til 8.
DK15704492.6T 2014-02-04 2015-02-04 Fremgangsmåde til oprensning af antistoffer, antistoffragmenter eller manipulerede varianter deraf ved anvendelse af specifikke anthraquinonfarvestofligand-strukturer DK3102637T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14159349.1A EP2918641A1 (en) 2014-03-13 2014-03-13 Method for purification of antibodies, antibody fragments or engineered variants thereof using specific anthraquinone dye-ligand structures
PCT/EP2015/052246 WO2015117984A1 (en) 2014-02-04 2015-02-04 Method for purification of antibodies, antibody fragments or engineered variants thereof using specific anthraquinone dye-ligand structures
IN324DE2014 IN2014DE00324A (da) 2014-02-04 2015-02-04

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DK3102637T3 true DK3102637T3 (da) 2018-07-23

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US (1) US20160347789A1 (da)
EP (1) EP3102637B1 (da)
JP (1) JP2017512131A (da)
KR (1) KR20160119134A (da)
CN (1) CN105980485B (da)
DK (1) DK3102637T3 (da)
IL (1) IL246881B (da)
SG (1) SG11201605954SA (da)
WO (1) WO2015117984A1 (da)

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JP6564539B1 (ja) 2018-09-14 2019-08-21 長瀬産業株式会社 スルホン酸化合物によるペプチド精製方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4016149A (en) * 1973-09-10 1977-04-05 Research Corporation Selective removal of albumin from blood fluid and compositions therefore
US4043997A (en) * 1976-05-28 1977-08-23 Cutter Laboratories, Inc. Method for isolating albumin using insoluble supports coupled to a dye
JPS635133B2 (da) * 1978-01-24 1988-02-02 Paburitsuku Herusu Raboratarii Saauisu Boodo
ES2332893T3 (es) * 1996-08-30 2010-02-15 Upfront Chromatography A/S Aislamiento de inmunoglobulinas.
AU2002951240A0 (en) * 2002-08-23 2002-09-19 Royal Women's Hospital Depletion of plasma proteins
BRPI0514435B8 (pt) * 2004-08-20 2021-05-25 American Nat Red Cross isolamento sequêncial de proteínas e esquemas de purificação através de cromatografia por afinidade
MY144344A (en) * 2005-04-08 2011-09-15 Ciba Holding Inc Adsorbents comprising anthraquinone dye-ligands for the separation of biological materials
SG144809A1 (en) * 2007-01-11 2008-08-28 Millipore U K Ltd Benzimidazole compounds and their use as chromatographic ligands
JP2011500757A (ja) * 2007-10-22 2011-01-06 メルク セローノ ソシエテ アノニム Fc含有タンパク質の精製方法
US9127043B2 (en) * 2009-03-05 2015-09-08 Biogen Ma Inc. Purification of immunoglobulins
WO2011044637A1 (en) * 2009-10-15 2011-04-21 Monash University Affinity ligands and methods for protein purification
GB201002824D0 (en) * 2010-02-19 2010-04-07 Temasek Polytechnic A method of preparing a substrate for immobilization of functional substances thereon and the substrate obtained therefrom
CN103732253A (zh) * 2011-08-19 2014-04-16 Emd密理博公司 小分子在纯化生物分子的方法中的用途

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JP2017512131A (ja) 2017-05-18
WO2015117984A1 (en) 2015-08-13
KR20160119134A (ko) 2016-10-12
EP3102637A1 (en) 2016-12-14
CN105980485B (zh) 2018-11-27
US20160347789A1 (en) 2016-12-01
EP3102637B1 (en) 2018-04-11
IL246881B (en) 2018-03-29
CN105980485A (zh) 2016-09-28
SG11201605954SA (en) 2016-08-30

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