DK2748181T3 - Fremgangsmåde til oprensning af spaltet pro-insulin - Google Patents

Fremgangsmåde til oprensning af spaltet pro-insulin Download PDF

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Publication number
DK2748181T3
DK2748181T3 DK12837180.4T DK12837180T DK2748181T3 DK 2748181 T3 DK2748181 T3 DK 2748181T3 DK 12837180 T DK12837180 T DK 12837180T DK 2748181 T3 DK2748181 T3 DK 2748181T3
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DK
Denmark
Prior art keywords
insulin
shell
distilled water
added
bead
Prior art date
Application number
DK12837180.4T
Other languages
English (en)
Inventor
Eggert Brekkan
Kjell Eriksson
Bo-Lennart Johansson
Jamil Shanagar
Original Assignee
Ge Healthcare Bioprocess R&D Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ge Healthcare Bioprocess R&D Ab filed Critical Ge Healthcare Bioprocess R&D Ab
Application granted granted Critical
Publication of DK2748181T3 publication Critical patent/DK2748181T3/da

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/62—Insulins
    • 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
    • B01D15/361—Ion-exchange
    • B01D15/362—Cation-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
    • B01J20/286—Phases chemically bonded to a substrate, e.g. to silica or to polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
    • B01J20/286—Phases chemically bonded to a substrate, e.g. to silica or to polymers
    • B01J20/288—Polar phases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30—Processes for preparing, regenerating, or reactivating
    • B01J20/32—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3202—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the carrier, support or substrate used for impregnation or coating
    • B01J20/3206—Organic carriers, supports or substrates
    • B01J20/3208—Polymeric carriers, supports or substrates
    • B01J20/321—Polymeric carriers, supports or substrates consisting of a polymer obtained by reactions involving only carbon to carbon unsaturated bonds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30—Processes for preparing, regenerating, or reactivating
    • B01J20/32—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3202—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating characterised by the carrier, support or substrate used for impregnation or coating
    • B01J20/3206—Organic carriers, supports or substrates
    • B01J20/3208—Polymeric carriers, supports or substrates
    • B01J20/3212—Polymeric carriers, supports or substrates consisting of a polymer obtained by reactions otherwise than involving only carbon to carbon unsaturated bonds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/30—Processes for preparing, regenerating, or reactivating
    • B01J20/32—Impregnating or coating ; Solid sorbent compositions obtained from processes involving impregnating or coating
    • B01J20/3291—Characterised by the shape of the carrier, the coating or the obtained coated product
    • B01J20/3293—Coatings on a core, the core being particle or fiber shaped, e.g. encapsulated particles, coated fibers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J39/00—Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
    • B01J39/26—Cation exchangers for chromatographic processes
    • 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
    • B01D15/361—Ion-exchange

Landscapes

  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Toxicology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Peptides Or Proteins (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (8)

1. Fremgangsmåde til oprensning af insulin fra pro-insulin omfattende følgende trin: påføre en prøve af spaltet pro-insulin til et kromatografimedium omfattende porøse skalkugler ("shell beads") med en indre kerne og et ydre funktionaliseret lag tilvejebragt med ionbytter-ligander; adsorbere insulin på liganderne; og eluere insulin fra kromatografimediet ved en strømningshastighed på 100-1000 cm/time, fortrinsvis 300-600 cm/time, hvor det eluerede insulin har en renhed på mere end 85%, fortrinsvis mere end 90%.
2. Fremgangsmåde ifølge krav 1, hvor skalkuglerne er 20-100 pm i diameter.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor skalkuglerne er 40-80 pm i diameter.
4. Fremgangsmåde ifølge krav 1, 2 eller 3, hvor det funktionaliserede lag af skalkuglerne omfatter et 3-9 pm tykt lag.
5. Fremgangsmåde ifølge ét eller flere af de ovenfor nævnte krav, hvor det funktionaliserede lag af skalkuglerne omfatter et 5-7 pm tykt lag.
6. Fremgangsmåde ifølge ét eller flere af de ovenfor nævnte krav, hvor liganden er en stærk kation bytter-gruppe, såsom sulfonat (SO3'), sulfat (-OSO3), phosphat (-OPO32 ) og phosphonat (PO32).
7. Fremgangsmåde ifølge ét eller flere af de ovenfor nævnte krav, hvor kernen er fyldt med en egnet polær polymer såsom agarose, dextran, cellulose, stivelse, pullulan eller en fuldstændig syntetisk polymer såsom polyacrylamid, polymethacrylamid, poly(hydroxyalkylacrylater).
8. Fremgangsmåde ifølge ét eller flere af de ovenfor nævnte krav, hvor insulinet produceres i bakterier.
DK12837180.4T 2011-09-30 2012-09-28 Fremgangsmåde til oprensning af spaltet pro-insulin DK2748181T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE1100722 2011-09-30
PCT/SE2012/051040 WO2013048330A1 (en) 2011-09-30 2012-09-28 Method for purification of cleaved pro-insulin

Publications (1)

Publication Number Publication Date
DK2748181T3 true DK2748181T3 (da) 2016-05-23

Family

ID=47996093

Family Applications (1)

Application Number Title Priority Date Filing Date
DK12837180.4T DK2748181T3 (da) 2011-09-30 2012-09-28 Fremgangsmåde til oprensning af spaltet pro-insulin

Country Status (7)

Country Link
US (1) US9409967B2 (da)
EP (1) EP2748181B1 (da)
JP (1) JP6093364B2 (da)
CN (1) CN103827136B (da)
DK (1) DK2748181T3 (da)
PL (1) PL2748181T3 (da)
WO (1) WO2013048330A1 (da)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10864512B2 (en) * 2016-04-06 2020-12-15 Cytiva Bioprocess R&D Ab Chromatography matrix
JPWO2018147393A1 (ja) * 2017-02-10 2019-11-21 三菱ケミカル株式会社 ヒトインスリン精製用分離剤及びヒトインスリンの精製方法
CA3236293A1 (en) * 2021-12-07 2023-06-15 Cytiva Bioprocess R&D Ab Separation matrix and methods for separating target molecules

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1054523A (da) 1965-11-17 1900-01-01
GB1285024A (en) 1968-08-09 1972-08-09 Novo Terapeutisk Labor As Process of purifying insulin
DE2629568C3 (de) 1976-07-01 1981-09-10 Hoechst Ag, 6000 Frankfurt Verfahren zur Reinigung von Insulin, seinen Analogen und Derivaten
AU5397579A (en) 1978-12-26 1980-07-03 Eli Lilly And Company Purifying insulin
DE3511270A1 (de) 1985-03-28 1986-10-09 Veb Berlin-Chemie, Ddr 1199 Berlin Insulin aus pankreasextrakten
DE3511269A1 (de) * 1985-04-12 1986-10-09 Veb Berlin-Chemie, Ddr 1199 Berlin Verfahren zur reinigung von insulin
DE3726655A1 (de) 1987-08-11 1989-02-23 Hoechst Ag Verfahren zur isolierung basischer proteine aus proteingemischen, welche solche basischen proteine enthalten
DE19652713C2 (de) * 1996-12-18 2001-11-22 Aventis Pharma Gmbh Verfahren zur Reinigung von Insulin und Insulinderivaten durch Chromatographie an stark saurem Kationenaustauscher
SE9700768D0 (sv) * 1997-03-04 1997-03-04 Pharmacia Biotech Ab Förfarande för att introducera funktionalitet
DE19838097A1 (de) 1998-08-24 2000-03-02 Hoechst Marion Roussel De Gmbh Verfahren zur chromatographischen Reinigung von Insulinen
US10562007B2 (en) * 2007-07-25 2020-02-18 Ge Healthcare Bioprocess R&D Ab Separation matrix
US20110155668A1 (en) 2008-07-08 2011-06-30 Ge Healthcare Bio-Sciences Ab Separation medium for chromatography of various biomolecules
CA2789994A1 (en) 2010-02-19 2011-08-25 Ge Healthcare Bio-Sciences Ab Method for production of chromatography media

Also Published As

Publication number Publication date
EP2748181B1 (en) 2016-03-30
PL2748181T3 (pl) 2016-08-31
US20140243498A1 (en) 2014-08-28
US9409967B2 (en) 2016-08-09
EP2748181A4 (en) 2015-04-15
JP6093364B2 (ja) 2017-03-08
CN103827136A (zh) 2014-05-28
JP2014530211A (ja) 2014-11-17
EP2748181A1 (en) 2014-07-02
CN103827136B (zh) 2016-07-06
WO2013048330A1 (en) 2013-04-04

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