DK2767546T3 - Lipoproteinkomplekser og fremstilling og anvendelser af disse - Google Patents

Lipoproteinkomplekser og fremstilling og anvendelser af disse Download PDF

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DK2767546T3
DK2767546T3 DK14150349.0T DK14150349T DK2767546T3 DK 2767546 T3 DK2767546 T3 DK 2767546T3 DK 14150349 T DK14150349 T DK 14150349T DK 2767546 T3 DK2767546 T3 DK 2767546T3
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cells
culture
embryonic stem
stem cells
medium
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DK14150349.0T
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Jean-Louis Dasseux
Daniela Carmen Oniciu
Rose Ackermann
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Cerenis Therapeutics Holding Sa
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/04—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length on carriers
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/04—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length on carriers
    • C07K1/042—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length on carriers characterised by the nature of the carrier
    • 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
    • C07K14/775—Apolipopeptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

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  • Health & Medical Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Claims (14)

1. Fremgangsmåde til ekspansion og opretholdelse af humane embryonale stamceller (hESC'er) i en udifferentieret tilstand, hvilken fremgangsmåde omfatter dyrkning af de humane embryonale stamceller i mindst 5 passager i en suspensionskultur under dyrkningsbetingelser uden adhærens til et eksternt substrat, og som tillader ekspansion af mindst 50 % af de humane embryonale stamceller i den udifferentierede tilstand, hvor det eksterne substrat omfatter komponenter af ekstracellulær matrix, en glasmikrobærer eller glasperler, og hvor dyrkningsbetingelserne omfatter et defineret, xenofrit og serumfrit dyrkningsmedium, der er valgt fra gruppen bestående af: et dyrkningsmedium, som omfatter basisk fibroblastvækstfaktor (bFGF), en opløselig interleukin-6-receptor (slL6R) i en koncentration på mindst 10 nanogram pr. milliliter (ng/ml) og opløseligt interleukin-6 (IL6), et dyrkningsmedium, som omfatter bFGF og mindst 1000 enheder pr. milliliter (u/ml) leukæmiinhibitorfaktor (LIF), et dyrkningsmedium, som omfatter bFGF og en IL6RIL6-kimære, og et dyrkningsmedium, der omfatter bFGF og en TGFp-isoform, og hvor dyrkningsbetingelserne omfatter dyrkning af de humane embryonale stamceller i en dyrkningsbeholder med en indvendig flade, som er udformet således, at de hESC'er, der dyrkes deri, ikke kan adhærere eller binde til fladen, hvorved de humane embryonale stamceller ekspanderes og holdes i den udifferentierede tilstand.
2. Fremgangsmåde til generering af cellelinjespecifikke celler ud fra humane embryonale stamceller, hvilken fremgangsmåde omfatter, at: (a) de humane embryonale stamceller dyrkes i en suspensionskultur ifølge fremgangsmåden ifølge krav 1, hvorved der opnås ekspanderede, udifferentierede humane embryonale stamceller; og (b) de ekspanderede, udifferentierede humane embryonale stamceller underkastes dyrkningsbetingelser, der er egnet til differentiering og/eller ekspansion af cellelinjespecifikke celler; hvorved de cellelinjespecifikke celler genereres ud fra de humane embryonale stamceller.
3. Fremgangsmåde til generering af embryoidlegemer ud fra humane embryonale stamceller, hvilken fremgangsmåde omfatter, at: (a) de humane embryonale stamceller dyrkes i en suspensionskultur ifølge fremgangsmåden ifølge krav 1, hvorved der opnås ekspanderede, udifferentierede humane embryonale stamceller; og (b) de ekspanderede, udifferentierede humane embryonale stamceller underkastes dyrkningsbetingelser, der er egnet til differentiering af de humane embryonale stamceller til embryoidlegemer; hvorved embryoidlegemerne genereres ud fra de humane embryonale stamceller.
4. Fremgangsmåde til generering af cellelinjespecifikke celler ud fra embryonale stamceller, hvilken fremgangsmåde omfatter, at: (a) de humane embryonale stamceller dyrkes i en suspensionskultur ifølge fremgangsmåden ifølge krav 1, hvorved der opnås ekspanderede, udifferentierede humane embryonale stamceller; (b) de ekspanderede, udifferentierede humane embryonale stamceller underkastes dyrkningsbetingelser, der er egnet til differentiering af de ekspanderede, udifferentierede humane embryonale stamceller til embryoidlegemer; og (c) celler af embryoidlegemerne underkastes dyrkningsbetingelser, der er egnet til differentiering og/eller ekspansion af cellelinjespecifikke celler; hvorved de cellelinjespecifikke celler genereres ud fra de humane embryonale stamcell
5. Fremgangsmåde ifølge krav 1, hvorTGF3-isoformen er en TGF3-isoform 1 (TGF3i).
6. Fremgangsmåde ifølge krav 1, hvorTGF3-isoformen er en TGF3-isoform 3 (TGF33).
7. Fremgangsmåde ifølge krav 1, hvor slL6R'en forekommer i en koncentration på 15-30 ng/ml.
8. Fremgangsmåde ifølge krav 1, hvor LIF'en forekommer i en koncentration på mindst 2000 enheder pr. milliliter (u/ml).
9. Fremgangsmåde ifølge et hvilket som helst af kravene 1 -8, hvor dyrkningen udføres under xenofrie betingelser.
10. Fremgangsmåde ifølge krav 5, hvorTGFPi'en forekommer i en koncentration på mindst 0,06 ng/ml.
11. Fremgangsmåde ifølge krav 6, hvor TGFPs'en forekommer i en koncentration på eller mindst 0,5 ng/ml.
12. Fremgangsmåde ifølge et hvilket som helst af kravene 1-11, hvor bFGF'en er i en koncentration på mindst 2 ng/ml.
13. Fremgangsmåde ifølge et hvilket som helst af kravene 1-11, hvor bFGF'en er i en koncentration på mindst 4 ng/ml.
14. Fremgangsmåde ifølge krav 1, hvor IL6RIL6-kimæren er i en koncentration på mindst 25 ng/ml.
DK14150349.0T 2011-02-07 2012-02-06 Lipoproteinkomplekser og fremstilling og anvendelser af disse DK2767546T3 (da)

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US201161440371P 2011-02-07 2011-02-07
US201161452630P 2011-03-14 2011-03-14
US201161487263P 2011-05-17 2011-05-17
EP12703947.7A EP2673296B1 (en) 2011-02-07 2012-02-06 Lipoprotein complexes and manufacturing and uses thereof

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