HRP20130975T1 - Pripravci i postupci proizvodnje pripravaka - Google Patents

Pripravci i postupci proizvodnje pripravaka Download PDF

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Publication number
HRP20130975T1
HRP20130975T1 HRP20130975TT HRP20130975T HRP20130975T1 HR P20130975 T1 HRP20130975 T1 HR P20130975T1 HR P20130975T T HRP20130975T T HR P20130975TT HR P20130975 T HRP20130975 T HR P20130975T HR P20130975 T1 HRP20130975 T1 HR P20130975T1
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Croatia
Prior art keywords
ctla4
treatment
molecules
preparation according
equal
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HRP20130975TT
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English (en)
Inventor
Kirk J. Leister
Eugene J. Schaefer
Ronald Bates
Elizabeth A. Bramhall
David M. Didio
Robert Donaldson
Alan R. Flesher
Helen G. Haggerty
David H. Kirkley
John M. Tabor
Lee K. Tay
Pallaiah Thammana
Ajoy Velayudhan
David E. Smolin
Reb J. Russell
Thomas Vanden Boom
Jeffrey Schrimsher
Joyce Whitehead
Dean Brownell
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Bristol-Myers Squibb Company
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38218674&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20130975(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bristol-Myers Squibb Company filed Critical Bristol-Myers Squibb Company
Publication of HRP20130975T1 publication Critical patent/HRP20130975T1/hr

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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
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • 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
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/70521—CD28, CD152
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/195—Chemokines, e.g. RANTES
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • 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
    • 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
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • B01D15/3804—Affinity chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Toxicology (AREA)
  • Epidemiology (AREA)
  • Rheumatology (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Analytical Chemistry (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (12)

1. Pripravak koji sadrži CTLA4-Ig molekule i naznačen je time što je: (a) prosječni molarni omjer N-acetil neuraminske kiseline (NANA) prema CTLA4-Ig molekulama od 8.0 do 11.9, i (b) manji ili jednak 2.0 posto površine CTLA4-Ig visoke molekulske težine kako je određeno kromatografijom isključenja po veličini i spektrofotometrijskim otkrivanjem.
2. Pripravak prema zahtjevu 1, dalje naznačen količinom proteina stanice domaćina koja je manja ili jednaka 95 ng/ml CTLA4-Ig molekula i količinom MCP-1 koja je manja od oko 9.55 ng/ml.
3. Pripravak prema zahtjevu 1, gdje su CTLA4-Ig molekule veće ili jednake 97.0 posto površine CTLA4-Ig dimera kako je određeno kromatografijom isključenja po veličini i manje ili jednake 0.5 posto površine od vrsta niske molekulske težine kako je određeno kromatografijom isključenja po veličini i spektrofotometrijskim otkrivanjem.
4. Pripravak prema zahtjevu 1, gdje su CTLA4-Ig molekule manje ili jednake 1.0 posto površine od vrsta visoke molekulske težine kako je određeno kromatografijom isključenja po veličini i spektrofotometrijskim otkrivanjem.
5. Pripravak prema zahtjevu 1, gdje su CTLA4-Ig molekule manje ili jednake 0.5 posto površine od vrsta visoke molekulske težine kako je određeno kromatografijom isključenja po veličini i spektrofotometrijskim otkrivanjem.
6. Pripravak prema zahtjevu 1, gdje CTLA4-Ig molekule sadrže jedan ili više polipeptida sa SEQ ID NO:2, 5, 6, 7, 8, 9, ili 10.
7. Pripravak prema zahtjevu 1, gdje CTLA4-Ig molekule sadrže jedan ili više polipeptida sa SEQ ID NO:18.
8. Pripravak prema zahtjevu 1, gdje je CTLA4-Ig molekula mutant CTLA4-Ig CTLA4A29YL104E-Ig.
9. Pripravak prema zahtjevu 8, gdje CTLA4-Ig molekule sadrže jedan ili više polipeptida sa SEQ ID NO:4, 11, 12, 13, 14, 15 ili 16.
10. Pripravak prema zahtjevu 8, gdje CTLA4-Ig molekule sadrže jedan ili više polipeptida sa SEQ ID NO:24.
11. Pripravak prema bilo kojem od zahtjeva 1 do 10, gdje je pripravak farmaceutski pripravak.
12. Pripravak prema bilo kojem od zahtjeva 1 do 11 za uporabu u liječenju ili prevenciji bolesti transplantata protiv primatelja (eng. graft versus host disease, GVHD), liječenju ili prevenciji odbacivanja transplantiranog organa, liječenju ili prevenciji odbacivanja transplantiranog organa, tkiva ili stanice, liječenju imunološkog poremećaja povezanog s odbijanjem transplantata, liječenju psorijaze, liječenju lupusa, liječenju reumatske bolesti, liječenju reumatoidnog artritisa, ili liječenju multiple skleroze.
HRP20130975TT 2005-12-20 2013-10-15 Pripravci i postupci proizvodnje pripravaka HRP20130975T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US75226705P 2005-12-20 2005-12-20
US75215005P 2005-12-20 2005-12-20
US84954306P 2006-10-05 2006-10-05
PCT/US2006/049074 WO2007076032A2 (en) 2005-12-20 2006-12-19 Compositions and methods for producing a composition

Publications (1)

Publication Number Publication Date
HRP20130975T1 true HRP20130975T1 (hr) 2013-11-22

Family

ID=38218674

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20130975TT HRP20130975T1 (hr) 2005-12-20 2013-10-15 Pripravci i postupci proizvodnje pripravaka

Country Status (25)

Country Link
US (4) US10508144B2 (hr)
EP (2) EP1969007B1 (hr)
JP (2) JP5096369B2 (hr)
KR (2) KR101398713B1 (hr)
CN (1) CN106589132B (hr)
AU (2) AU2006330922B2 (hr)
BR (2) BRPI0622251A2 (hr)
CA (2) CA2634760C (hr)
CY (1) CY1114887T1 (hr)
DK (2) DK2253644T3 (hr)
EA (1) EA017765B1 (hr)
ES (2) ES2433092T3 (hr)
HK (1) HK1121173A1 (hr)
HR (1) HRP20130975T1 (hr)
IL (2) IL192098A (hr)
MX (1) MX336807B (hr)
NO (1) NO20082716L (hr)
NZ (1) NZ597215A (hr)
PE (1) PE20080556A1 (hr)
PL (2) PL2253644T3 (hr)
PT (2) PT2253644E (hr)
SI (2) SI1969007T1 (hr)
TW (2) TWI398520B (hr)
WO (1) WO2007076032A2 (hr)
ZA (1) ZA200805301B (hr)

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