CA2861932C - Chromatographic media for storage and delivery of therapeutic biologics and small molecules - Google Patents

Chromatographic media for storage and delivery of therapeutic biologics and small molecules Download PDF

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Publication number
CA2861932C
CA2861932C CA2861932A CA2861932A CA2861932C CA 2861932 C CA2861932 C CA 2861932C CA 2861932 A CA2861932 A CA 2861932A CA 2861932 A CA2861932 A CA 2861932A CA 2861932 C CA2861932 C CA 2861932C
Authority
CA
Canada
Prior art keywords
composite material
certain embodiments
dried
protein
stabilizing agent
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CA2861932A
Other languages
English (en)
French (fr)
Other versions
CA2861932A1 (en
Inventor
John A. Chickosky
Charles H. Honeyman
Molly S. Mcglaughlin
Amro Ragheb
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck Millipore Ltd
Original Assignee
Merck Millipore Ltd
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 Merck Millipore Ltd filed Critical Merck Millipore Ltd
Priority to CA3124806A priority Critical patent/CA3124806C/en
Publication of CA2861932A1 publication Critical patent/CA2861932A1/en
Application granted granted Critical
Publication of CA2861932C publication Critical patent/CA2861932C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • 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
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/544Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being organic

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CA2861932A 2012-01-19 2013-01-18 Chromatographic media for storage and delivery of therapeutic biologics and small molecules Active CA2861932C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3124806A CA3124806C (en) 2012-01-19 2013-01-18 Chromatographic media for storage and delivery of therapeutic biologics and small molecules

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261588312P 2012-01-19 2012-01-19
US61/588,312 2012-01-19
PCT/US2013/022057 WO2013109825A1 (en) 2012-01-19 2013-01-18 Chromatographic media for storage and delivery of therapeutic biologics and small molecules

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3124806A Division CA3124806C (en) 2012-01-19 2013-01-18 Chromatographic media for storage and delivery of therapeutic biologics and small molecules

Publications (2)

Publication Number Publication Date
CA2861932A1 CA2861932A1 (en) 2013-07-27
CA2861932C true CA2861932C (en) 2021-09-14

Family

ID=48797397

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2861932A Active CA2861932C (en) 2012-01-19 2013-01-18 Chromatographic media for storage and delivery of therapeutic biologics and small molecules
CA3124806A Active CA3124806C (en) 2012-01-19 2013-01-18 Chromatographic media for storage and delivery of therapeutic biologics and small molecules

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3124806A Active CA3124806C (en) 2012-01-19 2013-01-18 Chromatographic media for storage and delivery of therapeutic biologics and small molecules

Country Status (10)

Country Link
US (2) US20130189322A1 (enExample)
EP (1) EP2804634B1 (enExample)
JP (2) JP6552822B2 (enExample)
KR (1) KR102113296B1 (enExample)
AU (1) AU2013209620B2 (enExample)
CA (2) CA2861932C (enExample)
DK (1) DK2804634T3 (enExample)
ES (1) ES2750211T3 (enExample)
IN (1) IN2014DN06817A (enExample)
WO (1) WO2013109825A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104968403A (zh) 2012-09-17 2015-10-07 格雷斯公司 色谱介质和装置
US9738683B2 (en) 2013-07-25 2017-08-22 Bio-Rad Laboratories, Inc. Enhanced functionality and delivery of a protein from a porous substrate
FR3012978A1 (fr) * 2013-11-12 2015-05-15 Biocarecell Filtre biocompatible et procede de fabrication d'un filtre biocompatible.
US11229896B2 (en) 2014-01-16 2022-01-25 W.R. Grace & Co.—Conn. Affinity chromatography media and chromatography devices
ES2929099T3 (es) 2014-05-02 2022-11-24 Grace W R & Co Material de soporte funcionalizado y métodos de fabricación y uso de material de soporte funcionalizado
IS3008B (is) * 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
PL3302784T3 (pl) 2015-06-05 2022-01-17 W.R. Grace & Co.-Conn. Adsorbentowe środki klarujące do bioprzetwarzania oraz sposoby ich wytwarzania i stosowania
CN112165951B (zh) * 2018-04-16 2024-12-13 默克专利股份有限公司 用于改善热稳定性的蛋白质制剂添加剂

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5059654A (en) * 1983-02-14 1991-10-22 Cuno Inc. Affinity matrices of modified polysaccharide supports
US4891319A (en) * 1985-07-09 1990-01-02 Quadrant Bioresources Limited Protection of proteins and the like
WO1992008790A1 (en) * 1990-11-14 1992-05-29 Cargill, Incorporated Conjugates of poly(vinylsaccharide) with proteins for the stabilization of proteins
US5159049A (en) * 1991-04-22 1992-10-27 Allen Robert C Method for stabilizing polyacrylamide gels
US5583162A (en) * 1994-06-06 1996-12-10 Biopore Corporation Polymeric microbeads and method of preparation
US6284282B1 (en) * 1998-04-29 2001-09-04 Genentech, Inc. Method of spray freeze drying proteins for pharmaceutical administration
SE9904475D0 (sv) * 1999-12-08 1999-12-08 Artursson Nucleic acid delivery system
US6896894B2 (en) * 2001-10-30 2005-05-24 Battelle Memorial Institute Proteins stabilized with polysaccharide gums
AU2003217367B2 (en) * 2002-02-08 2005-09-08 Alkermes Controlled Therapeutics, Inc. Polymer-based compositions for sustained release
US6666281B2 (en) * 2002-03-19 2003-12-23 Deere & Company Bearing guard for a ground-working implement
US20040137004A1 (en) * 2002-03-19 2004-07-15 Glenn Gregory M Patch for transcutaneous immunization
AU2004212641B2 (en) 2003-02-19 2009-08-06 Merck Millipore Ltd. Composite materials comprising supported porous gels
US7785769B2 (en) * 2003-07-25 2010-08-31 The United States of America as reprsented by the Secretary of the Navy Immobilization of oligonucleotides and proteins in sugar-containing hydrogels
CA2558859C (en) 2004-04-08 2014-02-04 Mcmaster University Membrane stacks
CA2567720A1 (en) * 2004-05-24 2005-12-08 Genvault Corporation Stable protein storage and stable nucleic acid storage in recoverable form
EP1773485B1 (en) * 2004-06-07 2015-09-16 Natrix Separations Inc. Stable composite material comprising supported porous gels

Also Published As

Publication number Publication date
EP2804634B1 (en) 2019-08-28
JP2015504092A (ja) 2015-02-05
KR20140117529A (ko) 2014-10-07
JP6552822B2 (ja) 2019-07-31
CA3124806C (en) 2023-09-26
CA2861932A1 (en) 2013-07-27
US20200069602A1 (en) 2020-03-05
JP2019011341A (ja) 2019-01-24
WO2013109825A1 (en) 2013-07-25
DK2804634T3 (da) 2019-11-04
EP2804634A1 (en) 2014-11-26
US20130189322A1 (en) 2013-07-25
IN2014DN06817A (enExample) 2015-05-22
ES2750211T3 (es) 2020-03-25
KR102113296B1 (ko) 2020-06-02
EP2804634A4 (en) 2015-07-22
AU2013209620B2 (en) 2017-06-15
CA3124806A1 (en) 2013-07-27
AU2013209620A1 (en) 2014-08-28

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Effective date: 20170822