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)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (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 (https=)
EP (1) EP2804634B1 (https=)
JP (2) JP6552822B2 (https=)
KR (1) KR102113296B1 (https=)
AU (1) AU2013209620B2 (https=)
CA (2) CA2861932C (https=)
DK (1) DK2804634T3 (https=)
ES (1) ES2750211T3 (https=)
IN (1) IN2014DN06817A (https=)
WO (1) WO2013109825A1 (https=)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2812091B1 (en) 2012-09-17 2021-03-10 W.R. Grace & CO. - CONN. Chromatography media and devices
WO2015013542A1 (en) 2013-07-25 2015-01-29 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.
ES2887110T3 (es) 2014-01-16 2021-12-21 Grace W R & Co Medios para cromatografía de afinidad y dispositivos para cromatografía
PL3137209T3 (pl) 2014-05-02 2023-01-02 W.R. Grace & Co. - Conn. Funkcjonalizowany materiał nośnikowy i sposoby wytwarzania oraz stosowania funkcjonalizowanego materiału nośnikowego
IS3008B (is) * 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
KR102566292B1 (ko) 2015-06-05 2023-08-10 더블유.알. 그레이스 앤드 캄파니-콘. 흡착성 바이오프로세싱 정화제와 이의 제조 및 사용 방법
US20210379186A1 (en) * 2018-04-16 2021-12-09 Merck Patent Gmbh Additives for protein formulations to improve thermal stability

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
JPH0779694B2 (ja) * 1985-07-09 1995-08-30 カドラント バイオリソ−シズ リミテツド 蛋白質および同類品の保護
EP0513332A4 (en) * 1990-11-14 1993-03-17 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
WO2003066585A2 (en) * 2002-02-08 2003-08-14 Alkermes Controlled Therapeutics, Inc. Polymer-based compositions for sustained release
US20040137004A1 (en) * 2002-03-19 2004-07-15 Glenn Gregory M Patch for transcutaneous immunization
US6666281B2 (en) 2002-03-19 2003-12-23 Deere & Company Bearing guard for a ground-working implement
KR101113201B1 (ko) 2003-02-19 2012-04-12 나트릭스 세퍼레이션즈, 인코포레이티드 지지된 다공성 젤을 함유하는 복합재
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
WO2005097304A1 (en) 2004-04-08 2005-10-20 Mcmaster University Membrane stacks
DE602005016402D1 (de) 2004-05-24 2009-10-15 Genvault Corp Stabile lagerung von protein und stabile lagerung von nukleinsäure in wiedergewinnbarer form
CA2564413C (en) * 2004-06-07 2013-10-01 Mcmaster University Stable composite material comprising supported porous gels

Also Published As

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

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