IN2014MN01714A - - Google Patents

Info

Publication number
IN2014MN01714A
IN2014MN01714A IN1714MUN2014A IN2014MN01714A IN 2014MN01714 A IN2014MN01714 A IN 2014MN01714A IN 1714MUN2014 A IN1714MUN2014 A IN 1714MUN2014A IN 2014MN01714 A IN2014MN01714 A IN 2014MN01714A
Authority
IN
India
Prior art keywords
methods
dried formulations
drying
polyol
dried
Prior art date
Application number
Inventor
Heleen Kraan
Jean Pierre Amorij
Original Assignee
Staat Der Nederlanden Vert Door De Minister Van Vwsministerie Van Volksgezondheid Welzijn En Sport D
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 Staat Der Nederlanden Vert Door De Minister Van Vwsministerie Van Volksgezondheid Welzijn En Sport D filed Critical Staat Der Nederlanden Vert Door De Minister Van Vwsministerie Van Volksgezondheid Welzijn En Sport D
Publication of IN2014MN01714A publication Critical patent/IN2014MN01714A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/125—Picornaviridae, e.g. calicivirus
    • A61K39/13—Poliovirus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/32011—Picornaviridae
    • C12N2770/32611—Poliovirus
    • C12N2770/32634—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

The present invention relates to methods for producing dried formulations of biopharmaceutical agents that aim to minimize the loss of activity of the agents upon drying and to provide dried formulations with an extended shelf life. The method comprises the step of drying an aqueous solution comprising in addition to the biopharmaceutical agent at least an amino acid a polyol and a metal salt. Preferably the amino acid is glutamate the polyol is sorbitol and optionally also mannitol and the metal salt is a magnesium salt. The solution is dried by vacuum drying or by lyophilization. The methods are particularly useful for preparing dried formulations of viruses such as poliovirus or respiratory syncytial virus to be used for vaccination. The invention also relates to dried formulations prepared in accordance with the methods of the invention and to their use as medicaments e.g. as vaccines.
IN1714MUN2014 2012-03-05 2013-03-05 IN2014MN01714A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261606577P 2012-03-05 2012-03-05
EP12158086 2012-03-05
PCT/NL2013/050139 WO2013133702A1 (en) 2012-03-05 2013-03-05 Methods and compositions for stabilizing dried biological materials

Publications (1)

Publication Number Publication Date
IN2014MN01714A true IN2014MN01714A (en) 2015-05-29

Family

ID=49117091

Family Applications (1)

Application Number Title Priority Date Filing Date
IN1714MUN2014 IN2014MN01714A (en) 2012-03-05 2013-03-05

Country Status (11)

Country Link
US (2) US9827303B2 (en)
EP (1) EP2822540B1 (en)
JP (1) JP6253161B2 (en)
KR (1) KR102108876B1 (en)
CN (1) CN104271119B (en)
AU (1) AU2013228096B2 (en)
BR (1) BR112014020930A2 (en)
CA (1) CA2865551C (en)
IN (1) IN2014MN01714A (en)
WO (1) WO2013133702A1 (en)
ZA (1) ZA201407198B (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104274827B (en) * 2013-07-01 2020-07-14 上海贺普药业股份有限公司 Formulations of He Pula peptide
US10538785B2 (en) 2013-12-23 2020-01-21 Renaud Vaillant Lyophilized lentiviral vector particles, compositions and methods
AU2017286375B2 (en) * 2016-06-16 2019-04-18 Janssen Vaccines & Prevention B.V. HIV vaccine formulation
JP6799135B2 (en) * 2017-02-24 2020-12-09 久光製薬株式会社 Manufacturing method of microneedle device
EP3615006A4 (en) * 2017-04-28 2020-12-30 Universal Stabilization Technologies, Inc. Antigenic thermostable polio vaccines&related methods
JP7198264B2 (en) * 2017-07-11 2022-12-28 ユニバーサル スタビリゼイション テクノロジーズ，インコーポレイテッド Methods for storing biopharmaceuticals
CN111166891B (en) * 2018-11-13 2022-04-05 中国药科大学 Mannitol eutectic auxiliary material and preparation method and application thereof
CN112111609A (en) * 2020-10-29 2020-12-22 上海伯杰医疗科技有限公司 Universal nucleic acid detection kit for enteroviruses
CN114748615A (en) * 2022-04-29 2022-07-15 成都安永鼎业生物技术有限公司 Freeze-dried preparation of recombinant BCG vaccine for treatment and preparation method and application thereof
CN115089864B (en) * 2022-07-14 2023-12-29 复旦大学 Method for preparing soluble microneedle patch by using freeze drying technology
CN116763914B (en) * 2023-02-06 2024-02-23 广东永顺生物制药股份有限公司 Swine fever and highly pathogenic porcine reproductive and respiratory syndrome bivalent heat-resistant protective agent live vaccine and preparation method thereof
CN117482072A (en) * 2023-11-17 2024-02-02 上海市浦东新区公利医院(第二军医大学附属公利医院) Application of sorbitol in preparation of medicine for treating diseases caused by respiratory syncytial virus

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2505657A1 (en) * 1981-05-13 1982-11-19 Pasteur Institut IMPROVEMENTS IN LIVE STABILIZING AGENTS FOR THE PREPARATION OF VACCINES, AND STABILIZED VACCINES CONTAINING SAID STABILIZING AGENTS
JPH0761955B2 (en) * 1988-04-28 1995-07-05 国立予防衛生研究所長 Lyophilized hepatitis A vaccine
AU739916B2 (en) * 1996-09-26 2001-10-25 Merck Sharp & Dohme Corp. Rotavirus vaccine formulations
US6210683B1 (en) * 1997-09-05 2001-04-03 Merck & Co., Inc. Stabilizers containing recombinant human serum albumin for live virus vaccines
CA2399321C (en) * 2000-03-07 2013-04-30 Robert K. Evans Adenovirus formulations
AU2001275371B9 (en) * 2000-06-08 2007-06-07 Powderject Vaccines, Inc. Powder compositions
GB0020089D0 (en) 2000-08-15 2000-10-04 Smithkline Beecham Biolog Vaccine Composition
FR2814957B1 (en) * 2000-10-06 2002-12-20 Aventis Pasteur VACCINE COMPOSITION AND STABILIZATION METHOD
AU2004299057B2 (en) * 2003-12-17 2010-06-24 Wyeth Llc Methods for porducing storage stable viruses and immunogenic compositions thereof
WO2005061698A1 (en) 2003-12-24 2005-07-07 De Staat Der Nederlanden, Vertegenwoordigd Door De Minister Van Volksgezondheid, Welzijn En Sport A respiratory syncytial virus with a genomic deficiency complemented in trans
GB0503337D0 (en) * 2005-02-17 2005-03-23 Glaxosmithkline Biolog Sa Compositions
TWI398272B (en) * 2005-03-08 2013-06-11 Intervet Int Bv Chemically defined stabiliser
EP1909831A4 (en) * 2005-06-14 2013-02-20 Amgen Inc Self-buffering protein formulations
EP2509634B1 (en) * 2009-12-11 2019-03-06 Pfizer Inc Stable formulations for lyophilizing therapeutic particles

Also Published As

Publication number Publication date
AU2013228096B2 (en) 2017-07-13
US9827303B2 (en) 2017-11-28
KR20150008848A (en) 2015-01-23
WO2013133702A1 (en) 2013-09-12
US10335479B2 (en) 2019-07-02
CN104271119A (en) 2015-01-07
US20150030629A1 (en) 2015-01-29
CA2865551C (en) 2021-01-12
KR102108876B1 (en) 2020-05-12
BR112014020930A2 (en) 2017-06-27
JP6253161B2 (en) 2017-12-27
EP2822540A1 (en) 2015-01-14
US20180055924A1 (en) 2018-03-01
ZA201407198B (en) 2016-02-24
CN104271119B (en) 2018-07-10
JP2015509529A (en) 2015-03-30
EP2822540B1 (en) 2020-04-08
AU2013228096A1 (en) 2014-09-11
CA2865551A1 (en) 2013-09-12

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