SG11201408262XA - Temperature stable vaccine formulations - Google Patents

Temperature stable vaccine formulations

Info

Publication number
SG11201408262XA
SG11201408262XA SG11201408262XA SG11201408262XA SG11201408262XA SG 11201408262X A SG11201408262X A SG 11201408262XA SG 11201408262X A SG11201408262X A SG 11201408262XA SG 11201408262X A SG11201408262X A SG 11201408262XA SG 11201408262X A SG11201408262X A SG 11201408262XA
Authority
SG
Singapore
Prior art keywords
international
maryland
gaithersburg
formulations
pct
Prior art date
Application number
SG11201408262XA
Inventor
Jee Look
Christian Fernando Ruiz
Aaron Paul Miles
Richard William Welch
Original Assignee
Emergent Product Dev Gaithersburg Inc
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 Emergent Product Dev Gaithersburg Inc filed Critical Emergent Product Dev Gaithersburg Inc
Publication of SG11201408262XA publication Critical patent/SG11201408262XA/en

Links

Classifications

    • 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
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/07—Bacillus
    • 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
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants

Abstract

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau „ (10) International Publication Number (43) International Publication Date ^ ^ WO 2014/004578 A1 3 January 2014 (03.01.2014) WIPO I PCT (51) International Patent Classification: A61K9/18 (2006.01) (21) International Application Number: (22) International Filing Date: (25) Filing Language: (26) Publication Language: PCT/US2013/047712 25 June 2013 (25.06.2013) English English (30) Priority Data: 61/664,062 61/801,385 25 June 2012 (25.06.2012) US 15 March 2013 (15.03.2013) US (71) Applicant: EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. [US/US]; 300 Professional Drive, Gaithersburg, Maryland 20879 (US). (72) Inventors: LOOK, Jee; 14604 Bubbling Spring Road, Boyds, Maryland 20841 (US). RUIZ, Christian Fernando; 13409 Wisteria Drive, Germantown, Maryland 20874 (US). MILES, Aaron Paul; 10711 Muirfield Drive, Potomac, Maryland 20854 (US). WELCH, Richard Willi­ am; 110 Woodland Road, Gaithersburg, Maryland 20877 (US). (74) Agents: STEFFE, Eric K. et al.; Sterne Kessler Goldstein & Fox P.L.L.C., 1100 New York Avenue N.W., Washing­ ton, District of Columbia 20005 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available)'. AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available)'. ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) — before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) — with sequence listing part of description (Rule 5.2(a)) 00 l> o o o CJ (54) Title: TEMPERATURE STABLE VACCINE FORMULATIONS (57) Abstract: Formulations of vaccine antigen, such as anthrax protective antigen, are provided that are stable after undergoing freeze and thaw conditions. Methods of using the formulations to prepare vaccine are also provided. Vaccines comprising the formu­ lations are useful, for example, to protect against, inhibit or alleviate a disease or infection, such as related to anthrax infection.
SG11201408262XA 2012-06-25 2013-06-25 Temperature stable vaccine formulations SG11201408262XA (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261664062P 2012-06-25 2012-06-25
US201361801385P 2013-03-15 2013-03-15
PCT/US2013/047712 WO2014004578A1 (en) 2012-06-25 2013-06-25 Temperature stable vaccine formulations

Publications (1)

Publication Number Publication Date
SG11201408262XA true SG11201408262XA (en) 2015-01-29

Family

ID=49783811

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201408262XA SG11201408262XA (en) 2012-06-25 2013-06-25 Temperature stable vaccine formulations

Country Status (13)

Country Link
US (1) US20150335752A1 (en)
EP (1) EP2863898A4 (en)
JP (1) JP2015525748A (en)
KR (1) KR20150034170A (en)
CN (1) CN104470506A (en)
AU (1) AU2013280480B2 (en)
CA (1) CA2877130A1 (en)
HK (1) HK1207312A1 (en)
IL (1) IL236380A0 (en)
IN (1) IN2015MN00038A (en)
RU (1) RU2014151424A (en)
SG (1) SG11201408262XA (en)
WO (1) WO2014004578A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10357559B2 (en) 2013-12-27 2019-07-23 Emergent Product Development Gaithersburg Inc. Temperature stable vaccine formulations
EA201691348A1 (en) * 2013-12-31 2016-11-30 Инфекшес Дизиз Рисерч Инститьют ONE-FLAKE VACCINE COMPOSITIONS
US11173197B2 (en) 2015-07-07 2021-11-16 Bluewillow Biologics, Inc. Methods and compositions for nanoemulsion vaccine formulations
US20170007690A1 (en) * 2015-07-07 2017-01-12 Nanobio Corporation Methods and compositions for the stabilization of anthrax recombinant protective antigen
EP3319930A4 (en) * 2015-07-07 2019-04-10 NanoBio Corporation Methods and compositions for the stabilizaton of proteins
US11510871B2 (en) 2016-09-16 2022-11-29 Leukocare Ag Method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation
EP3512545B1 (en) 2016-09-16 2022-10-26 Leukocare AG A novel method for stabilization of a biopharmaceutical drug product during processing
KR101744900B1 (en) 2017-01-20 2017-06-08 주식회사 대웅 Stable Liquid Composition Comprising Botulinum Toxin

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69530196T2 (en) * 1994-06-02 2003-11-20 Elan Drug Delivery Ltd METHOD FOR PREVENTING THE AGGREGATION OF PROTEINS / PEPTIDES IN REHYDRATION OR THAWING
US7201912B2 (en) * 2002-04-12 2007-04-10 Emergent Biodefense Operation Lansing Inc. Recombinant immunogenic compositions and methods for protecting against lethal infections from Bacillus anthracis
US9283260B2 (en) * 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
CN100556400C (en) * 2006-07-20 2009-11-04 上海交通大学 The preparation method of the polysaccharide vitreous particle of carrying active vaccine or antibody
EP2068834A2 (en) * 2006-09-08 2009-06-17 Becton, Dickinson & Company Stable powder formulations of aluma-dsorbed vaccines
AU2008231072B2 (en) * 2007-03-22 2013-08-01 The Regents Of The University Of Colorado Method of preparing an immunologically-active adjuvant-bound dried vaccine composition
WO2010053610A2 (en) * 2008-07-30 2010-05-14 Emergent Biosolutions, Inc. Stable anthrax vaccine formulations
US20110212127A1 (en) * 2008-09-24 2011-09-01 Stabilitech Ltd. Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine
CA2750321A1 (en) * 2009-01-22 2010-07-29 Pharmathene, Inc. Stable vaccine compositions and methods of use

Also Published As

Publication number Publication date
KR20150034170A (en) 2015-04-02
AU2013280480B2 (en) 2018-03-15
IN2015MN00038A (en) 2015-10-16
IL236380A0 (en) 2015-02-26
US20150335752A1 (en) 2015-11-26
CN104470506A (en) 2015-03-25
EP2863898A1 (en) 2015-04-29
HK1207312A1 (en) 2016-01-29
RU2014151424A (en) 2016-08-20
AU2013280480A1 (en) 2015-01-22
EP2863898A4 (en) 2016-04-27
CA2877130A1 (en) 2014-01-03
JP2015525748A (en) 2015-09-07
WO2014004578A1 (en) 2014-01-03

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