DK2603100T3 - Tør stabiliserende sammensætning til opbevaring af biologiske materialer - Google Patents

Tør stabiliserende sammensætning til opbevaring af biologiske materialer Download PDF

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DK2603100T3
DK2603100T3 DK11817090.1T DK11817090T DK2603100T3 DK 2603100 T3 DK2603100 T3 DK 2603100T3 DK 11817090 T DK11817090 T DK 11817090T DK 2603100 T3 DK2603100 T3 DK 2603100T3
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acid
mixture
drying
dry
protein
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Moti Harel
Qiong Tang
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Advanced Bionutrition Corp
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Claims (13)

  1. TØR STABILISERENDE SAMMENSÆTNING TIL OPBEVARING AF BIOLOGISKE MATERIALER
    1. Tør stabiliserende sammensætning i en glasagtig tilstand, hvilken sammensætning er fremstillet ifølge fremgangsmåden til fremstilling ifølge et hvilket som helst af kravene 7 til 10, hvilken sammensætning omfatter et biologisk materiale, hvor den stabiliserende sammensætning omfatter: (a) 0,5-90 % af en carbohydratkomponent der omfatter et disaccharid, et olig-osaccharid og et polysaccharid, (b) 0,5-40 % af en proteinkomponent der omfatter et hydrolyseret protein, og (c) et salt af en organisk syre der omfatter mellem 0,5-20 % carboxylsyre, hvilket biologisk materiale omfatter en levende, død eller svækkede celle, en mikrobe, en virus, en bakterie, en probiotisk bakterie, en plante eller jordbakterie, en gær, en cellekultur, et protein, et rekombinant protein, et enzym, et peptid, et hormon, en vaccine, et antibiotikum, et lægemiddel eller en blanding deraf; hvor polysaccharidet er valgt fra gruppen, der består af celluloseacetatphthalat (CAP), carboxymethylcellulose, pektin, natriumalginat, salte af alginsyre, hydro-xylpropylmethylcellulose (HPMC), methylcellulose, carrageenan, gellangummi, guargummi, acaciagummi, xanthangummi, johannesbrødgummi, chitosan og chitosan-derivater, polyglycolsyre, stivelser og modificerede stivelser og en blanding deraf; hvor oligosaccharidet er valgt fra gruppen, der består af cyclodextriner, inulin, maltodextriner, dextraner, fructo-oligosaccharider (FOS), galacto-oligosaccharider (GOS), mannan-oligosaccharider (MOS) og en blanding deraf; hvor carboxylsyren er valgt fra gruppen, der består af mælkesyre, ascorbinsyre, maleinsyre, oxalsyre, malonsyre, æblesyre, ravsyre, citronsyre, gluconsyre, glutaminsyre og en blanding deraf.
  2. 2. Tør stabiliserende sammensætning ifølge krav 1, hvor disaccharidet er til stede ved 40-80 %, oligosaccharidet er til stede ved 5-10 %, og polysaccharidet er til stede ved 5-10 %, hvor hver procentdel er baseret på den samlede vægt af carbohydratkomponenten.
  3. 3. Tør stabiliserende sammensætning ifølge krav 1, hvor det hydrolyserede protein er valgt fra gruppen, der består af hydrolyseret casein, hydrolyseret valleprotein, hydrolyseret ærteprotein, hydrolyseret sojaprotein og en blanding deraf.
  4. 4. Tør stabiliserende sammensætning ifølge krav 1, hvor disaccharidet er valgt fra gruppen, der består af trehalose, saccharose, lactose og en blanding deraf.
  5. 5. Tør stabiliserende sammensætning ifølge krav 1, hvor vægtforholdet mellem disaccharid/oligosaccharid/polysaccharid er fra ca. 10 : 0,2 : 0,1 til ca. 10 : 2 : 1.
  6. 6. Tør stabiliserende sammensætning ifølge krav 1, hvor disaccharidet er til stede ved 10-90 %, oligosaccharidet er til stede ved 1-10 %, og polysaccharidet er til stede ved 0,1-10 %, hvor hver procentdel er baseret på den samlede vægt af carbohydratkomponenten.
  7. 7. Fremgangsmåde til fremstilling for at bevare et biologisk materiale, hvilken fremgangsmåde omfatter: (a) at tilsætte en tør sammensætningsblanding til et biologisk materiale i et vækstmedium for at danne en viskøs opslæmning, hvor vægtmassen af det biologiske materiale i vækstmediet er mellem 5 og 30 % w/v, og hvor den tilsatte sammensætningsblanding i vækstmediet er mellem 10 og 60 %, hvor det endelige faste indhold i opslæmningen er fra 20 til 60 %, hvor den tørre sammensætningsblanding omfatter et disaccharid, et oligosaccharid, et polysaccharid, et hydrolyseret protein og et carboxylsyresalt; (b) hurtig frysning af opslæmningen i flydende nitrogen for at danne faste frosne partikler i form af perler, dråber eller strenge; (c) primær tørring af de frosne partikler ved inddampning under vakuum ved en temperatur over frysetemperaturen af de frosne partikler for at danne en primær tørret formulering; og (d) sekundær tørring af den primær tørrede formulering ved maksimal vakuum og en temperatur på 20 °C eller højere i en tid, der er tilstrækkelig til at reducere vandaktiviteten af den primær tørrede formulering, hvorved der fremstilles et konserveret biologisk materiale i glasagtig tilstand, hvor det konserverede biologiske materiale omfatter: (a) 0,5-90 % af en carbohydratkomponent der omfatter disaccharidet, oligosac-charidet og polysaccharidet, (b) 0,5-40% af en proteinkomponent der omfatter det hydrolyserede protein og (c) et salt af en organisk syre der omfatter mellem 0,5-20 % carboxylsyre, hvilket biologisk materiale omfatter en levende, død eller svækket celle, en mikrobe, en virus, en bakterie, en probiotisk bakterie, en plante eller jordbakterie, en gær, en cellekultur, et protein, et rekombinant protein, et enzym, et peptid, et hormon, en vaccine, et antibiotikum, et lægemiddel eller en blanding deraf; hvor polysaccharidet er valgt fra gruppen, der består af celluloseacetatphthalat (CAP), carboxymethylcellulose, pektin, natriumalginat, salte af alginsyre, hydro-xylpropylmethylcellulose (HPMC), methylcellulose, carrageenan, gellangummi, guargummi, acaciagummi, xanthangummi, johannesbrødgummi, chitosan og chitosan-derivater, polyglycolsyre, stivelser og modificerede stivelser og en blanding deraf; hvor oligosaccharidet er valgt fra gruppen, der består af cyclodextriner, inulin, maltodextriner, dextraner, fructo-oligosaccharider (FOS), galacto-oligosaccharider (GOS), mannan-oligosaccharider (MOS) og en blanding deraf; hvor carboxylsyren er valgt fra gruppen, der består af mælkesyre, ascorbinsyre, maleinsyre, oxalsyre, malonsyre, æblesyre, ravsyre, citronsyre, gluconsyre, glutaminsyre og en blanding deraf.
  8. 8. Fremgangsmåden ifølge krav 7 der yderligere omfatter et akklimatiseringstrin af den faste frosne partikel inden initiering af det primære tørringstrin, hvor akklimatiseringstrinnet udføres under vakuum og temperatur under fryseprocessen af de frosne partikler.
  9. 9. Fremgangsmåden ifølge krav 7, hvor opslæmningen størknes til en fast hydrogel ved pH eller temperaturændring eller ved tværbinding af polymerkæder før hurtig frysning.
  10. 10. Fremgangsmåden ifølge krav 7, hvor vandaktiviteten (Aw) af den tørre stabiliserende sammensætning er Aw < 0,3 eller lavere.
  11. 11. Produkt til oral indtagelse, hvilket produkt omfatter den tørre stabiliserende sammensætning ifølge krav 1.
  12. 12. Produktet ifølge krav 11, hvor produktet er et nutraceutisk, farmaceutisk eller vaccineprodukt.
  13. 13. Produkt ifølge krav 11, hvor produktet er et fødevare- eller dyrefoderprodukt.
DK11817090.1T 2010-08-13 2011-08-12 Tør stabiliserende sammensætning til opbevaring af biologiske materialer DK2603100T3 (da)

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