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    • 6. 发明授权
    • Dry storage stabilizing composition for biological materials
    • 用于生物材料的干燥储存稳定组合物
    • US09504275B2
    • 2016-11-29
    • US13208459
    • 2011-08-12
    • Moti HarelQiong Tang
    • Moti HarelQiong Tang
    • A61K47/42A23L1/30A01N1/02A23L1/00A23L3/44A23P1/04A61K39/12C12N1/04A61K39/00
    • A23K20/10A01N1/0221A01N1/0284A01N1/0289A23K10/18A23K20/142A23K20/147A23K20/163A23K40/30A23L3/44A23L33/135A23P10/30A61K39/12A61K2039/5252A61K2039/542C12N1/04C12N2760/16011C12N2760/16034
    • The present invention includes compositions and drying methods for preserving sensitive bioactive materials, such as peptides, proteins, hormones, nucleic acids, antibodies, drugs vaccines, yeast, bacteria (probiotic or otherwise), viruses and/or cell suspensions, in storage. The compositions include a carbohydrates component and a glass enhancer component, wherein the carbohydrate component includes a mixture of di-, oligo- and polysaccharides and the glass enhancer includes ions of organic acid and protein hydrolysates. The composition is prepared by dispersing all the solid components in a solution and then snap-frozen to form small beads, strings or droplets. The preferred drying method of the frozen beads, strings or droplets is initiated by a short purging and structure stabilizing step of the frozen particles under a vacuum pressure of less than 2000 mTORR and at a desired temperature. During the secondary and final drying step of the material a full vacuum pressure and elevated temperature are applied, to achieve a final desirable water activity of the dry material.
    • 本发明包括用于保存灵敏生物活性物质(例如肽,蛋白质,激素,核酸,抗体,药物疫苗,酵母,细菌(益生菌或其他)),病毒和/或细胞悬液的组合物和干燥方法。 组合物包括碳水化合物组分和玻璃增强剂组分,其中碳水化合物组分包括二糖,寡糖和多糖的混合物,玻璃增强剂包括有机酸和蛋白质水解产物的离子。 通过将所有固体组分分散在溶液中制备组合物,然后快速冷冻以形成小的珠粒,细丝或液滴。 冻结的珠粒,丝束或液滴的优选干燥方法是通过在小于2000mTORR的真空压力下的冷冻颗粒的短清洗和结构稳定步骤引发的,随后在大于> 2000的真空压力下进行初步干燥步骤 mTORR并在所需温度下进行。 在材料的二次和最终干燥步骤期间,施加完全真空压力和升高的温度,以达到干燥材料的最终期望的水活度。