Spray: single-donor plasma product for room temperature storage.
Spray: single-donor plasma product for room temperature storage.
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DOI：
10.1111/j.1537-2995.2011.03419.x
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发表时间：
2012-04
期刊：
影响因子：
2.9
通讯作者：
Flegel WA
中科院分区：
文献类型：
--
作者：
Booth GS;Lozier JN;Nghiem K;Clibourn D;Klein HG;Flegel WA
喷雾干燥技术通常用于制药、乳制品和动物饲料行业，用于将液体加工成粉末，但尚未应用于人类血液产品。众所周知，喷雾干燥的蛋白质产品在室温下储存时保持稳定。在捐赠者设施收集的血浆单位在室温下连夜运往处理设施，在那里进行一次性喷雾干燥。室温保存48h后，将喷雾干燥的血浆产品一分为二，用1.5%甘氨酸或去离子水复水，并测定化学分析和凝血因子。配对的新鲜冰冻血浆(FFP)平行分析作为对照。两个复水组均在5分钟内完成重建(n=6)。总蛋白、白蛋白、Ig G、Ig A和Ig M的回收率(96%或更高)在组间差异无统计学意义。除第VIII因子(58%)外，甘氨酸重组产品中凝血因子的回收率在72%至93%之间。甘氨酸重组优于去离子水。我们记录了重组喷雾干燥血浆产品中的蛋白质和凝血活性在生理性数量上得到恢复。进一步优化喷雾干燥方法和重建液可能会得到更好的回收率。喷雾干燥是一种很有前途的制备人体血浆的技术，可以很容易地在室温下储存、运输和重组。微粒的快速重组导致了一种来自单一捐赠者的新型血浆产品。
Spray drying techniques are commonly utilized in the pharmaceutical, dairy and animal feed industries for processing liquids into powders but have not been applied to human blood products. Spray dried protein products are known to maintain stability during storage at room temperature. Plasma units collected at the donor facility were shipped overnight at room temperature to a processing facility where single-use spray drying occurred. After 48 hours storage at room temperature, the spray dried plasma product was split in two and rehydrated with 1.5% glycine or deionized water and assayed for chemistry analytes and coagulation factors. Matched fresh frozen plasma (FFP) was analyzed in parallel as controls. Reconstitution was achieved for both rehydration groups within five minutes (n=6). There was no statistically significant intergroup difference in recovery for total protein, albumin, IgG, IgA, and IgM (96% or higher). With the exception of factor VIII (58%), the recovery of clotting factors in the glycine reconstituted products ranged from 72% to 93%. Glycine reconstitution was superior to deionized water. We documented proteins and coagulation activities were recovered in physiologic quantities in reconstituted spray dried plasma products. Further optimization of the spray drying method and reconstitution fluid may result in even better recoveries. Spray drying is a promising technique for preparing human plasma that can be easily stored at room temperature, shipped, and reconstituted. Rapid reconstitution of the microparticles results in a novel plasma product from single donors.
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