Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
Transfusion. 2012 Apr;52(4):828-33. doi: 10.1111/j.1537-2995.2011.03419.x. Epub 2011 Nov 2.
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 was analyzed in parallel as controls.
Reconstitution was achieved for both rehydration groups within 5 minutes (n = 6). There was no significant intergroup difference in recovery for total protein, albumin, immunoglobulin (Ig)G, 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.
喷雾干燥技术常用于制药、乳制品和动物饲料行业，可将液体加工成粉末，但尚未应用于人类血液制品。已知喷雾干燥的蛋白质产品在室温下储存时保持稳定。
在捐赠点收集的血浆单位在室温下连夜运送到处理设施，在那里进行一次性喷雾干燥。在室温下储存 48 小时后，将喷雾干燥的血浆产品分为两部分，并用 1.5%甘氨酸或去离子水重新水化，并测定化学分析物和凝血因子。作为对照，平行分析匹配的新鲜冷冻血浆。
两种再水化组在 5 分钟内（n = 6）均可实现再水化。总蛋白、白蛋白、免疫球蛋白（Ig）G、IgA 和 IgM 的回收率在两组间无显著差异（96%或更高）。除因子 VIII（58%）外，甘氨酸再水化产品中凝血因子的回收率范围为 72%至 93%。甘氨酸再水化优于去离子水。
我们记录了再水化喷雾干燥血浆产品中生理量的蛋白质和凝血活性得到回收。进一步优化喷雾干燥方法和再水化液可能会导致更好的回收率。喷雾干燥是一种有前途的制备可在室温下轻松储存、运输和再水化的人类血浆的技术。微颗粒的快速再水化可从单个供体产生新型血浆产品。
