Innovation and Development, Terumo BCT, Lakewood, CO 80215, USA.
Mil Med. 2021 Jan 25;186(Suppl 1):400-407. doi: 10.1093/milmed/usaa347.
Terumo BCT is developing a system to produce a freeze-dried plasma product, Terumo's freeze-dried plasma (TFDP), that is stored in a rugged, light-weight plastic package suitable for field use, which retains a stable level of specific coagulation factors and proteins within clinical range, when stored for up to 2 years at room temperature and 4°C.
Plasma frozen within 24 hours of phlebotomy (PF24) were thawed, sampled, and individually lyophilized to produce a corresponding TFDP unit. Fresh frozen plasma (FFP) units were thawed, sampled, pooled in groups of 10 units (also sampled) and lyophilized to produce 2 lots of TFDP. Each TFDP unit was reconstituted with water for injection (WFI) and tested for pH, prothrombin time, activated partial thromboplastin time, factors V and VIII, fibrinogen, protein C, and protein S. Results were compared with PF24/FFP. Additional FFP units were thawed, sampled, pooled, divided to generate 2 TFDP units for each time point (1, 2, 3, 6, 12, 18, and 24 months, one each stored at 4°C and 25°C) and lyophilized. Postlyophilization, TFDP units were stored at 4°C or 25°C, reconstituted with WFI, and tested for the factors listed above. Residual moisture content of the lyophilized plasma was also tested.
Coagulation factor activity of TFDP was ±20% of PF24/FFP. Pooling standardized variation in TFDP coagulation factor activities, which were within clinical ranges postlyophilization. The pH of TFDP and PF24/FFP were within required range. Residual moisture content of TFDP was <2%.
The TFDP process had no negative impact on coagulation factor activity. Input plasma and anticoagulant type did not affect TFDP quality. Pooling FFP normalized factor variability in TFDP and did not negatively impact product quality. The TFDP is stable for up to 24 months at room and refrigerated temperatures. Terumo's freeze-dried plasma is comparable to PF24/FFP. It does not require complex logistics or time-consuming thawing. Terumo's freeze-dried plasma may be suitable for rapid treatment of coagulopathies with logistical advantages over PF24/FFP.
泰尔茂 BCT 正在开发一种生产冻干血浆产品的系统，即泰尔茂的冻干血浆（TFDP），它储存在坚固、轻便的塑料包装中，适合现场使用，在室温下储存长达 2 年，在 4°C 下储存长达 4°C。在采血后 24 小时内冷冻的血浆（PF24）解冻后进行采样，并单独冻干以产生相应的 TFDP 单位。新鲜冷冻血浆（FFP）单位解冻后进行采样，每 10 个单位（也进行采样）进行分组冻干，以产生 2 批 TFDP。每个 TFDP 单位用注射用水（WFI）复溶，然后测试 pH 值、凝血酶原时间、活化部分凝血活酶时间、因子 V 和 VIII、纤维蛋白原、蛋白 C 和蛋白 S。结果与 PF24/FFP 进行比较。另外解冻了更多的 FFP 单位，采样，混合，分成 2 个 TFDP 单位，每个时间点（1、2、3、6、12、18 和 24 个月，每个在 4°C 和 25°C 下储存），然后冻干。冻干后，TFDP 单位在 4°C 或 25°C 下储存，用 WFI 复溶，测试上述因子。还测试了冻干血浆的残余水分含量。
TFDP 的凝血因子活性为 PF24/FFP 的±20%。TFDP 凝血因子活性的标准化变化在冻干后处于临床范围内。TFDP 和 PF24/FFP 的 pH 值在要求范围内。TFDP 的残余水分含量<2%。
TFDP 工艺对凝血因子活性没有负面影响。输入血浆和抗凝剂类型不影响 TFDP 质量。FFP 的混合使 TFDP 中的因子变异性标准化，且不影响产品质量。TFDP 在室温下和冷藏温度下可稳定 24 个月。泰尔茂的冻干血浆与 PF24/FFP 相当。它不需要复杂的物流或耗时的解冻。泰尔茂的冻干血浆可能适合于治疗凝血功能障碍，与 PF24/FFP 相比具有后勤优势。
