Smit Sibinga C T, Daenen S M, van Imhoff G W, Maas A, Das P C
Thromb Haemost. 1984 Feb 28;51(1):12-5.
New approaches and techniques for improving source material collection and Factor VIII production at Blood Bank level have been reported recently. Heparin has been shown to be of importance in increasing yields and stability of FVIII in the purification and concentration process. Work has been done to develop on a routine scale the heparin double cold precipitation technique for the production of a freeze-dried high yield purified FVIII concentrate. The product has been tested clinically in 4 severe hemophilia A patients for recovery, half-life and acute side-effects, using two dosages over 8 infusions. There was no significant difference between the two dosages. Mean recovery 99.1% and mean half-life 8 hr, ranging from 6.5 to 10.3 hr. No side-effects justify further exploration of the potential of heparin for high yield purified FVIII production.
最近有报道称，血库层面提高原料采集和凝血因子VIII生产的新方法和技术。肝素已被证明在纯化和浓缩过程中对于提高FVIII的产量和稳定性至关重要。已经开展工作，以常规规模开发用于生产冻干高产量纯化FVIII浓缩物的肝素双冷沉淀技术。该产品已在4名重度甲型血友病患者中进行了临床测试，采用两种剂量分8次输注，以检测回收率、半衰期和急性副作用。两种剂量之间没有显著差异。平均回收率为99.1%，平均半衰期为8小时，范围在6.5至10.3小时之间。没有副作用表明有必要进一步探索肝素用于高产量纯化FVIII生产的潜力。
