octaplasLG（人血浆蛋白）提高输血
octaplasLG®是一种药用许可的，经过验证的替代新鲜冰冻血浆。
OctaplasLG®为经S/D处理过的、具有凝血活性的混合血浆，用于输血。OctaplasLG适用于多种场合，包括：多种凝血因子缺乏、大出血或需要血浆置换的时候。
octaplasLG®一样的优良品质和安全性，此外因属于血浆输血而具有独立于血型的优势。其制备过程是将A型、B型和AB型供血中提取的血浆按一定单位比例进行优化组合，混合比例已经过透彻研究。
Human plasma proteins
Advancement in Transfusion
octaplasLG® is a pharmaceutically licensed, proven alternative to fresh-frozen plasma.
Octapharma's manufacturing process ensures that octaplasLG® is produced into standardised 200ml bags as either A,B,O or AB blood groups.
The latest variation includes the addition of a prion reduction stage to the manufacturing process1 (a 'Ligand Gel' chromotography column) in line with a 2004 Committee for Medicinal Products for Human Use (CHMP) position statement on variant Creutzfeldt-Jakob disease2.
The product also demonstrates:
Robust solvent-detergent virus inactivation3
Standardised and consistent coagulation factor content4
Reduced rate of febrile, allergic and anaphylactic transfusion reactions compared to National Blood Service standard fresh-frozen plasma5
Proven clinical efficacy6
These positive product features have contributed to more than 7.2 million units of octaplas® being used worldwide over 20 years since 1991, and over 130,000 units of octaplasLG® being used in Germany since 20097.
BACKGROUND: OctaplasLG(®) is a 2nd-generation virus inactivated pooled plasma for infusion. Prions are removed by the principle of chromatography, utilizing an affinity ligand gel (LG) developed for binding of prion proteins and their infectivity. The goal of this study was to verify, using the gold standard animal bioassay system, whether or not prion infectivity can be removed by the LG affinity step under conditions used in the routine manufacturing process.
MATERIALS AND METHODS: Aliquots of pooled plasma were spiked with a microsomal/cytosolic (MIC) fraction of brain-derived hamster-adapted scrapie 263K and subjected to the OctaplasLG(®) manufacturing process. Validated Western blot tests and animal bioassays studies were performed to determine the logarithmic reduction factors (RF) and the prion infectivity binding capacity.
RESULTS: Bioassay studies demonstrated different logarithmic RFs (i.e. 1·73 and 0·76 log(10)) at two different plasma-to-resin ratios, the latter one representing the actual manufacturing ratio of 100:1, which can be explained by the differences in the study design. However, both bioassay studies showed a reproducible and high prion infectivity binding capacity of ≥5·64 log(10) ID(50)/ml gel.
CONCLUSION: Bioassay studies confirmed the capacity of the LG to bind brain-derived MIC prion proteins spiked into plasma. Even through infectivity was still detected following passage over the LG, this can be attributed to the high loads used in the study design, and the binding capacity of the LG still ensures a significant safety margin--binding the prion agents at the levels of prion infectivity that might be present in plasma and beyond.
