Schulz Petra M, Gehringer Werner, Nöhring Sabine, Müller Sebastian, Schmidt Torben, Kekeiss-Schertler Stephanie, Solomon Cristina, Pock Katharina, Römisch Jürgen
Octapharma Pharmazeutika Produktionsgesellschaft mbH, R&D Plasma Vienna, Oberlaaerstraße 235, 1100 Vienna, Austria.
Octapharma Pharmazeutika Produktionsgesellschaft mbH, R&D Plasma Vienna, Oberlaaerstraße 235, 1100 Vienna, Austria.
Biologicals. 2018 Mar;52:72-77. doi: 10.1016/j.biologicals.2017.12.003. Epub 2018 Jan 12.
Fibryga is a new lyophilized fibrinogen concentrate for intravenous use for the treatment of congenital fibrinogen deficiency. fibryga is produced from pooled human plasma and the final product is characterized by high purity, integrity, and pathogen safety. Functional activity of fibrinogen was demonstrated by cross-linking studies and thromboelastometry; integrity of the fibrinogen molecule was demonstrated by size exclusion chromatography and the detection of only trace amounts of activation markers in the final product. Pathogen safety of fibryga was proved by downscaling studies for the two dedicated pathogen inactivation/removal steps, i.e. solvent detergent treatment and nanofiltration. Fibryga is stable for at least three years when stored at room temperature. In conclusion, the performed studies demonstrated that fibryga meets the requirements for a state-of-the-art fibrinogen concentrate, such as a satisfactory activity profile combined with a favorable pathogen safety profile and stability.
Fibryga是一种新型冻干纤维蛋白原浓缩剂，用于静脉注射治疗先天性纤维蛋白原缺乏症。Fibryga由混合人血浆制成，最终产品具有高纯度、完整性和病原体安全性的特点。通过交联研究和血栓弹力测定法证明了纤维蛋白原的功能活性；通过尺寸排阻色谱法以及最终产品中仅检测到痕量激活标志物证明了纤维蛋白原分子的完整性。通过对两个专门的病原体灭活/去除步骤（即溶剂去污剂处理和纳滤）的缩小规模研究，证明了Fibryga的病原体安全性。Fibryga在室温下储存时至少稳定三年。总之，所进行的研究表明，Fibryga符合最先进纤维蛋白原浓缩剂的要求，例如具有令人满意的活性特征，同时具有良好的病原体安全性特征和稳定性。
