Asper M, Hanrieder T, Quellmalz A, Mihranyan A
Charles River Biopharmaceutical Services GmbH, Gottfried-Hagen Str. 20, 51105, Köln, Germany.
Nanotechnology and Functional Materials, Department of Engineering Sciences, Box 534, Uppsala University, 75121 Uppsala, Sweden.
Biologicals. 2015 Nov;43(6):452-6. doi: 10.1016/j.biologicals.2015.08.001. Epub 2015 Aug 30.
The removal of xenotrpic murine leukemia virus (xMuLV) by size-exclusion filter paper composed of 100% naturally derived cellulose was validated. The filter paper was produced using cellulose nanofibers derived from Cladophora sp. algae. The filter paper was characterized using atomic force microscopy, scanning electron microscopy, helium pycnometry, and model tracer (100 nm latex beads and 50 nm gold nanoparticles) retention tests. Following the filtration of xMuLV spiked solutions, LRV ≥5.25 log10 TCID50 was observed, as limited by the virus titre in the feed solution and sensitivity of the tissue infectivity test. The results of the validation study suggest that the nanocellulose filter paper is useful for removal of endogenous rodent retroviruses and retrovirus-like particles during the production of recombinant proteins.
验证了由100%天然衍生纤维素制成的尺寸排阻滤纸对嗜异性鼠白血病病毒(xMuLV)的去除效果。该滤纸由来源于枝状绿藻的纤维素纳米纤维制成。使用原子力显微镜、扫描电子显微镜、氦比重瓶法以及模型示踪剂(100 nm乳胶珠和50 nm金纳米颗粒)保留测试对滤纸进行了表征。在对加标xMuLV的溶液进行过滤后,由于进料溶液中的病毒滴度和组织感染性测试的灵敏度限制,观察到对数减少值(LRV)≥5.25 log10 TCID50。验证研究结果表明,这种纳米纤维素滤纸在重组蛋白生产过程中可用于去除内源性啮齿动物逆转录病毒和逆转录病毒样颗粒。