Berting A, Goerner W, Spruth M, Kistner O, Kreil T R
Global Pathogen Safety, Vienna, Austria.
J Med Virol. 2005 Apr;75(4):603-7. doi: 10.1002/jmv.20299.
As a consequence of the September 2001 terrorist events, programs to protect against further such acts including potentially the use of biological warfare agents have been launched in the USA and elsewhere. As part of these initiatives, Vaccinia virus was procured for the pre-emptive vaccination of key personnel against smallpox as well as population-wide protection after an eventual exposure. The introduction of this live virus into a population at a relatively large scale represents a theoretical challenge for the safety of the blood supply, and potentially for plasma for fractionation. To strengthen further the demonstration of safety margins for plasma derived products against Vaccinia virus, the capacity of sterile filtration procedures to remove the virus was investigated. An infectivity assay for the Vaccinia virus strain which represents the majority of smallpox vaccine stocks available currently was used to investigate the potential removal of this virus by sterile filtration processes during the manufacture of plasma derivatives. Vaccinia virus behaves as predicted based on its size, i.e., an artificially added virus load is removed about 10,000-fold by the sterile filtration procedures tested. As the current investigation covered a range of different protein concentrations, filter materials and filters from different manufacturers, the results obtained are considered to be widely applicable. The current investigation supports further the high safety margins of plasma derivatives against any potential Vaccinia virus content of plasma for fractionation. As the large size is a general feature of Orthopox viruses, the results would also provide assurance against poxviruses identified more recently, for example, Monkeypox virus.
作为2001年9月恐怖事件的结果，美国及其他地区已启动了防范此类进一步行为（包括可能使用生物战剂）的计划。作为这些举措的一部分，采购了痘苗病毒，用于关键人员的天花预防接种以及在最终暴露后对全体人群的保护。将这种活病毒相对大规模地引入人群，对血液供应的安全性以及潜在的用于分馏的血浆安全性构成了理论挑战。为了进一步加强血浆衍生产品对痘苗病毒的安全边际论证，研究了无菌过滤程序去除该病毒的能力。使用针对代表目前可用大多数天花疫苗株的痘苗病毒株的感染性测定法，来研究在血浆衍生物制造过程中通过无菌过滤工艺潜在去除该病毒的情况。痘苗病毒的行为与其大小预测相符，即通过所测试的无菌过滤程序，人工添加的病毒载量可被去除约10000倍。由于当前研究涵盖了一系列不同的蛋白质浓度、过滤材料以及来自不同制造商的过滤器，因此所获得的结果被认为具有广泛适用性。当前研究进一步支持了血浆衍生物对于分馏用血浆中任何潜在痘苗病毒含量具有较高的安全边际。由于大尺寸是正痘病毒的普遍特征，这些结果也将为抵御最近发现的痘病毒（例如猴痘病毒）提供保证。
