Aranha-Creado H, Peterson J, Huang P Y
Scientific and Laboratory Services Dept., Pall Corporation, Port Washington, NY 11050, USA.
Biologicals. 1998 Jun;26(2):167-72. doi: 10.1006/biol.1998.0130.
Continuous cell lines (used in the manufacture of monoclonal antibodies and other therapeutic proteins) may harbour retroviral particles; nevertheless, they are deemed acceptable if the production system is validated for clearance of these contaminants. As part of a campaign to evaluate and validate appropriate virus removal methodologies for monoclonal immunoglobulin G (IgG) products, studies were undertaken with a hydrophilic polyvinylidene fluoride (PVDF) microporous membrane-the Ultipor(R) VF grade DV50 virus removal membrane. Testing conducted with murine leukaemia virus, a specific model virus used in viral validation studies to document removal of retroviruses, demonstrated a greater that 7 log clearance by the Ultipor(R) VR grade DV50 membrane. Filterability testing established the feasibility of positioning the filter at either of two different stages during manufacture. The results presented in this study demonstrate that membrane filtration through the Ultipor VF grade DV50 virus removal filter can constitute part of the purification regimen to effect removal of endogenous retrovirus-like contaminants from monoclonal IgG products.
连续细胞系（用于生产单克隆抗体和其他治疗性蛋白质）可能含有逆转录病毒颗粒；然而，如果生产系统经过验证能够清除这些污染物，那么它们被认为是可接受的。作为评估和验证单克隆免疫球蛋白G（IgG）产品合适病毒去除方法活动的一部分，研究人员使用了亲水性聚偏二氟乙烯（PVDF）微孔膜——Ultipor® VF级DV50病毒去除膜。使用鼠白血病病毒进行的测试，这是一种在病毒验证研究中用于记录逆转录病毒去除情况的特定模型病毒，结果表明Ultipor® VR级DV50膜的清除率超过7个对数。过滤性测试确定了在生产过程中将过滤器放置在两个不同阶段中任意一个阶段的可行性。本研究呈现的结果表明，通过Ultipor VF级DV50病毒去除过滤器进行膜过滤可以构成从单克隆IgG产品中去除内源性逆转录病毒样污染物的纯化方案的一部分。
