Walter J K, Werz W, Berthold W
Department Biotech Production, Dr. Karl Thomae GmbH, Biberach, Germany.
Dev Biol Stand. 1996;88:99-108.
This paper focuses on the scale of validation studies that are performed in order to demonstrate viral clearance in downstream processing of biopharmaceutical products. A serious concern for rDNA-derived proteins from recombinant mammalian cell cultures and monoclonal antibodies (MAbs) derived from hybridoma cultures is the potential risk from contaminating retroviral particles or adventitious viruses. Accordingly the downstream process has to be designed to reduce a potential virus load significantly: by virus removal and by virus inactivation methods. Such viral clearance is essential for drug safety- and has to be validated. This means that the design of downstream processing has to take into consideration both the capability for viral clearance and the capability for validation respectively.
本文聚焦于为证明生物制药产品下游加工过程中病毒清除情况而开展的验证研究规模。对于重组哺乳动物细胞培养产生的重组DNA衍生蛋白以及杂交瘤培养产生的单克隆抗体（MAb）而言，一个严重问题是来自污染逆转录病毒颗粒或外来病毒的潜在风险。因此，下游工艺必须设计成能显著降低潜在病毒载量：通过病毒去除和病毒灭活方法。这种病毒清除对于药物安全性至关重要，并且必须进行验证。这意味着下游加工的设计必须分别考虑病毒清除能力和验证能力。
