生物制药
生物制药
生化工程
过滤(数学)
下游加工
结垢
错流过滤
病毒
病毒学
化学
工程类
生物技术
色谱法
膜
生物
生物化学
数学
生物活性
生药学
统计
体外
作者
Dong-Woo Suh,Mina Kim,Changha Lee,Youngbin Baek
标识
DOI:10.1080/15422119.2022.2143379
摘要
Virus clearance, a critical aspect of biopharmaceutical manufacturing processes, ensures the safety of biopharmaceutics. Virus filtration is widely used during biopharmaceutical downstream processes to remove viruses effectively by separating small viruses (e.g., parvovirus with a size of 18–26 nm) from biopharmaceutics (e.g., monoclonal antibodies with a size of ~12 nm) based on a size-exclusion mechanism (i.e., more than 4-log10 removal of viruses with high product recovery). This paper presents a review of key factors such as filter morphology, feed solution composition, and the performance of high-throughput virus filtration, mainly focusing on the log reduction value for virus removal efficiency. Flow interruption and protein fouling issues are also discussed.
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