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Review: High temperature short time treatment of cell culture media and feed solutions to mitigate adventitious viral contamination in the biopharmaceutical industry

机译:综述:高温短时间治疗细胞培养介质和饲料解决方案,以减轻生物制药行业的不定毒性污染

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摘要

Events of viral contaminations occurring during the production of biopharmaceuticals have been publicly reported by the biopharmaceutical industry. Upstream raw materials were often identified as the potential source of contamination. Viral contamination risk can be mitigated by inactivating or eliminating potential viruses of cell culture media and feed solutions. Different methods can be used alone or in combination on raw materials, cell culture media, or feed solutions such as viral inactivation technologies consisting mainly of high temperature short time, ultraviolet irradiation, and gamma radiation technologies or such as viral removal technology for instance nanofiltration. The aim of this review is to present the principle, the advantages, and the challenges of high temperature short time (HTST) technology. Here, we reviewed effectiveness of HTST treatment and its impact on media (filterability of media, degradation of components), on process performance (cell growth, cell metabolism, productivity), and product quality based on knowledge shared in the literature.
机译:生物制药期间发生的病毒污染事件已被生物制药业公开报告。上游原料通常被鉴定为潜在的污染源。通过灭活或消除细胞培养基和饲料溶液的潜在病毒,可以减轻病毒污染风险。不同的方法可以单独使用或组合原料,细胞培养基,或饲料溶液,例如主要是高温短时间,紫外线辐射和伽马辐射技术等的病毒灭活技术,例如纳米过滤等病毒去除技术。本综述的目的是提出高温短时间(HTST)技术的原则,优势和挑战。在这里,我们审查了HTST治疗的有效性及其对培养基的影响(培养基的过滤性,组分降解),基于文献中的知识的过程性能(细胞生长,细胞代谢,生产率)和产品质量。

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