Considerations for risk and control of mycoplasma in bioprocessing
作者： Phillip Angart , Casey Kohnhorst , Meng-Jung Chiang , Nilou Sarah Arden
DOI: 10.1016/J.COCHE.2018.09.012
关键词:
摘要: Adventitious agents are a safety risk to biomanufacturing pipelines, from cell line development upstream and downstream processes. A contamination event can has effectively shut down plant operations resulted in drug shortages. To ensure the highest levels of product quality patient safety, comprehensive control strategies must be place. Mycoplasma particularly challenging due their prevalence environment, small size that allows them pass through 0.1 μm sterilizing filters, ability persist without noticeable changes culture. This review highlights detrimental impact mycoplasma on bioprocessing, technologies being developed implemented both reduce entry bolster detection mycoplasma.
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