Quality by Design in Downstream Process Development of Romiplostim

Saeedeh Pouri,Fatemeh Torkashvand,Hooman Aghamirza Moghim Aliabadi,Pezhman Fard-Esfahani,Majid Golkar,Behrouz Vaziri

Iranian biomedical journal（2022）

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摘要

Conclusion: This research presents a precise and exhaustive model for mapping the design space in order to describe and anticipate the link between the yield and quality of romiplostim and its downstream process parameters.

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关键词

Quality by Design,Romiplostim,CQA,Design space,risk assessment

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