Satisfying QTPP of Erythropoietin Biosimilar by QbD through DoE-Derived Downstream Process Engineering
通过基于实验设计(DoE)的下游工艺工程,利用质量源于设计(QbD)满足促红细胞生成素生物类似药的质量目标产品性能(QTPP)要求。
期刊:Pharmaceutics
影响因子:5.5
doi:10.3390/pharmaceutics15082087
Nag, Kakon; Sarker, Enamul Haq; Kumar, Samir; Chakraborty, Sourav; Khan, Maksusdur Rahman; Chowdhury, Mashfiqur Rahman; Roy, Rony; Roy, Ratan; Biswas, Bipul Kumar; Bappi, Emrul Hasan; Mohiuddin, Mohammad; Sultana, Naznin