biostudies-literatureUnknown26(6)Pouri S<h4>Background</h4>Background: Downstream processing of therapeutic recombinant proteins expressed as the inclusion bodies (IBs) in E. coli is quite challenging. This study aimed to use the quality by design approach for developing the multi-step downstream process of a structurally complex therapeutic Fc-Peptide fusion protein, romiplostim.<h4>Methods</h4>Methods: For development of a successful downstream process, risk analysis and experimental designs were used to characterize the most critical quality attributes (CQAs) and effects of process parameters on these quality attributes.<h4>Results</h4>Results: The solubilization of IBs was optimized by design of experiment on three parameters with a focus on solubility yield, which resulted in >75% increase of the target protein solubilizatiIranian biomedical journal414-25https://www.ebi.ac.uk/biostudies/studies/S-EPMC9841220biostudies-literatureQuality by Design in Downstream Process Development of RomiplostimPMC9841220Golkar MPouri SFard-Esfahani PTorkashvand FAghamirza Moghim Aliabadi HVaziri BfalseQuality by Design in Downstream Process Development of Romiplostim<h4>Background</h4>Background: Downstream processing of therapeutic recombinant proteins expressed as the inclusion bodies (IBs) in E. coli is quite challenging. This study aimed to use the quality by design approach for developing the multi-step downstream process of a structurally complex therapeutic Fc-Peptide fusion protein, romiplostim.<h4>Methods</h4>Methods: For development of a successful downstream process, risk analysis and experimental designs were used to characterize the most critical quality attributes (CQAs) and effects of process parameters on these quality attributes.<h4>Results</h4>Results: The solubilization of IBs was optimized by design of experiment on three parameters with a focus on solubility yield, which resulted in >75% increase of the target protein solubilizati2022-01-01T00:00:00Z2022 Nov2025-04-04T18:53:49.476Z2025-04-04T18:53:49.476ZS-EPMC98412203643927410.52547/ibj.3790