Abstract:Background: Downstream processing of therapeutic recombinant proteins expressed as the IBs in E. coli is quite challenging. This study aimed to use the QbD approach for developing the multi-step downstream process of a structurally complex therapeutic Fc-Peptide fusion protein, romiplostim. Methods: For development of a successful downstream process, risk analysis and experimental designs were used to characterize the most CQAs and effects of process parameters on these quality attributes. Results: The solubil… Show more
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