A new algorithm for bioprocess feasibility index under uncertainty

TL;DRAbstract

To comply FDA strict regulatory requirements, it is necessary to design the bioprocess so that the process performance satisfies the specifications not only at set points but also in a wide range of set points, and limit for the process failure occurs needs to be defined as well. It is crucial to understand the bioprocess feasibility under uncertainty in order to design safe and robust manufacturing process for the new generation therapeutic products arising from advanced life science discovery. Motivated by the needs for feasibility studies of bioprocess operational variables, a new feasibility index to indicate the robust operating ranges for the process has been defined in the sense of worst case scenario, i.e., the operating point is robustly feasible if it is feasible under all of the range of variations of the variables. A largest hyperrectangle centred at the operating point is sought to define the process feasibility and its upper and lower bounds for the variations of operatin

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