Most industrial processes are composed of multiple subsequent steps. In this article, we provide a statistical approach to design experiments and to define the manufacturing design space of multi-step processes by taking into account the complex system of interactions among steps. We consider each intermediate outcome as an additional input factor in the next step and we plan experiments following a particular sequential structure. To encompass the potential deviations from the target levels of such input factors, designs are selected according to the D-optimality in average criterion and, in order to assess their prediction capabilities, a suitable extension of the fraction of design space technique has been proposed. The manufacturing design space of the process is then defined by combining the interconnected manufacturing design spaces of the process steps and by deriving the linear combination of the process inputs that ensures the required quality standard for the final outcome. Appealing properties of this approach are also shown by the application to a three-steps biochemical process of expression and purification of a recombinant protein in which 10 input factors are included in the design.

Design of experiments and manufacturing design space for multi‐step processes / Rosamarie Frieri, Marco Mariti, Marilena Paludi. - In: APPLIED STOCHASTIC MODELS IN BUSINESS AND INDUSTRY. - ISSN 1524-1904. - ELETTRONICO. - 37:5(2021), pp. 942-960. [10.1002/asmb.2620]

Design of experiments and manufacturing design space for multi‐step processes

Rosamarie Frieri
;
2021

Abstract

Most industrial processes are composed of multiple subsequent steps. In this article, we provide a statistical approach to design experiments and to define the manufacturing design space of multi-step processes by taking into account the complex system of interactions among steps. We consider each intermediate outcome as an additional input factor in the next step and we plan experiments following a particular sequential structure. To encompass the potential deviations from the target levels of such input factors, designs are selected according to the D-optimality in average criterion and, in order to assess their prediction capabilities, a suitable extension of the fraction of design space technique has been proposed. The manufacturing design space of the process is then defined by combining the interconnected manufacturing design spaces of the process steps and by deriving the linear combination of the process inputs that ensures the required quality standard for the final outcome. Appealing properties of this approach are also shown by the application to a three-steps biochemical process of expression and purification of a recombinant protein in which 10 input factors are included in the design.
2021
Design of experiments and manufacturing design space for multi‐step processes / Rosamarie Frieri, Marco Mariti, Marilena Paludi. - In: APPLIED STOCHASTIC MODELS IN BUSINESS AND INDUSTRY. - ISSN 1524-1904. - ELETTRONICO. - 37:5(2021), pp. 942-960. [10.1002/asmb.2620]
Rosamarie Frieri, Marco Mariti, Marilena Paludi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/819257
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