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QbD/PAT—State of the Art of Multivariate Methodologies in Food and Food-Related Biotech Industries

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Abstract

Several investigations have been made at lab scale considering the quality by design (QbD) and process analytical technology (PAT) approaches. Nonetheless, such applications have been focused on the analyzers or multivariate tools used at small scales. This comprehensive review presents the state of the art of both QbD and PAT. In addition, the key historical events since 1940 which have influenced the development of the QbD/PAT system are also highlighted. Moreover, the application of the recommended PAT tool of multivariate tools for design, data acquisition, and analysis (design of experiments, multivariate data analysis, and multivariate process control) is revised for the food and food-related biotechnology industries and describes the applications reported over the last 20 years. On this subject, only 34 studies were found in literature whose relation was close with both industries at industrial or pilot plant scales; a description of each of them focusing on multivariate tools is presented. Finally, some conclusions and future perspectives on this topic are given, with the aim of initiating a change in the field.

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Acknowledgements

C.H. Pérez-Beltrán acknowledges the scholarship provided by the Autonomous University of Sinaloa (México). A. Torrente-López acknowledges the FPU predoctoral grant (ref.: FPU18/03131), which is currently receiving from the Ministry of Universities, Spain.

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All the authors contributed to the review conception and design. Literature search was performed by Christian H. Pérez-Beltrán and Luis Cuadros-Rodríguez. The first draft of the manuscript was written by Christian H. Pérez-Beltrán, and all the authors revised and commented on subsequent versions. All the authors read and approved the final manuscript.

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Correspondence to Christian H. Pérez-Beltrán.

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Pérez-Beltrán, C.H., Jiménez-Carvelo, A.M., Torrente-López, A. et al. QbD/PAT—State of the Art of Multivariate Methodologies in Food and Food-Related Biotech Industries. Food Eng Rev 15, 24–40 (2023). https://doi.org/10.1007/s12393-022-09324-0

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