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

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.

Automated summary

This review explores the current status and historical development of quality by design and process analytical technology, discusses the application of multivariate tools in the food industry, and offers future perspectives on the topic.