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

• Published in: Food engineering reviews 2023-03, Vol.15 (1), p.24-40
• Main Authors: Pérez-Beltrán, Christian H., Jiménez-Carvelo, Ana M., Torrente-López, Anabel, Navas, Natalia A., Cuadros-Rodríguez, Luis
• Format: Article
• Language: English
• Subjects: Analyzers; Biotechnology; Chemistry; Chemistry and Materials Science; Chemistry/Food Science; Data acquisition; Data analysis; Data processing; Design; Design analysis; Design of experiments; Food; Food industry; Food Science; Multivariate analysis; Process control; Process controls; State-of-the-art reviews; Technology assessment
• ISSN: 1866-7910; 1866-7929
• DOI: 10.1007/s12393-022-09324-0

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.