Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review

Abstract

This multiauthor review article aims to bring readers up to date with some of the current trends in the field of process analytical technology (PAT) by summarizing each aspect of the subject (sensor development, PAT based process monitoring and control methods) and presenting applications both in industrial laboratories and in manufacture e.g. at GSK, AstraZeneca and Roche. Furthermore, the paper discusses the PAT paradigm from the regulatory science perspective. Given the multidisciplinary nature of PAT, such an endeavour would be almost impossible for a single author, so the concept of a multiauthor review was born. Each section of the multiauthor review has been written by a single expert or group of experts with the aim to report on its own research results. This paper also serves as a comprehensive source of information on PAT topics for the novice reader.

Quality-by-Design approach to monitor the operation of a batch bioreactor in an industrial avian vaccine manufacturing process

“…QbD fits well with the process analytical technology (PAT) framework (FDA, 2004), which promotes the use state-of-the-art pharmaceutical science and engineering principles to achieve effective quality control through increased process understanding, thus building a system to manage product quality (Menezes, 2011). Several mathematical modeling tools can serve as effective PAT tools (Simon et al, 2015;Troup and Georgakis, 2013;Gernaey et al, 2012). Among them, chemometrics plays an important role (Menezes et al, 2009), and in this study we make use of a class of data-driven modeling tools known as latent variable models (LVMs).…”

Systematic retrofitting methodology for pharmaceutical drug purification processes

“…In this publication Nagy elucidated the work of Snyder et al (2008), who studied the evolution of crystal shape of an organic substance during dissolution with a prediction model and experimental studies. The control and monitoring of the crystallization in pharmaceutical processes was widely discussed by Simon et al (2015), as well in several other works, e.g., Samad et al (2010Samad et al ( , 2011Samad et al ( , 2013.…”

In-situ crystal morphology identification using imaging analysis with application to the L-glutamic acid crystallization

“…With the rapid development of process analytical technology (PAT) for chemical and pharmaceutical crystallization, image-based monitoring methods have been increasingly explored for in-situ analysis of crystal morphology, polymorph and growth quality (Yu et al, 2007;Chen et al, 2011;Qiao et al, 2011;Nagy et al, 2013;Simon et al, 2015). Ex-situ imaging methods were developed in the early literature (e.g.…”