Process Analytical Technologies – Advances in bioprocess integration and future perspectives

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 207; p. 114379
• Main Authors: Gerzon, Gabriella, Sheng, Yi, Kirkitadze, Marina
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 05.01.2022
• Subjects: Biologics; Pharmaceuticals; Process Analytical Technology (PAT); Vaccines; ANN; PAT; CPP; MVDA; PVM; 27Al; DLS; Vaccines; FT; CQA; PLS; FTIR; Biologics; FBRM; Process Analytical Technology (PAT); DAD; IR; mAb; PCA; QbD; NMR; 31P; NIR; MIR; MALS; LD; ATR; Pharmaceuticals
• ISSN: 0731-7085; 1873-264X; 1873-264X
• DOI: 10.1016/j.jpba.2021.114379

Process Analytical Technology (PAT) instruments include analyzers capable of measuring physical and chemical process parameters and key attributes with the goal of optimizing process controls. PAT in the form of a probe or sensor is designed to integrate within the pharmaceutical manufacturing line and is coupled with computing equipment to perform chemometric modeling for result interpretation and multilayer statistical control of processes. PAT solutions are intended for understanding bioprocesses with a goal to control quality at all stages of product manufacturing and achieve quality by design (QbD). The goal of PAT implementation is to promote real-time release of products to decrease the cycle time and cost of production. This review focuses on the applications of PAT solutions at different stages of the manufacturing process for vaccine production, the advantages, challenges at present state, and the vision of the future development of biopharmaceutical industries. Overview of Process Analytical Technology (PAT) design lifecycle for biopharmaceuticals (vaccines) Created with Biorender.com. [Display omitted] •PAT solutions in pharmaceuticals and vaccines.•In-line and on-line technologies for the upstream and downstream process: Raman, NIR, mid-IR, DLS, NMR.•In-line probes for the formulation: mid-IR, particle sizing and imaging.•PAT is a portal to digital manufacturing – statistical methods and machine learning.•PAT for decisions in real time – compression of time for faster product development.