Affiliation:
1. Clausthal University of Technology, Institute for Separation and Process Technology , Leibnizstr. 15, D-385678 Clausthal-Zellerfeld , Germany
Abstract
Abstract
Continuous bioprocesses have become a significant technological change in regulated industries, with process analytical technology (PAT) and quality-by-design (QbD) being essential for enabling continuous biomanufacturing. PAT and QbD are associated with process automation and control, providing real-time key process information. Continuous manufacturing eliminates hold times and reduces processing times, providing benefits such as improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and agility. Over the past decade, advancements in science and engineering, along with the adoption of QbD and the advancement of PAT, have progressed the scientific and regulatory readiness for continuous manufacturing. Regulatory authorities support the implementation of continuous manufacturing using science- and risk-based approaches, providing a great deal of potential to address issues of agility, flexibility, cost, and robustness in the development of pharmaceutical manufacturing processes.
Subject
General Physics and Astronomy,General Materials Science,General Chemistry
Reference203 articles.
1. Fisher, AC, Lee, SL, Harris, DP, Buhse, L, Kozlowski, S, Yu, L, et al.. Advancing pharmaceutical quality: an overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality. Int J Pharm 2016;515:390–402. https://doi.org/10.1016/j.ijpharm.2016.10.038.
2. Fisher, AC, Liu, W, Schick, A, Ramanadham, M, Chatterjee, S, Brykman, R, et al.. An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US. Int J Pharm 2022;622:121778. https://doi.org/10.1016/j.ijpharm.2022.121778.
3. Lee, SL, O’Connor, TF, Yang, X, Cruz, CN, Chatterjee, S, Madurawe, RD, et al.. Modernizing pharmaceutical manufacturing: from batch to continuous production. J Pharm Innov 2015;10:191–9. https://doi.org/10.1007/s12247-015-9215-8.
4. ISPE | International Society for Pharmaceutical Engineering. Continuous manufacturing as a tool for accelerated development. https://ispe.org/pharmaceutical-engineering/july-august-2021/continuous-manufacturing-tool-accelerated-development [Accessed 19 Apr 2023].
5. Jarrett, S, Pagliusi, S, Park, R, Wilmansyah, T, Jadhav, S, Santana, PC, et al.. The importance of vaccine stockpiling to respond to epidemics and remediate global supply shortages affecting immunization: strategic challenges and risks identified by manufacturers. Vaccine X 2021;9:100119. https://doi.org/10.1016/j.jvacx.2021.100119.
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献