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.
Acknowledgments
The authors would like to thank the editor Dirk Holtmann for their guidance and review of this article before its publication.
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Research ethics: Not applicable.
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Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: Not applicable.
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Articles in the same Issue
- Frontmatter
- Reviews
- Biopolymeric conjugation with metals and their applications
- Itaconic acid: microbial production using organic wastes as cost-effective substrates
- Global organic acids production and their industrial applications
- Book 1. Biopolymer conjugates industrial applications Chapter 1. Biopolymeric conjugation with thermoplastics and applications
- Continuous biomanufacturing in upstream and downstream processing
- In situ product removal
- Biopolymeric conjugation with polynucleotides and applications
- Intensification of bioprocesses – definition, examples, challenges and future directions
- The workshops on computational applications in secondary metabolite discovery (CAiSMD)
- Green chemistry: current status and challenges in Zimbabwe
Articles in the same Issue
- Frontmatter
- Reviews
- Biopolymeric conjugation with metals and their applications
- Itaconic acid: microbial production using organic wastes as cost-effective substrates
- Global organic acids production and their industrial applications
- Book 1. Biopolymer conjugates industrial applications Chapter 1. Biopolymeric conjugation with thermoplastics and applications
- Continuous biomanufacturing in upstream and downstream processing
- In situ product removal
- Biopolymeric conjugation with polynucleotides and applications
- Intensification of bioprocesses – definition, examples, challenges and future directions
- The workshops on computational applications in secondary metabolite discovery (CAiSMD)
- Green chemistry: current status and challenges in Zimbabwe