6 Continuous biomanufacturing in upstream and downstream processing
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Axel Schmidt
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.
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.
Kapitel in diesem Buch
- Frontmatter I
- Contents V
- List of contributing authors XI
- 1 Intensification of bioprocesses – definition, examples, challenges and future directions 1
- 2 Miniaturization and microfluidic devices: an overview of basic concepts, fabrication techniques, and applications 17
- 3 Integration of chemo- and bio-catalysis to intensify bioprocesses 45
- 4 Intensification of biocatalytic processes by using alternative reaction media 71
- 5 Bioprocess intensification with modelassisted DoE-strategies for the production of biopharmaceuticals 95
- 6 Continuous biomanufacturing in upstream and downstream processing 117
- 7 Microbial electrotechnology – Intensification of bioprocesses through the combination of electrochemistry and biotechnology 173
- 8 Light-driven bioprocesses 193
- 9 Process intensification using immobilized enzymes 227
- 10 In situ product removal 247
- 11 Intensification of bioprocesses with filamentous microorganisms 265
- 12 Process intensification in biopharmaceutical process development and production – an industrial perspective 313
- Index 367
Kapitel in diesem Buch
- Frontmatter I
- Contents V
- List of contributing authors XI
- 1 Intensification of bioprocesses – definition, examples, challenges and future directions 1
- 2 Miniaturization and microfluidic devices: an overview of basic concepts, fabrication techniques, and applications 17
- 3 Integration of chemo- and bio-catalysis to intensify bioprocesses 45
- 4 Intensification of biocatalytic processes by using alternative reaction media 71
- 5 Bioprocess intensification with modelassisted DoE-strategies for the production of biopharmaceuticals 95
- 6 Continuous biomanufacturing in upstream and downstream processing 117
- 7 Microbial electrotechnology – Intensification of bioprocesses through the combination of electrochemistry and biotechnology 173
- 8 Light-driven bioprocesses 193
- 9 Process intensification using immobilized enzymes 227
- 10 In situ product removal 247
- 11 Intensification of bioprocesses with filamentous microorganisms 265
- 12 Process intensification in biopharmaceutical process development and production – an industrial perspective 313
- Index 367
