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Perfusion Cell Culture Processes for Biopharmaceuticals: Process Development, Design, and Scale-up [Kietas viršelis]

(Eidgenössische Technische Hochschule Zürich), , (Eidgenössische Technische Hochschule Zürich)
  • Formatas: Hardback, 216 pages, aukštis x plotis x storis: 250x175x15 mm, weight: 550 g, Worked examples or Exercises; 55 Line drawings, color; 30 Line drawings, black and white
  • Serija: Cambridge Series in Chemical Engineering
  • Išleidimo metai: 06-Aug-2020
  • Leidėjas: Cambridge University Press
  • ISBN-10: 1108480039
  • ISBN-13: 9781108480031
  • Formatas: Hardback, 216 pages, aukštis x plotis x storis: 250x175x15 mm, weight: 550 g, Worked examples or Exercises; 55 Line drawings, color; 30 Line drawings, black and white
  • Serija: Cambridge Series in Chemical Engineering
  • Išleidimo metai: 06-Aug-2020
  • Leidėjas: Cambridge University Press
  • ISBN-10: 1108480039
  • ISBN-13: 9781108480031
Master the design and operation of perfusion cell cultures with this authoritative reference. Discover the current state-of-the-art in the design and operation of continuous bioreactors, with emphasis on mammalian cell cultures for producing therapeutic proteins. Topics include the current market for recombinant therapeutic proteins, current industry challenges and the potential contribution of continuous manufacturing. Provides coverage of every step of process development and reactor operation, including small scale screening to lab-scale and scale-up to manufacturing scale. Illustrated through real-life case studies, this is a perfect resource for groups active in the cell culture field, as well as graduate students in areas such as chemical engineering, biotechnology, chemistry and biology, and to those in the pharmaceutical industry, particularly biopharma, biotechnology and food or agro industry.

Master the design and operation of perfusion cell cultures with this authoritative reference. A perfect resource for groups active in the cell culture field, as well as graduate students in areas such as chemical engineering, biotechnology, chemistry and biology.

Recenzijos

'Captures in a masterful way the many dimensions of perfusion cell culture technology, including its history, key concepts, relevant cell biology, hardware and instrumentation, mathematical modeling, and scale up technics, all supported by lucid examples that will resonate with the biotechnology professional. The book captures the cutting-edge advances in the field achieved only over the last few years, with a broad applicability to the manufacture of traditional molecular biotherapeutic, as well as complex new modalities, such as gene and cell therapies, and vaccines. Not surprisingly, the leading expertise of [ this] team in continuous downstream operation is reflected in the introduction of a fully integrated continuous biomanufacturing platform, which has all the requisite qualities to become the dominant architectural design of the future.' Konstantin Konstantinov, Codiak BioSciences 'A delightful guide full of important information for those of us who want to make perfusion great again thanks to the appearance of new cell retention technologies, single use bioreactors and sensors. It will greatly help biotech developers to better understand the fundamentals of cell culture in perfusion, to design appropriately their systems and to control optimally their processes in order to deliver high quality product at a better cost efficiency than the classical large-scale fed-batch processes.' Hervé Broly, Biotech Process Sciences

Daugiau informacijos

Master the design and operation of perfusion cell cultures with this authoritative reference.
List of Abbreviations
ix
List of Symbols
xii
1 Perfusion Mammalian Cell Culture for Recombinant Protein Manufacturing
1(19)
1.1 Biotechnology: From Early Applications to Biotherapeutics
1(8)
1.2 Mammalian Cell Cultures for Recombinant Proteins
9(4)
1.3 Development and Operation of Perfusion Cultivations
13(6)
1.4 Conclusion
19(1)
2 Perfusion Bioreactors: The Set-Up and Process Characterisation
20(26)
2.1 Challenges and Objectives in Perfusion Culture Operation
20(3)
2.2 Equipment
23(5)
2.3 Perfusion-Specific Control Variables: P, VCD and CSPR
28(2)
2.4 Control
30(4)
2.5 Media for Perfusion Cell Cultures
34(5)
2.6 Steady-State Operation and Process Dynamics
39(6)
2.7 Conclusion
45(1)
3 Scale-Down Models and Sensors for Process Development
46(21)
3.1 Perfusion Cell Culture at Different Scales
46(1)
3.2 Nanofluidic Chips
47(1)
3.3 Incubated Devices As Scale-Down Models
48(4)
3.4 Wavebags
52(1)
3.5 Bioreactors
53(5)
3.6 Sensors
58(8)
3.7 Conclusion
66(1)
4 Design and Optimisation of Mammalian Cell Perfusion Cultures
67(33)
4.1 Principles of Optimal Perfusion Bioreactor Design
67(7)
4.2 Development of a Commercial Perfusion Culture
74(1)
4.3 Part 1: Clone and Media Screening for Perfusion Processes
75(4)
4.4 Part 2: Perfusion Cell Culture Development
79(14)
4.5 Product Quality Attributes: Considerations on Their Control
93(4)
4.6 Part 3: Scale-Up to clinical and Commercial Reactors
97(1)
4.7 Conclusion
98(2)
5 Clinical-and Commercial-Scale Reactors
100(38)
5.1 Scale-Up Challenges and Future Perspectives
100(3)
5.2 Scale-Up of Stirred Bioreactors
103(8)
5.3 Hydrodynamic Stress
111(4)
5.4 Computational Fluid Dynamics
115(1)
5.5 Characterisation of the Bioreactor: Case Studies
116(4)
5.6 Cell Retention at Large Scale
120(7)
5.7 Process Intensification
127(5)
5.8 Single-Use Technology
132(2)
5.9 Economical Drivers
134(3)
5.10 Conclusion
137(1)
6 Mechanistic and Statistical Modelling of Bioprocesses
138(36)
6.1 Role of Mathematical Models in Upstream Processes
138(1)
6.2 Modelling of Chemical Systems
139(2)
6.3 Modelling of Biological Systems
141(2)
6.4 Bioreactor Operation Modes
143(6)
6.5 Mechanistic Models and Their Implementation
149(12)
6.6 Statistical and Hybrid Modelling
161(9)
6.7 Hybrid Modelling Approach
170(1)
6.8 Advanced Process Monitoring and Control
171(2)
6.9 Conclusion
173(1)
References 174(24)
Index 198
Moritz Wolf is a management consultant at McKinsey & Company and a former post-doctoral fellow at ETH Zurich in the department of Chemistry and Applied Biosciences. He has obtained the degree of Doctor of Science from ETH Zurich. Jean-Marc Bielser is an associate manager in the Biopharma Technology and Innovation group at Merck Serono SA (Switzerland). He obtained his master in Chemical Engineering and Biotechnology from EPFL, and the degree of Doctor of Science from ETH Zürich. Massimo Morbidelli is Professor Emeritus in the Department of Chemistry and Applied Biosciences at ETH Zurich and Professor at the Department of Chemistry, Materials and Chemical Engineering at the Politecnico di Milano. Member of the Italian Academy of Sciences (Accademia dei Lincei), he received the Excellence in Process Development Research Award in 2017 from the American Institute of Chemical Engineers, the 2018 Separations Science and Technology Award from the American Chemical Society and the 2019 Award in Integrated Continuous Biomanufacturing. He is the co-author of Continuous Biopharmaceutical Processes (Cambridge, 2018), and Parametric Sensitivity in Chemical Systems (Cambridge, 2005).