Buch, Englisch
Buch, Englisch
ISBN: 978-1-394-27854-1
Verlag: John Wiley & Sons Inc
Solve downstream bottlenecks with expert strategies for antibody purification
With monoclonal antibody sales exceeding $210 billion and upstream productivity outpacing downstream capacity, manufacturers face urgent purification bottlenecks. Process Scale Purification of Antibodies, now in its Third Edition, assembles top-tier technology experts to address process-scale challenges. This established resource delivers practical solutions for each unit operation while maintaining the currency that biopharmaceutical professionals require.
This edition updates protein A chromatography coverage, adds CMC considerations, addresses raw material control strategies, and introduces machine learning and AI applications in purification processes. Contributors provide fresh perspectives on traditional chromatography alongside innovative methods for processing antibodies at scale. The book consolidates proven approaches with emerging technologies to meet increasing production demands without sacrificing product quality.
Readers will also find: - Comprehensive coverage of purification strategies from leading experts addressing problems specific to each unit operation in antibody manufacturing
- Updated guidance on protein A chromatography optimization and emerging alternatives for process-scale downstream operations in biopharmaceutical production
- New chapters covering CMC considerations and regulatory requirements essential for successful antibody drug development and manufacturing approval
- Practical approaches to raw material control and quality assurance that support robust and economical large-scale purification processes
- Applications of machine learning and artificial intelligence to optimize purification workflows and improve process efficiency in downstream operations
Pharmaceutical and biotech scientists, chemical engineers in biopharmaceutical processing, and professionals in product development or process science departments will find this resource indispensable. Process Scale Purification of Antibodies delivers the technical depth and practical guidance needed to overcome downstream bottlenecks and deliver pure therapeutic antibodies efficiently.
Autoren/Hrsg.
Fachgebiete
- Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie
- Naturwissenschaften Chemie Analytische Chemie Instrumentelle Analytik, Chromatographie
Weitere Infos & Material
List of Contributors
Preface
Chapter 1 Downstream processing of monoclonal antibodies: current practices and future opportunities (Brian Kelley)
Chapter 2 The development of antibody purification technologies (John Curling)
Chapter 3 Harvest and recovery of monoclonal antibodies: cell removal and clarification (Abhinav A. Shukla and Dustin Costello)
Chapter 4 Next-generation clarification technologies for the downstream processing of antibodies (Nripen Singh and Srinivas Chollangi)
Chapter 5 Protein A-based affinity chromatography (Hans J Johansson)
Chapter 6 Purification of human monoclonal antibodies: non-protein a strategies (Alahari Arunakumari and Jue Wang)
Chapter 7 Hydrophobic interaction chromatography for the purification of antibodies (Judith Thoma and Egbert Müller)
Chapter 8 Disposable prepacked-bed chromatography for downstream purification: form, fit, function, and industry adoption (Stephen K. Tingley)
Chapter 9 Integrated polishing steps for monoclonal antibody purification (Sanchayita Ghose, Mi Jin, Jia Liu, John Hickey and Steven Lee)
Chapter 10 Orthogonal virus clearance: applications in monoclonal antibody production (Joe X. Zhou)
Chapter 11 Development of a platform process for the purification of therapeutic monoclonal antibodies (Yuling Li, Min Zhu, Haibin Luo and Justin R. Weaver)
Chapter 12 The evolution of platform technologies for the downstream processing of antibodies (Lee Allen)
Chapter 13 Countercurrent chromatography for the purification of monoclonal antibodies, bispecifics and antibody–drug conjugates (Thomas Müller-Späth and Massimo Morbidelli)
Chapter 14 The evolution of continuous chromatography from bulk chemicals to biopharma (Marc Bisschops)
Chapter 15 Process economic drivers in industrial monoclonal antibody manufacture (Suzanne S. Farid)
Chapter 16 Design and optimization of manufacturing (Andrew Sinclair)
Chapter 17 Smart design for an efficient facility with a validated disposable system (Joe X. Zhou)
Chapter 18 High-throughput screening and modeling technologies for process development in antibody purification (Tobias Hahn, Thiemo Huuk and Jürgen Hubbuch)
Chapter 19 Downstream processing of Fc fusion proteins, bispecific antibodies and antibody–drug conjugates (Abhinav A Shukla and Carly Catella)
Chapter 20 Manufacturing concepts for antibody–drug conjugates (Thomas Rohrer)
Chapter 21 Purification of IgM and IgA (Charlotte Cabanne and Xavier Santarelli)
Chapter 22 Very-large-scale production of monoclonal antibodies in plants (Johannes F. Buyel and Richard M. Twyman)
Chapter 23 Trends in formulation and drug delivery for antibodies (Hanns-Christian Mahler and Andrea Allmendinger)
Chapter 24 Future of antibody purification (Anurag Rathore, David Roush and Nihal Tugcu)
Chapter 25 Current CMC considerations for mAb and bsAb purification process development and manufacturing (Yanhuai (Richard) Ding, Bruce Andrien and Mark Aimone)
Chapter 26 Convective chromatography media for advanced antibody processing (James Stout, Mochao Zhao, Takuo Kawase and Raja Ghosh)
Chapter 27 Relevance and biophysical attributes of monoclonal antibody isoforms (Solomon Isu and Melissa Holstein)
Index
