PROCESS SCALE PURIFICATION OF ANTIBODIES, 2ND EDITION

1 Downstream Processing of Monoclonal Antibodies: Current Practices and Future Opportunities 1
2 The Development of Antibody Purification Technologies 23
3 Harvest and Recovery of Monoclonal Antibodies: Cell Removal and Clarification 55
4 Next -Generation Clarification Technologies for the Downstream Processing of Antibodies 81
5 Protein A -Based Affinity Chromatography 113
6 Purification of Human Monoclonal Antibodies: Non -Protein A Strategies 135
7 Hydrophobic Interaction Chromatography for the Purification of Antibodies 155
8 Purification of Monoclonal Antibodies by Mixed -Mode Chromatography 181
9 Advances in Technology and Process Development for Industrial -Scale Monoclonal Antibody Purification 199
10 Alternatives to Packed -Bed Chromatography for Antibody Extraction and Purification 215
11 Process -Scale Precipitation of Impurities in Mammalian Cell Culture Broth 233
12 Charged Ultrafiltration and Microfiltration Membranes for Antibody Purification 247
13 Disposable Prepacked -Bed Chromatography for Downstream Purification: Form, Fit, Function, and Industry Adoption 269
14 Integrated Polishing Steps for Monoclonal Antibody Purification 303
15 Orthogonal Virus Clearance Applications in Monoclonal Antibody Production 325
16 Development of a Platform Process for the Purification of Therapeutic Monoclonal Antibodies 343
17 The Evolution of Platform Technologies for the Downstream Processing of Antibodies 365
18 Countercurrent Chromatography for the Purification of Monoclonal Antibodies, Bispecific Antibodies, and Antibody–Drug Conjugates 391
19 The Evolution of Continuous Chromatography: From Bulk Chemicals to Biopharma 409
20 Accelerated Seamless Antibody Purification: Simplicity is Key 431
21 Process Economic Drivers in Industrial Monoclonal Antibody Manufacture 445
22 Design and Optimization of Manufacturing 467
23 Smart Design for an Efficient Facility With a Validated Disposable System 495
24 High -Throughput Screening and Modeling Technologies for Process Development in Antibody Purification 515
25 Downstream Processing of Monoclonal Antibody Fragments 537
26 Downstream Processing of Fc Fusion Proteins, Bispecific Antibodies, and Antibody–Drug Conjugates 559
27 Manufacturing Concepts for Antibody–Drug Conjugates 595
28 Purification of IgM and IgA 615
29 Purification of Monoclonal Antibodies From Plants 631
30 Very -Large -Scale Production of Monoclonal Antibodies in Plants 655
31 Trends in Formulation and Drug Delivery for Antibodies 673
32 Antibody Purification: Drivers of Change 699

Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification.

• Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing
• Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification
• Emphasizes antibodies and innovative chromatography methods for processing

Author Information
Uwe Gottschalk, PhD,is Chief Technology Officer at Lonza Pharma/Biotech, Switzerland. Previously, he served as Group Vice President at Sartorius Stedim Biotech (2004-2014) and in various development and manufacturing capacities at Bayer Health Care (1991–2004). Dr. Gottschalk received a doctorate in chemistry from the University of Münster (Germany) for work on antibody-drug conjugates at the Cancer Research Campaign Laboratories in Nottingham (UK). He is Head Lecturer at the University of Duisburg-Essen, Germany, and has written extensively in the areas of industrial biotechnology and somatic gene therapy.