Process Scale Purification of Antibodies »

Uwe Gottschalk, PhD, is Group Vice President, Purification Technologies, at Sartorius Stedim Biotech. Previously, he worked for Bayer Health Care, overseeing the purification of monoclonal antibodies and recombinant proteins produced in various expression systems. Dr. Gottschalk received a doctorate in chemistry from the University of Münster. He lectures at the University of Duisburg-Essen and the EPFL in Lausanne, Switzerland and has written extensively in the areas of biotechnology and somatic gene therapy.

The cutting edge in antibody purification written by industry experts

Biopharmaceutical companies are under extreme pressure to develop robust and economical large-scale processes while consistently meeting regulatory standards for safety and purity. Traditional column chromatography dominates today's purification trains, and many of the productivity gains rely on upscaling such devices. This comes with a cost penalty, however, and further increases in upstream productivity make it a challenge to keep downstream processing manageable. Advances in purification technology are urgently needed to meet the requirements of the marketplace without sacrificing product quality.

Process Scale Purification of Antibodies offers scientists, researchers, and engineers an essential resource that focuses on current best practice in the manufacturing of antibody drugs, addresses problems in antibody purification, and offers suggestions to overcome current challenges and limitations. Written by experts in the field, the book examines old and new separation methods and includes an analysis of innovative trends that can help meet the economic pressures and escalating demand for antibody drugs.

Process Scale Purification of Antibodies:

• Provides an overview of state-of-the-art methods in the downstream processing of therapeutic antibodies
• Compiles information for the development of generic platform purification processes
• Analyzes innovative technology trends such as weak partitioning chromatography, charged membranes, and new precipitation methods, as well as orthogonal and integrated strategies to improve throughput
• Provides resources for solving technical challenges in antibody manufacturing
• Discusses the economic drivers and benchmark values in antibody purification

1 Downstream Processing of Monoclonal Antibodies: Current Practices and Future Opportunities Brian Kelley Kelley, Brian Greg Blank Blank, Greg Ann Lee Lee, Ann 1

2 The Development of Antibody Purification Technologies John Curling Curling, John 25

3 Harvest and Recovery of Monoclonal Antibodies: Cell Removal and Clarification Abhinav A. Shukla Shukla, Abhinav A. Jagannadha Rao Kandula Kandula, Jagannadha Rao 53

4 Protein A-Based Affinity Chromatography Suresli Vrmnum Vrmnum, Suresli Ganesh Vedalltham Vedalltham, Ganesh Brian Hubbard Hubbard, Brian 79

5 Purification of Human Monoclonal Antibodies: Non-Protein A Strategies Alahari Arunakumari Arunakumari, Alahari Jue Wang Jue, Wang 103

6 Purification of Monoclonal Antibodies by Mixed-Mode Chromatography Pete Gagnon Gagnon, Pete 125

7 Integrated Polishing Steps for Monoclonal Antibody Purification Sanchayita Ghose Ghose, Sanchayita Mi Jin Mi, Jin Jia Liu Jia, Liu John Hickey Hickey, John 145

8 Orthogonal Virus Clearance Applications in Monoclonal Antibody Production Joe X. Zhou Zhou, Joe X. 169

9 Development of A Platform Process for the Purification of Therapeutic Monoclonal Antibodies Yuling Li Li, Yuling David W. Kahn Kahn, David W. Olga Galperina Galperina, Olga Erich Blatter Blatter, Erich Robert Luo Luo, Robert Yaling Wu Wu, Yaling Guihang Zhang Zhang, Guihang 187

10 Advances in Technology and Process Development for Industrial-Scale Monoclonal Antibody Purification Nuno Fontes Fontes, Nuno Robert van Reis van Reis, Robert 203

11 Continuous Chromatography for the Purification of Monoclonal Antibodies Thomas Muller-Spath Muller-Spath, Thomas Massimo Morbidelli Morbidelli, Massimo 223

12 Process EconomicDrivers in Industrial Monoclonal Antibody Manufacture Suzanne S. Farid Farid, Suzanne S.

13 Design and Optimization of Manufacturing Andrew Sinclair Sinclair, Andrew 263

14 Alternatives to Packed-Bed Chromatography for Antibody Extraction and Purification Jorg Thommes Thommes, Jorg Uwe Gottschalk Gottschalk, Uwe 293

15 Process-Scale Precipitation of Impurities in Mammalian Cell Culture Broth Judy Glynn Glynn, Judy 309

16 Charged Ultrafiltration and Microfiltration Membranes in Antibody Purification Mark R. Etzel Etzel, Mark R. 325

17 Downstream Processing of Monoclonal Antibody Fragments Mariangela Spitali Spitali, Mariangela 349

18 Purification of Antibodies Other Than IgG: The Case of IgM and IgA Charlotte Cabanne Cabanne, Charlotte Xavier Santarelli Santarelli, Xavier 373

19 Purification of Antibodies From Transgenic Plants Zivko L. Nikolov Nikolov, Zivko L. Jeffrey T. Regan Regan, Jeffrey T. Lynn F. Dickey Dickey, Lynn F. Susan L. Woodard Woodard, Susan L. 387

20 Antibody Purification: Drivers of Change Narahari Pujar Pujar, Narahari Duncan Low Low, Duncan Rhona O'Leary O'Leary, Rhona 407

Index 427