Handbook of Therapeutic Antibodies

Still the most comprehensive reference source on the development, production and therapeutic application of antibodies, this second edition is thoroughly updated and now has 30% more content.

Volume 1 covers selection and engineering strategies for new antibodies, while the second volume presents novel therapeutic concepts and antibodies in clinical study, as well as their potential. Volumes 3 and 4 feature detailed and specific information about each antibody approved for therapeutic purposes, including clinical data. This unique handbook concludes with a compendium of marketed monoclonal antibodies and an extensive index.

Beyond providing current knowledge, the authors discuss emerging technologies, future developments, and intellectual property issues, such that this handbook meets the needs of academic researchers, decision makers in industry and healthcare professionals in the clinic.

Stefan Dübel received his Ph.D. at the Center for Molecular Biology in Heidelberg, Germany, before moving on to the German Cancer Research Center in 1989 where he started research on the development of antibody libraries with naive or synthetic CDRs. In the following years, he substantially participated in the invention of antibody phage display, as well as other recombinant antibody technologies and the development of various antibody fusion proteins. In 1996, he moved to the University of Heidelberg to establish the antibody engineering group at the Institute of Molecular Genetics. He was appointed full professor at the Technische Universität Braunschweig in 2002, where he currently is head of the Department of Biotechnology and managing director of the Institute of Biochemistry, Biotechnology and Bioinformatics. He has co-authored more than 100 original papers, many patents, as well as several acknowledged textbooks in the field of recombinant antibodies. He is also on the editorial board of several scientific journals and cofounder of two antibody engineering companies.

Janice M. Reichert is an internationally recognized expert in the development of antibody therapeutics. She is Founder and Managing Director of Reichert Biotechnology Consulting LLC, a pharmaceutical business intelligence research firm, and the founding Editor-in-Chief of "mAbs", a peer-reviewed, PubMed-indexed biomedical journal that focuses on topics relevant to antibody research and development. Dr. Reichert has published extensively on development trends for antibody therapeutics and she has presented her research results as an invited speaker at conferences held worldwide. She is President of The Antibody Society and serves on the editorial boards of several biomedical journals. Dr. Reichert received her Ph.D. from the University of Pennsylvania and her post-doctoral training at Harvard Medical School.

VOLUME I: DEFINING THE RIGHT ANTIBODY COMPOSITION
Therapeutic Antibodies -
From Past to Future (Stefan Dübel)
PART 1: SELECTING AND SHAPING THE ANTIBODY MOLECULE
Selection Strategies I: Monoclonal Antibodies (Gerhard Moldenhauer)
Selection Strategies II: Antibody Phage Display (Michael Hust, Andre Frenzel, Florian Tomszak, Jonas Köller)
Transgenic Animals Derived by DNA Microinjection (Marianne Brüggemann, Michael J. Osborn, Biao Moa, Suzanne Avis, Ignacio Anegon, Roland Bülow)
Molecular Engineering I: Humanisation Strategies (Jose Saldanha)
Antibody Affinity (Andre Frenzel, Lorin Roskos, Scott Klakamp, Meina Liang, Rosalin Arends, Larry Green)
Molecular Engineering III: Fc (Thomas Valerius, Matthias Peipp, Stefanie Derer, Stefan Lohse, Christian Kellner)
Glycosylation of Antibody Molecules (Roy Jefferis)
Bioinformatics Tools for Analysis of Antibodies (Andrew C. R. Martin, James Allen)
How to use IMGT for Therapeutic Antibody Engineering (Marie-Paul Lefranc)
PART 2: MODIFIED ANTIBODIES
Bispecific Antibodies (Roland E. Kontermann, Dafne Müller)
Single Domain Antibodies: An Overview (Carrie Enever, Edward Coulstock, Malgorzata Pupecka-Swider, B. Hamilton)
Antibody-Drug Conjugates (ADCs): New Frontier in Cancer Therapeutics (Ravi Chari, Rajeeva Singh, John M. Lambert)
Antibody Targeted Drugs: From Chemical Immunoconjugates to Recombinant Fusion Proteins (Jürgen Krauss, Athanasios Mavratzas, Michaela A. E. Arndt, Stefan Kiesgen)
PART 3: EMERGING TECHNOLOGIES
Emerging Technologies for Antibody Selection (Mike Taussig, Mingyue He)
Anti-idiotypic Antibodies (Alejandro Lopez-Requena, Oscar Roberto Burrone, Rolando Perez)
Non-antibody Scaffolds as Alternative Therapeutic Agents (Arne Skerra, Markus Fiedler)
Antibody Directed Enzyme Prodrug Therapy (ADEPT) (Surinder K. Sharma, Kerry A. Chester, Kenneth D. Bagshawe)
Engineered Antibody Domains as Candidate Therapeutics (Weizao Chen, Ponraj Prabakaran, Dimiter S. Dimitrov)
Chimeric Antigen Receptors - "CARs" (Thomas Schirrmann, Ulf Petrausch)
Emerging Alternative Production Systems (Thomas Jostock, Benjamin Sommer, Holger Laux, Andre Frenzel)
VOLUME II: CLINICAL DEVELOPMENT OF ANTIBODIES
PART 4: THE WAY INTO THE CLINIC
Process Development and Manufacturing of Therapeutic Antibodies (Hitto Kaufmann, Alexander Jacobi, Barbara Enenkel, Patrick Garidel, Christian Eckermann, Mathias Knappenberger, Ingo Presser)
The Immunogenicity of Therapeutic Antibodies (Melody Sauerborn)
Biosimilar Monoclonal Antibodies (Susanne D. Pippig, Carsten Brockmeyer, Robert E. Zoubek)
Patent Issues Relating to Therapeutic Antibodies (Michael Braunagel, Barbara Rigby, Deborah Owen)
PART 5: THERAPEUTIC ANTIBODY PIPELINE
Monoclonal Antibodies in Phase III Clinical Trials (Peter Markus Deckert, Ulf Petrausch)
Antibodies in Early Phase Clinical Studies: Cancer Therapy (Anthony Olszanski, Matthew Zibelman, Hossein Borghaei)
Targeting Angiogenesis by Therapeutic Antibodies (Thomas Effert, Onat Kadioglu, Ean Jeong Seo)
Antibodies in Phase 3: Immunological Disorders (Penelope Ward, Mark Bodmer)
Monoclonal Antibodies in Phase 1 and 2 Studies for Immunological Disorders (Frank Brennan)
MAbs Targeting Soluble Mediators in Phase 1 and 2 Clinical Studies Immunological Disorders (Frank Brennan)
T Cell Inhibitors in Phase 1 and 2 Clinical Studies for Immunological Disorders (Frank Brennan)
B Cell Inhibitors in Phase 1 and 2 Clinical Studies for Immunological Disorders (Frank Brennan)
Inhibitors of Leukocyte Adhesion and Migration in Phase 1 and 2 Clinical Studies for Immunological Disorders (Frank Brennan)
Toll-Like Receptor Inhibitors in Phase 1 and 2 Clinical Studies for Immunological Disorders (Frank Brennan)
IgE Inhibitors in Phase 1 and 2 Clinical Studies for Immunological Disorders (Frank Brennan)
Complement Inhibitors in Phase 1 and 2 Clinical Studies for Immunological Disorders (Frank Brennan)
mAbs Targeting Apoptosis, Angiogenesis Inhibitors and other mAbs in Phase 1 and 2 Clinical Studies for Immunological Disorders (Frank Brennan)
Antibodies in Clinical Study: Infectious Diseases (Guillaume Descoubeaux)
Immunotherapeutics for Neurological Disorders (Anne Messer, Kevin Manley, Cynthia A. Lemere)
PART 6: GAINING MARKETING APPROVAL
Regulatory Considerations in the Development of Monoclonal Antibodies for Diagnosis and Therapy (Marjorie A. Shapiro, Patrick G. Swann, Stacey Ricci)
Regulatory Review: Clinical to Market Transition (Gabriele Dallmann)
Monoclonal antibody nomenclature for clinical studies (USA) (Stephanie Shubat)
VOLUME III: APPROVED THERAPEUTIC ANTIBODIES
PART 7: APPROVED THERAPEUTIC ANTIBODIES
Oligoclonal and Polyclonal Antibody Preparations (Mark C. Glassy, Rishab K. Gupta)
Adalimumab (Humira) (Janice Reichert)
Alemtuzumab (Lemtrada, MabCampath) (Janice Reichert, Thomas Elter, Michael Hallek)
Basiliximab and Daclizumab (Nasimul Ahsan, Burcin Taner, Nadim Mahmud)
Belimumab (Benlysta) (David P. D´Cruz, Pamela M.K. Lutalo, Natasha Jordan, Thi-Sau Migone)
Brentuximab vedotin (Adcetris) (Neils van de Donk)
Canakinumab (ILARIS) (Hermann Gram)
Catumaxomab (Removab) -
Trifunctional Antibodies: Combining Direct Tumor Cell Killing with Therapeutic Vaccination (Horst Lindhofer, M. Stanglmaier, R. Buhmann, M. Jäger, D. Klunker, P. Ruf, J. Hess)
Cetuximab (Erbitux) (Sonja Wilke, Michael Hust)
Denosumab (Prolia) (Torsten Meyer)
Efalizumab (Raptiva) (Karlheinz Schmitt-Rau)
Calicheamycin Conjugates: Gemtuzumab Ozogamicin (Mylotarg), Inotuzumab Ozogamicin (Martin Gramatzki, Matthias Peipp)
Golimumab (Simponi) (Janice Reichert, Sohini Mazumdar)
Yttrium-90 Ibritumomab Tiuxetan (Zevalin) (Karin Hohloch, Björn Chapuy, Lorenz Trümper)
Infliximab (Remicade) (Christian Antoni)
Ipilimumab (Yervoy) (Javier Puente, Teresa Alonso Gordoa, Eduardo Diaz-Rubio)
Muromonab-CD3 (Orthoclone OKT3) (Janice Reichert, Harald Becker)
Nimotuzumab: A Humanized Anti-EGFR Antibody (Tania Crombet)
Obinutuzumab (Christian Klein, Marina Bacac, Pablo Umana, Michael Wenger)
VOLUME IV: APPROVED THERAPEUTIC ANTIBODIES AND IN VIVO DIAGNOSTICS
Ofatumumab: A Next-Generation Human Therapeutic CD20 Antibody with Potent Complement-Dependent Cytotoxicity (Ronald P. Taylor, Margaret A. Lindorfer, Joost Bakker, Paul Parren)
Omalizumab (Xolair) -
Anti-Immunoglobulin E Treatment in Allergic Diseases (Klaus Kroegel, Martin Foerster)
Palivizumab (Louis Bont)
Panitumumab (Vectibix) -
A Treatment for Metastatic Colorectal Cancer (Jonas Kügler)
Pertuzumab (Perjeta) (Jose Angel Garcia-Saenz, Fernando Moreno Anton, Coralia Bueno Muino)
Ranibizumab (Lucentis): A New Anti-angiogenic Treatment in Ophthalmology (Nicolas Leveziel, Marc Ohresser, Gilles Paintaud)
Raxibacumab -
Human Monoclonal Antibody Against Anthrax Toxin (Sally Bolmer, Thi-Sau Migone)
Rituximab (Rituxan) (Stefan Dübel, Axel Boehnke, Michael Wenger)
Tocilizumab (Actemra) (Graeme Jones)
Trastuzumab (Herceptin) and Ado-Trastuzumab Emtansine (T-DM1) (M. H. Ruhe Chowdhury, Paul Ellis)
Ustekinumab (Stelara) (Stefan Dübel, Oya Cingoz, Janice Reichert)
Abciximab, Bevacizumab, Certolizumab pegol, Eculizumab, Natalizumab (Janice Reichert)
Itolizumab (Alzumab), Mogamulizumab (Poteligeo) and Tositumomab (Bexxar) (Stefan Dübel)
PART 8: IN VIVO DIAGNOSTICS
Radiolabeled Antibodies for Diagnostic Imaging (Christopher J. Palestro)

Appendix
Index