Although the utility of human antibodies as medical therapeutics for cancer and immune diseases has been well-established, it is only beginning to be realized for the treatment of viral infectious diseases. Polyclonal immunoglobulins have long been used for some viral diseases, but they have limited potency and disease scope. Only a single humanized monoclonal antibody (pavilizumab) has been approved as a viral countermeasure.

Published in 1997: Antibody Therapeutics is a comprehensive evaluation of progress toward using humanized antibodies as a new generation of therapeutics. The humanized antibodies that have led the way in product approval are discussed as case studies, offering an insight into the preclinical and clinical data acquired during the regulatory approval process. Leading experts offer their findings as examples of what works and what does not, saving you time and making your research more cost effective. This book is essential reading for researchers, clinicians, development and regulatory staff in pharmaceutical and biotechnology companies, and hospital staff, including policy and decision makers. It also provides postgraduate and medical students with an authoritative overview of the field.

Antibody Engineering comprises in vitro selection and modification of human antibodies including humanization of mouse antibodies for therapy, diagnosis, and research. This book comprises an overview about the generation of antibody diversity and essential techniques in antibody engineering: construction of immune, naive and synthetic libraries, all available in vitro display methods, humanization by chain shuffling, affinity maturation techniques, de novo synthesis of antibody genes, colony assays for library screening, construction of scFvs from hybridomas, and purification of monoclonal antibodies by exclusion chromatography. In addition, other topics that are discussed in this book are application and mechanism of single domain antibodies, structural diversity of antibodies, immune-mediated skin reactions induced by TNF-alpha recombinant antibodies, and bioinformatic approaches to select pathogen-derived peptide sequences for antibody targets.

Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Monthly. Abstracts from world literature about all aspects of virology and virus research. Classified arrangement of entries. Subject, author indexes. References in this section were formerly carried in Excerpta medica. Section 4, Microbiology. About 4500 abstracts, 1971.