If the antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continue to emerge. This book presents an overview of the current advances applied in the manufacture of monoclonal antibody including:
-concepts in development of manufacturing strategies,
-importance of antibody fragments,
-application of chromatography method development,
-quality control,
-effect of expression on antibody properties,
-virus removal and safety,
-pharmacokinetics,
-regulatory aspects.

Antibodies Volume 1: Production and Purification together with Volume 2: Novel Technologies and Therapeutic Use will be of great value to all of those who are actively working in the field of antibodies.
Volume 2: Novel Technologies and Therapeutic Use brings to the forefront current advances in novel technologies for the manufacturing of monoclonal antibodies and also their extensive clinical importance. Following on from Antibodies Volume 1: Production and Purification, this volume concentrates on:
-new technologies in the manufacture of monoclonal antibodies,
-the application of antibodies in cancer therapy and functional genomic therapy,
-the importance of antibodies and prospects of antibody engineering for the future.

It is now over one hundred years since von Behring and Kitsato first concluded experiments that led to the use of passive immunisation, employing antibodies raised in animals against tetanus and diphtheria toxins. The advancement of technology both in manufacturing purity product in a cost effective way and the clinical research has proved that antibodies are one ofthe most successful products in biotechnology. Monoclonal antibodies account for between one-third and one-halfof all pharmaceutical products in development and human clinical trials. Both the nature of monoclonal antibody therapies and the relatively large size of the monoclonal antibody dictate the production requirements, for many ofthese therapeutics the monoclonal antibody product will be 100 kilogrammes or more per year. It is widely acknowledged that there is currently a worldwide shortage of biomanufacturing capacity, and the active pharmaceutical ingredient material requirements for these products are expected to increase. Thus the industry is looking for new sources and extensive studies are being carried out not only for alternative technology to meet the needs but also to reveal the new therapeutic applicationsofantibodies. This book brings to the forefront current advances in novel technologies for the manufacturing of monoclonal antibodies and also their extensive clinical importance. The first four chapters give an overview of the new technologies and the successful application in the manufacture of monoclonal antibodies with clinical purity. The next chapters address the application of antibodies in cancer therapy and functional genomic therapy.

Advances in molecular biology and recombinant DNA technology have accelerated progress in many fields of life science research, including gene therapy. A large number of genetic engineering approaches and methods are readily available for gene cloning and therapeutic vector construction. Significant progress is being made in genomic, DNA sequencing, gene expression, gene delivery and cloning. Thus gene therapy has already shown that it holds great promise for the treatment of many diseases and disorders. In general it involves the delivery of recombinant genes or transgenes into somatic cells to replace proteins with a genetic defect or to transfer with the pathological process of an illness. The viral and non-viral delivery systems may hold the potential for future non-invasive, cost-effective oral therapy of genetically-based disorders. Recent years have seen considerable progress in the discovery and early clinical development of a variety of gene therapeutic products. The availability, validation, and implementation of gene therapeutic products has also enabled success in testing and evaluation. New challenges will need to be overcome to ensure that products will also be successful in later clinical development and ultimately for marketing authorisation. These new challenges will include improvements in delivery systems, better control of in-vivo targeting, increased level transduction and duration of expression of the gene, and manufacturing process efficiencies that enable reduction in production costs. Perhaps profound understanding of regulated gene design may result in innovative bioproducts exhibiting safety and efficacy profiles that are significantly superior to those achieved by the use of naturally occurring genes. This procedure may contribute considerably to fulfilling standards set by regulatory authorities. This book provides an overview of the current advances in the field of gene therapy and the methods that are being successfully applied in the manufacture of gene therapeutic products, and hopefully will stimulate further progress and advancement in this field to meet the ever-increasing demands.

Advances in molecular biology and recombinant DNA technology have accelerated progress in many fields of life science research, including gene therapy. A large number of genetic engineering approaches and methods are readily available for gene cloning and therapeutic vector construction. Significant progress is being made in genomic, DNA sequencing, gene expression, gene delivery and cloning. Thus gene therapy has already shown that it holds great promise for the treatment of many diseases and disorders. In general it involves the delivery of recombinant genes or transgenes into somatic cells to replace proteins with a genetic defect or to transfer with the pathological process of an illness. The viral and non-viral delivery systems may hold the potential for future non-invasive, cost-effective oral therapy of genetically-based disorders. Recent years have seen considerable progress in the discovery and early clinical development of a variety of gene therapeutic products. The availability, validation, and implementation of gene therapeutic products has also enabled success in testing and evaluation. New challenges will need to be overcome to ensure that products will also be successful in later clinical development and ultimately for marketing authorisation. These new challenges will include improvements in delivery systems, better control of in-vivo targeting, increased level transduction and duration of expression of the gene, and manufacturing process efficiencies that enable reduction in production costs. Perhaps profound understanding of regulated gene design may result in innovative bioproducts exhibiting safety and efficacy profiles that are significantly superior to those achieved by the use of naturally occurring genes. This procedure may contribute considerably to fulfilling standards set by regulatory authorities. This book provides an overview of the current advances in the field of gene therapy and the methods that are being successfully applied in the manufacture of gene therapeutic products, and hopefully will stimulate further progress and advancement in this field to meet the ever-increasing demands.

If the antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continue to emerge. This book presents an overview of the current advances applied in the manufacture of monoclonal antibody including: -concepts in development of manufacturing strategies, -importance of antibody fragments, -application of chromatography method development, -quality control, -effect of expression on antibody properties, -virus removal and safety, -pharmacokinetics, -regulatory aspects.

It is now over one hundred years since von Behring and Kitsato first concluded experiments that led to the use of passive immunisation, employing antibodies raised in animals against tetanus and diphtheria toxins. The advancement of technology both in manufacturing purity product in a cost effective way and the clinical research has proved that antibodies are one ofthe most successful products in biotechnology. Monoclonal antibodies account for between one-third and one-halfof all pharmaceutical products in development and human clinical trials. Both the nature of monoclonal antibody therapies and the relatively large size of the monoclonal antibody dictate the production requirements, for many ofthese therapeutics the monoclonal antibody product will be 100 kilogrammes or more per year. It is widely acknowledged that there is currently a worldwide shortage of biomanufacturing capacity, and the active pharmaceutical ingredient material requirements for these products are expected to increase. Thus the industry is looking for new sources and extensive studies are being carried out not only for alternative technology to meet the needs but also to reveal the new therapeutic applicationsofantibodies. This book brings to the forefront current advances in novel technologies for the manufacturing of monoclonal antibodies and also their extensive clinical importance. The first four chapters give an overview of the new technologies and the successful application in the manufacture of monoclonal antibodies with clinical purity. The next chapters address the application of antibodies in cancer therapy and functional genomic therapy.