Chirality describes the fact that a particular molecule can have a "right-hand" structure or its mirrored "left-hand" structure, both of which may display very different characteristics. For example, a "right-hand" structure can be an important active substance for a drug while its "left-hand" variation is highly toxic. For this reason, chiral separation techniques are indispensable for production and safety testing in biotechnology, food and pharmaceutical industries.

Thoroughly revised, with either entirely new or completely updated contents, this is a practical manual for the small and large-scale preparation of enantiomerically pure products. The result is a vital resource for meeting the highest purity standards in the manufacture of chiral pharmaceuticals, food additives and related compounds. All the approaches covered here are highly relevant to modern manufacturing and quality control schemes in the pharmaceutical and biotech industries, addressing the increasingly important issue of drug safety in view of tougher regulatory standards worldwide.

This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the technology, the last decade has demonstrated the utility of continuous processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor's Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing.

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

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.

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.

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.

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.

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.