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This volume reflects the proceedings of the WHO Consultation on the Safety of Biological Products Prepared from Mammalian Cell Substrates, and forms the basis upon which the revised WHO requirements were formulated and accepted by the 1996 Expert Committee on Biological Standardization (ECBS). Primary cells, diploid cells, and continuous cell lines (CCLs) are considered both in terms of potential risks and as appropriate methods to reduce and control those risks during the manufacturing process. Also discussed is the past clinical experience with products derived from these three types of cell substrates. Bringing together contributions by international experts in the field, this volume is important reading for cell and molecular biologists, and all those concerned with the development and manufacture of biological products.
​Animal cells are the preferred “cell factories” for the production of complex molecules and antibodies for use as prophylactics, therapeutics or diagnostics. Animal cells are required for the correct post-translational processing (including glycosylation) of biopharmaceutical protein products. They are used for the production of viral vectors for gene therapy. Major targets for this therapy include cancer, HIV, arthritis, cardiovascular and CNS diseases and cystic fibrosis. Animal cells are used as in vitro substrates in pharmacological and toxicological studies. This book is designed to serve as a comprehensive review of animal cell culture, covering the current status of both research and applications. For the student or R&D scientist or new researcher the protocols are central to the performance of cell culture work, yet a broad understanding is essential for translation of laboratory findings into the industrial production. Within the broad scope of the book, each topic is reviewed authoritatively by experts in the field to produce state-of-the-art collection of current research. A major reference volume on cell culture research and how it impacts on production of biopharmaceutical proteins worldwide, the book is essential reading for everyone working in cell culture and is a recommended volume for all biotechnology libraries.
Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering laboratory safetyâ€"and more.
A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.
The United States is entering an era when, more than ever, the sharing of resources and information might be critical to scientific progress. Every dollar saved by avoiding duplication of efforts and by producing economies of scale will become increasingly important as federal funding enters an era of fiscal restraint. This book focuses on six diverse case studies that share materials or equipment with the scientific community at large: the American Type Culture Collection, the multinational coordinated Arabidopsis thaliana Genome Research Project, the Jackson Laboratory, the Washington Regional Primate Research Center, the Macromolecular Crystallography Resource at the Cornell High-Energy Synchrotron Source, and the Human Genome Center at Lawrence Livermore National Laboratory. The book also identifies common strengths and problems faced in the six cases, and presents a series of recommendations aimed at facilitating resource sharing in biomedical research.
This book is the culmination of three decades of accumulated experience in teaching biotechnology professionals. It distills the fundamental principles and essential knowledge of cell culture processes from across many different disciplines and presents them in a series of easy-to-follow, comprehensive chapters. Practicality, including technological advances and best practices, is emphasized. This second edition consists of major updates to all relevant topics contained within this work. The previous edition has been successfully used in training courses on cell culture bioprocessing over the past seven years. The format of the book is well-suited to fast-paced learning, such as is found in the intensive short course, since the key take-home messages are prominently highlighted in panels. The book is also well-suited to act as a reference guide for experienced industrial practitioners of mammalian cell cultivation for the production of biologics.
Transboundary animal diseases (TADs) are a major threat to livestock. They are highly contagious or transmissible, and they have the potential to cause high morbidity and mortality in both susceptible animal populations and humans. In addition, not only are TADs detrimental to national economies, they are also a serious threat to world food security. This volume presents the proceedings of an international workshop on Vaccines and Diagnostics for Transboundary Animal Diseases that was held in Ames (Iowa, USA) in 2012. Experts and scientists from academia, industry and government reviewed the current status of vaccines and diagnostics for high priority TADs, decision-making and regulatory processes for veterinary biologics, and the roles and responsibilities of government agencies. The discussions also addressed achievements and gaps in vaccine and diagnostics development for 11 important TADs as well as the translation of research findings into licensed novel vaccines and diagnostics for high-priority TADs.
The editors have enlisted a broad range of experts, including microbial ecologists, physiologists, geneticists, biochemists, molecular biologists, and biochemical engineers, who offer practical experience not found in texts and journals. This comprehensive perspective makes MIMB a valuable "how to" resource, the structure of which resembles the sequence of operation involved in the development of a commercial biological process and product.
"It includes a review of the state of the art in animal genomics and its applications to animal health. The contributions describe the new tools available, such as HapMaps for chicken and cattle, and show how the understanding of gene structure and function can be successfully applied to delineate the molecular mechanisms of disease and determine complex phenotypes associated with health traits. A critical evaluation of future needs and future applications of animal genomics is also presented. The integration of animal genomics in animal health research is likely to revolutionize the way scientists approach the challenges of discovering highly effective drugs and vaccines for animal diseases."--BOOK JACKET.