Safety of Biological Products Prepared from Mammalian Cell Culture PDF Download
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Author: Fred Brown
Publisher: S. Karger AG (Switzerland)
ISBN:
Category : Medical
Languages : en
Pages : 260
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Book Description
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.
Author: Fred Brown
Publisher: S. Karger AG (Switzerland)
ISBN:
Category : Medical
Languages : en
Pages : 260
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Book Description
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.
Author:
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 264
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Book Description
Author: Division on Engineering and Physical Sciences
Publisher: National Academies Press
ISBN: 0309039754
Category : Science
Languages : en
Pages : 237
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Book Description
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.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470117109
Category : Medical
Languages : en
Pages : 1681
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Book Description
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.
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 62
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309055822
Category : Science
Languages : en
Pages : 105
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Book Description
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.
Author: Zhenhai Chen
Publisher: Frontiers Media SA
ISBN: 2889637220
Category :
Languages : en
Pages : 134
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Book Description
Author: Morteza Jalali
Publisher: Academic Press
ISBN: 012803078X
Category : Science
Languages : en
Pages : 383
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Book Description
Basic Science Methods for Clinical Researchers addresses the specific challenges faced by clinicians without a conventional science background. The aim of the book is to introduce the reader to core experimental methods commonly used to answer questions in basic science research and to outline their relative strengths and limitations in generating conclusive data. This book will be a vital companion for clinicians undertaking laboratory-based science. It will support clinicians in the pursuit of their academic interests and in making an original contribution to their chosen field. In doing so, it will facilitate the development of tomorrow’s clinician scientists and future leaders in discovery science. Serves as a helpful guide for clinical researchers who lack a conventional science background Organized around research themes pertaining to key biological molecules, from genes, to proteins, cells, and model organisms Features protocols, techniques for troubleshooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data Appendices provide resources for practical research methodology, including legal frameworks for using stem cells and animals in the laboratory, ethical considerations, and good laboratory practice (GLP)
Author: Arnold L. Demain
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 854
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Book Description
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.
Author: William R Strohl
Publisher: Elsevier
ISBN: 1908818093
Category : Medical
Languages : en
Pages : 697
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Book Description
The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships Integration of knowledge across all areas of antibody engineering, development, and marketing Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity
