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Author : WHO Study Group on Biologicals
Publisher :
ISBN 13 :
Total Pages : 36 pages
Book Rating : 4.3/5 (9 download)
Download or read book Acceptability of Cell Substrates for Production of Biologicals written by WHO Study Group on Biologicals and published by . This book was released on 1987 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : J. C. Petricciani
Publisher : Springer Science & Business Media
ISBN 13 : 1468409972
Total Pages : 218 pages
Book Rating : 4.4/5 (684 download)
Download or read book Cell Substrates written by J. C. Petricciani and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume stems from a symposium sponsored by the W. Alton Jones Cell Science Center, Lake Placid New York. The Second Annual W. Alton Jones Cell Science Center Symposium: Cell Substrates and Their Use in the Production of Vaccines and Other Biologicals was held October 23-26, 1978. The Center is an operational unit of the Tissue Culture Association and offers, in collaboration with the Association's Education Committee, a wide range of educational and research activities. During the past 20 years there have been numerous national and international conferences on the topic of cell cultures used to produce biological products. Those largely dealt with the technology and associated issues that were current at the time of the meetings. For example, as human diploid cells were developed and proposed for use in vaccine production, a number of meetings were held to examine the pros and cons of human diploid cells. A large amount of data was provided at those conferences which formed the basis for the eventual acceptance of that cell system. Each meeting added to the general base of knowledge in the area of cell cultures and their application to the current and novel set of problems encountered. In general, the participants reaffirmed the basic premises that were formulated in the early days of polio virus vaccine production regarding the criteria for acceptability of cells when used in the manufacture of biologics intended for humans.
Author : WHO Expert Committee on Biological Standardization. Meeting
Publisher : World Health Organization
ISBN 13 : 924120978X
Total Pages : 398 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2013 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 18 to 22 October 2010"--Introduction.
Author : Hansjörg Hauser
Publisher : Walter de Gruyter
ISBN 13 : 3110809281
Total Pages : 513 pages
Book Rating : 4.1/5 (18 download)
Download or read book Mammalian Cell Biotechnology in Protein Production written by Hansjörg Hauser and published by Walter de Gruyter. This book was released on 2011-07-13 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: „Hauser und Wagner haben die neuen Möglichkeiten der Mammalian Cell Biology sehr anregend dargestellt.“ Prof. Dr. Hans Fritz, Ludwig-Maximilians-Universität München
Author : James P. Agalloco
Publisher : CRC Press
ISBN 13 : 1420019791
Total Pages : 762 pages
Book Rating : 4.4/5 (2 download)
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9240074481
Total Pages : 350 pages
Book Rating : 4.2/5 (4 download)
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2023-05-26 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 76th meeting of the WHO Expert Committee on Biological Standardization was held from 24 to 28 October 2023 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Clive Ondari, Director, Health Products Policy and Standards. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, policymakers, health workers, developers of vaccines and other biological products and academia.
Author : Lubiniecki
Publisher : Routledge
ISBN 13 : 1351435701
Total Pages : 650 pages
Book Rating : 4.3/5 (514 download)
Download or read book Large-Scale Mammalian Cell Culture Technology written by Lubiniecki and published by Routledge. This book was released on 2018-05-02 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: An interdisciplinary approach, integrating biochemistry, biology, genetics, and engineering for the effective production of protein pharmaceuticals. The volume offers a biological perspective of large-scale animal cell culture and examines diverse processing strategies, process management, regulator
Author : Gail Sofer
Publisher : CRC Press
ISBN 13 : 1420001655
Total Pages : 377 pages
Book Rating : 4.4/5 (2 download)
Download or read book Process Validation in Manufacturing of Biopharmaceuticals written by Gail Sofer and published by CRC Press. This book was released on 2000-03-24 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness wh
Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1000436012
Total Pages : 1062 pages
Book Rating : 4.0/5 (4 download)
Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Author : G. Stacey
Publisher : Springer Science & Business Media
ISBN 13 : 940114916X
Total Pages : 257 pages
Book Rating : 4.4/5 (11 download)
Download or read book Safety in Cell and Tissue Culture written by G. Stacey and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is now more than half a century since animal cells first came into regular use in the laboratory. Instances of laboratory acquired infection and con tamination of therapeutic products, derived from the use of animal cell cultures are rare. The use of animal cells, in addition to an established role in the production of vaccines and therapeutic proteins, has many new medical applications including gene therapy, tissue engineering and cell therapy. Furthermore, C;ldvances in molecular and cell biology are enabling rapid development and application of these technologies and the development of new and more sensitive methods, such as nucleic acid amplification, for the characterisation of cells and the detection of adven titious agents. However, it is clear that there is no room for complacency in this field and the recent expansion in the use of animal cells in the manufacture of medical products and the development of new biological assays for diagnostic and pharmaco-toxicological screening, underlines the need for vigilance regarding the correct and safe use of animal cells as substrates. This book is therefore very timely and should prove to be a highly valuable text, finding a wider audience beyond those with respon sibility for laboratory safety. The book guides the reader from fundamental cell biology issues and the establishment of new in vitro methods, through testing and validation of cell lines and on to issues in the use of animal cells in manufacturing processes.
Author : Manfred R. Koller
Publisher : Springer Science & Business Media
ISBN 13 : 079235821X
Total Pages : 342 pages
Book Rating : 4.7/5 (923 download)
Download or read book Human Cell Culture written by Manfred R. Koller and published by Springer Science & Business Media. This book was released on 1999-07-31 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes research technology for the growth and differentiation of all 12 types of the primary hematopoietic cells that develop into the various types of blood cells. Also provides background information, discusses current and future clinical applications of large-scale culture methods, and considers regulatory and ethical implications associated with using human and fetal tissues. The 13 studies include treatments of hematopoietic stem and progenitor cells, monocytes and macrophages, isolating and culturing human dendritic cells, purifying and culturing erythroid progenitor cells, the in vitro development of megakaryocytes and platelets, the mature polyclonal and antigen- specific cell expansion of T-lymphocytes, and in vitro T- lymphopoiesis. They are not indexed. Annotation copyrighted by Book News, Inc., Portland, OR
Author : Fred Brown
Publisher :
ISBN 13 :
Total Pages : 564 pages
Book Rating : 4.3/5 (91 download)
Download or read book Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development written by Fred Brown and published by . This book was released on 2001 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: In September 1999, the cell substrate workshop entitled 'Evolution of Cell Substrates Used in the Manufacture of Biologicals' was held as a means to consider in depth the issues raised by the need to use neoplastic, i.e. continuous, cells as substrates for viral vaccine manufacture. Workshop goals included identifying the risks and concerns associated with the use of neoplastic cell substrates and determining the manner in which these could be assessed. Volume 106 of Developments in Biologicals presents the edited proceedings of this workshop. It is the latest in a series of monographs that go back to 1967 and record the proceedings of meetings devoted to issues concerning the use of cells cultured in vitro as substrates for the manufacture of viral vaccines. The current workshop covered the following: - a review of the history of cell substrate use in the production of biologicals - scientific issues related to the development of the neoplastic state and tumorigenicity - viral-viral and viral-cell interactions - the oncogenic potential of residual cell-substrate DNA - adventitious agent testing - ways to generate immortalized cells in vitro The purpose of these discussions was to build on the concepts and precedents for the scientifically based, regulatory management of viral vaccines documented in the earlier monographs. It is the hope of the meeting organizers and sponsors that this volume will assist in generating confidence among vaccine developers, manufacturers, regulatory agencies and the general public that the use of neoplastic cell substrates, within an effective, reasoned, regulatory approach, is feasible.
Author : R. E. Spier
Publisher : Butterworth-Heinemann
ISBN 13 : 1483165159
Total Pages : 853 pages
Book Rating : 4.4/5 (831 download)
Download or read book Production of Biologicals from Animal Cells in Culture written by R. E. Spier and published by Butterworth-Heinemann. This book was released on 2013-09-24 with total page 853 pages. Available in PDF, EPUB and Kindle. Book excerpt: Production of Biologicals from Animal Cells in Culture reviews the state of the art in animal cell biotechnology, with emphasis on the sequence of events that occur when generating a biological from animal cells in culture. Methods that enable adjustment of nutrient feed streams into perfusion bioreactors so as to increase productivity are described. A number of issues are also addressed, such as the usefulness of the fingerprint method for cell characterization. Comprised of 135 chapters, this book begins with an overview of the problems and benefits of animal cell culture, followed by a discussion on the isolation of immortal murine macrophage cell lines. The reader is systematically introduced to the use of DNA fingerprinting to characterize cell banks; immortalization of cells with oncogenes; lipid metabolism of animal cells in culture; and energetics of glutaminolysis. Subsequent chapters explore serum-free and protein-free media; the physiology of animal cells; gene expression in animal cell systems; and animal cell bioreactors. The monitoring and assay of animal cell parameters are also considered, along with downstream processing and regulatory issues. This monograph will be of interest to students, practitioners, and investigators in the fields of microbiology and biotechnology.
Author : F. Koller
Publisher : Springer Science & Business Media
ISBN 13 : 0306468867
Total Pages : 342 pages
Book Rating : 4.3/5 (64 download)
Download or read book Human Cell Culture written by F. Koller and published by Springer Science & Business Media. This book was released on 2006-04-11 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The daily production of hundreds of billions of blood cells through the process of hematopoiesis is a remarkable feat of human physiology. Transport of oxygen to tissues, blood clotting, antibody- and cellular-mediated immunity, bone remodeling, and a host of other functions in the body are dependent on a properly functioning hematopoietic system. As a consequence, many pathological conditions are attributable to blood cell abnormalities, and a fair number of these are now clinically treatable as a direct result of hematopoietic research. Proliferation of hematopoietic stem cells, and their differentiation into the many different lineages of functional mature cells, is highly regulated and responsive to many environmental and physiological challenges. Our relatively advanced understanding of this stem cell system provides potentially important insights into the regulation of development in other tissues, many of which are now being acknowledged as stem ce- based, perhaps even into adulthood. The recent public and scientific fanfare following announcement of human embryonic stem cell studies suggests that stem cell research will continue to be a relevant and exciting topic.
Author : National Library of Medicine (U.S.)
Publisher :
ISBN 13 :
Total Pages : 1144 pages
Book Rating : 4.3/5 (91 download)
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on with total page 1144 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
Author : Steve L. Nail
Publisher : Springer Science & Business Media
ISBN 13 : 1461505496
Total Pages : 479 pages
Book Rating : 4.4/5 (615 download)
Download or read book Development and Manufacture of Protein Pharmaceuticals written by Steve L. Nail and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.
Author :
Publisher :
ISBN 13 :
Total Pages : 484 pages
Book Rating : 4.:/5 (319 download)
Download or read book Technical Report Series written by and published by . This book was released on 2011 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt:
