Download or read book Genetic Stability and Recombinant Product Consistency written by International Association of Biological Standardization and published by S. Karger AG (Switzerland). This book was released on 1994 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication assesses the current state of technology aimed at ensuring the high quality of recombinant-derived biologicals. It will also assist industry and regulatory authorities in their efforts to develop a consensus on the scientific criteria required for the evaluation of genetic stability and product consistency. The papers describe recent progress in methods of nucleic acid sequencing and analytical protein chemistry, as well as strategies for their application. Advances in our understanding of the biology of gene expression are also reviewed. This information is related to data on the development, production and quality control of recombinant biological products. The volume also provides a useful discussion of the value of different approaches.
Download or read book Genetic Stability and Product Consistency of RDNA Derived Biologicals written by J. S Robertson and published by . This book was released on 1993 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO NIBSC Workshop on Genetic Stability and Product Consistency of RDNA Derived Biologicals written by Workshop on Genetic Stability and Product Consistency of rDNA Derived Biologicals. 1992, South Mimms and published by . This book was released on 1993 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
Download or read book Developments in Biological Standardization written by and published by . This book was released on 1999 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Upstream Industrial Biotechnology 2 Volume Set written by Michael C. Flickinger and published by John Wiley & Sons. This book was released on 2013-07-22 with total page 3600 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology represents a major area of research focus, and many universities are developing academic programs in the field. This guide to biomanufacturing contains carefully selected articles from Wiley's Encyclopedia of Industrial Biotechnology, Bioprocess, Bioseparation, and Cell Technology as well as new articles (80 in all,) and features the same breadth and quality of coverage and clarity of presentation found in the original. For instructors, advanced students, and those involved in regulatory compliance, this two-volume desk reference offers an accessible and comprehensive resource.
Download or read book Biological Signals written by and published by . This book was released on 1994 with total page 798 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
Download or read book Genetics of Streptococci Enterococci and Lactococci written by Joseph J. Ferretti and published by S. Karger AG (Switzerland). This book was released on 1995 with total page 684 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Modern Biopharmaceuticals 4 Volume Set written by Jörg Knäblein and published by John Wiley & Sons. This book was released on 2005-10-28 with total page 2074 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical market has come along way since 1982 when the first biopharmaceutical product, recombinant human insulin, was launched. Over 120 such products are currently being marketed around the world including nine blockbuster drugs. The global market for biopharmaceuticals, which is currently valued at US$41 billion, has been growing at an impressive compound annual growth rate of 21% over the previous five years. With over one third of all pipe-line products in active development are biopharmaceuticals, this segment is set to continue outperforming the total pharmaceutical market and could easily reach US$100 billion by the end of this decade.
Download or read book Cumulated Index Medicus written by and published by . This book was released on 1994 with total page 1364 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Vaccines and Diagnostics for Transboundary Animal Diseases written by J.A. Roth and published by Karger Medical and Scientific Publishers. This book was released on 2013-04-18 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Animal Cell Technology Developments towards the 21st Century written by E.C. Beuvery and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 1083 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal cell technology is a discipline of growing importance, which aims not merely at understanding structure, function and behaviour of differentiated animal cells, but especially at the development of their abilities useful for clinical application. Topics of interest in this regard include: viral vaccines, pharmaceutical proteins and novel applications such as gene therapy and organ culture. Undoubtedly, these Proceedings of the joint Meeting of the European Society for Animal Cell Technology and the Japanese Association for Animal Cell Technology (Veldhoven, The Netherlands, September 1994) review the most recent status of the field, and will be most valuable to anyone actively involved in the culture of animal cells and its applications. The contributions to this volume were strictly selected on the basis of quality and novelty of contents. Kluwer is honoured to be able to add this work to its strongly developing publication programme in cell and tissue culture, which now has its connections to all major Societies in this field worldwide. Audience: Cell biologists, biochemists, molecular biologists, immunologists, virologists and all other disciplines related to animal cell technology, working in an academic environment, as well as in (biotechnology or pharmaceutical) industry.
Download or read book Fundamentals of Biologicals Regulation written by Rebecca Sheets and published by Academic Press. This book was released on 2017-12-01 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. - Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond - Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different - Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated - Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products
Download or read book Development of Biopharmaceutical Parenteral Dosage Forms written by Cosimo Prantera and published by CRC Press. This book was released on 1997-07-25 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Formsdetails biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable.
Download or read book Methods in Protein Sequence Analysis 1986 written by Kenneth A. Walsh and published by Springer Science & Business Media. This book was released on 1987-06-17 with total page 654 pages. Available in PDF, EPUB and Kindle. Book excerpt: Methods in Protein Sequence Analysis -1986 brings together reports of the most recent methodology available to protein chemists for studying the molecular detail of proteins. The papers in this volume constitute the proceedings of the Sixth International Conference on Methods in Protein Sequence Analysis, which was held at the University of Washington in Seattle, Washington on August 17-21, 1986. This series of conferences has taken place during a period when new techniques in protein chemistry and molecular biology have enabled not only exploration of the control of protein function, but also deduction of the genetic origin of proteins, and labo ratory generation of rare protein molecules for therapeu tic and commercial use. The current reports are focused on the means by which experimental questions can be answered rather than on the biological implications in specific systems. The scope of the meeting was quite broad, empha sizing microanalytical techniques and the relative merits of DNA sequencing, mass spectrometry and more tradi tional degradation techniques. A highlight of the meeting was the Qrowing awareness of the role of mass spec trometry In the analysis of proteins. The complementarity of protein sequencing and DNA sequencing techniques was apparent throughout the discussions and several papers dealt with the strategy of obtaining sequence in formation from small amounts of protein in order that ap propriate oligonucleotide probes could be constructed and the encoding nucleic acids se. quenced and manipu lated.
Download or read book Animal Genomics for Animal Health written by Marie-Hélène Pinard and published by Karger Medical and Scientific Publishers. This book was released on 2008-01-01 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
