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Author : Fred Douglas Kelley
Publisher :
ISBN 13 :
Total Pages : 388 pages
Book Rating : 4.E/5 ( download)
Download or read book Design and Development of a Controlled Rate Biological Freeze-thaw Device written by Fred Douglas Kelley and published by . This book was released on 1981 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Wade Shafer
Publisher : Springer Science & Business Media
ISBN 13 : 1461337003
Total Pages : 335 pages
Book Rating : 4.4/5 (613 download)
Download or read book Masters Theses in the Pure and Applied Sciences written by Wade Shafer and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Masters Theses in the Pure and Applied Sciences was first conceived, published, and disseminated by the Center for Information and Numerical Data Analysis and Synthesis (CINDAS) * at Purdue University in 1957, starting its coverage of theses with the academic year 1955. Beginning with Volume 13, the printing and dissemination phases of the activity were transferred to University Microfilms/Xerox of Ann Arbor, Michigan, with the thought that such an arrangement would be more beneficial to the academic and general scientific and technical community. After five years of this joint undertaking we had concluded that it was in the interest of all con cerned if the printing and distribution of the volume were handled by an international publishing house to assure improved service and broader dissemination. Hence, starting with Volume 18, Masters Theses in the Pure and Applied Sciences has been disseminated on a worldwide basis by Plenum Publishing Cor poration of New York, and in the same year the coverage was broadened to include Canadian universities. All back issues can also be ordered from Plenum. We have reported in Volume 26 (thesis year 1981) a total of 11 ,048 theses titles from 24 Canadian and 21 8 United States universities. We are sure that this broader base for these titles reported will greatly enhance the value of this important annual reference work. While Volume 26 reports theses submitted in 1981, on occasion, certain univer sities do report theses submitted in previous years but not reported at the time.
Author :
Publisher :
ISBN 13 :
Total Pages : 776 pages
Book Rating : 4.3/5 (91 download)
Download or read book Paper written by and published by . This book was released on 1981 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 1020 pages
Book Rating : 4.:/5 (31 download)
Download or read book Scientific and Technical Aerospace Reports written by and published by . This book was released on 1988 with total page 1020 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David E. Pegg
Publisher : Springer Science & Business Media
ISBN 13 : 1468454692
Total Pages : 481 pages
Book Rating : 4.4/5 (684 download)
Download or read book The Biophysics of Organ Cryopreservation written by David E. Pegg and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Feroz Jameel
Publisher : Springer Nature
ISBN 13 : 3030314154
Total Pages : 888 pages
Book Rating : 4.0/5 (33 download)
Download or read book Development of Biopharmaceutical Drug-Device Products written by Feroz Jameel and published by Springer Nature. This book was released on 2020-03-13 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.
Author : Cornell University. Engineering Library
Publisher :
ISBN 13 :
Total Pages : 576 pages
Book Rating : 4.E/5 ( download)
Download or read book Newsletter written by Cornell University. Engineering Library and published by . This book was released on 1979 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 936 pages
Book Rating : 4.E/5 ( download)
Download or read book Selected Water Resources Abstracts written by and published by . This book was released on 1986 with total page 936 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : John G. Baust
Publisher : CRC Press
ISBN 13 : 1420004220
Total Pages : 426 pages
Book Rating : 4.4/5 (2 download)
Download or read book Advances in Biopreservation written by John G. Baust and published by CRC Press. This book was released on 2006-08-15 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: Moving rapidly from science fiction to science fact, cryopreservation is an integral part of many research, development, and production processes in industry and academia. The preservation sciences have emerged as an interdisciplinary platform that incorporates the fundamentals of cell and molecular biology, and bioengineering, with the classic met
Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1439825440
Total Pages : 495 pages
Book Rating : 4.4/5 (398 download)
Download or read book Advanced Aseptic Processing Technology written by James Agalloco and published by CRC Press. This book was released on 2016-04-19 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies
Author : Feroz Jameel
Publisher : Springer
ISBN 13 : 1493923161
Total Pages : 710 pages
Book Rating : 4.4/5 (939 download)
Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Author :
Publisher :
ISBN 13 :
Total Pages : 412 pages
Book Rating : 4.E/5 ( download)
Download or read book Proceedings written by and published by . This book was released on 1992 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Brian McNeil
Publisher : John Wiley & Sons
ISBN 13 : 0470725281
Total Pages : 402 pages
Book Rating : 4.4/5 (77 download)
Download or read book Practical Fermentation Technology written by Brian McNeil and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: A hands-on book which begins by setting the context;- defining 'fermentation' and the possible uses of fermenters, and setting the scope for the book. It then proceeds in a methodical manner to cover the equipment for research scale fermentation labs, the different types of fermenters available, their uses and modes of operation. Once the lab is equipped, the issues of fermentation media, preservation strains and strain improvement strategies are documented, along with the use of mathematical modelling as a method for prediction and control. Broader questions such as scale-up and scale down, process monitoring and data logging and acquisition are discussed before separate chapters on animal cell culture systems and plant cell culture systems. The final chapter documents the way forward for fermenters and how they can be used for non-manufacturing purposes. A glossary of terms at the back of the book (along with a subject index) will prove invaluable for quick reference.Edited by academic consultants who have years of experience in fermentation technology, each chapter is authored by experts from both industry and academia. Industry authors come from GSK (UK), DSM (Netherlands), Eli Lilly (USA) and Broadley James (UK-USA).
Author :
Publisher :
ISBN 13 :
Total Pages : 1000 pages
Book Rating : 4.F/5 ( download)
Download or read book Government Reports Announcements written by and published by . This book was released on 1974 with total page 1000 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 368 pages
Book Rating : 4.3/5 (91 download)
Download or read book Aerospace Medicine and Biology written by and published by . This book was released on 1981 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: A selection of annotated references to unclassified reports and journal articles that were introduced into the NASA scientific and technical information system and announced in Scientific and technical aerospace reports (STAR) and International aerospace abstracts (IAA).
Author :
Publisher :
ISBN 13 :
Total Pages : 264 pages
Book Rating : 4.3/5 (91 download)
Download or read book U.S. Government Research Reports written by and published by . This book was released on 1964 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Richard H. Baltz
Publisher : American Society for Microbiology Press
ISBN 13 : 155581512X
Total Pages : 1894 pages
Book Rating : 4.5/5 (558 download)
Download or read book Manual of Industrial Microbiology and Biotechnology written by Richard H. Baltz and published by American Society for Microbiology Press. This book was released on 2010-03-25 with total page 1894 pages. Available in PDF, EPUB and Kindle. Book excerpt: A rich array of methods and discussions of productive microbial processes. • Reviews of the newest techniques, approaches, and options in the use of microorganisms and other cell culture systems for the manufacture of pharmaceuticals, industrial enzymes and proteins, foods and beverages, fuels and fine chemicals, and other products. • Focuses on the latest advances and findings on the current state of the art and science and features a new section on the microbial production of biofuels and fine chemicals, as well as a stronger emphasis on mammalian cell culture methods. • Covers new methods that enhance the capacity of microbes used for a wide range of purposes, from winemaking to pharmaceuticals to bioremediation, at volumes from micro- to industrial scale.
