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.

Download or read book Bulletin of Hygiene written by and published by . This book was released on 1950 with total page 1502 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Current Programs written by and published by . This book was released on 1975 with total page 534 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Beer written by Charles W. Bamforth and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: This important and extremely interesting book is a seriousscientific and authoritative overview of the implications ofdrinking beer as part of the human diet. Coverage includes ahistory of beer in the diet, an overview of beer production andbeer compositional analysis, the impact of raw materials, thedesirable and undesirable components in beer and the contributionof beer to health, and social issues. Written by Professor Charlie Bamforth, well known for alifetime's work in the brewing world, Beer: Health andNutrition should find a place on the shelves of all thoseinvolved in providing dietary advice.

Download or read book Exploration of the Seas written by National Research Council and published by National Academies Press. This book was released on 2003-11-04 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the summer of 1803, Thomas Jefferson sent Meriwether Lewis and William Clark on a journey to establish an American presence in a land of unqualified natural resources and riches. Is it fitting that, on the 200th anniversary of that expedition, the United States, together with international partners, should embark on another journey of exploration in a vastly more extensive region of remarkable potential for discovery. Although the oceans cover more than 70 percent of our planet's surface, much of the ocean has been investigated in only a cursory sense, and many areas have not been investigated at all. Exploration of the Seas assesses the feasibility and potential value of implementing a major, coordinated, international program of ocean exploration and discovery. The study committee surveys national and international ocean programs and strategies for cooperation between governments, institutions, and ocean scientists and explorers, identifying strengths, weaknesses, and gaps in these activities. Based primarily on existing documents, the committee summarizes priority areas for ocean research and exploration and examines existing plans for advancing ocean exploration and knowledge.

Download or read book American Men of Science written by and published by . This book was released on 1949 with total page 2852 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Cattleman written by and published by . This book was released on 1954 with total page 2120 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

Download or read book The Marketing and Transportation Situation written by and published by . This book was released on 1961 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Activities Report of the Quartermaster Food and Container Institute for the Armed Forces written by Quartermaster Food and Container Institute for the Armed Forces (U.S.). and published by . This book was released on 1955 with total page 1346 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Liposomes as Drug Carriers written by Gregory Gregoriadis and published by . This book was released on 1988-06 with total page 928 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sixty contributions on liposomes and their uses in drug delivery. Conventional use of drugs suffers from indiscriminate drug action leading to side effects; failure of drugs to reach areas in need of pharmacological intervention; and premature drug inactivation and secretion. This book describes how liposomes incorporating drugs can direct these to diseased areas (in isolation from non-target biological areas) and introduce drugs to areas otherwise inaccessible. Discusses the interaction of liposomes with the biological milieu in vitro and in vivo, ways of optimizing liposomal behavior by manipulation of the carrier, applications related to antimicrobial and cancer therapy, vaccines, enzyme therapy, metal detoxification, diagnostics, and more.

Download or read book China Handbook written by and published by . This book was released on 1965 with total page 1036 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Transplantation Immunology Literature Index written by and published by . This book was released on 1977 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Marketing and Transportation Situation written by and published by . This book was released on 1963 with total page 574 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Freeze Drying Lyophilization Of Pharmaceutical Biological Products Revised and Expanded written by Louis Rey and published by CRC Press. This book was released on 2004-01-21 with total page 634 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.

Download or read book Scientific and Technical Aerospace Reports written by and published by . This book was released on 1976 with total page 1004 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lists citations with abstracts for aerospace related reports obtained from world wide sources and announces documents that have recently been entered into the NASA Scientific and Technical Information Database.

Download or read book Scientific American written by and published by . This book was released on 1958 with total page 1014 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monthly magazine devoted to topics of general scientific interest.