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Biopharmaceutical manufacturing progress, trends and challenges
Source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation.
Biopharmaceutical drug design and development
Biopharmaceutical Drug Design and Development, Second Edition, updates the widely successful first edition, published in 1999. This new, expanded edition investigates the dozens of new biopharmaceutical drugs that have become available since the publication of the first edition. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, such as bioinformatics, DNA microarrays, transgenics, therapeutic gene delivery, stem cells, nucleic acid-based therapeutics, and macromolecular drug delivery. Authors also study pharmacogenetics in the clinic and changes in biologic drug approval at the FDA. Biopharmaceutical Drug Design and Development, Second Edition, is a worthy sequel in the discussion on the dynamic, exciting field of biotechnology.
Biomolecular and bioanalytical techniques : Theory, methodology and applications
Offers an introduction to, and a basic understanding of, a wide range of biophysical techniques. The text takes an interdisciplinary approach with contributions from a panel of distinguished experts. With a focus on research, the text comprehensively covers a broad selection of topics drawn from contemporary research in the fields of chemistry and biology. Each of the internationally reputed authors has contributed a single chapter on a specific technique. The chapters cover the specific technique’s background, theory, principles, technique, methodology, protocol and applications.
Biomining
Biomining is the biotechnology that uses microorganisms to recover metals, in particular copper and gold, from ores and concentrates. Having developed from a very simple operational (in terms of both engineering and biology) process, biomining has developed into a multifaceted technology, to the extent that many of the largest industrial stirred tanks and heaps throughout the world are employed for bioprocessing minerals. This book has a strong applied approach and describes emerging and established industrial processes, as well as the underlying theory of the process, and the biology of the microorganisms involved. Chapters have been written by personnel from leading biomining companies, consultants and internationally recognized researchers and academics
Biomedical Informatics : Computer Applications in Health Care and Biomedicine
This series is directed to healthcare professionals who are leading the transformation of health care by using information and knowledge. Launched in 1988 as Computers in Health Care, the series offers a broad range of titles: some addressed to specific prof- sions such as nursing, medicine, and health administration; others to special areas of practice such as trauma and radiology.
Biomedical applications and toxicity of nanomaterials
Covers the recent trends on the biological applications of nanomaterials, methods for their preparation, and techniques for their characterization. Further, the book examines the fundamentals of nanotoxicity, methods to assess the toxicity of engineered nanomaterials, approaches to reduce toxicity during synthesis. It also provides an overview of the state of the art in the application of Artificial intelligence-based methodologies for evaluation of toxicity of drugs and nanoparticles. The book further discusses nanocarrier design, routes of various nanoparticle administration, nano based drug delivery systems, and the toxicity challenges associated with each drug delivery method. It presents the latest advances in the interaction of nanoparticles with the cellular environment and assess nanotoxicity of these engineered nanoparticles. The book also explores the comparative and mechanistic genotoxicity assessment of the nanomaterials. This book is useful source of information for industrial practitioners, policy makers, and other professionals in the fields of toxicology, medicine, pharmacology, food, and drugs.
Biomaterials and bionanotechnology ; 1st ed.
Examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields.
Biomaterials : An Introduction
Biomaterials, an Introduction is intended as a general introduction to the uses of artificial materials in the human body for the purposes of aiding healing, correcting deformities, and restoring lost function. Enhancing on the field developments since the successful last edition, Biomaterials, an Introduction continues in its tradition as an outgrowth of an undergraduate course for senior students in biomedical engineering developed by the authors With 60 years of combined experience, the authors have emphasized the fundamental materials science, structure-property relationships and biological responses as a foundation for a wide array of biomaterials applications.
Biomarkers for alzheimer’s disease drug development
Helping to accelerate Alzheimer’s disease drug development. Addressing the latest advances in preclinical and clinical research, including new insights into the molecular mechanisms and emerging therapeutic strategies, the book continues by exploring digital biomarkers and advanced neuroimaging analysis which will transform how clinical trials in the Alzheimer’s disease field are performed.
Biomarkers for alzheimer’s disease drug development
Aims to build a new generation of experts with a broader understanding of key topics in the Alzheimer’s disease field. Chapters guide readers through innovative approaches to the discovery of novel biomarkers in cerebrospinal fluid, innovation in blood-based biomarkers, a comprehensive overview of magnetic resonance imaging and molecular imaging approaches and their value for developing drugs for Alzheimer’s disease, cutting-edge developments in neuropathology and their relevance for Alzheimer’s disease trials, novel genomic strategies for biomarker development, and related topics including neuropsychological testing and advanced analytical methods.Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls.
Biomarkers as targeted herbal drug discovery : A pharmacological approach to nanomedicines
Looks at the applications of biomarkers as important tools for herbal drug discovery, presenting research on phytoconstituents with advanced nanotechnological applications for healthcare benefits. Herbal drug discovery based on biomarkers is an emerging area in complementary and alternative medicine that has tremendous potential in healthcare. Conventional medications have limited efficacy and high toxicity, whereas herbal drugs are said to provide wide structural diversity that is not usually seen with conventional/synthetic drug molecules. Recognition of various herbal constituents, such as terpenoids, fatty acids, flavonoids and steroids, are well explored in the management and treatment of various disorders in this volume. These agents target various biomarkers such as nitric oxide (NO), cytokines, chemokines, adhesion molecules, NF- kβ, lipoxygenase (LOX), and arachidonic acid. Reviews the literature on inflammatory biomarkers in the treatment of diseases Looks at the development of herbal drug discovery based on biomarkers Explores emerging concepts of nanomedicines for herbal drug delivery Takes an interdisciplinary approach, with application to disciplines related to medical, pharmaceutical, biotechnological, Ayurvedic, Unani and biomedical engineering fields
Biology and Ecology of Norway Spruce
This book presents a concise and comprehensive review of the biology, ecology, and management of Norway spruce. It integrates classic and contemporary literature (more than 2000 works cited in the text), highlighting basic research and forestry practices in central and eastern Europe. The topics include anatomy and morphology, physiology and nutrition, reproductive biology and genetics, and ecology. In addition, it examines mycorrhiza, diseases and pests as well as silviculture and wood products. In the light of increasing threats to forest health from air pollution, climate change, and insects and disease, it provides an essential information source to those concerned with the ecology, conservation, and management of the species
Biologie und epidemiologie der hormonersatztherapie : Diskussionen zur postmenopausalen gesundheit = Biology and epidemiology of hormone replacement therapy : Discussions on postmenopausal health
The advantages and disadvantages of hormone replacement therapy (HRT) are discussed by a group of experts with regard to the epidemiological evidence. However, the focus of the discussion is the problem of breast cancer risk. Among other things, it is shown that the results derived from epidemiological studies do not coincide with the growth characteristics of these tumors, so that further population studies with the inclusion of pathobiological expertise appear necessary. The benefits and risks of hormone replacement therapy (HRT) are discussed by a group of experts with a view towards the evidence provided by recent epidemiological studies. Although all aspects of HRT indications and contra-indications are reviewed, the particular emphasis of this discussion is on breast cancer. Among other things, it is shown that the evidence on breast cancer provided in epidemiological studies does not match the growth characteristics of the tumors, and that further population research incorporating pathobiological assessments is required.
Biologics, biosimilars, and biobetters : An introduction for pharmacists, physicians and other health practitioners
Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Biologics in General Medicine
The idea for this book was born during the symposium on biologics organized by ZAFES (Center for Drug Research, Development and Safety at the University of Frankfurt am Main) in September 2005. Highly distinguished researchers special- ing in the field of biologics had gathered together to exchange information on this relatively new subject. Realizing that this symposium was one of the few sources of condensed information on biologics, it became obvious that we had to create a means of informing an interested wider circle of scientists and especially general c- nicians. Therefore, the editors of this book suggested to the researchers at the symposium andalsotoprominent scientists andcliniciansinvolvedinthe developmentand application of biologics as their major field of interest the idea of assembling this compendium. We received an overwhelmingly positive response – thankfully also from the publisher – most being more than willing to support this innovative project with highly relevant chapters on the latest state of the art.
Biological Invasions in New Zealand
Man’s recent colonization of New Zealand has dramatically altered the resident biota and resulted in the introduction of numerous alien organisms to these once remote islands. In reverse, there is increasing evidence of a lesser known export of species to other regions of the world. This volume presents an in-depth review of the level and rate of such invasions, and investigates what controls the success of invaders and the consequences for ecosystems both on land and offshore. It provides invasion biologists everywhere with tests of current theories about those factors leading to the success of invaders as well as evaluating principles for understanding the nature of their impacts that form a solid basis for the effective management of biological invasions worldwide.
Biological Invasions Belowground : Earthworms as Invasive Species
he most conspicuous biological invasions in terrestrial ecosystems have been by exotic plants, insects and vertebrates. Less conspicuous but possibly of equal importance are invasions by soil invertebrates, which are occurring literally beneath our feet. Familiar examples include the South American fire ant (Solenopsis invicta) which has invaded North America and Australia, and the New Zealand flatworm (Arthurdendyus triangulatus) which has become wide-spread in the United Kingdom; both have caused considerable ecological and economic damage. There is now evidence that exotic earthworm invasions are increasing world-wide and may be having significant impacts on soil processes and plant communities in some regions. Much remains to be learned about these ‘cryptic’ biological invasions. The papers in this book are based on efforts by an international group of soil ecologists to assess the biological and ecological mechanisms of earthworm invasions, their geographic extent and impacts on terrestrial ecosystems, and possible means by which earthworm invasions might be mitigated.
Biological Calcification : Normal and Pathological Processes in the Early Stages
This book follows a precursor volume devoted to biological calci?cation, - sued by the CRC Press, Boca Raton (Florida) in 1992. Several basic aspects of the calci?cation process were analyzed in it by outstanding authors who had unquestioned competence in their respective research areas. Its main aim was that of giving readers access to a series of papers which, even though they discussed divergent aspects of biological calci?cations drawn from the study of systems as different as vertebrate skeletons and mollusks, in vitro cultures and unicellular organisms, ectopic calci?cation and urinary stones, provided elements permitting a coherent approach to a comprehensive view of the calci?cation process in biological tissues.
Biological Basis of Geriatric Oncology
Biological Basis of Geriatric Oncology highlights research issues that are specific to geriatric oncology in the field of carcinogenesis and cancer prevention and treatment, based on the biologic interactions of cancer and age. It illustrates the benefit of the principles of geriatrics in the management of cancer in the older individual.
Bioinspired engineering of thermal materials
A comprehensive overview and summary of recent achievements and the latest trends in bioinspired thermal materials. Following an introduction to different thermal materials and their effective heat transfer to other materials, the text discusses heat detection materials that are inspired by biological systems, such as fire beetles and butterflies. There then follow descriptions of materials with thermal management functionality, including those for evaporation and condensation, heat transfer and thermal insulation materials, as modeled on snake skins, polar bears and fire-resistant trees.
