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Biosimilars : Regulatory, clinical, and biopharmaceutical development
Provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development.
Biosaline Agriculture and High Salinity Tolerance
this book reviews the current state of knowledge in biosaline agriculture and high salinity tolerance in plants. It mainly focuses on the biotic approach to economically utilize the stress-prone areas by growing resistant plants.This volume comprises three sections: physiology and biochemistry, ecology, and molecular biology. Thus, a systematic approach has been adopted to uncover plant responses to various ecological factors at physiological and molecular levels.
Bioreactors for Tissue Engineering : Principles, Design and Operation
This volume addresses the issue of mechanical conditioning of the tissue, and describes the use of techniques such as MRI for monitoring tissue growth. It also deals with the application of bioreactor technology to tissue engineering products.
Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: •Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries •Includes illustrative case studies that review six milestone bio-products •Discuses a wide selection of host strain types and disruptive bioprocess technologies
Biopolymers in nutraceuticals and functional foods
Comprehensive book covers new applications of biopolymers in the research and development of industrial scale nutraceutical and functional food grade products.
Biophysical characterization of functional peptides
Presents reproducible and step-by-step procedures for the peptide synthesis, their characterization and applications. The volume includes an introductory section on in silico modelling of new peptide molecules, Molecular Dynamics Simulations, Docking, Electrostatic fingerprinting of peptides, and other modelling tools for peptide designing and optimization. Further, it covers protocols for the solid phase peptide synthesis, chromatographic and mass spectrometric characterization of peptides. Importantly, it covers methods for biophysical characterizations of peptides for their potential applications as drug delivery vehicles, peptide nano-assembly, bionanocatalysis, protein aggregation diseases, and peptide-based anti-bacterial.
Biopharmaceutics : From fundamentals to industrial practice
Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow.
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.
Bionanotechnology : Proteins to Nanodevices
Bionanotechnology is the key integrative technology of the 21st century and aims to use the knowledge, gathered from the natural construction of cellular systems, for the advancement of science and engineering. Investigating the topology and communication processes of cell parts can lead to invention of novel biological devices with exciting applications. Though microscale to nanoscale research offers an excellent space for the development of futuristic technologies, a number of challenges must be overcome. Due to paucity of a dedicated literature on the protein based nanodevices we bring you this monograph that combines collective research works of scientists probing into this fascinating universe of bionanotechnology. The monograph has been written with an aim of surveying engineering design principles of biomolecular nanodevices, prototype nanodevices based on redox proteins, bacteriorhodopsins and natural fibers, and touching upon the future developments in the field.
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 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.
Bio-mechanisms of swimming and flying ; Fluid dynamics, biomimetic robots, and sports science
This book follows "Bio-mechanisms of Animals in Swimming and Flying" published in 2004 including 11 chapters. This time, the book includes 31 chapters on the latest researches into natural autonomous systems and locomotion in both flying and swimming organisms. The area of sports science such as analysis and simulation of human swimming is newly added. The computational frameworks for the modeling, simulation and optimization of animals in swimming and flying demonstrate an important role in the progress of interdisciplinary work in the fields of biology and engineering. An innovative technology is exhibited for the flight of an insect size micro air vehicle. Neuronal science is not only unveiling the locomotion mechanisms of swimming in fish from the aspect of the neuronal activities, but also applied to underwater biomimetic robots. The interdisciplinary works are exhibited in the fields of biology and engineering, yielding real-world benefits in innovative technologies.
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.
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 adhesives
Many plants, animals, and microbes use adhesive polymers and structures to attach to inert substrates, to each other, or to other organisms. This is the first major review that brings together research on many of the well-known biological adhesives. Emphasizing the diversity of biological adhesives and associated adhesion processes, it deals with bacteria, fungi, algae, and marine and terrestrial animals. It bridges a variety of disciplines including biochemistry, molecular biology, biomechanics, bioengineering, microbiology, organism structure and function, and ultrastructure. As we learn more about the molecular and mechanical properties of these adhesives, we begin to understand why they adhere so well and how they develop cohesive strength. With this understanding comes the prospect of developing synthetic or semi-synthetic adhesives with broad applications in areas such as medicine, dentistry, and biotechnology. The book is suitable for both industrial and academic researchers.
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.
Bioimage Data Analysis Workflows
This book provides students and researchers in the life sciences with essential practical information on how to quantitatively analyze data images. It refrains from focusing on theory, and instead uses practical examples and step-by step protocols to familiarize readers with the most commonly used image processing and analysis platforms such as ImageJ, MatLab and Python.
Biodiversity and Ecophysiology of Yeasts
In the last few decades more and more yeast habitats that were not investigated earlier, spanning cold climates to tropical regions and dry deserts to rainforests, have been explored. As a result, a large body of ecological data has been accumulated and the number of known yeast species has increased rapidly. This book provides an overview of the biodiversity of yeasts in different habitats. The recent advances achieved by the application of molecular biological methods in the field of yeast taxonomy and ecology are also incorporated in the book. Wherever possible, the interaction between yeasts and the surrounding environment is discussed.
