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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.
Biopharmaceutics applications in drug development
This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.
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 processing : Development, design, and Implementation of manufacturing processes
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies.
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.
Biomineralization : From molecular and nano-structural analyses to environmental science
Over the past 45 years, biomineralization research has unveiled details of the characteristics of the nano-structure of various biominerals; the formation mechanism of this nano-structure, including the initial stage of crystallization; and the function of organic matrices in biominerals, and this knowledge has been applied to dental, medical, pharmaceutical, materials, agricultural and environmental sciences and paleontology. As such, biomineralization is an important interdisciplinary research area, and further advances are expected in both fundamental and applied research.
BioMEMS and biomedical nanotechnology ; Vol. III : Therapeutic Micro/Nanotechnology
The human body is composed of structures organized in a hierarchical fashion: from biomolecules assembled into polymers, to multimeric assemblies such as cellular or-ganelles, to individual cells, to tissues, to organ systems working together in health and disease- each dominated by a characteristic length scale. Decades of science and engineer-ing are now converging to provide tools that enable the orderly manipulation of biological systems at previously inaccessible, though critically important, length scales (<100 mi-crons). Thus, the approaches described in this volume provide a snapshot of how micro-and nanotechnologies can enable the investigation, prevention, and treatment of human disease.The volume is divided into three parts. The first part, Cell-based therapeutics; cov- ers the merger of cells with micro- and anosystems for applications in regenerative medicine spanning the development of novel nanobiomaterials.
BioMEMS and Biomedical Nanotechnology : Vol. I: Biological and Biomedical Nanotechnology
Abe Lee has been working on micro/ and nanotechnology for biomedical and biotech applications since 1992. His recent research focuses on the development of integrated micro and nano fluidic chip processors for the following applications: point-of-care diagnostics, "smart" nanomedicine for early detection and treatment, stem cell biology and therapeutics, the synthesis of novel and pure materials, and biosensors to detect environmental and terrorism threats. Jim Lee's research interest includes BioMEMS/NEMS, and polymer micro/nanotechnology. In the last 4 years, he has over 20 refereed journal publications, 2 book chapters, and 5 patents in these areas. He is now leading an NSF Nanoscale Science and Engineering Center for Affordable Nanoengineering of Polymer Biomedical Devices at OSU.
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.
Biomarkers in drug discovery and development : A handbook of practice, application, and strategy
Discusses biomarker characterization and validation and applications throughout drug discovery and development. Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine. Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory. Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring. Includes case studies of biomarkers that have helped and hindered decision making
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 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
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
This new volume on Biological Invasions deals with both plants and animals. It differs from previous books on the subject by extending from the level of individual species to an ecosystem and global level. Topics of highest societal relevance, such as the impact of genetically modified organisms, are interlinked with more conventional ecological aspects, including biodiversity. The combination of these approaches is new and makes compelling reading for researchers and environmentalists. The book’s 22 chapters cover a huge range of subjects relevant to the field. These include pathways of biological invasions (e.g. ballast water, waterways), traits of successful invaders (e.g. chemical weapons, empty niches), and patterns of invasion and invasibility, such as man-induced predisposition by fire, land use and eutrophication, and the role of climate change.
Bioinformatics tools for pharmaceutical drug product development
Presents the latest information on bioinformatics tools, artificial intelligence, machine learning, computational methods, protein interactions, peptide-based drug design, and omics technologies. And include bioinformatics tools for the pharmaceutical sector and the healthcare sector. Bioinformatics brings a new era in research to accelerate drug target and vaccine design development, improving validation approaches as well as facilitating and identifying side effects and predicting drug resistance. As such, this will aid in more successful drug candidates from discovery to clinical trials to the market, and most importantly make it a more cost-effective process overall.
Bioequivalence of topical generic products
Bioequivalence (BE) assessment of topical dermatological products is a long standing challenge. The development of generic topical dermatological products has often been hampered due to the limited number of acceptable approaches, which are capable of determining the BE between generic products and reference list products. Currently, except in the case of dermatological corticosteroids, the golden rule to establish the BE of most topical dermatological products still heavily relied on clinical endpoint trials, which are often unreliable, time-consuming and expensive. The regulatory agencies and pharmaceutical industries are forging ahead to the development of new surrogate BE assessment approaches for other topical dermatological products. These promising approaches include dermatopharmacokinetic study (DPK), dermal microdialysis (DMD), near-infrared spectrometry (NIR), and confocal Raman spectroscopy (CRS).
