Therapeutic Monoclonal Antibodies and Antibody Drug Conjugates (ADC): From Lot Release to Stability Testing is a highly topical resource on a subject of interest for scientists and researchers working on monoclonal antibodies' characterization, release testing, stability testing and similarity assessments of monoclonal antibodies in the biopharmaceutical industry. Monoclonal antibodies (mAbs) are large, extremely complex and dynamic biomolecules, so it can be challenging to develop well-characterized therapeutic antibodies that meet regulatory expectations that are also in-line with commercialized standards for different drug markets. Lot release testing and understanding the stability of the mAb over a period of time, and in different environmental conditions, is an indispensable aspect of mAb physicochemical characterization. This book covers the process, including extensive analysis that starts with quantifying the purity attribute to glycan profiling and identifying the mAb primary structure. The book has a primary purpose of focusing on both Lot release testing and stability testing of monoclonal antibodies (subjects not covered in any great detail in other books).

Advanced Nanoformulations: Theranostic Nanosystems, Volume Three examines the applications of nanotherapeutic systems and nanodiagnostics in relation to polymeric nanosystems. In the last decade, numerous biopolymers have been utilized to prepare polymeric nanosystems for therapeutic applications. These biopolymers include polylactic acid, polylactide-co-glycolide, polycaprolactone, acrylic polymers, cellulose and cellulose derivatives, alginates, chitosan, gellan gum, gelatin, albumin, chontroitin sulfate, hyaluronic acid, guar gum, gum Arabic, gum tragacanth, xanthan gum, and starches. Besides these biopolymers, grafted polymers are also being used as advanced polymeric materials to prepare many theranostic nanocarriers and nanoformulations. This book explores the array of polymeric nanosystems to understand therapeutic potentials. It will be useful to pharmaceutical scientists, including industrial pharmacists and analytical scientists, health care professionals, and regulatory scientists actively involved in the pharmaceutical product and process development of tailor-made polysaccharides in drug delivery applications.

Frontiers in Aquaculture Biotechnology presents a broad-spectrum of topics, covering different key aspects of aquaculture. With the rising importance of aquaculture research, evidence-based information is integral in advancing this field. This book provides a solid resource of information on DNA barcoding for fish species authentication and seafood labelling and cell culture, including stem cell culture, in vitro research using fish cell lines such as in vitro fish meat, reproductive biotechnology, including surrogate technology, gene editing and genetically modified aquaculture species, biofloc technology, and omic technologies such as proteomics, artificial intelligence and biobanking. This book will be a valuable resource to students, researchers a nd entrepreneurs interested in a better understanding of this emerging field of aquaculture.

Environmental change is affecting the world's agricultural productivity. This is coupled with an increase in population: according to the United Nations Department for Economic and Social Affairs, the global population is estimated to reach 9.7 billion by 2050. Therefore, the current situation requires that we develop climate-smart technologies to improve crop productivity to sustain the ever-rising global population. Current-day farmers are introducing a considerable amount of agrochemicals to enhance crop productivity. Indiscriminate agrochemical application has altered not only the soil's physic-chemical and biological properties but also affected human health through food chain contamination. Cyanobacteria, under these changing environmental conditions, may help to resolve the problem significantly without changing the natural soil properties. In spite of their well-known stress tolerance potential, most of the cyanobacterial stress management and signaling pathways are yet to be fully characterized. Therefore, there is an urgent need to explore cyanobacterial metabolism under stress as well as their regulatory pathways to exploit them for sustainable agriculture. In recent decades, the application of cyanobacteria has attracted scientists because of uniqueness, better adaptability, and synthetic products. Diverse cyanobacterial communities with the ability to fix atmospheric nitrogen, together with their photosynthetic properties, have demonstrated their application under field conditions. Several cyanobacterial species have thus been exploited to enhance soil fertility, mitigate biotic and abiotic stress, and contamination management. Cyanobacterial Lifestyle and its Applications in Biotechnology has been designed to discuss different aspects of cyanobacterial physiology with the aim of helping to provide a better understanding of advanced cyanobacterial molecular biology and their metabolism to uncover the potential of cyanobacteria in the tailoring of stress smart crops for sustainable agriculture. Chapters include valuable information about the role of cyanobacteria in the evolution of life, cyanobacterial photosynthesis, stress-tolerant cyanobacterium, biological nitrogen fixation, circadian rhythms, genetics and molecular biology of abiotic stress responses.

Advances in Applied Microbiology, Volume 114 continues the comprehensive reach of this widely read and authoritative review source in microbiology. Users will find invaluable references and information on a variety of areas relating to the topic of microbiology, with this release focusing on recent advances in the biosynthesis of isoprenoids in the engineered Saccharomyces cerevisiae.

Comprehensive Foodomics, Three Volume Set offers a definitive collection of over 150 articles that provide researchers with innovative answers to crucial questions relating to food quality, safety and its vital and complex links to our health. Topics covered include transcriptomics, proteomics, metabolomics, genomics, green foodomics, epigenetics and noncoding RNA, food safety, food bioactivity and health, food quality and traceability, data treatment and systems biology. Logically structured into 10 focused sections, each article is authored by world leading scientists who cover the whole breadth of Omics and related technologies, including the latest advances and applications. By bringing all this information together in an easily navigable reference, food scientists and nutritionists in both academia and industry will find it the perfect, modern day compendium for frequent reference. List of sections and Section Editors: Genomics - Olivia McAuliffe, Dept of Food Biosciences, Moorepark, Fermoy, Co. Cork, Ireland Epigenetics & Noncoding RNA - Juan Cui, Department of Computer Science & Engineering, University of Nebraska-Lincoln, Lincoln, NE Transcriptomics - Robert Henry, Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, St Lucia, Australia Proteomics - Jens Brockmeyer, Institute of Biochemistry and Technical Biochemistry, University Stuttgart, Germany Metabolomics - Philippe Schmitt-Kopplin, Research Unit Analytical BioGeoChemistry, Neuherberg, Germany Omics data treatment, System Biology and Foodomics - Carlos Leon Canseco, Visiting Professor, Biomedical Engineering, Universidad Carlos III de Madrid Green Foodomics - Elena Ibanez, Foodomics Lab, CIAL, CSIC, Madrid, Spain Food safety and Foodomics - Djuro Josic, Professor Medicine (Research) Warren Alpert Medical School, Brown University, Providence, RI, USA & Sandra Kraljevic Pavelic, University of Rijeka, Department of Biotechnology, Rijeka, Croatia Food Quality, Traceability and Foodomics - Daniel Cozzolino, Centre for Nutrition and Food Sciences, The University of Queensland, Queensland, Australia Food Bioactivity, Health and Foodomics - Miguel Herrero, Department of Bioactivity and Food Analysis, Foodomics Lab, CIAL, CSIC, Madrid, Spain

Targeting Chronic Inflammatory Lung Diseases Using Advanced Drug Delivery Systems explores the development of novel therapeutics and diagnostics to improve pulmonary disease management, looking down to the nanoscale level for an efficient system of targeting and managing respiratory disease. The book examines numerous nanoparticle-based drug systems such as nanocrystals, dendrimers, polymeric micelles, protein-based, carbon nanotube, and liposomes that can offer advantages over traditional drug delivery systems. Starting with a brief introduction on different types of nanoparticles in respiratory disease conditions, the book then focuses on current trends in disease pathology that use different in vitro and in vivo models. The comprehensive resource is designed for those new to the field and to specialized scientists and researchers involved in pulmonary research and drug development.

Comprehensive Biotechnology, Third Edition, Six Volume Set unifies, in a single source, a huge amount of information in this growing field. The book covers scientific fundamentals, along with engineering considerations and applications in industry, agriculture, medicine, the environment and socio-economics, including the related government regulatory overviews. This new edition builds on the solid basis provided by previous editions, incorporating all recent advances in the field since the second edition was published in 2011.

Bioinspired Design of Materials Surfaces reviews novel methods and technologies used to design surfaces and materials for smart material and device applications. The author discusses how materials wettability can be impacted by the fabrication of micro- and nanostructures, anisotropic structures, gradient structures, and heterogeneous patterned structures on the surfaces of materials. The design of these structures was inspired by nature, including lotus, cactus, beetle back and butterfly wings, spider silk, and shells. The author reviews the various wettability functions that can result from these designs, such as self-cleaning, directional adhesion, droplet driving, anti-adhesion, non-wetting, liquid repellent properties, liquid separation, liquid splitting, and more. This book presents a key reference on how to fabricate bioinspired structures on materials for desired functions of materials wettability. It also discusses challenges, opportunities and many potential applications, such as oil-water separation devices, water harvesting devices and photonic device applications.

Statistical, Mapping and Digital Approaches in Healthcare addresses all health territories, starting from the analysis of geographical data (health data, population data, health data systems and environmental data), to new health areas (Health 3.0), i.e. digital health territories. Specific tools are used to question environmental changes, such as health statistics, mapping, mathematical models, optimization models and serious games.

Computerized machines can be found in many forms and all around us - in our pockets, and even sometimes in our body. For many of us, they are now essential elements of everyday life. When it comes to smartphones, connected objects, medical digital devices and e-health, these digital tools have proliferated in our environment, continually transforming our modes of social organization. They act as prostheses and orthotics that "enhance" our cognitive capacities and influence our inherent behaviors. Are digital tools that perpetually envelop the body and the spirit able to overwhelm the social order? Could our cognitive prosthetics lead to permanent, radical change to our society, which could become similar to a hive? This book explores this reflection, which is at the center of social research on digital tools.

Advances in Applied Microbiology, Volume 105 continues the comprehensive reach of this widely read and authoritative review source in microbiology. Users will find invaluable references and information on a variety of areas, with this updated volume including chapters covering The Genus Macrococcus: an insight into its evolution, biology and relationship with Staphylococcus, The use of electrobiochemical reactors for in vitro and in vivo metabolic engineering, Advances in the Microbial Ecology of Biohydrometallurgy, Optimizing yeast alcoholic fermentations, Methods to reduce spoilage and microbial contamination of plant produce, Microbial Diversity and Functional Analysis, and more.

Enzymes in Food Biotechnology: Production, Applications, and Future Prospects presents a comprehensive review of enzyme research and the potential impact of enzymes on the food sector. This valuable reference brings together novel sources and technologies regarding enzymes in food production, food processing, food preservation, food engineering and food biotechnology that are useful for researchers, professionals and students. Discussions include the process of immobilization, thermal and operational stability, increased product specificity and specific activity, enzyme engineering, implementation of high-throughput techniques, screening to relatively unexplored environments, and the development of more efficient enzymes.

New and Future Developments in Microbial Biotechnology and Bioengineering: Microbial Genes Biochemistry and Applications consolidates the most widely used genetic methods available, bringing together the fields of biochemistry, biotechnology, and microbiology. The chapters outlined give clear and concise direction on both standard and applied microbial genetic improvements, presenting undergraduates, postgraduates, and researchers with the latest developments in microbial gene technology. In addition, the book describes the background and usefulness of each experiment in question. All chapters covered in the book are derived from current peer-reviewed literature as accepted by the international scientific community.

Stem Cells: Therapeutic Innovations under Control traces the discovery of stem cells and induced pluripotent cells. It establishes the link between knowledge about cell development and tissue engineering, and presents perspectives in regenerative medicine. Cell proliferation and tissue architecture open up unexpected applications in tissue engineering, with the development of tissues or organs. In this context emerges the need to address the issue of bioethics and regulatory considerations. Because stem cells can multiply and differentiate into cells specific to a particular tissue or organ, they represent vast potential in the health field.

Nanostructured Nonlinear Optical Materials: Formation and Fabrication covers the analysis of the formation, characterization and optical nonlinearities of various nanostructures using different methods. It addresses many areas of research in the field, including the modification of the surfaces of materials for the formation of various nanostructures, transmission electron microscopy and time-of-flight mass spectroscopy studies of ablated bulk and nanoparticle targets, the low-order nonlinearities of metal and semiconductor nanoparticles, the nonlinear refraction and nonlinear absorption of carbon-contained nanoparticles, and low- and high-order harmonic generation in nanoparticle-contained plasmas, amongst other topics. The book is an essential reference for all nanomaterials researchers in the fields of photonics, materials, physics, chemistry and nanotechnology.

Actinobacteria: Diversity and Biotechnological Applications: New and Future Developments in Microbial Biotechnology and Bioengineering, a volume in the series New and Future Developments in Microbial Biotechnology and Bioengineering series, offers the latest on the biotechnology of Kingdom actinobacteria, covering unique niches like their endosphere, rhizospheric soil and contaminated sites, etc. The book also covers the bioactive secondary metabolites obtained from actinobacteria and describes the application of microorganism (Actinobacteria) in plant growth promotion and in environmental cleanup. Finally, the book describes the biocontrol aspects of actinobacteria and how they can control fungal phytopathogens and the production of secondary metabolites.

Advances in Applied Microbiology, Volume 102, the latest release in one of the most widely read and authoritative review sources in microbiology, contains comprehensive reviews of the most current research in applied microbiology. This latest release includes specific chapters on a variety of topics, most notably, Twenty-five Years of Investigating the Universal Stress Protein: Structure, function and applications, Fungal Genomes and Genotyping, Fungi in deep subsurface environments, Spore germination in pathogenic fungi, Host sensing by pathogenic fungi, Advances in the Microbial Ecology of Biohydrometallurgy, and The mycosphere and turnover of contaminants, amongst others.

Electrofluidodynamic Technologies (EFDTs) for Biomaterials and Medical Devices: Principles and Advances focuses on the fundamentals of EFDTs - namely electrospinning, electrospraying and electrodynamic atomization - to develop active platforms made of synthetic or natural polymers for use in tissue engineering, restoration and therapeutic treatments. The first part of this book deals with main technological aspects of EFDTs, such as basic technologies and the role of process parameters. The second part addresses applications of EFDTs in biomedical fields, with chapters on their application in tissue engineering, molecular delivery and implantable devices. This book is a valuable resource for materials scientists, biomedical engineers and clinicians alike.

Multiscale Biomechanics provides new insights on multiscale static and dynamic behavior of both soft and hard biological tissues, including bone, the intervertebral disk, biological membranes and tendons. The physiological aspects of bones and biological membranes are introduced, along with micromechanical models used to compute mechanical response. A modern account of continuum mechanics of growth and remodeling, generalized continuum models to capture internal lengths scales, and dedicated homogenization methods are provided to help the reader with the necessary theoretical foundations. Topics discussed include multiscale methods for fibrous media based on discrete homogenization, generalized continua constitutive models for bone, and a presentation of recent theoretical and numerical advances. In addition, a refresher on continuum mechanics and more advanced background related to differential geometry, configurational mechanics, mechanics of growth, thermodynamics of open systems and homogenization methods is given in separate chapters. Numerical aspects are treated in detail, and simulations are presented to illustrate models. This book is intended for graduate students and researchers in biomechanics interested in the latest research developments, as well as those who wish to gain insight into the field of biomechanics.

Evidence-Based Validation of Herbal Medicines brings together current thinking and practice in the areas of characterization and validation of natural products. This book reviews all aspects of evaluation and development of medicines from plant sources, including their cultivation, collection, phytochemical and phyto-pharmacological evaluation, and therapeutic potential. Emphasis is placed on describing the full range of evidence-based analytical and bio-analytical techniques used to characterize natural products, including -omic technologies, phyto-chemical analysis, hyphenated techniques, and many more.

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders.

A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.

This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts.
An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicinesA number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan)Acomprehensive guide for performing risk management more effectively throughout a product s life-cycle"

Cancer can affect people of all ages, and approximately one in three people are estimated to be diagnosed with cancer during their lifetime. Extensive research is being undertaken by many different institutions to explore potential new therapeutics, and biomaterials technology is now being developed to target, treat and prevent cancer. This unique book discusses the role and potential of biomaterials in treating this prevalent disease.
The first part of the book discusses the fundamentals of biomaterials for cancer therapeutics. Chapters in part two discuss synthetic vaccines, proteins and polymers for cancer therapeutics. Part three focusses on theranosis and drug delivery systems, whilst the final set of chapters look at biomaterial therapies and cancer cell interaction.
This extensive book provides a complete overview of the latest research into the potential of biomaterials for the diagnosis, therapy and prevention of cancer. Biomaterials for cancer therapeutics is an essential text for academics, scientists and researchers within the biomedical industry, and will also be of interest to clinicians with a research interest in cancer therapies and biomaterials.
A complete overview of the latest research into the potential of biomaterials for the diagnosis, therapy and prevention of cancerDiscusses the fundamentals of biomaterials for cancer therapeuticsDiscusses synthetic vaccines, proteins and polymers for cancer therapeutics

With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.
Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing.
A focus on the issues associated with the application of lean principles to biomanufacturingPractical examples of factors which can affect biopharmaceutical processesCoverage of key factors which require integration to run an efficient biopharmaceutical process

Carbon is light-weight, strong, conductive and able to mimic natural materials within the body, making it ideal for many uses within biomedicine. Consequently a great deal of research and funding is being put into this interesting material with a view to increasing the variety of medical applications for which it is suitable. Diamond-based materials for biomedical applications presents readers with the fundamental principles and novel applications of this versatile material.
Part one provides a clear introduction to diamond based materials for medical applications. Functionalization of diamond particles and surfaces is discussed, followed by biotribology and biological behaviour of nanocrystalline diamond coatings, and blood compatibility of diamond-like carbon coatings. Part two then goes on to review biomedical applications of diamond based materials, beginning with nanostructured diamond coatings for orthopaedic applications. Topics explored include ultrananocrystalline diamond for neural and ophthalmological applications, nanodiamonds for drug delivery systems, and diamond nucleation and seeding techniques for tissue regeneration. Finally, the book concludes with a discussion of diamond materials for microfluidic devices.
With its distinguished editors and international team of expert contributors, Diamond-based materials for biomedical applications is an authoritative guide for all materials scientists, researchers, medical practitioners and academics investigating the properties and uses of diamond based materials in the biomedical environment.
Presents the fundamental principles and novel applications of this versatile materialDiscusses the functionalization of diamond particles and surfaces, biotribology and biological behaviour of nanocrystalinediamond coatings and blood compatibility of diamond-like carbon coatingsReviews nanostructured diamond coatings for orthopaedic coatings