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

Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized and roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete 'how-to' manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing.
Addresses practical considerations for the field of tissue engineering and regenerative medicine from the perspective of the biotechnology industryWritten as a manual for tissue engineering and regenerative medicine product development applicable to the US and EUIllustrates pathway integration of science and business required for successful product development

DNA sequence specificity is a sub-specialty in the general area of molecular recognition. This area includes macromolecular-molecular interactions (e.g., protein-DNA), oligomer-DNA interacitons (e.g., triple strands), and ligand-DNA interactions (e.g., drug-DNA). It is this latter group of DNA sequence specificity interactions that is the subject of Volumes 1 and 2 of "Advances in DNA Sequence Specific Agents." As was the case for Volume 1, Part A also covers methodology, but in Volume 2 we include calorimetric titrations, molecular modeling, X-ray crystallographic and NMR structural studies, and transcriptional assays. Part B also follows the same format as Volume 1 and describes the sequence specificities and covalent and noncovalent interactions of small ligands with DNA.
This volume is aimed in general at scientists who have an interest in deciphering the molecular mechanisms for sequence recognition of DNA. The methods have general applicability to small molecules as well as oligomers and proteins, while the examples provide general principles involved in sequence recognition.

Gene probes, whether RNA or DNA, have played a central role in the rapid development of molecular biology. The wide variety of applications is matched by a considerable diversity in the methods used for generating probes, a complete account of which would be very difficult to make. Instead, this second volume in the series combines a selection of newer gene probe procedures with a review of the most important established methods, together with some examples of the ways in which gene probes can be applied. In doing so, the book aims to act not only as an introductory manual for newcomers to the field, but also as a means of broadening the horizons of existing researchers.

In recent decades there has been an explosion in work in the social and physical sciences describing the similarities between human and nonhuman as well as human and non-animal thinking. This work has explicitly decentered the brain as the sole, self-contained space of thought, and it has found thinking to be an activity that operates not only across bodies but also across bodily or cellular membranes, as well as multifaceted organic and inorganic environments. For example, researchers have looked at the replication and spread of slime molds (playfully asking what would happen if they colonized the earth) to suggest that they exhibit 'smart behavior' in the way they move as a potential way of considering the spread of disease across the globe. Other scholars have applied this model of non-human thought to the reach of data mining and global surveillance. In The Biopolitics of Alphabets and Embryos, Ruth Miller argues that these types of phenomena are also useful models for thinking about the growth, reproduction, and spread of political thought and democratic processes. Giving slime, data and unbounded entities their political dues, Miller stresses their thinking power and political significance and thus challenges the anthropocentrism of mainstream democratic theories. Miller emphasizes the non-human as highly organized, systemic and productive of democratic growth and replication. She examines developments such as global surveillance, embryonic stem cell research, and cloning, which have been characterized as threats to the privacy, dignity, and integrity of the rational, maximizing and freedom-loving democratic citizen. By shifting her level of analysis from the politics of self-determining subjects to the realm of material environments and information systems, Miller asks what might happen if these alternative, nonhuman thought processes become the normative thought processes of democratic engagement.

The book "Green Technologies for the Environment" brings together experts in the field of biotechnology, chemistry, chemical engineering, environmental engineering and toxicology from both academia and industry, to discuss green processes for the environment. The topics included finding replacements for crude oil to meet both our energy needs as well as the supply of chemicals for the production of essential products, advances in chemical processing, waste valorization, alternative solvents, and developments in homogeneous and heterogeneous catalysis as well as enzyme-based processes for chemical transformations. Advances in green chemistry concepts will further enhance the field through the design of new chemicals and solvents. In addition, obtaining a better understanding of the mechanistic pathways involved in various reactions is essential toward advances in the field. The goal of the work described in each of the chapters is to address the need for best practices for chemical processes and for the production of chemicals, while promoting sustainability.

Chiral molecules are ubiquitous in nature. Thus, it is not surprising to come across this phenomenon in the world of flavor substances. This book provides an overview on the analytical procedures currently applied to analyze chiral flavor substances at trace levels. It demonstrates several examples for the application of these techniques to determine naturally occurring enantiomeric compositions of chiral key flavor compounds in various natural systems. In addition to the analytical aspects, the contributions focus on the sensory properties of enantiomers and enlarge our knowledge on the correlation between configurations and odor properties and intensities of chiral flavor compounds. The practical importance of the topic is reflected by a discussion of merits and limitations of chiral analysis for the authenticity control of food flavorings. In addition, examples for the use of enzymes and microorganisms to obtain enantiopure flavor substances and thus to meet legal requirements for "natural" labeling are presented. Finally, the book covers aspects recently getting more and more in the focus of flavor science: What are the physiological mechanisms underlying the perception of sensory properties and does chirality matter in that respect?

The full inside story of the high-stakes global race for the lifesaving vaccine to end the pandemic.

Heroic science. Chaotic politics. Billionaire entrepreneurs. In The First Shots, award-winning journalist Brendan Borrell brings to life the defining story of our times through absorbing, first-time reporting on those leading the fight against a vicious virus.

Borrell draws on exclusive, high-level access to take us inside the intense competition among brilliant scientists and the epic rivalries among Washington power players. His propulsive narrative depicts key players such as infectious-diseases expert Michael Callahan, who was secretly on the ground in Wuhan to gauge the terrifying ravages of ‘disease X’; Robert Kadlec, one of Operation Warp Speed’s architects, whose audacious plans ran straight into the buzz-saw of the Trump White House factions; and Stéphane Bancel of Moderna Therapeutics, the upstart company that went toe to toe with pharma behemoth Pfizer.

A real-life thriller playing out over eighteen months of fear, resolve and triumph, The First Shots lays bare the stunning story behind the medical-science ‘moonshot’ of our lifetimes.

Biotechnology for Beginners, Third Edition presents the latest developments in the evolving field of biotechnology which has grown to such an extent over the past few years that increasing numbers of professional's work in areas that are directly impacted by the science. This book offers an exciting and colorful overview of biotechnology for professionals and students in a wide array of the life sciences, including genetics, immunology, biochemistry, agronomy and animal science. This book will also appeals to lay readers who do not have a scientific background but are interested in an entertaining and informative introduction to the key aspects of biotechnology. Authors Renneberg and Loroch discuss the opportunities and risks of individual technologies and provide historical data in easy-to-reference boxes, highlighting key topics. The book covers all major aspects of the field, from food biotechnology to enzymes, genetic engineering, viruses, antibodies, and vaccines, to environmental biotechnology, transgenic animals, analytical biotechnology, and the human genome.

Bioengineered Nanomaterials for Wound Healing and Infection Control is a key reference for those working in the fields of materials science, pharmacy, nanotechnology, biomedical engineering and microbiology. Bioengineered nanomaterials have unique physicochemical properties which promote accelerated wound healing and treatment of infections. The biosynthesis of these nanomaterials also offers a clean, safe and renewable alternative to traditional nanomaterials, helping reduce environmental impact alongside antibacterial resistance.

Valorization of Wastes for Sustainable Development: Waste to Wealth highlights the various valorization of organic and non-organic waste to offer a way forward to a sustainable world. Categorizing the various types of waste valorization for renewable fuel production and other valorizations utilizing organic and non-organic waste, this book offers the reader a comprehensive view of various waste valorizations together with their potential applications. Split into four sections, the book's chapters cover the general scenarios and challenges of current waste management and the valorization of waste specifically for renewable fuels as the alternative energy source to depleting fossil fuels. Other chapters cover waste valorizations categorized into organic and non-organic waste for various applications and the future prospect of waste valorizations with possible plans and strategies for effective global waste management.

Algae Based Bioelectrochemical Systems for Carbon Sequestration, Carbon Storage, Bioremediation and Bioproduct Generation explores the integration of carbon capture, storage and sequestration technologies with bioelectrochemical fuels cells (BEFC), showing how conventional technologies can be renovated to aid in the reduction in GHG emissions and simultaneously optimize BEFC performance. The book focuses on the integration of algal biogas upgradation with electrochemical systems, providing a guide to the renovation of conventional technologies to combine energy production and carbon sequestration. Chapters discuss the latest advancements in carbon sequestration biocatalyst and microbial platforms and integrations for rapid carbon biotransformations. In addition, the book highlights the potential of algae and chemolithotrophs as candidates for carbon delivery, biocatalyst orientation and architecture for optimal BEFC performance.

Quantitative Perfusion MRI: Techniques, Applications, and Practical Considerations, Volume 11 clearly and carefully explains the basic theory and MRI techniques for quantifying perfusion non-invasively in deep tissue, covering all aspects of perfusion imaging, from acquisition requirements to selection of contrast agents and appropriate pharmacokinetic models and for reliable quantification in different diseases and tissue types. Specifically, this book enables the reader to understand what microvascular functional parameters can be measured with perfusion MRI, learn the basic techniques to measure perfusion in different organs, apply the appropriate perfusion MRI technique to the organ of interest, and much more. This complete reference on quantitative perfusion MRI is highly suitable for both early and experienced researchers, graduate students and clinicians wishing to understand how quantitative perfusion MRI can apply to their application area of interest.

Polyurea: Synthesis, Properties, Composites, Production, and Applications is a comprehensive and practical guide to polyurea, a material used for its exceptional properties and performance in a range of high value industrial applications. Sections cover polyurea formulations and properties, comparing aromatic polyurea with aliphatic polyurea and computation modeling of properties for polyurea and polyurea composites. This is followed by in-depth coverage of synthesis, structure and production methods of polyurea, with the connections between production, performance and properties examined thoroughly. Other sections explain the preparation, characterization, modeling and applications of polyurea and polyurea composites with the required properties for specific advanced applications. Finally, environmental issues, recycling and future potential of polyurea are considered. This is a valuable resource for researchers and advanced students in polymer science, chemistry, composite science, civil engineering, materials science and mechanical engineering, as well as R&D professionals, engineers and industrial scientists with an interest in polyurea-based materials for advanced applications.