Woodhead Publishing Series in Biomedicine – serie

Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific and Regulatory Aspects provides a practical guide and overview of the ethical, scientific and regulatory aspects of clinical research in pediatric psychopharmacology, also discussing practical points to consider when developing clinical research in this field. The book is ideal for professionals involved in clinical research in pediatric psychopharmacology, i.e., including, but not limited to pediatricians, health care professionals, researchers, investigators, pharmaceutical company personals and potentially ethics committee members.

Topics discussed include the role of patient organization and advocacy groups in research, the role of families and patients: 'should I involve my kid in clinical research, and historical, ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology.

Covers both theoretical and practical aspects of clinical research in paediatric psychopharmacology Approaches the topic from different angles from the regulatory framework to the patient perspective Discusses ethical and safety considerations for research in paediatric psychopharmacology Offers future perspective for paediatric development

Allergens and respiratory pollutants is a collection of 12 authoritative papers that draws upon the collective expertise of world leaders in the fields of innate immunity, immunotoxicology and pulmonary biology. The book critically explores the biological and immunological mechanisms that contribute to immune dysfunction on exposure to allergens and the susceptibility to infectious disease on exposure to ambient pollutants. The clinical relevance of exposure to ambient airborne xenobiotics is critically discussed and collectively, this book provides an educational forum that links the health effects of environmental exposures, immune dysfunction and inflammatory airways disease.Discusses recent advances in our understanding of cell-mediated innate immune mechanisms that occur during allergic inflammation and provides important timely coverage of diseases of concern and how such diseases are influenced by a dysfunctional immune systemProvides useful information on linking environmental 'danger signals' that provoke immune dysfunction and exacerbation of existing diseaseDraws upon the collective expertise of an international college of leaders in the field, but also provides chapters that provide essential reference material

Concepts and techniques in genomics and proteomics covers the important concepts of high-throughput modern techniques used in the genomics and proteomics field. Each technique is explained with its underlying concepts, and simple line diagrams and flow charts are included to aid understanding and memory. A summary of key points precedes each chapter within the book, followed by detailed description in the subsections. Each subsection concludes with suggested relevant original references.Provides definitions for key conceptsCase studies are included to illustrate ideasImportant points to remember are noted

The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity.

The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India.Constitutes the first ever comprehensive insight on the Indian biopharma sectorProvides a perspective based on practical hands-on legal experienceSimply structured, clearly presented and free from excessive legal jargon

Computer-Aided Applications in Pharmaceutical Technology: Delivery Systems, Dosage Forms, and Pharmaceutical Unit Operations, Second Edition covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with an emphasis on their applications in process control, neural computing, data science, computer-aided biopharmaceutical characterization, as well as the application of computational fluid dynamics in pharmaceutical technology. Completely updated, the book introduces the theory and practice of computational tools through new case studies. Chapters cover Quality by Design in pharmaceutical development, overview data mining methodologies, present computer-aided formulation development, cover experimental design applications, and much more.Presents a comprehensive review of the current state of the art on various computer-aided applications in pharmaceutical technologyIncludes case studies to facilitate understanding of various concepts in computer-aided applicationsCovers applications such as the development of dosage forms and/or delivery systems, pharmaceutical unit operations, and relevant physiologically based pharmacokinetic simulations

Strategies to Modify the Drug Release from Pharmaceutical Systems, Second Edition serves as a vital reference on contemporary models aimed at achieving the precise therapeutic dosage and timing of drug release. The book provides updated strategies, mathematical models, routes of administration, and technologies, all presented succinctly and objectively. This six-chapter guide covers general concepts of drug release modification and classification of therapeutic systems, including passive versus active targeting. It delves into mechanisms to control drug release, discussing materials and technologies, and introduces mathematical and physicochemical models of drug release.Furthermore, it reviews drug delivery systems like 3D printing, nose-to-brain delivery, environmentally responsive systems, and new lipid systems, making it indispensable for pharmaceutical scientists, graduate students, materials scientists, and chemists.Includes up to date physicochemical principles and mathematical modelsCovers new drug delivery systems such as 3D printed systemsPresents the advances in drug delivery from the past decade

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations, Second Edition is an in-depth guide to the world of pharmaceutical sterilization. This new edition has been updated to reflect the latest standards and regulations, ensuring alignment with current practices. It explores emerging methods and techniques, complemented by new case studies that provide practical examples. Readers will gain comprehensive knowledge about sterilization’s critical role in healthcare and pharmaceutical manufacturing, highlighting the importance of controlling microbial challenges to ensure product safety and patient well-being.The book discusses sterility, sterilization methods such as gamma radiation, e-beam, dry heat, steam, gas, vapor, filtration, and new techniques like X-ray sterilization, liquid-phase sterilization, ultraviolet light, supercritical gases, and sterilization assurance governance. It covers biopharmaceutical manufacturing processes, including aseptic filling, container and packaging design, and cleanroom environments. This edition is essential for professionals in pharmaceuticals, healthcare, and medical device manufacturing, providing the knowledge needed to comply with current standards and regulations.Includes nine new chapters with many new case studiesOffers coverage on the most current standards and regulationsProvides full coverage of novel sterilization methods

Transporters in Drug Discovery and Development: Detailed Concepts and Best Practice, 2nd Edition is a comprehensive book providing a detailed overview of significant drug transporter families, their roles in disease causation due to functional defects, and their importance in drug discovery and development. Building upon the foundation set by the first edition, this updated version covers various topics, including clinically relevant drug transporter-related pharmacokinetics variations, drug-drug interactions (DDIs), genetic polymorphisms, transporter-related organ toxicity, and methodologies for studying drug transporters. It also highlights the translational aspect in drug discovery and development. The revision explores the advancements in transporter research, such as the emerging use of transporters as pharmacological targets, the evolving application of modeling and simulation, and the innovative use of endogenous biomarkers in assessing transporter activities during drug clinical trials. Transporters in Drug Discovery and Development: Detailed Concepts and Best Practice, 2nd Edition provides a deeper understanding of transporter research and its implications. It is an invaluable resource for researchers, students, and professionals in the field, offering insights that could potentially revolutionize drug discovery and development.

Medicinal Plants: Chemistry, Biology, and Omics, Second Edition is a reference to help researchers identify and master the patterns in the distribution of medicinal compounds on the phylogenetic tree to explore new drug resources and develop novel therapies against different diseases. The book provides a deeper understanding of how the interrelationship between phytometabolites, bioactivities and omics techniques facilitates sustainable conservation and application of phytomedicine resources. Now in 2nd edition, the contents have been updated to include topics as machine learning applications, geographic distribution of phytometabolites, comparative analysis of alkaloids, expanded coverage of selected taxa, and conditions like cardiovascular disease and cancer. The book is structured around chemotaxonomy. After an introduction and review of taxonomy, chemistry, biology and omics, the authors dive into a taxon-guided exploration of medicinal resources for Fritillaria, Chelidoniae, Dichocarpum, Aconitum, Cimicifugeae, Clematis, Potentilla, Rubus, Cannabis, and other taxa. All chapters follow a similar and consistent structure, offering detailed information on each of them. Researchers in phytopharmacology can acquire in-depth understanding of the interrelationships between chemistry, biology and omics, as well as the implications of the link between phylogeny, phytometabolites and bioactivities in medical biotechnology and sustainability. Clinicians can better understand the principles of mutual interactions between phytometabolites and drug efficacy.Includes multiple new chapter sections and updates to provide a current overview of researchProvides a comprehensive overview of how plant phylogeny can impact phytometabolites and the consequent therapeutic effectsContains insights into phylogenetic distribution of individual medicinal compounds and efficacies for bioprospecting and mining pharmaceutical resourcesCovers the latest applications of AI and Machine Learning to the field of pharmacophylogeny

The second edition of Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control is an authoritative reference designed for pharmaceutical microbiologists, sterilization personnel, and production scientists. It addresses the evolving landscape of microbiological standards, regulatory requirements, and scientific innovations in the pharmaceutical industry. The book emphasizes the importance of maintaining compliance through updated practices, new testing methodologies, and comprehensive contamination control strategies, ensuring safety and quality in pharmaceutical manufacturing.This book provides invaluable insights for professionals seeking to optimize microbiological quality assurance, meet regulatory expectations, and adopt innovative technologies. It supports laboratory managers, microbiologists, and quality assurance specialists in implementing best practices, ensuring product safety, and staying abreast of scientific progress in pharmaceutical microbiology.Updates regulations, standards, and scientific advancements in pharmaceutical microbiologyIntroduces new chapters on cell culture, biocontamination control, and beneficial microorganism usesExpands on rapid microbiological methods, water system assessment, and container closure integrityReflects recent developments in GMP, endotoxin testing, and sterilization technologiesProvides comprehensive guidance for microbiology laboratories and quality assurance

MATLAB� in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In the last decade Matlab has been presented to students as the first computer program they learn. Consequently, many non-programmer students, engineers and scientists have come to regard it as user-friendly and highly convenient in solving their specific problems. Numerous books are available on programming in Matlab for engineers in general, irrespective of their specialization, or for those specializing in some specific area, but none have been designed especially for such a wide, interdisciplinary, and topical area as bioengineering. Thus, in this book, Matlab is presented with examples and applications to various school-level and advanced bioengineering problems - from growing populations of microorganisms and population dynamics, reaction kinetics and reagent concentrations, predator-prey models, mass-transfer and flow problems, to sequence analysis and sequence statistics.This is the first book intended as a manual introducing biologists and other biotechnology engineers to work with MatlabIt is suitable for beginners and inexperienced users; however, applications of Matlab to advanced problems such as the Monte Carlo method, curve fitting, and reliable machine diagnostics make the book relevant to university teachers as wellThe book is different in that it assumes a modest mathematical background for the reader and introduces the mathematical or technical concepts with a somewhat traditional approach; Matlab is then used as a tool for subsequent computer solution

This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar levels of investment are needed from a pharmaceutical company to bring a drug to the market for both small and large patient groups.The journey from application of an orphan drug designation to a reimbursed market- approved drug is long and many obstacles occur during the journey.After reading the book, readers will: Understand who the players/stakeholders are in the rare orphan disease field and their specific needs and concerns: patients and patient organizations, researchers and treating physicians within the field, industry, regulatory and reimbursement bodies* Understand the strong partnership between the different players and the various initiatives to improve and increase access to treatment for patients; minimizing the gap between numbers of known diseases, orphan designations, approved drugs and paid drugs.The book also provides short practical case stories from patients and researchers, as well as representatives from industry and authorities on the challenges they came across in developing orphan drugs or getting access to orphan drugs.A comprehensive overview of strategy, key activities and considerations of how to bring an orphan drug from concept to the market and make it available to patientsA source of updated information, news and trends for those who are already active in this fast-evolving fieldCovers the global definitions and the criteria for getting an orphan drug designation in, for example, the US and Europe

Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products.Includes empirical research to relate innovation to drug lawA multidisciplinary approach is taken, including the intersection of IP (intellectual property) law, drug law and innovationDiscusses the impact of government regulation on firm innovation

A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur.No other 'how to' manual exists for this sectorWritten by a range of expert professionals in each area, all in one bookIs the only 'bench to bedside' book covering the whole spectrum of development

Electroporation-Based Therapies for Cancer reviews electroporation-based clinical studies in hospitals for various cancer treatments, including melanomas, head and neck cancers, chest wall breast carcinomas, and colorectal cancers, as well as research studies in the lab using cell lines, primary cells, and animals.

Cancer kills about one American per minute, amounting to over 500,000 deaths in the United States and millions, worldwide, each year. There is a critical need for safe, effective, and affordable alternative treatment modalities, especially for inoperable, recurring, and chemo-resistant cancers, that do not respond well to current treatment regimen. An electrical-pulse-mediated, enhanced drug delivery technique known as electroporation is one way to effectively treat these patients.

This technique is especially suitable for low- and middle-income countries, where lack of infrastructure and resources leads to cancer diagnoses at late stages. This quick, safe, effective, economical, out-patient-based technique is a boon to these patients for palliative and other care with enhanced quality of life. This book features discussions by interdisciplinary authors-including practicing oncological surgeons, medical professionals, and academic and other researchers-of the basics and clinical medical applications of electroporation.

Provides novel and recent clinical applications of electrochemotherapy for various cancers, including melanomas, sarcomas, superficial extreme melanoma, chest wall breast carcinoma, and colorectal cancersExtensive study of a number of cell lines, including human breast cancer, lung cancer, cervical cancer, leukemia, and mouse breast cancer using both reversible and irreversible electroporation techniquesIn vitro study of delivery of various commonly prescribed/administered breast cancer chemo and hormone drugs, such as Doxorubicin, Paclitaxel, Bleomycin, and Tamoxifen

Protein folding is a process by which a protein structure assumes its functional shape of conformation, and has been the subject of research since the publication of the first software tool for protein structure prediction. Protein folding in silico approaches this issue by introducing an ab initio model that attempts to simulate as far as possible the folding process as it takes place in vivo, and attempts to construct a mechanistic model on the basis of the predictions made. The opening chapters discuss the early stage intermediate and late stage intermediate models, followed by a discussion of structural information that affects the interpretation of the folding process. The second half of the book covers a variety of topics including ligand binding site recognition, the "fuzzy oil drop" model and its use in simulation of the polypeptide chain, and misfolded proteins. The book ends with an overview of a number of other ab initio methods for protein structure predictions and some concluding remarks.Discusses a range of ab initio models for protein structure predictionIntroduces a unique model based on experimental observationsDescribes various methods for the quantitative assessment of the presented models from the viewpoint of information theory

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.Provides a list and description of commercially available therapeutic drug products and their formulationsA comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinicDiscusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles

Written by a leading researcher in the field, Transporters in Drug Discovery and Development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development. It covers: an overview of transporter families and organ distribution; clinical relevant drug-drug interaction; clinical relevant polymorphism; drug transporter related pharmacokinetic, pharmacodynamics and toxicity; in vitro/in vivo probes of drug transport studies; the practical methodologies of industrial transporter screening and translational aspect in drug discovery and developments. A comprehensive overview of drug transporter families and their clinical relevance in drug discovery and development Balanced coverage of molecular biology aspects and functional outcomes State of art knowledge related to transporter-mediated DDI and the clinical relevance in pharmacokinetics, dynamics, and toxicity

The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship. Encompasses the full lifecycle of common pharmaceuticals, from prescription and dispensing practices to their occurrence in a range of different types of natural waters and their environmental impact Explores the role of the healthcare system and its affect on users Beneficial for environmental engineers involved in the design and operation of appropriate degradation technologies of the pharmaceutical prescription and disposal practices

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-Aided Applications in Pharmaceutical Technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology.A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technologyCase studies are presented in order to facilitate understanding of various concepts in computer-aided applications

With the appearance of methods for the sequencing of genomes and less expensive next generation sequencing methods, we face rapid advancements of the -omics technologies and plant biology studies: reverse and forward genetics, functional genomics, transcriptomics, proteomics, metabolomics, the movement at distance of effectors and structural biology. From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory, the roles of non-coding RNAs, applicative uses of RNA silencing and RNA interference in plant physiology and in experimental transgenics and plants modified to specific aims. In the forthcoming years these advancements will support the production of plant varieties better suited to resist biotic and abiotic stresses, for food and non-food applications.This book covers these issues, showing how such technologies are influencing the plant field in sectors such as the selection of plant varieties and plant breeding, selection of optimum agronomic traits, stress-resistant varieties, improvement of plant fitness, improving crop yield, and non-food applications in the knowledge based bio-economy.Discusses a broad range of applications: the examples originate from a variety of sectors (including in field studies, breeding, RNA regulation, pharmaceuticals and biotech) and a variety of scientific areas (such as bioinformatics, -omics sciences, epigenetics, and the agro-industry)Provides a unique perspective on work normally performed 'behind closed doors'. As such, it presents an opportunity for those within the field to learn from each other, and for those on the 'outside' to see how different groups have approached key problemsHighlights the criteria used to compare and assess different approaches to solving problems. Shows the thinking process, practical limitations and any other considerations, aiding in the understanding of a deeper approach

Biobanks represent an invaluable research tool and, as a result of their intrinsic and extrinsic nature, may be looked upon as archives or repositories largely made up of libraries, or collections of content where the content is the biological material derived from different individuals or species, representing valuable tangible assets. Biobanks analyses aspects of the commons and common intellectual property relating to the concepts of private property, not only concerning data but biological materials as well, and the advantages and disadvantages of patents in scientific research. Several recent initiatives in biomedical research have attempted to make their data freely available to others, so as to foster innovation. Many of these initiatives have adopted the open source model, which has gained widespread recognition in the computer industry. This title is structured into eight chapters and begins with an introduction, which is followed by chapters that discuss how the term ‘biobank’ came about in scientific literature; legal matters relating to biobanks; and intellectual and physical property. Later chapters comprehensively analyse the intellectual property of biobanks within the sphere of copyright; biotechnological inventions and research patentability; open data sharing in biobanks; and biobanks as commons or vault.

Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort.Presents a comprehensive view of the field of quality assuranceAn approach grounded in direct experienceUses diagrams and figures to clarify analytical points

The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering.Goes beyond the standard engineering issues covered by most books and delves into structure-function relationshipsIntegration of knowledge across all areas of antibody engineering, development, and marketingDiscusses how current and future genetic engineering of cell lines will pave the way for much higher productivity

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.Covers the main sterilisation methods of physical removal, physical alteration and inactivationIncludes discussion of medical devices, aseptically filled products and terminally sterilised productsDescribes bacterial, pyrogenic, and endotoxin risks to devices and products

Gene therapy is emerging as a new class of therapeutics for the treatment of inherited and acquired diseases. However, poor cellular uptake and instability of DNA in the physiological milieu limits its therapeutic potential, hence a vector which can protect and efficiently transport DNA to the target cells must be developed. Nanotechnology-based non-viral vectors have been proposed as potential candidates. Various polymeric nanoparticles have been shown to be suitable, with high cellular uptake efficiencies and reduced cytotoxicity. These delivery vectors form condensed complexes with DNA which result in shielding against enzymatic degradation and enhanced cellular targeting. Advantages including easy manipulatibility, high stability, low cost and high payload, mean that nanoparticles from various polymers have been exploited. Gene therapy gives a systematic account of the many aspects of nanotechnology mediated gene therapy, from the preparation of nanoparticles to physicochemical characterization, and follows with applications in in vitro and in vivo models. This book emphasizes the various aspects of nanotechnology-based gene therapy, with initial chapters detailing the tools and techniques available for preparation and in vitro and in vivo characterization of nanoparticles. Later chapters provide exhaustive details on polymeric systems employed for gene therapy.Provides an overview of nanotechnology applications in gene therapy, from preparation of nanoparticles to in vitro and in vivo studiesDetails the tools and techniques available for preparation, characterization and in vitro and in vivo study of nanoparticlesDetails the limitations of nanoparticle-mediated gene therapy and proposes ways in which they may be overcome

Computational pre-screening of antigens is now routinely applied to the discovery of vaccine candidates.Computer-aided vaccine design is a comprehensive introduction to this exciting field of study. The book is intended to be a textbook for researchers and for courses in bioinformatics, as well as a laboratory reference guide. It is written mainly for biologists who want to understand the current methods of computer-aided vaccine design. The contents are designed to help biologists appreciate the underlying concepts and algorithms used, as well as limitations of the methods and strategies for their use. Chapters include: MHC and T cell responses; Immunoglobulins and B cell responses; Scientific publications and databases; Database design; Computational T cell vaccine design; Computational B cell vaccine design; infectious disease informatics; Vaccine safety and quality assessments; and Vaccine adjuvant informatics.Essential reading for any biologist who wants to understand methods of computer-aided vaccine designDescription of available data sources and publicly available software, with detailed analysis of strengths and weaknessesTheoretical concepts and practical examples of database design and development for a virtual screening campaign

Ultrafiltration for Bioprocessing is key reading for all those involved in the biotechnology and biopharmaceutical areas. Written by a leading worker in the area, it includes many practical applications and case studies in the key process of ultrafiltration (UF), which is used in almost every bioprocess. Focuses on ultrafiltration for biopharmaceuticals-other books look at general ultrafiltration or general biopharmaceuticals A mix of theory and practical applications-other books tend to be more theory-oriented Addresses the main issues encountered in development and scale-up through recommendations and case studies