"Development of novel vaccines" gives an overview of the tasks in basic research leading to the final product -- the vaccine and its applications, belonging to the most complex biologics in the pharmaceutical field. Distinct from most textbooks in the vaccine arena, the current issue focuses on the translational aspect, namely, how research results can be transformed into life-saving medical interventions. Each chapter of the book deals with one important paradigm for the development of novel vaccines, along the value chain towards the final vaccine, and furthermore, with the inevitable tools required for this process. Contributions are prepared by teams of scientists, all of whom are experts in the field, most of them anchored in biomedical organizations devoted to translational culture, thereby lighting the certain topics from different views. This volume is a must read for researchers engaged in vaccine development and who really want to see their research results to become a product.

This book provides an integrated description of methods used to rear vectors of human, higher animal, and plant pathogens in the laboratory. It deals with diverse subject areas, and contains descriptions of standard, as well as highly specialized, methods used by medical, veterinary, entomology, and plant pathology experts. The text brings together the standard breeding and manipulation methods developed in America, Europe, Asia, and Africa. It describes the cultivating, handling, sterile techniques, and cell culture as well as safety measures to prevent contamination and escape of insects, ticks, nematodes and fungal vectors.

Over the past 25 years, biobanks of human specimens have become a cornerstone for research on human health and have empowered the "omics "revolution that characterizes biomedical science in the XXIst Century. Today, biobanking of human specimens is a critical component of the interface between clinical practice and translational research, supporting the discovery and validation of new biomarkers of disease etiology, risk, early detection, diagnosis, prognosis, prediction and relapse. With the development of personalized medicine, biobanking of cryopreserved specimens has become standard practice in order to investigate genetic, transcriptomic, proteomic, metabolomics and immunological biomarkers useful to inform caregivers for therapeutic decisions. Data generated from biobanked specimens represent a rapidly growing and highly valuable resource, participating in the emergence of Big Data Medicine. With the development of large computing capabilities and artificial intelligence, data associated with biobanked specimens constitute a unique resource for the discovery and validation of new biomarkers and therapeutically actionable targets. Interconnecting, interoperating and sharing this data have become major issues for national health systems, raising enormous stakes as well as major societal, legal and cybersecurity challenges in terms of compliance with the protection of personal sensitive information. This book project is the second part of an initiative launched in 2012 to produce a published corpus of knowledge encompassing all aspects of human biobanking as a central practice for research and medicine. The first volume, published in 2017, is entitled: Human Biobanking: Principles and Practice. This first volume compiled a series of high level contributions overseeing the main developments that carried the progression of human biobanking as a research and biotechnological field over the past two decades. This new book project will constitute de facto Volume 2 of the same initiative, under the title: Biobanking of Human Biospecimens: lessons from 25 years of biobanking experience. Hence, the two volumes will share the same generic title (Biobanking of Human Biospecimens), with different subtitles, making clear that the two volumes are interrelated while highlighting their specificities in terms of what they actually cover. As a result, the two books are "twins" but can also be used independently of each other. The overarching aim of the two volumes of Biobanking of Human Biospecimens is to provide a published "one-stop shop" for state-of-the-art information on what constitutes the field of human biobanking, from conception of a biobank, standard operating procedures, ethical and societal aspects, governance, networking, interoperability and economic sustainability. This inclusive publication concept meets the needs of a vast readership, including scientists, doctors and technical staffs who are directly involved in biobanking operations, scientists in other disciplines that heavily rely on biobanking (such as genomics or proteomics), stakeholders and policy makers, and of course students for whom biobanking is becoming an important part of the training curriculum. So far, there has been a lack of major textbooks on biobanking. Documentation for biobanking is widely available through numerous publications, regulatory documents published by International or Governmental Agencies, and sets of recommendations essentially accessible through the Internet. However, it is difficult to access a single, top-of-the shelf reference that provides at a glance a large coverage of all aspects of human biobanking. Fulfilling this need is the main origin of the concept for this back-to-back publication project. To our knowledge, there is currently no other publication project with the same breath and scope as this one in the field of biobanking.

This accessible text brings together mathematical techniques that will be indispensable to every student, teacher, practitioner, and user of chemistry- or biology-related laboratory work. Responding to the concerns of both instructors and students, CLINICAL LABORATORY MATHEMATICS begins with a review of arithmetic and algebra. Next, it presents example-rich chapters on exponential notation and logarithms, rounding and figure significance, measurement systems, solutions and concentrations, dilutions, proportionality, graphs, rates of change, statistics, chemistry, quality control, and method evaluation. It answers frequently asked questions, identifies common misunderstandings, and offers an optional advanced section online. Throughout, the author explains why a solid understanding of math is critical in today's high-technology clinical laboratories. Practice problems are strategically designed to present real-world scenarios with both context and consequence. Supporting both self-guided study and traditional lecture-discussion, the text is logically organized and liberally cross-referenced, revealing hidden connections and common motifs.

Rats have long been recognized as a valuable biomedical research model, notably in the investigation of aging, toxicology, addiction, and common human diseases such as diabetes and hypertension. In many instances, individuals conducting such research studies are charged with important responsibilities, including animal facility management, animal husbandry, veterinary care, regulatory compliance, and various experimental methodologies. With the advent of genetic manipulations and biomedical research technological advances such as bioimaging, the versatility and usefulness of the rat as an animal model has soared. The Laboratory Rat, Second Edition captures the multiple advances in this important animal model's husbandry, veterinary care, and experimental methodology. This edition features augmented, expanded, and novel information on biology, anesthesia, analgesia, and experimental techniques benefiting personnel working with rats-from the animal care staff to the researcher and everyone in between. The book is also extremely useful to institutional animal care and use program supporters and elements, including animal care and use committees, institutional officials, occupational health and safety professionals, veterinary technicians, and veterinarians.

Early detection of cancer at the cellular level, even before anatomic anomalies are visible, is critical to more efficacious and cost effective diagnosis and therapeutic advances. In Cancer Nanotechnology: Methods and Protocols, an international panel of experts provide the most recent, cutting-edge, "how-to" approaches developed and employed by researchers in a variety of disciplines to identify cancer specific biomarkers, construct suitable multifunctional targeted nanostructure platforms, along with enhanced imaging and therapeutic applications. Covering such topics as multifunctional and multimodal nanoparticles, nanoparticle mediated cancer theranostics, molecular targets for cancer nanotechnology, and nanoparticles for non-invasive image-guided cancer therapy, the volume addresses the key challenges of the field today, specifically targeted and localized delivery of the drugs. As a volume in the highly successful Methods in Molecular Biology(TM) series, the protocols chapters include brief introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and notes on troubleshooting and avoiding known pitfalls.

Authoritative and cutting-edge, Cancer Nanotechnology: Methods and Protocols integrates cancer biology, clinical oncology, molecular cancer imaging, materials science and chemical engineering, biomedical engineering, toxicology, computer science, electrical engineering, chemistry, physics, and mathematics in order to achieve the vital goals of nanotechnology-mediated early cancer detection and more efficacious and less toxic therapies for these devastating diseases.

The perfect balance of theory and practice! Here's the practical introduction you need to understand the essential theoretical principles of clinical immunology and the serological and molecular techniques commonly used in the laboratory. You'll begin with an introduction to the immune system; then explore basic immunologic procedures; examine immune disorders; and study the serological and molecular diagnosis of infectious disease. An easy-to-read, student-friendly approach emphasizes the direct application of theory to clinical laboratory practice. Each chapter is a complete learning module with learning outcomes, chapter outlines, theoretical principles, illustrations, and definitions of relevant terminology. Review questions and case studies help you assess your mastery of the material. A glossary at the end of the book puts must-know information at your fingertips. An access code inside new printed texts unlocks Lab Exercises and Branching Case Studies online at FADavis.com that offer more opportunities to apply theory to clinical laboratory practice.

This volume covers methods for determination of autoantibodies in rheumatic connective tissue diseases and organ-specific diseases. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Autoantibodies: Methods and Protocols aims to be helpful for all persons working with research and development of autoimmune laboratory diagnostics and for clinicians using autoantibody tests in daily work with patients.

Quality refers to the amount of the unpriced attributes contained in each unit of the priced attribute. Leffler, 1982 Quality is neither mind nor matter, but a third entity independent of the two, even though Quality cannot be defined, you know what it is. Pirsig, 2000 The continuous formulation of good practices and procedures across fields reflects the importance of the recognition and maintenance of "quality" for nearly every profession. The widespread introduction of point-of-care testing, centralization of activities in large core laboratories, and the increase in number and complexity of diagnostic testing worldwide has driven changes in the organization of laboratory diagnostics over the past decades. As such, laboratory diagnostics, continuously catching up to updated techniques and complex procedures, need to stay vigilant about safety and good practices adjustments. Although widely defined and quantified, the concept of quality is an intrinsic feature of the human psyche and decision making. Written to improve laboratory work, Quality Assurance in the Pathology Laboratory examines: Quality assurance of quantifiable methods applied in laboratory medicine and toxicology Quality aspects of emerging disciplines including personalized therapy and virtopsy Regulatory and logistic instrumentation that ensure quality in laboratory methods Professional education at the graduate and postgraduate levels Laboratory diagnostics substantially contributes to clinical decision making by providing valuable information for the screening, diagnosis, therapeutic monitoring, and follow-up of most-if not all-human disorders. Providing general insights into the quality assurance aspects of pathology and laboratory medicine, this book aids in improving laboratory work and, at the same time, shows the possibilities and limits of all logistic and legal tools related to quality issues.

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries Includes downloadable resources with downloadable training courses that can be adopted and directly customized to a particular organization Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

Authoritative experts in transfusion medicine describe in critical detail the most important procedures for obtaining, selecting, and transfusing red blood cells to patients. The topics covered include such key issues as transfusion problems in the immunocompromised, the complications of autoantibodies, transfusion of infants with hemolytic disease, difficulties arising from solid organ transplantation, stem cell transfusions, and the challenges of massive transfusion. Also discussed are the use, limitations, and alternatives to autogeneic cells; long-term red cell transfusion; the management of adverse reactions to red cell transfusions; and the question of blood group antigens and their association with disease and differential diagnosis. The book offers transfusion specialists fresh insights and information to maximize and extend their current knowledge.

This combination manual and DVD provides much-needed training on the proper handling of mice used in biomedical research. The DVD includes narrated video clips that demonstrate and describe each procedural technique. The manual contains handouts with color illustrations and descriptive text for each technique, including the purpose and application of the procedure, recommended skills, and necessary supplies. It can be used as a training resource and refresher for lab animal veterinarians, veterinary technicians, animal care staff, trainers, and research investigators and staff who work with mice.

Microbiologists, medical mycologists, immunologists, and biochemists are increasingly working together to focus on the processes involved in the progression and treatment of fungal disease. Host-Fungus Interactions: Methods and Protocols is designed for research scientists who are involved in this work and interested in undertaking new or comparative studies of interactions between the mammalian host and clinically important fungal pathogens. Aiming to combine approaches for reverse genetics in pathogenic fungi with methods for their application in in vitro and in vivo models of disease, the book includes methods for the culture and genetic manipulation of the primary fungal pathogens and the opportunistic pathogens, as well as methods for investigating host-fungus interactions in model systems. Written in the highly successful Methods in Molecular Biology (TM) series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and practical, Host-Fungus Interactions: Methods and Protocols describes available molecular methods and fungal infection models in great detail in order to encourage researchers to try new approaches to investigating host-fungus interactions with added levels of confidence.

A precise, practical handbook, Clinical Laboratory Investigation and Psychiatry is an invaluable tool that explores day-to-day psychiatric practices and various situations that arise in the field of mental health. This unique and resourceful textbook is a must-have aid for front-line clinicians, psychiatrists, and other professionals working in the field of adult mental health.

This complete guide to clinical psychiatry:

• examines methods for improving patient care and clinical outcomes
• extensively investigates which blood samples and tests to consider when dealing with mental health patients
• illustrates the possible clinical outcomes and interprets them in an easy-to-access format
• deals with the complexities of patients under difficult circumstances
• guides clinicians through the proper use of the clinical laboratory

Recent years have witnessed dramatic advances in the development and use of magnetic resonance imaging (MRI) techniques that can provide quantitative measures with some degree of pathological specificity for the heterogeneous substrates of multiple sclerosis (MS). Magnetic resonance spectroscopy (MRS) is one of the most promising of these techniques. Thanks to MRS, axonal damage is no longer considered an end-stage phenomenon typical of only the most destructive lesions and the most unfortunate cases, but rather as a major component of the MS pathology of lesions and normal-appearing white matter at all the phases of the disease. This new concept is rapidly changing our understanding of MS pathophysiology and, as a consequence, the therapeutic strategies to modify the disease course favorably. Many of the authors have pionereed the use of MRS in MS, thus contributing to the foundation of the "axonal hypothesis".

Understanding the diagnostic methods necessary to identify bloodstream infections. In the clinical microbiology laboratory, blood is a critical diagnostic sample that, in the majority of cases is sterile (or is it?). However, when microbes gain access to and multiply in the bloodstream, it can result in life-threatening illness including sepsis. Mortality rates from bloodstream infection and sepsis range from 25% to 80%, killing millions of people annually. Blood cultures are a vital technology used in the microbiology laboratory to isolate and identify microbes and predict their response to antimicrobial therapy. The Dark Art of Blood Cultures, edited by Wm. Michael Dunne, Jr., and Carey-Ann D. Burnham, surveys the entire field of blood culture technology, providing valuable information about every phase of the process, from drawing samples to culture methods to processing positive cultures. The Dark Art of Blood Cultures is organized around several major topics.

ASCP requirement. "To pass the ASCP and become a licensed medical lab tech, this text is the ultimate blood bank source for the required classes." - Amazon Reviewer "Great resource for anyone in a Medical Technology or Medical Laboratory Science Program! I would highly recommend this book!" - Mary L., Amazon Reviewer "Amazing legendary book in the field. Helpful for practicing Transfusion Medicine and Hematology." - Zubair S., Amazon Reviewer Join the generations of students who have embarked on successful careers with a firm foundation in the theory and practice of blood banking and transfusion practices. Denise Harmening's classic text teaches you not only how to perform must-know tests and tasks, but to understand the scientific principles behind them. You'll begin with a review of the basic concepts of red blood cell and platelet preservation, genetics, immunology, and molecular biology. Then you'll move to the hows and whys of clinical practice. And, you'll be prepared for new advances in the field.

Biotin and Other Interferences in Immunoassays: A Concise Guide is aimed at clinical laboratory scientists, medical technologists and pathologists who are often the first individuals contacted by a clinician when a laboratory test result does not correlate with clinical presentation. Research scientists working in diagnostics companies will also find this information essential. Sources of errors in non-immunoassay based methods used in clinical chemistry and toxicology laboratory are also discussed so readers can get all important information from one concise guide. This succinct, user-friendly reference provides the necessary information to address high levels of biotin in clinical laboratory results.

I found this textbook to be a real bonus for my phlebotomy class. It had plenty of illustrations that complemented the text. I wound up getting an A in the class so I think the book is worth the money!" - Amazon Reviewer "Used this whole training for phlebotomy! Such a helpful informative book!" - Stacy T., Amazon Reviewer "Great book for a phlebotomy class. …lots of tips and warnings along with pertinent information and pictures." - Amazon Reviewer Enter the classroom and the laboratory with confidence! Rely on this comprehensive resource to master the techniques you need to safely obtain quality specimens. You'll understand all the hows and whys that lead to success in this rapidly changing field. Inside, you'll find the up-to-date coverage of routine procedures and their complications as well specialized procedures, quality and infection control, state-of-the-art equipment, medical terminology, ethical and legal issues, body systems, and related diagnostic laboratory tests. Videos and animations online help you to excel.

This detailed volume explores protocols for studying the many facets of Ca2+-imaging, Ca2+-signaling, and Ca2+-binding along with background information on the principles and application of these techniques. The content of the book delves into 48 chapters including subjects such as data analysis and modern technologies to study calcium-binding and signaling in cells, the superfamily of calcium-binding proteins characterized by the EF-hand structural motif, as well as their use as diagnostic and prognostic biomarkers in Laboratory Medicine and novel therapeutic drug targets. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and comprehensive, Calcium-Binding Proteins of the EF-Hand Superfamily: From Basics to Medical Applications presents state-of-the-art, lab-based methods and easy-to-follow protocols for daily use, making it interesting for basic and medical researchers, cell- and molecular biologists, clinicians, clinical chemists, and the diagnostic industry.

Proper nutrition is the single most important component of preventative health care. Heart disease, diabetes, and other ailments are all linked to dietary habits. Accurate nutritional assessment can be a matter of life or death.
Laboratory Tests for the Assessment of Nutritional Status explores the expanded number of nutrients that can now be evaluated. The author makes a compelling case for the practice and advancement of this critical health care tool. Nutritional assessment identifies undernutrition, overnutrition, specific nutrition deficiencies, and imbalances. Diligent assessment determines the appropriate nutrition intervention and monitors its effects.
This book is a total revision of the 1974 version of the same title co -authored by Sauberlich. Since then, remarkable progress has been made on the methodologies applicable to nutrition status assessment and to the expanded number of nutrients that can be evaluated, especially trace elements. The introduction of high-performance liquid chromatography, amperometric detectors, and other technologies has advanced nutritional assessment by leaps and bounds. Today, nutritionists can gauge the value of microminerals, trace elements, and ultratrace elements. Sauberlich's revision updates the reader to the latest and most important trends in nutrition. These laboratory methods for the assessment of nutritional status are vital for identifying individuals as well as populations with nutritional risks.

This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried. Ljungqvist and Reinmuller draw on years of experience in clean room design and operation. The book contains maps of the effect of human interference on unidirectional airflow and the potential for contamination. Particle challenge test methods and tracer gas detection methods are explained, and the impact and interpretation of the results obtained from these test methods are discussed. Topics include: o Dispersion of Airborne Contaminants o Contamination Risks o Wakes (including factual situations) o Open, Unidirectional Air Flow Benches (laminar flow benches) o Microbiological Assessment o Weighing Stations o Air Flow Through Openings o Mathematical Treatment of Contamination Risks o Simulation of Air Flows & Dispersion of Contaminants through Doorways in a Suite of Clean Rooms o Regulatory Requirements

This book is a compilation of experimentally determined solubility ranges of over 1,700 compounds in the National Toxicology Program's Chemical Repository. Each compound's solubility was determined in a consistent manner in one to six solvents. Solvents chosen were those most commonly used for toxicology studies, spill cleanups, and chemical synthesis or chemical reaction experiments. These solvents include acetone, 95% ethanol, water, dimethyl sulfoxide, methanol, and toluene. Data for many of the research and industrial chemicals featured in this volume do not exist anywhere else. If you are a toxicologist, safety professional, industrial hygienist, or chemist, this book is a valuable reference tool you'll find yourself using every day.

Volume 66 in the internationally acclaimed Advances in Clinical Chemistry contains chapters authored by world renowned clinical laboratory scientists, physicians and research scientists. The serial provides the latest and most up-to-date technologies related to the field of Clinical Chemistry and is the benchmark for novel analytical approaches in the clinical laboratory.

Volume65 in the internationally acclaimed "Advances in Clinical Chemistry" contains chapters authored by world renowned clinical laboratory scientists, physicians and research scientists.The serialprovides the latest and most up-to-date technologies related to the field of Clinical Chemistry andis the benchmark for novel analytical approaches in the clinical laboratory.
Expertise of international contributorsLatest cutting-edge technologiesComprehensive in scope"