Building on a solid foundation of knowledge and skills, this classic text from trusted author Mary Louise Turgeon clearly explains everything from basic immunologic mechanisms and serologic concepts to the theory behind procedures performed in the lab.This go-to resource prepares you for everything from mastering automated techniques to understanding immunoassay instrumentation and disorders of infectious and immunologic origin. Packed with learning objectives, review questions, step-by-step procedures, and case studies, this text is the key to your success in today's modern laboratory environment. Procedural protocols help you transition from immunology theory to practical aspects of the clinical lab. Case studies allow you to apply your knowledge to real-world situations and strengthen your critical thinking skills. Updated illustrations, photographs, and summary tables visually clarify key concepts and information. Full-color presentation clearly showcases diagrams and micrographs, giving you a sense of what you will encounter in the lab. Learning objectives and key terms at the beginning of each chapter provide measurable outcomes and a framework for organizing your study efforts. Review questions at the end of each chapter provide you with review and self-assessment opportunities. NEW! Highlights of Immunology chapter presents a clear, accessible, and easy-to-understand introduction to immunology that will help you grasp the complex concepts you need to understand to practice in the clinical lab. NEW! Stronger focus on molecular laboratory techniques. NEW! Ten chapters include COVID-19 related topics, including Primer on Vaccines chapter covering newer vaccine production methods focusing on DNA and RNA nucleic acids and viral vectors, and covering eight different platforms in use for vaccine research and development against SARS-CoV-2 virus. NEW! All chapters include significant updates based on reviewer feedback. NEW! Key Concepts interwoven throughout each chapter highlight important facts for more focused learning.

This book is dedicated to label-free, non-invasive monitoring of cell-based assays and it comprises the most widely applied techniques. Each approach is described and critically evaluated by an expert in the field such that researchers get an overview on what is possible and where the limitations are. The book provides the theoretical basis for each technique as well as the most successful and exciting applications. Label-free bioanalytical techniques have been known for a long time as valuable tools to monitor adsorption processes at the solid-liquid interface in general - and biomolecular interaction analysis (BIA) in particular. The underlying concepts have been progressively transferred to the analysis of cell-based assays. The strength of these approaches is implicitly given with the name 'label-free': the readout is independent of any label, reagent or additive that contaminates the system under study and potentially affects its properties. Thus, label-free techniques provide an unbiased analytical perspective in the sense that the sample is not manipulated by additives but pure. They are commonly based on physical principles and read changes in integral physical properties of the sample like refractive index, conductivity, capacitance or elastic modulus to mention just a few. Even though it is not implied in the name, label-free approaches usually monitor the cells under study non-invasively meaning that the amplitude of the signal (e.g. electric field strength, mechanical elongation) that is used for the measurement is too low to interfere or affect. In contrast to label-based analytical techniques that are commonly restricted to a single reading at a predefined time point, label-free approaches allow for a continuous observation so that the dynamics of the biological system or reaction become accessible.

This book provides the most up-to-date review on new mechanisms and provides exciting insights into how heat shock proteins modulate the hosts' immune response. Written by leaders in the field of heat shock protein immunobiology, the chapters systematically and in a step-wise fashion take the reader through the fascinating sequence of events by which heat shock proteins activate immune responses and provide answers as to its biological significance to the host. From the early stages of binding and receptors-mediated signalling, to new paradigms by which heat shock proteins are released into the circulation, to antigen processing and presentation, and finally to the immune response itself this book is a must read for graduate and postgraduates in the field of Biology (plant and mammal), Biochemistry (pro- and eukaryotic), Immunology, Microbiology, Exercise Medicine, Physiology, Inflammatory diseases, Autoimmunity, Pharmacology and Pathology.

Drs. Leonard Scinto and Kirk Daffner provide a comprehensive survey of new diagnostic approaches to Alzheimer's disease. The authoritative contributors critically survey the most promising current research on early diagnostic markers for Alzheimer's disease, including the elucidation of changes in the brain revealed by structural and functional neuroimaging, as well as the characteristic patterns of cognitive decline that are documented by sensitive neuropsychological tests, various genetic markers, and biological assays. Early Diagnosis of Alzheimer's Disease illuminates the complex issues surrounding the search for early markers of this increasingly widespread disease. It will establish a new standard reference guide for all those working with Alzheimer's patients.

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.

Recent critical advances in the field of immunotoxicology have led to incredible contributions to basic science, including crucial improvements in human risk assessment. In Immunotoxicity Testing: Methods and Protocols, expert researchers explore these changes, providing the reader with current, lab-ready procedures, along with the corresponding background information that is necessary to identify effective testing approaches for chemicals and drugs. Among the first volumes to meld consideration of immunotoxicity testing strategies with a comprehensive presentation of detailed laboratory protocols, chapters include a description of the evolution of immunotoxicity testing, a look at the importance of immunotoxicity testing for health risk reduction, and ideas concerning the future of the field. Composed in the highly successful Methods in Molecular Biology(tm) series format, most chapters contain a brief introduction, step-by-step methods, a list of necessary materials, and a Notes section which shares tips from the experts on troubleshooting and avoiding known pitfalls. Comprehensive and innovative, Immunotoxicity Testing: Methods and Protocols is a critical, one-stop reference resource for the most important and commonly used laboratory protocols in immunotoxicology.

This volume describes important medical discoveries, from the introduction of the first antibiotic to the present, where serendipity, intuition, coincidence, or laboratory accident played an important role in bringing a discovery to light. Although chance is the principal determinant, the book emphasizes other factors, such as economic and political exigencies and being in the right place at the right time.

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to insufficient clinical activity, unacceptable toxicity, rapid appearance of drug resistance, or other factors that should be, at least partially, predictable from preclinical testing. This new text asks the question, "How can we use computational methods to improve the success rate in drug development?" Computer Techniques in Preclinical and Clinical Drug Development shows how modeling makes it possible to extract the maximum amount of information and predictive value from preclinical data. Computer modeling methods from the areas of pharmacokinetics, pharmacodynamics, cytokinetics, and inhibition kinetics of multi-enzyme pathways are all discussed in this unique reference source.

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

In the last decade, a large number of major discoveries have shed light on the molecular mechanisms of lymphocyte migration and the anatomy of immune responses. In T-Cell Trafficking: Methods and Protocols, expert researchers explore how the development of novel and cutting-edge techniques, particularly in the field of real-time imaging and genetic manipulation, have led to an increased understanding of lymphocyte trafficking. Written by internationally recognized experts in their respective fields, chapters provide state-of-the-art protocols to study lymphocyte migration and T-cell: endothelial cell interactions in vitro, address various approaches used for direct visualization of the development of the lymphoid system, lymphocyte recirculation, and effector responses in experimental models in vivo, and explore lymphocyte migration and inflammation in the human system. Composed in the highly successful Methods in Molecular Biology series format, each chapter contains a brief introduction, step-by-step methods, a list of necessary materials, and a Notes section which shares tips on troubleshooting and avoiding known pitfalls.

Innovative and highly practical, T-Cell Trafficking: Methods and Protocols is an essential manual for newcomers in this ever-expanding and exciting area of research, as well as a valuable addition to more specialized laboratories."

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

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.

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors' more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary. Grounded in practicality, the book's applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

Contents:
Preface Acknowledgements The Pacific Theatre, World War II Introduction Part I. Japanese Factories of Death 1. Manchuria 2. Ishii Shiro 3. The Beiyinhe Bacteria Factory 4. Phase 1. Building Ping Fan 5. Phase 2. Hell in Ping Fan 6. The Secret of Secrets: Human Experiments 7. The Death Factory in Changchun 8. The Death Factory in Nanking 9. Experiments on prisoners of War 10. Who Knew? Part II. American Cover-Up The American Biological Warfare Program 12. Discovery of the Secret of Secrets 13. Investigations 14. Scientists and the Cover-Up 15. The Military and the Cover-Up 16. Epilogue Notes Select Bibliography Index

This book discusses why specific diseases are being targeted for cell-based retinal therapy, what evidence exists that justifies optimism for this approach, and what challenges must be managed in order to bring this technology from the laboratory into routine clinical practice. There are a number of unanswered questions (e.g., surgical approach to cell delivery, management of immune response, optimum cell type to transplant) that very likely are not going to be answered until human trials are undertaken, but there is a certain amount of "de-risking" that can be done with preclinical experimentation. This book is essential reading for scientists, clinicians, and advanced students in stem cell research, cell biology, and ophthalmology.

Stem cell research has the potential to affect the lives of millions of people around the world. This research is now regularly front-page news, and realizing the promise of mesenchymal stem cells for yielding new medical therapies will require us to grapple with more than just scientific uncertainties. "Mesenchymal Stem Cells for the Heart - From Bench to Bedside" presents the cytobiological characteristics of mesenchymal stem cells from the isolation, culture, transmembrane ion currents, migration and differentiation in vitro to the repairing of injured myocardium and tissue reconstruction in vivo, including the results of basic research and the real possibility for treatments and ultimately for cures for cardiac diseases for which adequate therapies do not exist. The book is intended for clinical stem cell researchers in cardiovasology, hematology, cytobiology, molecular biology, cell and tissue engineering, and other related fields.

Jian-an Wang, MD, PhD, Professor of Cardiology at Zhejiang University and investigator at Loma Linda University, Southern California, has broad expertise in the molecular and cellular biological processes underlying cardiovascular disease. He has won the Chinese Medical Science and Technology Medal of Honor.

Factories of Death details the activities of the Japanese army scientists that conducted numerous horrifying experiments upon live human beings. It investigates who from the upper echelons of the Japanese military and political establishments knew of the experiments, also the question of whether or not Allied POWs were subjected to such tests, and the nature of the deal that was brokered with US authorities after the war. This new edition has been completely updated, and contains an entirely new chapter detailing the numerous revelations that have surfaced since the book's initial publication in 1994.

This book summarizes the state-of-the art in the development of T cell-based "in vitro" assays, which offer useful tools for hazard identification, risk assessment and improvement of diagnostics. It will be of interest to scientists, the chemical and pharmaceutical industry, and regulators involved in the replacement of animal testing methods.

The identification of hazardous chemicals and drugs is essential to ensuring human health. The ban on animal testing for the cosmetics industry since 2009 and international efforts to reduce and replace animal testing in research and immunotoxicology call for alternative "in vitro" methods. The most specific immune response to chemicals and drugs that cause allergic contact dermatitis, respiratory disease and adverse drug reactions is the highly antigen-specific T lymphocyte response. Therefore the use of T cells as tools for identifying contact allergens and drugs that may cause health problems is of great interest.

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

• GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
• ICH Guidance Q8, Q9, and Q10 expectations
• FDA cGMPs for the 21st Century Initiative and associated guidance
• PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
• WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• the indirect developments from FDA/EU/Japan regulators and industry
• the role of QA department, and internal and external suppliers
• the integration of computer systems validation into single overall approach for wider system
• practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
• managing outsource partners and handling legacy systems
• topical issues uncovered by regulatory authorities including US FDA

This work presents and evaluates methods employed to identify the potential of certain types of chemicals to adversely affect the skin. A variety of test methods are included such as tests for skin penetration, metabolism, irritation, the skin immune system, photo effects, skin cancer, and topical effects of retinoids and depigmenting chemicals. Tests for chemicals that affect the reproductive and nervous system are also included. Both animal and human tests that have been standardised and tests that are under development and employ animal alternatives are addressed in this book. Besides different testing methods, a rationale for accepting non-animal models and a review of some regulatory agency discussions about animal alternative tests are included.

The field of Chemical Engineering and its link to computer science is in constant evolution and new engineers have a variety of tools at their disposal to tackle their everyday problems. Introduction to Software for Chemical Engineers, Second Edition provides a quick guide to the use of various computer packages for chemical engineering applications. It covers a range of software applications from Excel and general mathematical packages such as MATLAB and MathCAD to process simulators, CHEMCAD and ASPEN, equation-based modeling languages, gProms, optimization software such as GAMS and AIMS, and specialized software like CFD or DEM codes. The different packages are introduced and applied to solve typical problems in fluid mechanics, heat and mass transfer, mass and energy balances, unit operations, reactor engineering, process and equipment design and control. This new edition offers a wider view of packages including open source software such as R, Python and Julia. It also includes complete examples in ASPEN Plus, adds ANSYS Fluent to CFD codes, Lingo to the optimization packages, and discusses Engineering Equation Solver. It offers a global idea of the capabilities of the software used in the chemical engineering field and provides examples for solving real-world problems. Written by leading experts, this book is a must-have reference for chemical engineers looking to grow in their careers through the use of new and improving computer software. Its user-friendly approach to simulation and optimization as well as its example-based presentation of the software, makes it a perfect teaching tool for both undergraduate and master levels.

The growing importance of the evidence-based movement has made experimental evaluation a key issue among researchers, practitioners, commissioners and policy makers. However, experimental evaluation remains controversial in the sexual health field. This partly reflects the diversity of groups involved in this area and their different views on the most appropriate research methods. This book provides an analysis of the methodological and practical issues involved in evaluating sexual health interventions.

The book will appeal to trial enthusiasts through discussion of specific issues in trial design, and also to those with a sceptical interest in the potential of experimentation and its appropriateness or feasibility. It is concerned with methodology rather than the substantive findings of research, and considers the requirements of research in both developed and developing countries. The focus of the book is on sexual health interventions, although many of the issues are equally applicable to other areas of behavioural and social research