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

"Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics" is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics.
Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceuticalContains the most pertinent international regulatory guidance documents for nonclinical evaluationCovers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars"A multi-authored book with chapters written by qualified experts in their respective fields

Innovative approach to drug design that's more likely to result in an approvable drug product Retrometabolic drug design incorporates two distinct drug design approaches to obtain soft drugs and chemical delivery systems, respectively. Combining fundamentals with practical step-by-step examples, Retrometabolic Drug Design and Targeting gives readers the tools they need to take full advantage of retrometabolic approaches in order to develop safe and effective targeted drug therapies. The authors, both pioneers in the fields of soft drugs and retrometabolic drug design, offer valuable ideas, approaches, and solutions to a broad range of challenges in drug design, optimization, stability, side effects, and toxicity. Retrometabolic Drug Design and Targeting begins with an introductory chapter that explores new drugs and medical progress as well as the challenges of today's drug discovery. Next, it discusses: * Basic concepts of the mechanisms of drug action * Drug discovery and development processes * Retrometabolic drug design * Soft drugs * Chemical delivery systems Inside the book, readers will find examples from different pharmacological areas detailing the rationale for each drug design. These examples set forth the relevant pharmacokinetic and pharmacodynamic properties of the new therapeutic agents, comparing these properties to those of other compounds used for the same therapeutic purpose. In addition, the authors review dedicated computer programs that are available to support and streamline retrometabolic drug design efforts. Retrometabolic Drug Design and Targeting is recommended for all drug researchers interested in employing this newly tested and proven approach to developing safe and effective drugs.

This authoritative volume focuses on emerging technologies in cancer nano medicine, characterized by their multi-functionality and potential to address simultaneously diverse issues of clinical relevance in the treatment of cancer. The book consists of sixteen chapters divided into six sections: 1) Biological Barriers in Cancer; 2) Tumor Targeting; 3) Targeting the Immune System; 4) Gene Therapy; 5) Nano theranostics and 6) Translational Aspects of Nano-Oncologicals. The volume starts with an introduction describing the biological barriers associated with cancer therapy and highlighting ways to overcome such barriers through the use of nanotechnology. This is followed by an analysis of the two major targeting strategies currently under investigation in cancer therapy: namely, the targeting of cancer cells and the targeting of the immune system. In the first case, the book presents liposomal and polymer-based therapies, including photodynamic approaches. In the second case, it analyzes in detail the possibility of either improving the efficiency of the immune system toward preventing cancer progression (cancer immunomodulation) or generating responses against specific cancer antigens (cancer vaccines).

Beyond these targeting options, "Nano-Oncologicals: New Targeting and Delivery Approaches" presents the most recent technological advances in the area of nucleic acid-based therapies, along with those in the area of theranostics, where the design of multifunctional nano carriers becomes vital. Following the study of the most promising nanotechnologies around the development of nano-oncologicals, the book ends with an overview of regulatory and toxicological issues, which are critical in their translational pathway, and the presentation of a nucleic acid-based therapy case-study. This book is an important resource for scientists interested in the design and development of anticancer nanotechnologies and also to those aiming to push their technology through clinical development.

This third edition volume expands on the previous editions both by presenting more detailed protocols for the techniques described in the first and second editions of High Throughput Screening: Methods and Protocols and by covering important new procedures. The first chapter of this book provides an overview of important assay development techniques, while the rest of the chapters detail how to develop and execute screens at whatever throughput the user needs. Some chapter examples are: structure-based virtual screening, high throughput screening using mass spectrometry, identification of state-dependent blockers for voltage gated calcium channels, bioluminescence resonance energy transfer platform to monitor protein-protein interactions in live cells, high throughput flow cytometry, and application of imaging-based assays in microplate formats for high content screening. 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. Cutting edge and thorough, High Throughput Screening: Methods and Protocols, Third Edition, is a valuable resource for anyone who is interested in HTS research.

"Annual Reports in Medicinal Chemistry "provides timely and critical reviews of important topics in medicinal chemistry together with an emphasis on emerging topics in the biological sciences, which are expected to provide the basis for entirely new future therapies.
Timely and critical reviews of important topics in medicinal chemistry

This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)-including its regulations and registration procedures-and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China's pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.

This six volume book set examines a range of topics and applications related to biotechnology. Volumes include fermentation and algal biotechnologies; agricultural biotechnology; medical biotechnology, biopharmaceutics; biosafety, bioethics, biotechnology policy; microbiomes; bioenergy and environmental biotechnology for sustainable development. The topics address significant aspects of the dairy and fermented foods; crop genetics, breeding and genomics; microalgae and novel products; molecular diagnostics and DNA forensics; biosafety, bioethics and legal issues in biotechnology; biotechnology policy advocacy, enlightenment and engagement with stakeholders; medical and pharmaceutical biotechnology; omics and bioinformatics; waste recycling, biofuels and environmental remediation; animal genetics, breeding and genomics; genetic resources conservation and utilization; medicinal and underutilized plants; medical insect biotechnology, genomics and molecular genetics of pests; microbiomes and microbial biotechnology; biotechnology education and curriculum development; and water and waste water research. Volumes include: I: Fermentation and Algal Biotechnologies for the Food, Beverage and other Bioproduct Industries II: Agricultural Biotechnology, Biodiversity and Bio-resources Conservation and Utilization III: Medical Biotechnology, Biopharmaceutics, Forensic Science and Bioinformatics IV: Biosafety and Bioethics in Biotechnology: Policy, Advocacy, and Capacity Building V: Microbiomes and Emerging Applications VI: Bioenergy and Environmental Biotechnology for Sustainable Development The book is a timely knowledge product that documents key issues on advances in biotechnology for use by a variety of readers including postgraduate students, professionals in the field, policy makers, science advocacy groups.

"Advances in Immunology, " a long-established and highly respected publication, presents current developments as well as comprehensive reviews in immunology. Articles address the wide range of topics that comprise immunology, including molecular and cellular activation mechanisms, phylogeny and molecular evolution, and clinical modalities. Edited and authored by the foremost scientists in the field, each volume provides up-to-date information and directions for the future.

This volume focuses on synthetic vaccines.

Key features:

* Contributions from leading authorities * Informs and updates on all the latest developments in the field

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

Fluorine chemistry is an expanding area of research that is attracting international interest, due to the impact of fluorine in drug discovery and in clinical and molecular imaging (e.g. PET, MRI). Many researchers and academics are entering this area of research, while scientists in industrial and clinical environments are also indirectly exposed to fluorine chemistry through the use of fluorinated compounds for imaging.This book provides an overview of the impact that fluorine has made in the life sciences. In the first section, the emphasis is on how fluorine substitution of amino acids, peptides, nucleobases and carbohydrates can provide invaluable information at a molecular level. The following chapters provide answers to the key questions posed on the importance of fluorine in drug discovery and clinical applications. For examples, the reader will discover how fluorine has found its place as a key element improving drug efficacy, with reference to some of the best-selling drugs on the market. Finally, a thorough review on the design, synthesis and use of 18F-radiotracers for positron emission tomography is provided, and this is complemented with a discussion on how 19F NMR has advanced molecular and clinical imaging.

This book reviews the current strategies and challenges for the treatment of bacterial, fungal, parasitic and viral infectious diseases in developing countries. Contributing authors present expert analysis on the transmission, epidemiology, bacteriology, pathogenesis and treatment of Neglected Tropical Bacterial Diseases such as Leprosy, Buruli ulcer, and Trachoma. Particular attention is also given to current antifungal agents, their spectrum of activity, mode of action, limitations, and current challenges in antifungal therapy. The authors explore the medicinal chemistry efforts that gave rise to currently launched drugs and new anti-HIV agents, and they also highlight the latest vaccine and drug developments in the clinical management of the Ebola Virus Disease, ignited by the 2014-2016 outbreak. This work has an interdisciplinary appeal and will engage scholars and professionals in the burden of communicable diseases.

This volume of Methods in Enzymology looks at Protein Engineering for Therapeutics. The chapters providean invaluable resource for academics, researchers and students alike. With an international board of authors, this volume is split into sections that cover subjects such as Antibodies, Protein conjugates, Peptides, Enzymes and Scaffolds
Chapters providean invaluable resource for academics, researchers and students alike. Iinternational board of authors. This volume is split into sections that cover subjects such as Antibodies, Protein conjugates, Peptides, Enzymes and Scaffolds"

The book "Nanocosmetics and nanomedicines: new approaches for skin care" contains a summary of the most important nanocarriers for skin delivery. Although "nanocosmetics" is a subject widely commented in the academy and the beauty industry, a book covering the skin care treatments using nanotechnological approaches with cosmetics and nanomedicines is still missing, therefore the need for this publication. This book is divided in three parts: The first one (Part A) is devoted to a brief review on the main topics related to the skin delivery and to the introduction of the subject "nanocosmetics". The second part (Part B) presents different types of nanocarriers applied as skin delivery systems for cosmetics or drugs. The last part (Part C) shows a wide range of applications of nanotechnology on the skin care area as well as on dermatocosmetic and dermatological fields.

This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.
This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.
A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry.
Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actionsManufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processesCovers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries

Pharmacology in Drug Discovery: Understanding Drug Response is designed for all students, recent graduates, and new researchers in the pharmaceutical and biotechnology industries who need to interpret change in physiology induced by a chemical substance. Physiological systems customize chemical signal input to their own needs; therefore the same drug can have different effects in different physiological systems. The field of pharmacology is unique in that it furnishes the tools to analyze these different behaviors and traces them to their root cause. This enables predictions of drug behavior to be made in all systems, an invaluable tool for drug discovery because almost all drugs are developed in test systems far removed from the therapeutic one.
This valuable resource provides simple explanations of the ways in which biological systems use basic biochemical mechanisms to produce fine chemical control of physiology, allowing for more informed predictions of drug effects in all systems and forming the basis of the drug-discovery process. Chapters follow a logical progression on how to characterize the pharmacology of any given molecule, and include important terminology, chapter summaries, references, and review questions to aid the reader in understanding and retention of the material.
Enables the reader to interpret drug dose-response data and make mechanistic inferences at the molecular levelBridges the gap between biochemistry and therapeutic medicineChapters include key topics such as drug affinity and efficacy, enzymes as drug targets, in vivo pharmacology, safety pharmacology, and more"

This book highlights the advances in essential oil research, from the plant physiology perspective to large-scale production, including bioanalytical methods and industrial applications. The book is divided into 4 sections. The first one is focused on essential oil composition and why plants produce these compounds that have been used by humans since ancient times. Part 2 presents an update on the use of essential oils in various areas, including food and pharma industries as well as agriculture. In part 3 readers will find new trends in bioanalytical methods. Lastly, part 4 presents a number of approaches to increase essential oil production, such as in vitro and hairy root culture, metabolic engineering and biotechnology. Altogether, this volume offers a comprehensive look at what researchers have been doing over the last years to better understand these compounds and how to explore them for the benefit of the society.

Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations-many of which will be nanoparticulates-can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.

This book was conceived from a simple question as to why cancer is so difficult to treat. Ultimately we want to find ways to cure cancers, but that may be an elusive dream at least with the technologies we have now and expect to have in the near future. This leads the question of whether it is possible to improve current cancer treatment methods, especially from the perspective of enhancing targeted drug delivery to tumors. This volume is designed to provide information related to the difficulties in treating cancers through targeted drug delivery, our current understanding of cancer biology, and potential technologies that might be used to achieve enhanced drug delivery to tumors. An ideal drug delivery system for treating cancers would maximize the therapeutic efficacy with minimal side effects in clinical applications. The seemingly improved anticancer efficacy of the current nanoparticle-based formulations needs to be viewed from the context of very poor success rates for translation to human applications. The results of in vitro cell culture models and small animal in vivo experiments have not been extrapolated to clinical applications. Finding the reasons for the lack of successful translation is required if we are to discover approaches to substantially extend the survival time of cancer patients, and hopefully identify cures. Cancer Targeted Drug Delivery: Elusive Dream describes some answers of achieving the so far elusive dream of treating cancers like other chronic diseases with therapies that focus using improved drug delivery systems designed to better align with the unique biological and physiological properties of cancer.

This second edition book explores breakthrough technologies in the field of drug target identification and validation. The volume emphasizes particularly revolutionary technologies, such as CRISPR-related screening, "big data," and in silico approaches, as well as in vivo applications of CRISPR and best uses of animal models in drug development. 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. Fully updated and authoritative, Target Identification and Validation in Drug Discovery: Methods and Protocols, Second Edition is an ideal guide for molecular and cellular biologists, pharmacologists, pathologists, bioinformaticians, clinical researchers, or investigators, as well as experts in other fields that need a quick overview of these state-of-the-art technologies.

Teaches proper procedures for using tools and analytical methods in a regulated lab setting
All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibration of instruments and validation of analytical methods. Following correct procedures ensures the generation of reliable data, which leads to the manufacture of safe and effective products.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions. Coverage includes: Method validation of potency, related substances, and dissolution testing Validation for pharmaceutical excipients, heavy metals, and bioanalysis Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters The LCMS system calibration Proper environmental chamber qualification Entire qualification process for computer equipment, hardware, and software Validation of Excel spreadsheets Regulatory requirements of the FDA, ICH, Europe, and Japan

Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment.

Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibrationscientists, and research and development scientists.

Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular Biology(TM) series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.

"Annual Reports in Medicinal Chemistry "provides timely and critical reviews of important topics in medicinal chemistry together with an emphasis on emerging topics in the biological sciences, which are expected to provide the basis for entirely new future therapies.
* Covers findings related to cardiovascular, inflammation, and pulmonary diseases
* Examines issues in oncology, from mTor inhibitors to drug targets
* Incorporates up-to-date information on drug design and discovery, including delivery to market

Provides an understanding of (mostly) enzymatic reactions that are responsible for the function and maintenance of living things This innovative text for non-biochemistry majors includes introductory material at the beginning of each chapter that contextualizes chapter themes in real-life scenarios Online supporting materials with further opportunities for research and investigation Synthesis questions at the end of each chapter that encourage students to make connections between concepts and ideas, as well as develop critical-thinking skills

Statistical Methods in Food and Consumer Research continues to be the only book to focus solely on the statistical techniques used in sensory testing of foods, pharmaceuticals, cosmetics, and other consumer products.
This new edition includes the most receent applications of statistical methods, and features significant updates as well as two new chapters.
Covering the application of techniques including R-index, the Bayesian approach for sensory differences tests, and preference mapping in addition to several other methodologies, this is the comprehensive reference needed by those studying sensory evaluation and applied statistics in agriculture and biological sciences. Research professionals working with food, beverages, healthcare, cosmetics, and other related areas will find the book a valuable guide to the variety of statistical methods available.

Key Features:
* Provides comprehensive coverage of statistical techniques in sensory testing
* Includes data compiled from real-world experiments
* Covers the latest in data interpretation and analysis
* Addresses key methods such as R-index, Thursonian Discriminal Distances, group sequential tests, beta-binomial tests, sensory difference and similarity tests, just-about-right data, signal-to-noise ratio, analysis of cosmetic data, Descriptive Analysis, claims substantiation and preference mapping