Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and challenges being encountered. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, and more. The container closure system may also be unique, and the product may require freezing storage or lyophilization based on the stability of the vaccine components. Based on the route of delivery, novel technologies and devices may be required. Covering formulation development, manufacture, and delivery considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students.

Modern Approaches in Drug Discovery, Volume 611, the latest release in the Methods in Enzymology series, highlights new advances in the field, with this new volume presenting interesting chapters on topics such as Target Identification and Validation, Cell Painting/High Content Imaging, Target ID using chemical probes, Mining the microbiome for targets, Data driven approaches for diversity and drug-likeness, Affinity-based screening, Fragment screening (X-ray), Array-based approaches, Hit-to-lead: assessment and improvement of drug-like properties, Hit assessment and prioritization, Lead Optimization: fine tuning and risk mitigation, and more.

Drug Delivery Nanosystems for Biomedical Application reviews some of the most challenging nanosystems with different routes of delivery that are useful for specific drugs, from both efficacy and bioavailability points-of-view. The chapters explore how this area is developing, the present state of the field, and future developments, in particular, inorganic, metallic, polymeric, composite and lipid nanosystems and their possible evolution to clinical applications. The book is a valuable research reference for both researchers and industrial partners who are not only interested in learning about this area, but also want to gain insights on how to move towards translational research.

Quantitative Systems Pharmacology: Models and Model-Based Systems with Applications, Volume 42, provides a quantitative approach to problem-solving that is targeted to engineers. The book gathers the contributions of doctors, pharmacists, biologists, and chemists who give key information on the elements needed to model a complex machine like the human body. It presents information on diagnoses, administration and release of therapeutics, distribution metabolism and excretion of drugs, compartmental pharmacokinetics, physiologically-based pharmacokinetics, pharmacodynamics, identifiability of models, numerical methods for models identification, design of experiments, in vitro and in vivo models, and more. As the pharma community is progressively acknowledging that a quantitative and systematic approach to drug administration, release, pharmacokinetics and pharmacodynamics is highly recommended to understand the mechanisms and effects of drugs, this book is a timely resource.

Cosmeceuticals are the latest additions to the health industry and have an ever-expanding market. They are considered to be a marriage between cosmetics and drugs and are defined as preparations applied on the body that may modify the physiological functions of the skin. However, as more cosmeceuticals are being launched in the market and more types of drugs are incorporated into the formulation, the composition of cosmeceuticals is becoming more complex. Handbook of Cosmeceutical Excipients and their Safeties summarises the current evidence relating to cosmeceuticals' side effects and highlights the important information that practitioners and consumers need to know, as well as ways to avoid the adverse effects of the excipients. Handbook of Cosmeceutical Excipients and their Safeties includes chapters covering topics such as the history of cosmeceuticals and the laws that regulate them, skin permeation, carcinogenicity as a systemic adverse effect and dermatitis as a topical adverse effect. It concludes with an appendix that gives brief information on the potency and permeability of common ingredients in cosmeceuticals. The appendix aims to highlight the maximum allowable quantity of each ingredient to ensure product safety for consumers. The appendix was prepared by compiling the ingredients of 257 products containing more than 500 compounds, collected from a hospital pharmacy in Singapore.

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders.

A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.

This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts.
An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicinesA number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan)Acomprehensive guide for performing risk management more effectively throughout a product s life-cycle"

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

With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.
Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing.
A focus on the issues associated with the application of lean principles to biomanufacturingPractical examples of factors which can affect biopharmaceutical processesCoverage of key factors which require integration to run an efficient biopharmaceutical process

A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools.
Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software.
Coverage of artificial intelligence tools, new expert systems, understanding of pharmaceutical processes, robust development of medicines, and new ways to develop medicinesDevelopment of drugs and medicines using mathematical toolsCompilation of expert system developed around the world

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

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

This volume examines recent developments in the use of intelligent materials and systems for drug delivery. Controlled release technology is moving from being a simple carrier of active agents to becoming a powerful and flexible method that permits subtle modulation of the delivery profile based on the needs of the biological host. The chapters collected here cover recent advances in materials with responsive properties, novel concepts in controlled release technology, new applications, and microanalytical techniques for rapid and accurate measurements of small samples.

Applications of Nanotechnology in Drug Discovery and Delivery, in the Drug Discovery Update series, presents complete coverage of the application of nanotechnology in the discovery of new drugs and efficient target delivery of drugs. The book highlights recent advances of nanotechnology applications in the biomedical sciences, starting with chapters that provide the basics of nanotechnology, nanoparticles and nanocarriers. Part II deals with the application of nanotechnology in drug discovery, with an emphasis on enhanced delivery of pharmaceutical products, with Part III discussing toxicological and safety issues arising from the use of nanomaterials. This book brings together a global team of experts, making it an essential resource for researchers, drug developers, medicinal chemists, toxicologists and analytical chemists.

Vaccine development is a complex and time consuming process that differs from the development of conventional pharmaceuticals. Primarily, vaccines are intended for use in healthy individuals as a preventative measure, requiring a long and rigorous process of research and many years of testing and development prior to clinical trials and regulatory approval. The average time for the development of vaccines to clinical is 12 to 15 years. Vaccine Development: From Concept to Clinic is a detailed overview of the development of new vaccines, covering the entire process and addresses all classes of vaccines from a processing, development and regulatory viewpoint. Utilising successful case studies the book will provide insight to the issues scientists face when producing a vaccine, the steps involved and will serve as an ideal reference tool regarding state-of-the-art vaccine development. This book is an ideal companion for any researchers working in vaccine discovery and development or with an interest in the field.

Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management. This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools.

Pharmaceuticals in Marine and Coastal Environments: Occurrence, Effects, and Challenges in a Changing World is divided into three sections that address a) coastal areas as the main entrance of pharmaceuticals into the ocean, b) the occurrence and distribution of pharmaceuticals in the environmental compartments of the ocean media, and c) the effects that such pollutants may cause to the exposed marine organisms. With its comprehensive discussions, the book provides a wide depiction of the current state-of-the-art on these topics in an effort to open new sources of investigation and find suitable solutions.

Alginates in Drug Delivery explores the vital precepts, basic and fundamental aspects of alginates in pharmaceutical sciences, biopharmacology, and in the biotechnology industry. The use of natural polymers in healthcare applications over synthetic polymers is becoming more prevalent due to natural polymers' biocompatibility, biodegradability, economic extraction and ready availability. To fully utilize and harness the potential of alginates, this book presents a thorough understanding of the synthesis, purification, and characterization of alginates and their derivative. This book collects, in a single volume, all relevant information on alginates in health care, including recent advances in the field. This is a highly useful resource for pharmaceutical scientists, health care professionals and regulatory scientists actively involved in the pharmaceutical product and process development of natural polymer containing drug delivery, as well as postgraduate students and postdoctoral research fellows in pharmaceutical sciences.

Polysaccharide Carriers for Drug Delivery presents the latest information on the selection of safe materials. Due to reported safety profiles on polysaccharides; they have been the natural choice for investigation. A wide variety of drug delivery and biomedical systems have been studied, however, the related information either concept-wise or application-oriented is scattered, therefore becoming difficult for readers and researchers to digest in a concise manner. This gathering of information will help readers easily comprehend the subject matter.

Quality Control and Evaluation of Herbal Drugs brings together current thinking and practices for evaluation of natural products and traditional medicines. The use of herbal medicine in therapeutics is on the rise in both developed and developing countries and this book facilitates the necessary development of quality standards for these medicines.This book elucidates on various challenges and opportunities for quality evaluation of herbal drugs with several integrated approaches including metabolomics, chemoprofiling, marker analysis, stability testing, good practices for manufacturing, clinical aspects, Ethnopharmacology and Ethnomedicine inspired drug development. Written by Prof. Pulok K Mukherjee, a leader in this field; the book highlights on various methods, techniques and approaches for evaluating the purity, quality, safety and efficacy of herbal drugs. Particular attention is paid to methods that assess these drugs' activity, the compounds responsible and their underlying mechanisms of action. The book describes the quality control parameters followed in India and other countries, including Japan, China, Bangladesh, and other Asian countries, as well as the regulatory profiles of the European Union and North America. This book will be useful in bio-prospecting of natural products and traditional medicine-inspired drug discovery and development.

New Developments for Nanosensors in Pharmaceutical Analysis presents an overview of developments in nanosensor usage in pharmaceutical analysis, thereby helping pharmaceutical companies attain reliable, precise, and accurate analysis of pharmaceuticals. This book presents very simple, precise, sensitive, selective, fast, and relatively inexpensive methods for pre-treatment, prior to analysis. These methods may be considered for further application in clinical studies and assays. The book includes the manufacturing of sensors for pharmaceutical analysis at nano- or smaller scales, and gives simple and relatable designs for the fabrication of sensors. Twelve chapters cover an introduction to the topic, immobilization techniques, mechanism effect of nanomaterials on structure, optical nanosensors for pharmaceutical detection, chemical nanosensors in pharmaceutical analysis, noble metal nanoparticles in electrochemical analysis of drugs, photo-electrochemical nanosensors for drug analysis, molecularly imprinted polymer based nanosensors for pharmaceutical analysis, nanomaterials for drug delivery systems, nanomaterials enriched nucleic acid-based biosensors, nanosensors in biomarker detection, and nanomaterials-based enzyme biosensors for electrochemical applications.