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Elsevier

Books in Biopharmaceuticals

  • Nano Meets Micro

    Revolutionizing Medicine through Microfluidic Devices
    • 1st Edition
    • Fatemeh Hataminia + 1 more
    • English
    Nano Meets Micro: Revolutionizing Medicine through Microfluidic Devices explores the transformative potential of integrating nanotechnology with microfluidics to revolutionize medical diagnostics, treatment, and personalized medicine. The book provides a detailed examination of how these cutting-edge technologies are making healthcare more precise, efficient, and personalized. Sections highlight nanomedicine and microfluidics, highlighting their importance in healthcare and their intersection with advanced healthcare solutions. It covers traditional and emerging fabrication techniques for microfluidic devices, the design and synthesis of nanoparticles, and the integration of nanomedicine into microfluidic systems. Examples and case studies illustrate how these technologies are used in drug delivery, disease diagnosis, and rapid diagnostics.With a strong focus on future implications, the book discusses emerging trends and potential advances in microfluidics and nanotechnology, including the integration of artificial intelligence and data analytics. It addresses the challenges and future directions in the commercialization of nanomedicine and microfluidic devices, providing a roadmap for translating laboratory innovations into clinical applications.

  • Probiotics

    A Comprehensive Exploration of Health Benefits and Innovation
    • 1st Edition
    • Ranbir Chander Sobti
    • English
    Probiotics: A Comprehensive Exploration of Health Benefits and Innovation explores the potential of probiotics and their fundamental role in human health and disease prevention. The book offers a thorough understanding of how beneficial microorganisms can enhance overall well-being and potentially transform treatment approaches across multiple disciplines. The first section lays the groundwork by exploring the fundamentals of probiotics, prebiotics, and their interactions with the human microbiome, while the second section examines the role of probiotics in disease prevention and management, highlighting their impact on conditions such as diabetes, obesity, and mental health.The third section discusses specialized applications of probiotics in women's health, pediatrics, and geriatrics, as well as their innovative uses in skin care and nutrition. Finally, the fourth section investigates the future potential of probiotics in synthetic biology, in personalized health, and in combatting antibiotic resistance. With contributions from a diverse group of experts in the field, the book serves as an interdisciplinary resource for researchers, clinicians, and industry professionals eager to explore the therapeutic potential and benefits of probiotics.

  • Bioinspired and Biomimetic Materials for Drug Delivery

    • 1st Edition
    • Md Nurunnabi
    • English
    Bioinspired and Biomimetic Materials for Drug Delivery delves into the potential of bioinspired materials in drug delivery, detailing each material type and its latest developments. In the last decade, biomimetic and bioinspired materials and technology has garnered increased attention in drug delivery research. Various material types including polymer, small molecular, protein, peptide, cholesterol, polysaccharide, nano-crystal and hybrid materials are widely considered in drug delivery research. However, biomimetic and bioinspired materials and technology have shown promising results for use in therapeutics, due to their high biocompatibility and reduced immunogenicity. Such materials include dopamine, extracellular exosome, bile acids, ionic liquids, and red blood cell. This book covers each of these materials in detail, reviewing their potential and usage in drug delivery. As such, this book will be a great source of information for biomaterials scientists, biomedical engineers and those working in pharmaceutical research.

  • Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics

    • 1st Edition
    • Allan Matte
    • English
    Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.

  • From Globular Proteins to Amyloids

    • 1st Edition
    • Irena Roterman-Konieczna
    • English
    From Globular Proteins to Amyloids proposes a model and mechanism for explaining protein misfolding. Concepts presented are based on a model originally intended to show how proteins attain their native conformations. This model is quantitative in nature and founded upon arguments derived from information theory. It facilitates prediction and simulation of the amyloid fibrillation process, also identifying the progressive changes that occur in native proteins that lead to the emergence of amyloid aggregations.

  • High-Throughput Formulation Development of Biopharmaceuticals

    Practical Guide to Methods and Applications
    • 1st Edition
    • Vladimir I. Razinkov + 1 more
    • English
    High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary.

  • Strategies to Modify the Drug Release from Pharmaceutical Systems

    • 1st Edition
    • Marcos Luciano Bruschi
    • English
    Since the earliest dosage forms to modern drug delivery systems, came a great development and growth of knowledge with respect to drug delivery. Strategies to Modify the Drug Release from Pharmaceutical Systems will address principles, systems, applications and advances in the field.It will be principally a textbook and a reference source of strategies to modify the drug release. Moreover, the characterization, mathematical and physicochemical models, applications and the systems will be discussed.

  • Monoclonal Antibodies

    Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product
    • 1st Edition
    • Steven Shire
    • English
    Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies.

  • Biophysical Characterization of Proteins in Developing Biopharmaceuticals

    • 1st Edition
    • Damian J. Houde + 1 more
    • English
    Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure this book takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help today’s industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered.

  • Genetics and Biochemistry of Antibiotic Production

    • 1st Edition
    • Colin Stuttard + 1 more
    • English
    * Emphasizes the molecular genetics of antibiotic production * Provides the latest information on the organization of genes encoding the biosynthetic pathway * Explores the mechanisms governing their expression and regulation * Examines the role of resistance genes in protecting organisms from their own lethal productsGenetics and Biochemistry of Antibiotic Production brings together the most up-to-date information on the genetic and biochemical mechanisms involved in antibiotic production. A collection of internationally recognized authors provide the latest information on the organization, function and regulation of genes responsible for antibiotic synthesis in a range of bacteria. This unique book groups antibiotics according to their biosynthetic affiliation, providing a background into evolutionaryrelation... while raising intriguing questions about the raison d'etre of antibiotics in nature.

  • The Funding of Biopharmaceutical Research and Development

    • 1st Edition
    • David R Williams
    • English
    The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decrease in the near future. A lack of understanding of the scale, scope, and inner workings of the funding aspects of R&D can, at times, act as a barrier for all involved, and can slow down or even eliminate the R&D process. The book lessens these barriers by describing the theoretical underpinnings, present practice, and trends in R&D funding in this market sector, both in the US and internationally. This includes a review and discussion of public-private partnership activity and their inner-workings, noting the complementary relationship between public and private funding. The book also contains an overview of the inner-workings of strategic alliance activity, including the advantages and disadvantages for each party. It goes on to provide an outline of venture capital activity, detailing the methods by which venture capital firms raise capital and are organized, a description of the venture capital-entrepreneur arrangement, and the effects of this arrangement. The book also presents an overview of the IPO process and the various fates of firms going public.

  • Enzymes as Targets for Drug Design

    • 1st Edition
    • Michael Palfreyman
    • English
    Enzymes as Targets for Drug Design is a collection of scientific discussions related to enzyme inhibitors that show the many facets of the drug discovery process from the basic sciences through clinical applications. Topics include the biogenesis of phosphatidylinositol glycosyl membrane proteins, structure and catalytic function of ADP-ribose polymerase (ADPRT), and modulation of the dopaminergic system in cardiovascular therapeutics. The therapeutic utility of selected enzyme-activated irreversible inhibitors, the role of proteinases in the fibrosis of systemic sclerosis, and therapeutic opportunities in eicosanoid biosynthesis are also discussed. This book consists of 18 chapters and begins with examples of enzymes whose activities have recently been elucidated, or for which newer insights have been gleaned, but which do not yet have selective or potent inhibitors. The second part provides examples of enzymes where inhibitors have been identified but it is still not clear whether or not such an enzymatic blockade will be therapeutically beneficial. The final section describes clinical studies of newer, and not so new, enzyme inhibitors that are clearly of therapeutic importance. The therapeutic activity of monoamine oxidase inhibitors and the associated clinical issues are considered. This book is intended for clinicians as well as basic scientists in biochemistry, chemistry, pharmacology, and cell biology.

  • Therapeutic Protein Drug Products

    Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic
    • 1st Edition
    • Brian K Meyer
    • English
    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.

  • Outsourcing Biopharma R&D to India

    • 1st Edition
    • P R Chowdhury
    • English
    The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India.

  • Practical Leadership for Biopharmaceutical Executives

    • 1st Edition
    • Jane Y Chin
    • English
    The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity.

  • Profiles of Drug Substances, Excipients and Related Methodology

    Critical Compilation of pKa Values for Pharmaceutical Substances
    • 1st Edition
    • Volume 33
    • Harry G. Brittain
    • English
    Whilst following in the footsteps of previous volumes by presenting comprehensive reviews of drug substances and additional materials, this title also heralds a significant expansion of the scope of the series. Traditional contributions will now also be augmented by publication of critical review chapters that summarize information related to the characterization of drug substances and excipients. This change is required to better meet the needs of the pharmaceutical communtiy and to allow the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series will encompass review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Unwanted Effects of Cosmetics and Drugs used in Dermatology

    • 3rd Edition
    • A.C. de Groot + 2 more
    • English
    This 3rd edition provides updated information on side effects of cosmetic products, topical and systemic drugs used in dermatology, and other therapeutic modalities used by dermatologists including PUVA therapy and (new in this edition) dermal implants, laser therapy, chemical face peels and cryotherapy.Because of the explosion of new knowledge since the last edition (the 2nd edition of this book was published 8 years ago), the section on cosmetics has largely been rewritten and extended, the section on side effects of systemic drugs used in dermatology has also been expanded, and the index of drugs has been made comprehensive.This book will be of great value to the practising physician who is confronted with a (possible) adverse reaction to a cosmetic or drug used in dermatological practice as well as to those who are scientifically interested, by providing access to recent relevant literature.