Download or read book Handbook of Biological Therapeutic Proteins written by Sarfaraz Niazi and published by CRC Press. This book was released on 2024-04-15 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 1972, which marks the invention of recombinant engineering, more than 500 therapeutic proteins have been approved for clinical use. Today, biological drugs constitute almost 70% of all new drugs and have a biological origin. The first edition of this book dealt with biosimilars, and this edition (i.e., the second edition) focuses on new drugs, yet limits to therapeutic proteins. Newer technologies for drug development represent the updated topics in the book and include repur-posing, AI- driven identification of newer designs, novel expression systems, manufacturing using these systems, rapidly changing regulatory pathways, and legal hurdles. This edition discusses how to identify, develop, manufacture, and take multibillion dollar products to market within the shortest possible time. Features: Complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins Comprehensive, discovery to market, newer technologies, regulatory planning and IP hurdles are included that are not found elsewhere Expanded volume that must be in the hands of every company interested in biological drugs, including the mRNA-based biopharmaceutical companies fast appearing on the market Discusses how to identify, develop, manufacture, and take multibillion dollar products to market in the shortest possible time Renowned author and entrepreneur in the field of drug discovery and production
Download or read book Handbook of Biogeneric Therapeutic Proteins written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2002-08-15 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato
Download or read book Handbook of Biogeneric Therapeutic Proteins written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2002-08-15 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic or similar biological products are soon to become a reality. Handbook of Biogeneric Therapeutic Proteins is the first book to review and analyze the status of biotechnology, regulatory environment, manufacturing methodologies, testing requirements and intellectual property issues. The book provides complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins and how to prepare detailed regulatory and manufacturing plans and policies. The author includes information on establishing a manufacturing system, securing regulatory approval, and setting up facilities to manufacture raw materials and prepare finished products. He also supplies details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products. In brief, the book supplies everything a manufacturer would need to plan the development of biogeneric products and complete the process of regulatory filing. Waiting for the FDA to issue guidelines is a mistake. The scramble to catch up could leave your company way behind in the game. Your organization needs to begin developing and characterizing genetically modified cells now and to complete initial GMP production runs through a CRO to get ready for the newer testing the FDA might impose. Packed with tables and figures that provide speedy access to precise, timely data, including full formulation details on all FDA approved biological product, this book contains a broad range of resource materials about suppliers, manufacturers, and testing facilities. These features combined with the author's hands-on, practical approach give you the edge you need.
Download or read book Protein Therapeutics written by Tristan Vaughan and published by John Wiley & Sons. This book was released on 2017-07-28 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.
Download or read book Therapeutic Proteins written by C. Mark Smales and published by Springer Science & Business Media. This book was released on 2008-02-04 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.
Download or read book Data Processing Handbook for Complex Biological Data Sources written by Gauri Misra and published by Academic Press. This book was released on 2019-03-23 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data Processing Handbook for Complex Biological Data provides relevant and to the point content for those who need to understand the different types of biological data and the techniques to process and interpret them. The book includes feedback the editor received from students studying at both undergraduate and graduate levels, and from her peers. In order to succeed in data processing for biological data sources, it is necessary to master the type of data and general methods and tools for modern data processing. For instance, many labs follow the path of interdisciplinary studies and get their data validated by several methods. Researchers at those labs may not perform all the techniques themselves, but either in collaboration or through outsourcing, they make use of a range of them, because, in the absence of cross validation using different techniques, the chances for acceptance of an article for publication in high profile journals is weakened. Explains how to interpret enormous amounts of data generated using several experimental approaches in simple terms, thus relating biology and physics at the atomic level Presents sample data files and explains the usage of equations and web servers cited in research articles to extract useful information from their own biological data Discusses, in detail, raw data files, data processing strategies, and the web based sources relevant for data processing
Download or read book Handbook of Therapeutic Antibodies written by Stefan Dübel and published by John Wiley & Sons. This book was released on 2014-12-03 with total page 2538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle.
Download or read book Handbook of Therapeutic Antibodies 3 Volume Set written by Stefan Dübel and published by Wiley-Blackwell. This book was released on 2007-03-26 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this most comprehensive reference source for the development, production and therapeutic application of antibodies, Volume I contains general chapters presenting established technologies and clinical applications. Volume II provides a look at emerging technologies, new therapeutic concepts, and clinical studies. The third volume features detailed and specific information about each currently approved type of antibody, including the clinical data. A must-have resource for academic researchers, decision makers in industry and healthcare professionals in the clinic.
Download or read book Handbook on Biological Warfare Preparedness written by S.J.S. Flora and published by Academic Press. This book was released on 2019-10-05 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook on Biological Warfare Preparedness provides detailed information on biological warfare agents and their mode of transmission and spread. In addition, it explains methods of detection and medical countermeasures, including vaccine and post-exposure therapeutics, with specific sections detailing diseases, their transmission, clinical signs and symptoms, diagnosis, treatment, vaccines, prevention and management. This book is useful reading for researchers and advanced students in toxicology, but it will also prove helpful for medical students, civil administration, medical doctors, first responders and security forces. As the highly unpredictable nature of any event involving biological warfare agents has given rise to the need for the rapid development of accurate detection systems, this book is a timely resource on the topic. Introduces different bacterial and viral agents, including Ebola and other emerging threats and toxins Discusses medical countermeasures, including vaccines and post-exposure therapeutics Includes a comprehensive review of current methods of detection
Download or read book Introduction to Proteins written by Amit Kessel and published by CRC Press. This book was released on 2018-03-22 with total page 1423 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Proteins provides a comprehensive and state-of-the-art introduction to the structure, function, and motion of proteins for students, faculty, and researchers at all levels. The book covers proteins and enzymes across a wide range of contexts and applications, including medical disorders, drugs, toxins, chemical warfare, and animal behavior. Each chapter includes a Summary, Exercies, and References. New features in the thoroughly-updated second edition include: A brand-new chapter on enzymatic catalysis, describing enzyme biochemistry, classification, kinetics, thermodynamics, mechanisms, and applications in medicine and other industries. These are accompanied by multiple animations of biochemical reactions and mechanisms, accessible via embedded QR codes (which can be viewed by smartphones) An in-depth discussion of G-protein-coupled receptors (GPCRs) A wider-scale description of biochemical and biophysical methods for studying proteins, including fully accessible internet-based resources, such as databases and algorithms Animations of protein dynamics and conformational changes, accessible via embedded QR codes Additional features Extensive discussion of the energetics of protein folding, stability and interactions A comprehensive view of membrane proteins, with emphasis on structure-function relationship Coverage of intrinsically unstructured proteins, providing a complete, realistic view of the proteome and its underlying functions Exploration of industrial applications of protein engineering and rational drug design Each chapter includes a Summary, Exercies, and References Approximately 300 color images Downloadable solutions manual available at www.crcpress.com For more information, including all presentations, tables, animations, and exercises, as well as a complete teaching course on proteins' structure and function, please visit the author's website: http://ibis.tau.ac.il/wiki/nir_bental/index.php/Introduction_to_Proteins_Book. Praise for the first edition "This book captures, in a very accessible way, a growing body of literature on the structure, function and motion of proteins. This is a superb publication that would be very useful to undergraduates, graduate students, postdoctoral researchers, and instructors involved in structural biology or biophysics courses or in research on protein structure-function relationships." --David Sheehan, ChemBioChem, 2011 "Introduction to Proteins is an excellent, state-of-the-art choice for students, faculty, or researchers needing a monograph on protein structure. This is an immensely informative, thoroughly researched, up-to-date text, with broad coverage and remarkable depth. Introduction to Proteins would provide an excellent basis for an upper-level or graduate course on protein structure, and a valuable addition to the libraries of professionals interested in this centrally important field." --Eric Martz, Biochemistry and Molecular Biology Education, 2012
Download or read book Biological Drug Products written by Wei Wang and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Download or read book Handbook of Research on Systems Biology Applications in Medicine written by Daskalaki, Andriani and published by IGI Global. This book was released on 2008-11-30 with total page 982 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book highlights the use of systems approaches including genomic, cellular, proteomic, metabolomic, bioinformatics, molecular, and biochemical, to address fundamental questions in complex diseases like cancer diabetes but also in ageing"--Provided by publisher.
Download or read book The Handbook of Biological Therapy written by Bruce Kirkham and published by OUP Oxford. This book was released on 2008-11-27 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drugs produced by molecular biological techniques, called the 'biologics', differ from the usual chemical medications. Their optimum use, and the detection and managemenet of adverse events, pose a significant challenge to the clinician. Licences for new biologics continue to be granted for the likes of rituximab, abatacept and certocizumals pegol. Intensive research is also defining new areas in which these drugs will be used in the future, increasing the number of practitioners using biologics. As the use of these drugs increases around the world, so the level of information needed by primary care practitioners and specialist prescribers needs to be expanded The Handbook of Biological Therapy provides the practising clinician with a practica guide to the use of Tumour Necrosis Factor Blocking Therapy (TNF-blockers), and important new class of biologic therapy for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis. It is a comprehensive distillation of the authors' clinical experience with these drugs, combined with data from diverse databases offering practical advice on their uses, specific indications, supporting clinical trial data and safety issues, with the aim of making the use of these drugs easier for the busy clinician. All of the authors have been involved from the beginnings of the clinical trial programmes with these drugs and continue to use them in daily practice.
Download or read book Handbook of Biologically Active Peptides written by Abba Kastin and published by Elsevier. This book was released on 2011-04-28 with total page 1682 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptides play a crucial role in many physiological processes including actions as neurotransmitters, hormones, and antibiotics. Research has shown their importance in such fields as neuroscience, immunology, pharmacology, and cell biology. The Handbook of Biologically Active Peptides presents, for the first time, this tremendous body of knowledge in the field of biologically active peptides in one single reference. The section editors and contributors represent some of the most sophisticated and distinguished scientists working in basic sciences and clinical medicine. The Handbook of Biologically Active Peptides is a definitive, all-encompassing reference that will be indispensable for individuals ranging from peptide researchers, to biochemists, cell and molecular biologists, neuroscientists, pharmacologists, and to endocrinologists. Chapters are designed to be a source for workers in the field and will enable researchers working in a specific area to examine other related areas with which they would not ordinarily be familiar. *Chapters are designed to be a source for workers in the field and will enable researchers working in a specific area to examine other related areas that they would not ordinarily be familiar.*Fascinating relationships described in the book include the presence of some peptides originally found in frog skin that persist in the human human and brain where they can affect food intake and obesity.
Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Download or read book Handbook of Drug Metabolism Third Edition written by Paul G. Pearson and published by CRC Press. This book was released on 2019-05-20 with total page 755 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition.
Download or read book Protocol Handbook for Cancer Biology written by Gauri Misra and published by Academic Press. This book was released on 2021-02-12 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Protocol Handbook for Cancer Biology brings together a comprehensive collection of the methods used for cancer assessment, diagnostics, and therapeutics. Various protocols are discussed along with alternative strategies, including the advantages and limitations of techniques that have been used in labs globally. These protocols are presented by cancer biology experts based on their real-world experience. The protocols in this book will be a valuable resource for cancer researchers and graduate students, who can utilize the techniques described to conduct research more efficiently and successfully. Presents comprehensive protocols used for cancer assessment, diagnostics, and therapeutics all in one place Encompasses alternative strategies considering the requirements of the end user and taking into consideration diverse research settings Discusses limitations and advantages of each method in experimental design and execution, thus saving time during the research process
