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Author: Wei Wang
Publisher: John Wiley & Sons
ISBN: 1118695224
Category : Medical
Languages : en
Pages : 531
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Book Description
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.
Author: Wei Wang
Publisher: John Wiley & Sons
ISBN: 1118695224
Category : Medical
Languages : en
Pages : 531
Get Book Here
Book Description
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.
Author: José M Alvarez-Suarez
Publisher: Springer
ISBN: 3319596896
Category : Medical
Languages : en
Pages : 301
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Book Description
This book presents an updated discussion of the chemical composition and biological properties of the main bee products. Specific attention is focused on the beneficial biological activities of bee products in human health. Honey, royal jelly, propolis, bee pollen and bee venom are used as nutriment and in traditional medicine. Their composition is rather variable and depends on the floral source and external factors, such as seasonal, environmental conditions and processing. Bee products are rich in several essential nutrients and non essential nutrients, as sugars, minerals, proteins, free amino acids, vitamins, enzymes and polyphenols, that seem to be closely related to their biological functions. The effects of these products in nutrition, aging and age-related diseases, cancer, neurodegenerative diseases and pathogen infections are discussed.
Author: Lokesh Bhattacharyya
Publisher: John Wiley & Sons
ISBN: 0470467096
Category : Medical
Languages : en
Pages : 484
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Book Description
This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. This book, with contributors from academia, pharma, the biotech industry, and instrument manufacturing, presents the different perspectives, experience, and expertise of the thought leaders of IC in a comprehensive manner. It explores potential IC applications in different aspects of product development and quality control testing. In addition, an appendix section gives information on critical physical and chromatographic parameters related to IC and information on current manufacturers of IC systems, columns, and other components.
Author: Marco Rito-Palomares
Publisher: Springer
ISBN: 3319593099
Category : Technology & Engineering
Languages : en
Pages : 196
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Book Description
This comprehensive and unique text presents a full overview of downstream processing useful for those new to the concept as well as professionals with experience in the area. The history and theoretical principles of Aqueous Two-Phase Systems (ATPS) are covered in depth. Information on ATPS characterization and application is included, and ATPS equilibria and system parameters that have significant effect on partition behavior are studied. Aqueous Two-Phase Systems for Bioprocess Development for the Recovery of Biological Products addresses specific applications of ATPS for the recovery and partial purification of high molecular weight compounds such as proteins, nucleic acids and polysaccharides, particulate bioproducts such as cells and organelles and low molecular weight compounds. Non-conventional strategies involving ATPS such as affinity systems, continuous liquid-liquid fractionation stages and the recovery from plant extracts are presented. Economic analysis of the application of ATPS in comparison to other fractionation techniques, particularly liquid chromatography, is considered, as are opportunity and current trends in the ATPS research area. Each chapter utilizes the contributors' experimental expertise in traditional and non-conventional ATPS strategies, as well as analysis of areas of opportunity and perspectives on the development and future applications of ATPS in both the lab and larger scale operations. The result is a thorough and singular overview of ATPS which has not been matched by any other text on the market.
Author:
Publisher: Elsevier
ISBN: 0081026919
Category : Science
Languages : en
Pages : 4266
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Book Description
Comprehensive Natural Products III, Third Edition, Seven Volume Set updates and complements the previous two editions, including recent advances in cofactor chemistry, structural diversity of natural products and secondary metabolites, enzymes and enzyme mechanisms and new bioinformatics tools. Natural products research is a dynamic discipline at the intersection of chemistry and biology concerned with isolation, identification, structure elucidation, and chemical characteristics of naturally occurring compounds such as pheromones, carbohydrates, nucleic acids and enzymes. This book reviews the accumulated efforts of chemical and biological research to understand living organisms and their distinctive effects on health and medicine and to stimulate new ideas among the established natural products community. Provides readers with an in-depth review of current natural products research and a critical insight into the future direction of the field Bridges the gap in knowledge by covering developments in the field since the second edition published in 2010 Split into 7 sections on key topics to allow students, researchers and professionals to find relevant information quickly and easily Ensures that the knowledge within is easily understood by and applicable to a large audience
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: Louis Rey
Publisher: CRC Press
ISBN: 0203021320
Category : Medical
Languages : en
Pages : 634
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Book Description
Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.
Author: Ronald P. Evens
Publisher: Springer Science & Business Media
ISBN: 0387329781
Category : Medical
Languages : en
Pages : 394
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Book Description
This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.
Author:
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144
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Book Description
Author: Daan J.A. Crommelin
Publisher: Springer
ISBN: 3319162411
Category : Medical
Languages : en
Pages : 390
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Book Description
The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.
