Автор: Jos? das Neves; Bruno Sarmento Название: Mucosal Delivery of Biopharmaceuticals ISBN: 1461495237 ISBN-13(EAN): 9781461495239 Издательство: Springer Рейтинг: Цена: 27950.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Mucosal Delivery of Biopharmaceuticals
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1461469155 ISBN-13(EAN): 9781461469155 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book highlights the challenges facing quality assurance/quality control (QA/QC) in today`s biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing.
Автор: Sergio Rosales-Mendoza Название: Algae-Based Biopharmaceuticals ISBN: 3319322303 ISBN-13(EAN): 9783319322308 Издательство: Springer Рейтинг: Цена: 19591.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book constitutes a key reference on the use of algae in the biopharmaceuticals production field; First, the features of algae as convenient hosts for the production of BFs are analyzed in terms of production costs, biosynthetic capacity, and safety (Chapter 1).
Complexity of Biologics CMC Regulation.- Biopharmaceutics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Biopharmaceutical Source Materials.- Manufacturing of Biopharmaceutical APIs.- Manufacturing of the Drug Product.- Complex Process-Related Impurity Profiles.- Product Characterization is a Journey.- Priceless Potency (Therapeutic Activity).- Quality Attributes of a Biopharmaceutical.- Designing the Stability Program.- The Art of Setting Specifications.- Demonstrating Product Comparability After Process Changes.- Invaluable CMC-Focused Meetings with Regulatory Authorities.
Автор: Kumar Название: An Introduction to Bioanalysis of Biopharmaceuticals ISBN: 3030971929 ISBN-13(EAN): 9783030971922 Издательство: Springer Рейтинг: Цена: 23757.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides. The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.
Автор: Jos? das Neves; Bruno Sarmento Название: Mucosal Delivery of Biopharmaceuticals ISBN: 1489978380 ISBN-13(EAN): 9781489978387 Издательство: Springer Рейтинг: Цена: 23508.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
.-1. Concepts in Mucosal Immunity and Mucosal Vaccines .-Simona Gallorini, Derek T. O'Hagan, Barbara C. Baudner
.-2. Mucoadhesion and Characterization of Mucoadhesive Properties .-Tao Yu, Gavin P. Andrews, David S. Jones
.-3. Mucus as a Barrier for Biopharmaceuticals and Drug Delivery Systems .-Hongbo Zhang, Mohammed-Ali Shahbazi, Patrick Almeida, Hйlder A. Santos
.-4. Epithelial Permeation and Absorption Mechanisms of Biopharmaceuticals .-Hanne M rck Nielsen
.-5. Oral Delivery of Biopharmaceuticals .-Catarina Oliveira Silva, Bruno Sarmento, Catarina Pinto Reis
.-6. Buccal Delivery of Biopharmaceuticals: Vaccines and Allergens .-Sevda Şenel, Merve Cansız, Michael J. Rathbone
.-7. Pulmonary Delivery of Biopharmaceuticals .-Fernanda Andrade, Catarina Moura, Bruno Sarmento
.-8. Nasal Delivery of Biopharmaceuticals .-Eiji Yuba, Kenji Kono
.-9. Ocular Delivery of Biopharmaceuticals .-Holly Lorentz, Heather Sheardown
.-10. Vaginal Delivery of Biopharmaceuticals .-Josй das Neves
.-11. Nanoparticles-in-Microsphere Oral Delivery Systems (NiMOS) for Nucleic Acid Therapy in the Gastrointestinal Tract .-Shardool Jain, Mansoor Amiji
.-12. Bacteria-Based Vectors for Oral Gene Therapy .-Yong Bai, Rachael Burchfield, Sangwei Lu, Fenyong Liu
.-13. Self-Assembled Polysaccharide Nanogels for Nasal Delivery of Biopharmaceuticals .-Tomonori Nochi, Yoshikazu Yuki, Kazunari Akiyoshi, Hiroshi Kiyono
.-14. Pheroid(TM) Vesicles and Microsponges for Nasal Delivery of Biopharmaceuticals .-Lissinda H. du Plessis, Awie F. Kotzй
.-15. Delivery Strategies for Developing siRNA-Based Vaginal Microbicides .-Joseph A Katakowski, Deborah Palliser
.-16. Delivery Strategies for Developing Vaginal DNA Vaccine Combining Cell-Penetrating Peptides and Jet Injection .-Takanori Kanazawa, Hiroaki Okada
.-17. Vaccine Delivery Systems for Veterinary Immunization .-Juan M. Irache, Ana I. Camacho, Carlos Gamazo
.-18. Eligen(R) Technology for Oral Delivery of Proteins and Peptides .-Sunita Prem Victor, Willi Paul, and Chandra P. Sharma
.-19. The RapidMist(TM) System for Buccal Delivery of Insulin .-Meena Bansal, Sanjay Bansal, Rachna Kumria
.-20. The Pharmaceutical Development of rhDNase (Dornase Alpha) for the Treatment of Cystic Fibrosis .-Steven J. Shire, Thomas M. Scherer
.-21. Development of the Exubera(R) Insulin Pulmonary Delivery System .-Cynthia L. Stevenson, David Bennett
.-22. Technosphere(R) An Inhalation System for Pulmonary Delivery of Biopharmaceuticals .-Antуnio J. Almeida, Ana Grenha
.-23. ChiSys(R) as a Chitosan-Based Delivery Platform for Nasal Vaccination .-Peter Watts, Alan Smith, Michael Hinchcliffe
.-24. Development of a Cationic Nanoemulsion Platform (Novasorb(R)) for Ocular Delivery .-Frйdйric Lallemand, Philippe Daull, Jean-Sйbastien Garrigue
.-25. Regulatory Aspects and Approval of Biopharmaceuticals for Mucosal Delivery: Quality, Toxicology and Clinical Aspects .-Karen Brigitta Goetz, Yuansheng Sun, Katrin Fйchir, Evelyne Kretzschmar, Isabel Buettel
Автор: Phuc Van Pham Название: Stem Cell Drugs - A New Generation of Biopharmaceuticals ISBN: 3030075893 ISBN-13(EAN): 9783030075897 Издательство: Springer Рейтинг: Цена: 15372.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This invaluable resource discusses the current revolution in stem cell-based drugs and their potential use in clinical applications. Each chapter is contributed by a pre-eminent scientist in the field. An introductory section presents current stem cell drugs and stem cell-based products and a discussion of production, quality control, mechanisms, and efficacy. Following sections include discussions on stem cell-derived microvesicles based products, and derived exosomes based products.
Stem Cell Drugs - A New Generation of Biopharmaceuticals and the other books in the Stem Cells in Clinical Applications series are invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering. This groundbreaking volume is also essential reading for those researching or studying drug development or pharmaceutical science.
Автор: Behera, Basanta Название: Biopharmaceuticals ISBN: 0815347774 ISBN-13(EAN): 9780815347774 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book highlights how traditional microbial process technology has been upgraded for the production of biologic drugs, and evolution of manufacturing process to meet the global market demand with quality products under the guide lines of internally recognised regulatory bodies.
Автор: Hefferon Название: Biopharmaceuticals in Plants ISBN: 1138114952 ISBN-13(EAN): 9781138114951 Издательство: Taylor&Francis Рейтинг: Цена: 12248.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Transgenic plants present enormous potential to become one of the most cost-effective and safe systems for large-scale production of proteins for industrial, pharmaceutical, veterinary, and agricultural uses. Over the past decade, much progress has been made with respect to the development of vaccines, antibodies, and other therapeutic proteins. Biopharmaceuticals in Plants: Toward the Next Century of Medicine provides a comprehensive survey of all major aspects of the development and production of plant-made biopharmaceuticals.
Accompanied by an exhaustive list of references to facilitate further study, this critical volume:
Describes the theory and practice of modern plant transformation techniques with respect to nuclear and plastic genomes
Outlines the steps involved in the generation of transgenic plants
Discusses the engineering of plant virus expression vectors for transient expression of vaccine proteins and other therapeutics in plant tissue
Addresses the significant role of glycosylation in the production of plant-made mammalian proteins
Investigates the basis of mucosal immunity using plant-based oral vaccines
Examines the scale-up of plant-derived vaccine and therapeutic proteins in entire crops or in large batch cell suspension cultures
Explores the development of clinical trials utilizing plant-derived biopharmaceutical proteins
Evaluates risks and biosafety concerns regarding plant-derived pharmaceuticals
The book concludes with a discussion of the future of plant-based vaccines and other therapeutic proteins with respect to commercial viability and as a tool to improve global public health. Far-reaching in its scope, this text is a baseline reference that students and researchers in a broad range of fields such as medicine, plant science, biotechnology, crop science, natural products chemistry, and engineering will consult regularly. It will also serve as a useful tool for individuals and companies seeking to invest in this dynamic area.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1493943995 ISBN-13(EAN): 9781493943999 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: In its new edition, this book reviews the challenges facing quality assurance and control (QA/QC) in today`s biopharmaceutical environment, putting into perspective the need for a graded approach to QA/QC from early clinical trials through market approval.
The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches to analysis exists, finding the most viable ones would be much easier with a consolidated reference that details the benefits and cost of each approach, with an emphasis on real results and real products.
Explores the Growing Role of Conformational Analysis in Comparing Generic Biopharmaceuticals
Approaches to the Conformational Analysis of Biopharmaceuticals gathers the most useful techniques and methods into a single volume, putting the greatest emphasis on those approaches that have proven the most fruitful. Rather than cover specific uses of techniques in detail, this book provides commercial biotechnologists and researchers with the information and references they need to make good choices about the technology they choose to use. With a large number of references that direct readers to primary source material, it includes studies drawn from the gamut of current literature, covering physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation. It also addresses chemical methods, such as hydrogen-deuterium exchange and trace labeling, along with infrared, ultraviolet, and Raman spectroscopy.
Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information researchers need to access when deciding on the most cost-effective approach, including:
Comparability of biopharmaceuticals
Characterization of follow-on biologics
Quality attributes of protein biopharmaceuticals
Confrontational analysis of biopharmaceutical products
With a clear focus on relevant commercial biotechnology, this book belongs on the shelves of those serious researchers who are paving the way for the next generation of biopharmaceutical polymers.
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