Process Validation in Manufacturing of Biopharmaceuticals, Rathore, Anurag S.
Новое издание
Автор: Edited By Anurag Singh Rathore, Hal Baseman, Scott Название: Process Validation in Manufacturing of Biopharmaceuticals ISBN: 0367697629 ISBN-13(EAN): 9780367697624 Издательство: Taylor&Francis Цена: 26796.00 р. Наличие на складе: Есть у поставщикаПоставка под заказ.
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field
Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature--and it's rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements.
Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future.
Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO--especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions
Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies
Includes many diagrams that clarify the design approach
Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
Описание: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
Описание: Master the design and operation of perfusion cell cultures with this authoritative reference. A perfect resource for groups active in the cell culture field, as well as graduate students in areas such as chemical engineering, biotechnology, chemistry and biology.
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: G. Walsh; B. Murphy Название: Biopharmaceuticals, an Industrial Perspective ISBN: 9048152372 ISBN-13(EAN): 9789048152377 Издательство: Springer Рейтинг: Цена: 36570.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides a unique and up-to-date insight into the biopharmaceutical industry. Largely written by industrial authors, its scope is multidisciplinary, rendering it an ideal reference source for students undertaking advanced undergraduate or postgraduate courses in biotechnology, pharmaceutical science, biochemistry, or medicine.
Описание: Preparative Chromatography for Separation of Proteins addresses a wide range of the most current modeling techniques, strategies, and case studies of industrial separation of proteins and peptides to aid in the efficiency and efficacy of this broadly-used technique in the purification 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.
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.
Автор: Cavagnaro, Joy A. Название: Translational Medicine ISBN: 0367644274 ISBN-13(EAN): 9780367644277 Издательство: Taylor&Francis Рейтинг: Цена: 26030.00 р. Наличие на складе: Поставка под заказ.
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: 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).
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