Warning: Trying to access array offset on false in E:\WWW\html\user.php on line 119 John Geigert The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 9783031319112
Описание: In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed.
Описание: Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: * Updates real-world CMC deficiency examples with current examples; * Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; * Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Описание: Fiona McFarlane`s blazingly brilliant new novel, The Sun Walks Down, tells the many-voiced, many-sided story of a boy lost in colonial Australia.
Автор: Kumar Название: An Introduction to Bioanalysis of Biopharmaceuticals ISBN: 3030971929 ISBN-13(EAN): 9783030971922 Издательство: Springer Рейтинг: Цена: 20733.00 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.
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.
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: Lee, Chi-Jen Название: Clinical Trials of Drugs and Biopharmaceuticals ISBN: 0849321859 ISBN-13(EAN): 9780849321856 Издательство: Taylor&Francis Рейтинг: Цена: 42108.00 р. Наличие на складе: Нет в наличии.
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: Gottschalk Название: Process Scale Purification of Antibodies, Second E dition ISBN: 1119126916 ISBN-13(EAN): 9781119126911 Издательство: Wiley Рейтинг: Цена: 29613.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification.
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 Рейтинг: Цена: 28327.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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