Continuous Biopharmaceutical Processes: Chromatography, Bioconjugation, and Protein Stability, David Pfister, Lucrece Nicoud, Massimo Morbidelli

Автор: Bolgar Mark S.
Название: Mass Spectrometry in Biopharmaceutical and Emerging Drug Modalities
ISBN: 1782629750 ISBN-13(EAN): 9781782629757
Издательство: Royal Society of Chemistry
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Цена: 223870.00 T
Наличие на складе: Невозможна поставка.
Описание: The focus of this book is on the use of mass spectrometry (MS) for the assessment of alternative modes of drug efficacy and inclusion of information on the use of MS in the development of protein biosimilars.

Автор: Avis
Название: Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation
ISBN: 1574910167 ISBN-13(EAN): 9781574910162
Издательство: Taylor&Francis
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Цена: 357280.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Describes practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, this book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques.

Автор: Chin Jane Y., Chin J. Y.
Название: Practical Leadership for Biopharmaceutical Executives
ISBN: 0081017332 ISBN-13(EAN): 9780081017333
Издательство: Elsevier Science
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Цена: 134610.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity.

• Focuses on personal leadership, where the executive has an opportunity to manage his/her own effectiveness as a leader and manager, and engage with their own career development and method of contribution within their chosen industry
• Discusses particularly the unique leadership challenges in biohealthcare: an industry that is at once highly innovative and emotive. Biohealthcare companies are often viewed with suspicion by the consumers who question corporate motives, and product marketing and sales practices. The effective biohealthcare leaders are well aware of these emotive features, and embody ethics through action - not just lip service
• Includes real life examples, including a series of both phone-based and email-based interviews of executives

Автор: Feroz Jameel; Susan Hershenson; Mansoor A. Khan; S
Название: Quality by Design for Biopharmaceutical Drug Product Development
ISBN: 1493951521 ISBN-13(EAN): 9781493951529
Издательство: Springer
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Цена: 204970.00 T
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Описание: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Автор: Niall Barron
Название: MicroRNAs as Tools in Biopharmaceutical Production
ISBN: 9400795262 ISBN-13(EAN): 9789400795266
Издательство: Springer
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Цена: 104480.00 T
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Описание: This book explores the uses of MicroRNAs in bioprocessing, especially in production of complex proteins in mammalian cells. Covers genomic organization, biogenesis and mode of action; miRNAs as biomarkers; manipulation of expression in cultured cells and more.

Автор: Feroz Jameel; Susan Hershenson; Mansoor A. Khan; S
Название: Quality by Design for Biopharmaceutical Drug Product Development
ISBN: 1493923153 ISBN-13(EAN): 9781493923151
Издательство: Springer
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Цена: 204970.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development.