How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
Discusses the development of strategy blueprints in the design of continuous processes
Shows how to create process flowsheet models from individual unit operation models
Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases
Covers the evolving regulatory expectations for continuous manufacturing
Provides readers with ways to more effectively navigate these expectations
Автор: Amit Singh Название: Stimuli-Responsive Drug Delivery Systems ISBN: 1788011139 ISBN-13(EAN): 9781788011136 Издательство: Royal Society of Chemistry Рейтинг: Цена: 25186.00 р. Наличие на складе: Поставка под заказ.
Описание: This book provides a comprehensive account on the design, materials chemistry, and application aspects behind these novel stimuli-responsive materials.
Описание: Implantable Technologies: Pepties and Biologic Drug Development is an ideal reference for any postgraduate or researcher interested in utilising implantable technologies and novel routes of drug administration.
Автор: Akers, Michael J. Название: Sterile Drug Products ISBN: 0849339936 ISBN-13(EAN): 9780849339936 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
Автор: Sharp, John Название: Good Pharmaceutical Manufacturing Practice ISBN: 0849319943 ISBN-13(EAN): 9780849319945 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on “Preservation of Biologicals” comprised of nine chapters written by experts and including case studies.
Описание: This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.
Автор: Groves Название: Aseptic Pharmaceutical Manufacturing II ISBN: 0935184775 ISBN-13(EAN): 9780935184778 Издательство: Taylor&Francis Рейтинг: Цена: 52826.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. This book covers aseptic technology, developments, and applications and helps in understanding the issues involved in aseptic manufacture.
Автор: LeBlanc, Destin A. Название: Cleaning Validation ISBN: 1032430834 ISBN-13(EAN): 9781032430836 Издательство: Taylor&Francis Рейтинг: Цена: 10411.00 р. Наличие на складе: Нет в наличии.
Описание: Explores, through innovative studies, case studies, systematic literature reviews, and reports, the key developments in digital entrepreneurship, circular economy and digitalization, digital business models, digital marketing and internationalization, digital economy, digital learning, trends and challenges, and digital entrepreneurial ecosystems.
Автор: Kolpakov, A. A. Kolpakov, A. G. Название: Active pharmaceutical ingredients ISBN: 1439803366 ISBN-13(EAN): 9781439803363 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Active Pharmaceutical Ingredients
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