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Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527341129
Category : Medical
Languages : en
Pages : 394
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Book Description
A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527341129
Category : Medical
Languages : en
Pages : 394
Get Book Here
Book Description
A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Author: Feroz Jameel
Publisher: Springer Nature
ISBN: 3030314154
Category : Medical
Languages : en
Pages : 888
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Book Description
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) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.
Author: Davide Fissore
Publisher: CRC Press
ISBN: 042966401X
Category : Medical
Languages : en
Pages : 212
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Book Description
Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.
Author: S. Padma Ishwarya
Publisher: CRC Press
ISBN: 1000571459
Category : Medical
Languages : en
Pages : 361
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Book Description
Spray-freeze-drying (SFD) is a synergistic drying technology that imbibes in it the merits of both spray drying and freeze-drying, whilst overcoming the limitations of these predecessor technologies. SFD produces uniquely powdered food and pharmaceutical products with porous microstructure and superior quality attributes. Owing to its atomization step and ultra-low-temperature operation, SFD is a competent drying technique for the production of valuable but sensitive bioactive components. Despite the costs and complexities involved, SFD has a competitive edge over the conventional drying techniques in providing distinctive product attributes. The applications of spray-freeze-drying in the area of food and bioproducts span across the product categories of instant food powders, dry flavors, active pharmaceutical ingredients, poorly water-soluble drugs, probiotics, proteins, enzymes and vaccines. Spray-Freeze-Drying of Foods and Bioproducts: Theory, Applications and Perspectives is the first exclusive title on this interesting drying technique. It provides a comprehensive understanding of the fundamentals of SFD and its food and pharmaceutical applications. The scope of this book, comprising 12 chapters, has been organizedunder four major headings: fundamentals of process-stages, applications with case-studies, recent advancements and the processing bottlenecks and solutions. Key Features Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics and flavors Serves as a ready-reckoner of characterization methods for spray-freeze-dried products Contains 200+ illustrations and tabulations The contents of this book are organized to cater to the knowledge needs of students, academicians, researchers and professionals in the food and pharmaceutical industry.
Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527802096
Category : Medical
Languages : en
Pages : 398
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Book Description
A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Author: Bhagyalakshmi Neelwarne
Publisher: Springer Science & Business Media
ISBN: 1461434580
Category : Technology & Engineering
Languages : en
Pages : 443
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Book Description
Biotechnology is a rapidly growing research area which is immediately translated into industrial applications. Although over 1000 research papers have emerged on various aspects of red beet and the chemistry of betalaines pigments, surprisingly no comprehensive book is available. The proposed Red Beet book encompasses a scholarly compilation of recent biotechnological research developments made in basic science, biochemistry of the chief components, technological developments in augmenting and recovery of such useful compounds and value-added products with discussions on future perspectives. The book will provide detailed information of the chemistry of the main components of normal and genetically engineered beetroot.
Author: Jorge del Real Olvera
Publisher: Intechopen
ISBN: 9535125664
Category : Technology & Engineering
Languages : en
Pages : 106
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Book Description
Introductory Chapter: Principles of Sustainable Drying.
Author: Henry R. Costantino
Publisher: Springer Science & Business Media
ISBN: 9780971176768
Category : Medical
Languages : en
Pages : 726
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Book Description
Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.
Author: Wenkui Li
Publisher: John Wiley & Sons
ISBN: 1118890892
Category : Science
Languages : en
Pages : 711
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Book Description
An informative and comprehensive book on the applications and techniques of dried blood spot sampling Dried blood spot (DBS) sampling involves the collection of a small volume of blood, via a simple prick or other means, from a study subject onto a cellulose or polymer paper card, which is followed by drying and transfer to the laboratory for analysis. For many years, this method of blood sample collection has been extensively utilized in some important areas of human healthcare (for example, newborn screening for inherited metabolic disorders and HIV-related epidemiological studies). Because of its advantages over conventional blood, plasma, or serum sample collection, DBS sampling has been valued by the pharmaceutical industry in drug research and development. Dried Blood Spots: Applications and Techniques features contributions from an international team of leading scientists in the field. Their contributions present a unique resource on the history, principles, procedures, methodologies, applications, and emerging technologies related to DBS. Presented in three parts, the book thoroughly examines: Applications of DBS sampling and associated procedures and methodologies in various human healthcare studies Applications and perspectives of DBS sampling in drug research and development, and therapeutic drug monitoring New technologies and emerging applications related to DBS sampling and analysis Dried Blood Spots: Applications and Techniques is a valuable working guide for researchers, professionals, and students in healthcare, medical science, diagnostics, clinical chemistry, and pharmaceuticals, etc.
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128163720
Category : Medical
Languages : en
Pages : 450
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Book Description
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies
