Download or read book Drying Technologies for Biotechnology and Pharmaceutical Applications written by Satoshi Ohtake and published by John Wiley & Sons. This book was released on 2020-02-10 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Freeze Drying Lyophilization Of Pharmaceutical Biological Products Revised and Expanded written by Louis Rey and published by CRC Press. This book was released on 2004-01-21 with total page 634 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.

Download or read book Freeze drying of Pharmaceuticals and Biopharmaceuticals written by Felix Franks and published by Royal Society of Chemistry. This book was released on 2008 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aimed at product and process developers in the biopharmaceutical industry and academia, this is the first book to describe freeze-drying, as related to the pharmaceutical industry.

Download or read book Freeze Drying of Pharmaceutical and Food Products written by Tse-Chao Hua and published by Elsevier. This book was released on 2010-07-30 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: Freeze-drying is an important preservation technique for heat-sensitive pharmaceuticals and foods. Products are first frozen, then dried in a vacuum at low temperature by sublimation and desorption, rather than by the application of heat. The resulting items can be stored at room temperature for long periods. This informative text addresses both principles and practice in this area.The first chapter introduces freeze-drying. The authors then review the fundamentals of the technique, heat-mass transfer analyses, modelling of the drying process and the equipment employed. Further chapters focus on freeze-drying of food, freeze-drying of pharmaceuticals and the protective agents and additives applied. The final chapter covers the important subjects of disinfection, sterilization and process validation.Freeze-drying of pharmaceutical and food products is an essential reference for food, pharmaceutical and refrigeration engineers and scientists with an interest in preservation techniques. It will also be of use to students in these fields. - Addresses the principles and practices used in this important preservation technique - Explains the fundamentals of heat-mass transfer analysis, modelling and the equipment used - Discusses the importance of disinfection, sterilization and process validation

Download or read book Handbook of Drying for Dairy Products written by C. Anandharamakrishnan and published by John Wiley & Sons. This book was released on 2017-02-07 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Drying for Dairy Products is a complete guide to the field’s principles and applications, with an emphasis on best practices for the creation and preservation of dairy-based food ingredients. Details the techniques and results of drum drying, spray drying, freeze drying, spray-freeze drying, and hybrid drying Contains the most up-to-date research for optimizing the drying of dairy, as well as computer modelling options Addresses the effect of different drying techniques on the nutritional profile of dairy products Provides essential information for dairy science academics as well as technologists active in the dairy industry

Download or read book Cryopreservation and Freeze Drying Protocols written by John G. Day and published by Springer Science & Business Media. This book was released on 2007-06-05 with total page 703 pages. Available in PDF, EPUB and Kindle. Book excerpt: In addition to outlining the fundamental principles associated with the conservation of biological resources, freeze-drying and cryopreservation, this text is a compilation of cryptopreservation and freeze-drying methodologies applicable to different biological materiels, developed by expert laboratories.

Download or read book Freeze Drying of Pharmaceutical Products written by Davide Fissore and published by CRC Press. This book was released on 2019-10-24 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Lyophilized Biologics and Vaccines written by Dushyant Varshney and published by Springer. This book was released on 2015-05-19 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Download or read book Lyophilization of Biopharmaceuticals written by Henry R. Costantino and published by Springer Science & Business Media. This book was released on 2005-12-05 with total page 726 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Advanced Drying Technologies written by Tadeusz Kudra and published by CRC Press. This book was released on 2009-02-11 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents Drying Breakthroughs for an Array of Materials Despite being one of the oldest, most energy-intensive unit operations, industrial drying is perhaps the least scrutinized technique at the microscopic level. Yet in the wake of today’s global energy crisis, drying research and development is on the rise. Following in the footsteps of the widely read first edition, Advanced Drying Technologies, Second Edition is the direct outcome of the recent phenomenal growth in drying literature and new drying hardware. This edition provides an evaluative overview of new and emerging drying technologies, while placing greater emphasis on making the drying process more energy efficient in the green age. Draws on the Authors’ 60+ Years of Combined Experience Fueled by the current energy crisis and growing consumer demand for improved quality products, this thoroughly updated resource addresses cutting-edge drying technologies for numerous materials such as high-valued, heat-sensitive pharmaceuticals, nutraceuticals, and some foods. It also introduces innovative techniques, such as heat-pump drying of foods, which allow both industrial practice and research and development projects to save energy, reduce carbon footprints, and thus improve the bottom line. Four New Chapters: Spray-Freeze-Drying Fry Drying Refractance Window Drying Mechanical Thermal Expression Requiring no prior knowledge of chemical engineering, this single-source reference should assist researchers in turning the laboratory curiosities of today into the revolutionary novel drying technologies of tomorrow.

Download or read book Advances in Freeze drying written by Louis Rey and published by . This book was released on 1966 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Development of Biopharmaceutical Drug Device Products written by Feroz Jameel and published by Springer. This book was released on 2021-08-26 with total page 893 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Innovative Food Processing Technologies written by and published by Elsevier. This book was released on 2020-08-18 with total page 2482 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food process engineering, a branch of both food science and chemical engineering, has evolved over the years since its inception and still is a rapidly changing discipline. While traditionally the main objective of food process engineering was preservation and stabilization, the focus today has shifted to enhance health aspects, flavour and taste, nutrition, sustainable production, food security and also to ensure more diversity for the increasing demand of consumers. The food industry is becoming increasingly competitive and dynamic, and strives to develop high quality, freshly prepared food products. To achieve this objective, food manufacturers are today presented with a growing array of new technologies that have the potential to improve, or replace, conventional processing technologies, to deliver higher quality and better consumer targeted food products, which meet many, if not all, of the demands of the modern consumer. These new, or innovative, technologies are in various stages of development, including some still at the R&D stage, and others that have been commercialised as alternatives to conventional processing technologies. Food process engineering comprises a series of unit operations traditionally applied in the food industry. One major component of these operations relates to the application of heat, directly or indirectly, to provide foods free from pathogenic microorganisms, but also to enhance or intensify other processes, such as extraction, separation or modification of components. The last three decades have also witnessed the advent and adaptation of several operations, processes, and techniques aimed at producing high quality foods, with minimum alteration of sensory and nutritive properties. Some of these innovative technologies have significantly reduced the thermal component in food processing, offering alternative nonthermal methods. Food Processing Technologies: A Comprehensive Review, Three Volume Set covers the latest advances in innovative and nonthermal processing, such as high pressure, pulsed electric fields, radiofrequency, high intensity pulsed light, ultrasound, irradiation and new hurdle technology. Each section will have an introductory article covering the basic principles and applications of each technology, and in-depth articles covering the currently available equipment (and/or the current state of development), food quality and safety, application to various sectors, food laws and regulations, consumer acceptance, advancements and future scope. It will also contain case studies and examples to illustrate state-of-the-art applications. Each section will serve as an excellent reference to food industry professionals involved in the processing of a wide range of food categories, e.g., meat, seafood, beverage, dairy, eggs, fruits and vegetable products, spices, herbs among others.

Download or read book Freeze drying of Foods written by Geraldine Antoinette Corridon and published by . This book was released on 1963 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Advances in Food Dehydration written by Cristina Ratti and published by CRC Press. This book was released on 2008-11-21 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive Assessment of This Globally Relevant Practice As a centuries-old food preservation method, dehydration technology has advanced significantly in the past decades as a result of new methods, sophisticated analytical techniques, and improved mathematical modeling. Providing practical and expert insight from an international panel of expe

Download or read book Therapeutic Dressings and Wound Healing Applications written by Joshua Boateng and published by John Wiley & Sons. This book was released on 2020-03-09 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest research on techniques for effective healing of chronic and difficult to heal wounds The healing of chronic wounds is a global medical concern, specifically for patients suffering from obesity and type II diabetes. Therapeutic Dressing and Wound Healing Applications is an essential text for research labs, industry professionals, and general clinical practitioners that want to make the shift towards advanced therapeutic dressing and groundbreaking wound application for better healing. This book takes a clinical and scientific approach to wound healing, and includes recent case studies to highlight key points and areas of improvement. It is divided into two key sections that include insight into the biochemical basis of wounds, as well as techniques and recent advancements. Chapters include information on: ● Debridement and disinfection properties of wound dressing ● Biofilms, silver nanoparticles, and honey dressings ● Clinical perspectives for treating diabetic wounds ● Treating mixed infections ● Wound healing and tissue regeneration treatments ● Gene based therapy, 3D bioprinting and freeze-dried wafers Anyone looking to update and improve the treatment of chronic wounds for patients will find the latest pertinent information in Therapeutic Dressing and Wound Healing Applications.

Download or read book Development and Manufacture of Protein Pharmaceuticals written by Steve L. Nail and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.