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 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.
Download or read book Heat and Mass Transfer in Drying of Porous Media written by Peng Xu and published by CRC Press. This book was released on 2019-07-16 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: Heat and Mass Transfer in Drying of Porous Media offers a comprehensive review of heat and mass transfer phenomena and mechanisms in drying of porous materials. It covers pore-scale and macro-scale models, includes various drying technologies, and discusses the drying dynamics of fibrous porous material, colloidal porous media and size-distributed particle system. Providing guidelines for mathematical modeling and design as well as optimization of drying of porous material, this reference offers useful information for researchers and students as well as engineers in drying technology, food processes, applied energy, mechanical, and chemical engineering.
Download or read book Process Control of Heat and Mass Transfer in Freeze drying written by Sajal Manubhai Patel and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Principles and Practices of Lyophilization in Product Development and Manufacturing written by Feroz Jameel and published by Springer Nature. This book was released on 2023-04-24 with total page 621 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), 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.
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 Handbook of Industrial Drying written by Arun S. Mujumdar and published by CRC Press. This book was released on 2006-11-08 with total page 1310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Still the Most Complete, Up-To-Date, and Reliable Reference in the FieldDrying is a highly energy-intensive operation and is encountered in nearly all industrial sectors. With rising energy costs and consumer demands for higher quality dried products, it is increasingly important to be aware of the latest developments in industrial drying technolog
Download or read book Handbook of Industrial Drying Fourth Edition written by Arun S. Mujumdar and published by CRC Press. This book was released on 2014-07-11 with total page 1350 pages. Available in PDF, EPUB and Kindle. Book excerpt: By far the most commonly encountered and energy-intensive unit operation in almost all industrial sectors, industrial drying continues to attract the interest of scientists, researchers, and engineers. The Handbook of Industrial Drying, Fourth Edition not only delivers a comprehensive treatment of the current state of the art, but also serves as a consultative reference for streamlining industrial drying operations. New to the Fourth Edition: Computational fluid dynamic simulation Solar, impingement, and pulse combustion drying Drying of fruits, vegetables, sugar, biomass, and coal Physicochemical aspects of sludge drying Life-cycle assessment of drying systems Covering commonly encountered dryers as well as innovative dryers with future potential, the Handbook of Industrial Drying, Fourth Edition not only details the latest developments in the field, but also explains how improvements in dryer design and operation can increase energy efficiency and cost-effectiveness.
Download or read book Freeze Drying Lyophilization of Pharmaceutical and Biological Products written by Louis Rey and published by CRC Press. This book was released on 2016-04-19 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulatio
Download or read book Food Engineering Laboratory Manual written by Gustavo V. Barbosa-Canovas and published by CRC Press. This book was released on 2017-11-13 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: FROM THE PREFACE The purpose of this laboratory manual is to facilitate the understanding of the most relevant unit operations in food engineering. The first chapter presents information on how to approach laboratory experiments; topics covered include safety, preparing for a laboratory exercise, effectively performing an experiment, properly documenting data, and preparation of laboratory reports. The following eleven chapters cover unit operations centered on food applications: dehydration . . . . , thermal processing, friction losses in pipes, freezing, extrusion, evaporation, and physical separations. These chapters are systematically organized to include the most relevant theoretical background pertaining to each unit operation, the objectives of the laboratory exercise, materials and methods . . ., expected results, examples, questions, and references. The experiments presented have been designed for use with generic equipment to facilitate the adoption of this manual . . . .
Download or read book PAT Applied in Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and published by CRC Press. This book was released on 2011-12-07 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Download or read book Encyclopedia of Pharmaceutical Technology written by and published by . This book was released on 1988 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the discovery development,regulation, manufacturing, and commercialization of drugs and dosage forms. Includes pharmaceuticals,pharmacokinetics, analytical chemistry, quality assurance, toxicology and the manufacturing process.
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 201 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 Freeze Drying written by Peter Haseley and published by John Wiley & Sons. This book was released on 2018-05-07 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: This completely updated and enlarged third edition of the classic text adopts a practical approach to describe the fundamentals of freeze-drying, backed by many explanatory examples. Following an introduction to the fundamentals, the book goes on to discuss process and plant automation as well as methods to transfer pilot plant qualifications and process data to production. An entire section is devoted to a large range of different pharmaceutical, biological, and medical products. New to this edition are chapters on antibodies, freeze-dry microscopy, TEMPRIS, microwave freeze-drying, spray freeze-drying, and PAT. Their many years of experience in freeze-drying enable the authors to supply valuable criteria for the selection of laboratory, pilot and production plants, discussing the advantages, drawbacks and limitations of different plant designs. Alongside guidelines for the evaluation and qualification of plants and processes, the author also includes a troubleshooting section.
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 211 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 Parenteral Medications Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 1125 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
