Download or read book Feasibility Evaluation of Single Pass Tangential Flow Filtration Concept for Diafiltration written by Sandra Paola Echeverry and published by . This book was released on 2009 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Evaluation of single pass tangential flow filtration written by and published by . This book was released on with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Countercurrent Staged Diafiltration for Monoclonal Antibody Formulation written by Anirudh Manoj Kumar Nambiar and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: There is significant interest in moving current biomanufacturing operations from traditional batch to continuous processes due to the potential for increased productivity, enhanced product quality, and greater flexibility. Considerable progress has been made in the development of continuous perfusion bioreactors and continuous chromatographic processes. However, the ultrafiltration / diafiltration step, which is currently used for concentration and final formulation of essentially all biotherapeutics, is currently an inherently batch operation. The objective of this project was to examine the feasibility and performance characteristics of a countercurrent staged diafiltration system for continuous protein formulation.Experimental studies were performed using Pall Cadence Inline Concentrators, which are specifically designed for continuous single-pass operation with high conversion (ratio of permeate to feed flow rate greater than 50%). Serum IgG was used as a model protein, with vitamin B12 as a model impurity.Data obtained in a 2-stage system with 90% conversion in each stage provided 98.8% removal of vitamin B12 with essentially 100% recovery of the IgG. Impurity removal was increased to 99.7% by increasing the conversion to 95%. The experimental results were in excellent agreement with model calculations based on the countercurrent staged configuration. 99.99% impurity removal could be achieved with 4 countercurrent stages, while using 40% less buffer due to the internal recycling of the buffer between the stages. These results provide the first demonstration that one can successfully use countercurrent staged diafiltration with single-pass tangential flow filtration modules for the continuous formulation of high value biological products.
Download or read book Microfiltration and Ultrafiltration written by Zeman and published by Routledge. This book was released on 2017-11-22 with total page 654 pages. Available in PDF, EPUB and Kindle. Book excerpt: Integrates knowledge on microfiltration and ultrification, membrane chemistry, and characterization methods with the engineering and economic aspects of device performance, device and module design, processes, and applications. The text provides a discussion of membrane fundamentals and an analytical framework for designing and developing new filtrations systems for a broad range of technologically important functions. It offers information on membrane liquid precursors, fractal and stochastic pore space analysis, novel and advanced module designs, and original process design calculations.
Download or read book Validation of tangential flow filtration in biopharmaceutical applications written by Parenteral Drug Association (Bethesda Md). Biotechnology Task Force on Purification and published by . This book was released on 2009 with total page 49 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Membrane Processes in Biotechnology and Pharmaceutics written by Catherine Charcosset and published by Elsevier. This book was released on 2012-01-25 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: Membrane processes are increasingly used in pharmaceutical and biochemical engineering and biotechnology for concentration and purification, synthesis of molecules and drug delivery systems, and support for biochemical reactions. This book provides a state-of-the art overview of the classical membrane processes used in pharmaceutical and biochemical engineering and biotechnology, such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactors. It describes the general rules (principles, choice of configurations, membranes, parameters, etc.), recent developments (fouling control, increase permeate flux and selectivity, etc.), applications, and theoretical descriptions. Further, it presents emerging processes such as solvent resistant nanofiltration and membrane crystallization. Presents classical membrane processes such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactors Presents emerging processes such as solvent resistant nanofiltration and membrane crystallization Gives a complete description of each technique (principles, membrane materials and devices, fouling control, and theoretical description) Contains numerous examples of applications Includes a uniform notation throughout the book enhancing the presentation and understanding of the content Includes extensive list of references
Download or read book Virus filtration written by Kurt Brorson and published by . This book was released on 2008 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Perfusion Cell Culture Processes for Biopharmaceuticals written by Moritz Wolf and published by Cambridge University Press. This book was released on 2020-08-06 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a monography about perfusion cell cultures for the production of biopharmaceuticals, such as therapeutic proteins (i.e. biomolecules like monoclonal antibodies), and describes the fundamentals, design and operation of these processes. Context is given in the first chapters to understand the state-of-the-art of the technology. We then give an overview of the challenges and objectives in operating mammalian cell perfusion cultures and provide guidelines for the design and setup of lab-scale bioreactor systems, and the required control structure to achieve stable operation. Scale-down devices and PAT tools are described in the context of continuous manufacturing and guidelines for process optimization are given using a variety of case studies to illustrate different approaches. Scale-up is also adressed with a strong focus on bioreactor aeration and mixing, shear stress and cell retention device. Finally, a general introduction for the application of mechanistic and statistic models in bioreactor process development and optimization is given in the last chapter.
Download or read book Ultrafiltration for Bioprocessing written by Herb Lutz and published by Elsevier. This book was released on 2015-02-17 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ultrafiltration for Bioprocessing is key reading for all those involved in the biotechnology and biopharmaceutical areas. Written by a leading worker in the area, it includes many practical applications and case studies in the key process of ultrafiltration (UF), which is used in almost every bioprocess. Focuses on ultrafiltration for biopharmaceuticals—other books look at general ultrafiltration or general biopharmaceuticals A mix of theory and practical applications—other books tend to be more theory-oriented Addresses the main issues encountered in development and scale-up through recommendations and case studies
Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceuticals from Microbes written by Divya Arora and published by Springer. This book was released on 2019-01-09 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book has been assembled with the hope of being an authoritative, comprehensive, conceptually sound and highly informative compilation of recent advances describing the concepts of bioengineering in the field of microbiology. It comprises of seven chapters written by eminent authors in their respective fields. Topics included deal with the significant advancement of microbial technology with emphasis on drug delivery strategies for healthcare products, vaccine delivery, biotransformation approaches to generate new molecules, upstream/downstream processing of biopharmaceuticals. It serves as excellent reference material for researchers, students and academicians in the fields of biotechnology, microbiology and pharmaceutical sciences.
Download or read book Approaches to the Purification Analysis and Characterization of Antibody Based Therapeutics written by Allan Matte and published by Elsevier. This book was released on 2020-09-07 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography
Download or read book Membranes for Food Applications written by Klaus-Viktor Peinemann and published by John Wiley & Sons. This book was released on 2011-08-04 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Edited by an internationally recognized leader in the field, this third volume in the series represents the complete reference to membrane processes in the food industry. The handbook adopts a highly practical approach to this hot topic, combining the hands-on experience of the expert authors involved. They provide chapters devoted to such varied applications as dairy fractionation, electrodialysis, pressure-driven membrane processes in alcoholic beverages, membrane emulsification, contactors and bioreactors, as well as membranes for food packaging.
Download or read book Bioprocess Engineering Principles written by Pauline M. Doran and published by Elsevier. This book was released on 1995-04-03 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emergence and refinement of techniques in molecular biology has changed our perceptions of medicine, agriculture and environmental management. Scientific breakthroughs in gene expression, protein engineering and cell fusion are being translated by a strengthening biotechnology industry into revolutionary new products and services. Many a student has been enticed by the promise of biotechnology and the excitement of being near the cutting edge of scientific advancement. However, graduates trained in molecular biology and cell manipulation soon realise that these techniques are only part of the picture. Reaping the full benefits of biotechnology requires manufacturing capability involving the large-scale processing of biological material. Increasingly, biotechnologists are being employed by companies to work in co-operation with chemical engineers to achieve pragmatic commercial goals. For many years aspects of biochemistry and molecular genetics have been included in chemical engineering curricula, yet there has been little attempt until recently to teach aspects of engineering applicable to process design to biotechnologists. This textbook is the first to present the principles of bioprocess engineering in a way that is accessible to biological scientists. Other texts on bioprocess engineering currently available assume that the reader already has engineering training. On the other hand, chemical engineering textbooks do not consider examples from bioprocessing, and are written almost exclusively with the petroleum and chemical industries in mind. This publication explains process analysis from an engineering point of view, but refers exclusively to the treatment of biological systems. Over 170 problems and worked examples encompass a wide range of applications, including recombinant cells, plant and animal cell cultures, immobilised catalysts as well as traditional fermentation systems. * * First book to present the principles of bioprocess engineering in a way that is accessible to biological scientists * Explains process analysis from an engineering point of view, but uses worked examples relating to biological systems * Comprehensive, single-authored * 170 problems and worked examples encompass a wide range of applications, involving recombinant plant and animal cell cultures, immobilized catalysts, and traditional fermentation systems * 13 chapters, organized according to engineering sub-disciplines, are groupled in four sections - Introduction, Material and Energy Balances, Physical Processes, and Reactions and Reactors * Each chapter includes a set of problems and exercises for the student, key references, and a list of suggestions for further reading * Includes useful appendices, detailing conversion factors, physical and chemical property data, steam tables, mathematical rules, and a list of symbols used * Suitable for course adoption - follows closely curricula used on most bioprocessing and process biotechnology courses at senior undergraduate and graduate levels.
Download or read book Fermentation and Biochemical Engineering Handbook written by Henry C. Vogel and published by William Andrew. This book was released on 1996-12-31 with total page 831 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a well-rounded handbook of fermentation and biochemical engineering presenting techniques for the commercial production of chemicals and pharmaceuticals via fermentation. Emphasis is given to unit operations fermentation, separation, purification, and recovery. Principles, process design, and equipment are detailed. Environment aspects are covered. The practical aspects of development, design, and operation are stressed. Theory is included to provide the necessary insight for a particular operation. Problems addressed are the collection of pilot data, choice of scale-up parameters, selection of the right piece of equipment, pinpointing of likely trouble spots, and methods of troubleshooting. The text, written from a practical and operating viewpoint, will assist development, design, engineering and production personnel in the fermentation industry. Contributors were selected based on their industrial background and orientation. The book is illustrated with numerous figures, photographs and schematic diagrams.
Download or read book Bioseparations Science and Engineering written by Roger G. Harrison and published by Oxford University Press. This book was released on 2015-01-27 with total page 577 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed for undergraduates, graduate students, and industry practitioners, Bioseparations Science and Engineering fills a critical need in the field of bioseparations. Current, comprehensive, and concise, it covers bioseparations unit operations in unprecedented depth. In each of the chapters, the authors use a consistent method of explaining unit operations, starting with a qualitative description noting the significance and general application of the unit operation. They then illustrate the scientific application of the operation, develop the required mathematical theory, and finally, describe the applications of the theory in engineering practice, with an emphasis on design and scaleup. Unique to this text is a chapter dedicated to bioseparations process design and economics, in which a process simular, SuperPro Designer® is used to analyze and evaluate the production of three important biological products. New to this second edition are updated discussions of moment analysis, computer simulation, membrane chromatography, and evaporation, among others, as well as revised problem sets. Unique features include basic information about bioproducts and engineering analysis and a chapter with bioseparations laboratory exercises. Bioseparations Science and Engineering is ideal for students and professionals working in or studying bioseparations, and is the premier text in the field.
