Download or read book Bioseparation and Bioprocessing Volume I Biochromatography Membrane Separations Modeling Validation Volume II Processing Quality and Characterisation Economics Safety and Hygiene written by G. Subramanian and published by Wiley-VCH. This book was released on 1998 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rapid developments in biotechnology create a demand for practical, up-to-date reviews written by and for experts in industry. This compact handbook provides all relevant up-to-date information on important bioseparation and bioprocessing techniques that are actively applied in the biotechnology industries. The handbook presents an applications-orientated overview on - case studies and general strategies for quality control and characterization - detailed guidelines on developing economic and technically feasible bioseparation schemes - strategies and methods for intracellular bioproduct release - chromatographic and membrane downstream processes used in biotechnology - applications of modern non-invasive methods such as neural networks for on-line estimation and control of fermentation variables on an industrial scale - a practical, commercially-relevant guide to biosafety and many more aspects which are indispensible for present and future industrial success.

Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2016-01-05 with total page 612 pages. Available in PDF, EPUB and Kindle. Book excerpt: What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set th

Download or read book Bioseparation and Bioprocessing Biochromatography membrane separations modeling validation written by G. Subramanian and published by . This book was released on 1998 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Bioseparation and Bioprocessing Processing quality and characterization economics safety and hygiene written by G. Subramanian and published by . This book was released on 1998 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Process Validation in Manufacturing of Biopharmaceuticals Third Edition written by Anurag S. Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Download or read book Process Scale Bioseparations for the Biopharmaceutical Industry written by Abhinav A. Shukla and published by CRC Press. This book was released on 2006-07-07 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceut

Download or read book Handbook of Process Chromatography written by Gunter Jagschies and published by Elsevier. This book was released on 2007-12-08 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems New topics include: - the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design

Download or read book Bioseparation and Bioprocessing written by Ganapathy Subramanian and published by Wiley-VCH. This book was released on 2007-11-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this new edition of the only resource to systematically cover all post-production issues, over 70% of the content is new or rewritten in line with the rapidly evolving technology in the field. By combining the experience of academic experts, managers from the pharmaceutical and biotech industry, as well as independent consultants, biological product recovery is viewed from every possible angle, including biosafety and regulatory issues.

Download or read book Chromatographic and Membrane Processes in Biotechnology written by C.A. Costa and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: Separation processes in biotechnology are of increasing industrial importance since they entail the major costs of bioprocessing especially when high purity is required. Chromatography and membranes are two of the most important technologies used for direct treatment of fermentation broths as well as for high resolution steps in product purification. The theoretical foundations of chromatographic and membrane processes are well understood for the case of small molecules. Nevertheless there is a need to adapt and further develop that knowledge to the processing of large biological molecules. This is being achieved with the contribution of other areas like molecular biology and materials science. The objective of this NATO Advanced Study Institute is to present an updated treatment of the fundamentals of chromatographic and membrane processes with special relevance in bioprocessing.This volume collects the lectures presented at this Institute. The lectures are arranged in five chapters. Chapter I deals with chromatographic processes covering topics like equilibrium, kinetics and contacting devices. Membrane processes and some applications in biotechnology are treated in chapter 2. Chapter 3 is devoted to affinity chromatographic and membrane processes. Chapter 4 considers the current developments on chromatographic supports and membranes both from the constitutive materials and form points of view. Scale-up, optimization and reaction/separation integration are the topics covered in chapter 5. We are very grateful to all lecturers and participants that made possible this Institute. Financial support from NATO Scientific Affairs Division, INIC, JNICT, FLAD, University of Ac;ores and DRT Ac;ores is gratefully acknowledged.

Download or read book The British National Bibliography written by Arthur James Wells and published by . This book was released on 1998 with total page 1648 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Handbook of Process Chromatography written by Gail K. Sofer and published by Academic Press. This book was released on 1997-06-24 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: With examples from companies with establised processes and approved biotherapeutics, this pack considers the entire scope of process chromatography, including scale-up, regulatory issues, equipment, evaluation studies, scheduling and cost effectiveness.

Download or read book Cumulated Index to the Books written by and published by . This book was released on 1999 with total page 1280 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Validating Chromatographic Methods written by David M. Bliesner and published by Wiley-Interscience. This book was released on 2006-09-11 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems. Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.

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.

Download or read book A Research Agenda for Transforming Separation Science written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-10-30 with total page 115 pages. Available in PDF, EPUB and Kindle. Book excerpt: Separation science plays a critical role in maintaining our standard of living and quality of life. Many industrial processes and general necessities such as chemicals, medicines, clean water, safe food, and energy sources rely on chemical separations. However, the process of chemical separations is often overlooked during product development and this has led to inefficiency, unnecessary waste, and lack of consensus among chemists and engineers. A reevaluation of system design, establishment of standards, and an increased focus on the advancement of separation science are imperative in supporting increased efficiency, continued U.S. manufacturing competitiveness, and public welfare. A Research Agenda for Transforming Separation Science explores developments in the industry since the 1987 National Academies report, Separation and Purification: Critical Needs and Opportunities. Many needs stated in the original report remain today, in addition to a variety of new challenges due to improved detection limits, advances in medicine, and a recent emphasis on sustainability and environmental stewardship. This report examines emerging chemical separation technologies, relevant developments in intersecting disciplines, and gaps in existing research, and provides recommendations for the application of improved separation science technologies and processes. This research serves as a foundation for transforming separation science, which could reduce global energy use, improve human and environmental health, and advance more efficient practices in various industries.

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 BIOSPERATIONS written by B. SIVASANKAR and published by PHI Learning Pvt. Ltd.. This book was released on 2005-01-01 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: This systematically organized and well-balanced book compresses within the covers of a single volume the theoretical principles and techniques involved in bio-separations, also called downstream processing. These techniques are derived from a range of subjects, for example, physical chemistry, analytical chemistry, bio-chemistry, biological science and chemical engineering. Organized in its 15 chapters, the text covers in the first few chapters topics related to chemical engineering unit operations such as filtration, centrifugation, adsorption, extraction and membrane separation as applied to bioseparations. The use of chromatography as practiced at laboratory as well as industrial scale operation and related techniques such as gel filtration, affinity and pseudoaffinity chromatography, ion-exchange chromatography, electrophoresis and related methods have been discussed. The important applications of these techniques have also been highlighted.