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 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 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 Disposable Bioprocessing Systems written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by a researcher with experience designing, establishing, and validating biological manufacturing facilities worldwide, this is the first comprehensive introduction to disposable systems for biological drug manufacturing. It reviews the current state of the industry; tackles questions about safety, costs, regulations, and waste disposal; and guides readers to choose disposable components that meet their needs. This practical manual covers disposable containers, mixing systems, bioreactors, connectors and transfers, controls and sensors, downstream processing systems, filling and finishing systems, and filters. The author also shares his predictions for the future, calling disposable bioprocessing technology a "game changer."

Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-03-07 with total page 849 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing

Download or read book New Insights into Membrane Science and Technology Polymeric and Biofunctional Membranes written by Dibakar Bhattacharyya and published by Elsevier. This book was released on 2003-05-23 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Membrane techniques provide a broad science and technology base. Although there are several books in the traditional membrane field, there is a great need for a highly comprehensive book. This refereed book covers materials from highly respected researchers. This title is highly multidisciplinary in nature and should be extremely valuable to scientists and engineers involved in a variety of activities. Students and faculty members around the world will find this title to be an excellent reference book. Invited contributions from leading researchers in the field Coverage of topic is of value to scientists/engineers working in a variety of related fields [separations/reactions, advanced biofunctional materials, contactor designs] Aims to fill market gap for a highly comprehensive book containing advances in both synthetic and biofunctional/bimimetic membranes

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 Handbook of Biogeneric Therapeutic Proteins written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2002-08-15 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

Download or read book Single Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2011-08-08 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives an overview of commonly-used disposables in the manufacture of biopharmaceuticals, their working principles, characteristics, engineering aspects, economics, and applications. With this information, readers will be able to come to an easier decision for or against disposable alternatives and to choose the appropriate system. The book is divided into two parts – the first is related to basic knowledge about disposable equipment; and the second discusses applications through case studies that illustrate manufacturing, quality assurance, and environmental influence.

Download or read book White Biotechnology written by Roland Ulber and published by Springer Science & Business Media. This book was released on 2007-02-13 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions by numerous experts

Download or read book Biological Reaction Engineering written by Elmar Heinzle and published by John Wiley & Sons. This book was released on 2021-04-06 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: Die Dynamik biotechnologischer Produktionsprozesse ist äußerst komplex. Ziel des Buches ist es, diese Vorgänge durch systematische Modellbildung und Computersimulation verständlich und durchschaubar zu machen. Es werden ohne viel mathematisches Rüstzeug Grundprinzipien erklärt und anhand von zahlreichen praxisrelevanten Beispielen alle wichtigen Aspekte der Bioverfahrenstechnik ausführlich beschrieben. Modellierte biologische Systeme reichen vom einzelnen Enzym bis zu ganzen metabolischen Netzwerken und Multi-Organismen Systemen. Die kinetischen Modelle werden mit Reaktormodellen kombiniert, was oft mit verschiedenen Konfigurationen von Zu- und Abläufen und Stofftransportprozessen kombiniert ist. In vielen Beispielen werden Regelung und Optimierung der Prozesse behandelt. Die Simulationsbeispiele reichen von theoretischen Schulbeispielen bis zu aktuellen Forschungsarbeiten. Die verwendete Simulationssprache Berkeley Madonna erlaubt nach einer sehr kurzen Einarbeitung ein schnelles interaktives Üben. Der Leser kann die vorgegebenen Beispiele beliebig verändern, um sie seinem Problemfall anzupassen. Die langjährige Lehrerfahrung der Autoren an Hochschulen und Weiterbildungskursen spiegelt sich in dem Buch wider und macht es geeignet für alle Biochemiker, Biotechnologen, Bioingenieure und Verfahrenstechniker, die an Modellierung und Simulation interessiert sind. Die eingesetzte Software Berkeley Madonna für Mac und PC kann direkt von der Berkeley Madonna Webseite bezogen werden: www.berkeleymadonna.com Zusätzliches Online Material, d.h. Programme für alle Simulationsbeispiele, eine kurze Beschreibung der Verwendung der eingesetzten Simulationssoftware Berkeley Madonna und Lösungen von Übungsaufgaben kann als Zusatzmaterial (Zip-Datei) direkt von dieser Webseite heruntergeladen werden. Alle Beispiele können auch mit der kostenlosen Demo-Version von Berkeley Madonna benützt werden. Für Käufer des Buches ist Berkeley Madonna zu einem reduzierten Preis erhältlich. Hinweise dazu gibt es im Anhang des Buches.

Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-30 with total page 599 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 that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Download or read book Current Trends in Monoclonal Antibody Development and Manufacturing written by Steven J. Shire and published by Springer Science & Business Media. This book was released on 2009-11-11 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Download or read book Disposable Bioreactors written by Regine Eibl and published by Springer. This book was released on 2009-12-02 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the past five years, the immense financial pressure on the development and manufacturing of biopharmaceuticals has resulted in the increasing use and acce- ance of disposables, which are discarded after harvest and therefore intended only for single use. In fact, such disposables are implemented in all the main bioprocess production stages today and an even higher growth than those in the biopharmac- tical market is predicted (reaching double figures). Alongside disposable filter capsules, membrane chromatography units, tubing, connectors, flexible containers processing or containing fluids, freezer systems, mixers and pumps, and fully c- trolled disposable bioreactors of up to 2,000 L culture volume are already available on the market. Numerous studies highlight the advantages of disposable bioreactors and reveal their potential for simple, safe and fast seed inoculum production, process devel- ment and small as well as middle volume production (e.g. bioactive substances, viruses for vaccines and gene therapies etc.). They suggest that such disposable bioreactors (typically characterized by the cultivation chamber or bag from plastic materials) may be advantageous for plant, animal and microbial cells. Running industrial activities such as CFD-modelling, development of single-use process monitoring and control technology, and standardized film formulations are attempting to resolve the limitations of the current disposable bioreactors. These achievements, along with substantial improvements in product yield, will reduce the use of stainless steel in the biomanufacturing facilities of the future.

Download or read book Protein Purification written by Jan-Christer Janson and published by John Wiley & Sons. This book was released on 2012-01-03 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authoritative guide on protein purification—now completely updated and revised Since the Second Edition of Protein Purification was published in 1998, the sequencing of the human genome and other developments in bioscience have dramatically changed the landscape of protein research. This new edition addresses these developments, featuring a wealth of new topics and several chapters rewritten from scratch. Leading experts in the field cover all major biochemical separation methods for proteins in use today, providing professionals in biochemistry, organic chemistry, and analytical chemistry with quick access to the latest techniques. Entirely new or thoroughly revised content includes: High-resolution reversed-phase liquid chromatography Electrophoresis in gels Conventional isoelectric focusing in gel slabs and capillaries and immobilized pH gradients Affinity ligands from chemical and biological combinatorial libraries Membrane separations Refolding of inclusion body proteins from E. coli Purification of PEGylated proteins High throughput screening techniques in protein purification The history of protein chromatography

Download or read book Therapeutic Fc Fusion Proteins written by Steven M. Chamow and published by John Wiley & Sons. This book was released on 2013-12-18 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future. An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field.

Download or read book Biological Reaction Engineering written by Irving J. Dunn and published by Wiley-VCH Verlag GmbH. This book was released on 2003 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Table of contents