Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing

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Publisher : John Wiley & Sons
ISBN 13 : 3527827331
Total Pages : 404 pages
Book Rating : 4.5/5 (278 download)

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Book Synopsis Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing by : Ganapathy Subramanian

Download or read book Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2021-12-15 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the ??technology, the last decade has demonstrated the utility of continuous ??processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor’s Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing.

Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 3527347690
Total Pages : 404 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing by : Ganapathy Subramanian

Download or read book Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2021-12-20 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the ??technology, the last decade has demonstrated the utility of continuous ??processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor’s Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing.

Continuous Biomanufacturing

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Publisher : John Wiley & Sons
ISBN 13 : 3527340637
Total Pages : 628 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Continuous Biomanufacturing by : Ganapathy Subramanian

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.

Digital Twins

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Publisher : Springer Nature
ISBN 13 : 3030716600
Total Pages : 262 pages
Book Rating : 4.0/5 (37 download)

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Book Synopsis Digital Twins by : Christoph Herwig

Download or read book Digital Twins written by Christoph Herwig and published by Springer Nature. This book was released on 2021-05-27 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first of two volumes that together provide an overview of the latest advances in the generation and application of digital twins in bioprocess design and optimization. Both processes have undergone significant changes over the past few decades, moving from data-driven approaches into the 21st-century digitalization of the bioprocess industry. Moreover, the high demand for biotechnological products calls for efficient methods during research and development, as well as during tech transfer and routine manufacturing. In this regard, one promising tool is the use of digital twins, which offer a virtual representation of the bioprocess. They reflect the mechanistics of the biological system and the interactions between process parameters, key performance indicators and product quality attributes in the form of a mathematical process model. Furthermore, digital twins allow us to use computer-aided methods to gain an improved process understanding, to test and plan novel bioprocesses, and to efficiently monitor them. This book explains the mathematical structure of digital twins, their development and the model’s respective parts, as well as concepts for the knowledge-driven generation and structural variability of digital twins. Covering fundamentals as well as applications, the two volumes offer the ideal introduction to the topic for researchers in academy and industry alike.

Bioprocess Intensification

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Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110760339
Total Pages : 386 pages
Book Rating : 4.1/5 (17 download)

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Book Synopsis Bioprocess Intensification by : Dirk Holtmann

Download or read book Bioprocess Intensification written by Dirk Holtmann and published by Walter de Gruyter GmbH & Co KG. This book was released on 2024-07-01 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: Application of Process Intensification (PI) presents a set of radically innovative principles in process and equipment design, which can bring significant benefits in terms of process efficiency, capital and operating expenses, quality, process safety, and sustainability. Typical approaches in bioprocess intensification are the reduction of the number of production steps, continuous processing, integrated processes, and alternative energy inputs.

Continuous Biopharmaceutical Processes

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Author :
Publisher : Cambridge University Press
ISBN 13 : 1108420222
Total Pages : 349 pages
Book Rating : 4.1/5 (84 download)

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Book Synopsis Continuous Biopharmaceutical Processes by : David Pfister

Download or read book Continuous Biopharmaceutical Processes written by David Pfister and published by Cambridge University Press. This book was released on 2018-10-11 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a coherent and critical view on the potential benefits of various continuous processes in the biopharmaceutical industry.

Process Intensification Technologies for Green Chemistry

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Publisher : John Wiley & Sons
ISBN 13 : 1118498534
Total Pages : 400 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis Process Intensification Technologies for Green Chemistry by : Kamelia Boodhoo

Download or read book Process Intensification Technologies for Green Chemistry written by Kamelia Boodhoo and published by John Wiley & Sons. This book was released on 2013-01-03 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The successful implementation of greener chemical processes relies not only on the development of more efficient catalysts for synthetic chemistry but also, and as importantly, on the development of reactor and separation technologies which can deliver enhanced processing performance in a safe, cost-effective and energy efficient manner. Process intensification has emerged as a promising field which can effectively tackle the challenges of significant process enhancement, whilst also offering the potential to diminish the environmental impact presented by the chemical industry. Following an introduction to process intensification and the principles of green chemistry, this book presents a number of intensified technologies which have been researched and developed, including case studies to illustrate their application to green chemical processes. Topics covered include: • Intensified reactor technologies: spinning disc reactors, microreactors, monolith reactors, oscillatory flow reactors, cavitational reactors • Combined reactor/separator systems: membrane reactors, reactive distillation, reactive extraction, reactive absorption • Membrane separations for green chemistry • Industry relevance of process intensification, including economics and environmental impact, opportunities for energy saving, and practical considerations for industrial implementation. Process Intensification for Green Chemistry is a valuable resource for practising engineers and chemists alike who are interested in applying intensified reactor and/or separator systems in a range of industries to achieve green chemistry principles.

Process Validation in Manufacturing of Biopharmaceuticals

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Publisher : CRC Press
ISBN 13 : 1003805469
Total Pages : 413 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Process Validation in Manufacturing of Biopharmaceuticals by : Anurag Singh Rathore

Download or read book Process Validation in Manufacturing of Biopharmaceuticals written by Anurag Singh Rathore and published by CRC Press. This book was released on 2023-12-18 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

Continuous Pharmaceutical Processing and Process Analytical Technology

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Publisher : CRC Press
ISBN 13 : 100080447X
Total Pages : 495 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Continuous Pharmaceutical Processing and Process Analytical Technology by : Ajit S. Narang

Download or read book Continuous Pharmaceutical Processing and Process Analytical Technology written by Ajit S. Narang and published by CRC Press. This book was released on 2023-03-01 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability. Features: Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

Biopharmaceutical Manufacturing

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Publisher : Springer Nature
ISBN 13 : 3031456696
Total Pages : 497 pages
Book Rating : 4.0/5 (314 download)

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Book Synopsis Biopharmaceutical Manufacturing by : Ralf Pörtner

Download or read book Biopharmaceutical Manufacturing written by Ralf Pörtner and published by Springer Nature. This book was released on 2024-02-11 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume “Cell Engineerring 11 - Biopharmaceutical Manufacturing: Progress, Trends and Challenges” is a source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation. The book comprises contributions of experts from academia and industry active in the field of cell culture development for the production of recombinant proteins, cell therapy and gene therapy, with consideration of Digital Twin ́s and facility design. The knowledge and expertise of the authors cover disciplines like cell biology, engineering, biotechnology and biomedical sciences. Inevitably, some omissions will occur in the test, but the authors have sought to avoid duplications by extensive cross-referencing to chapters in other volumes of this series and elsewhere. We hope the volume provides a useful compendium of techniques for scientists in industrial and research laboratories active in this field.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

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Publisher : National Academies Press
ISBN 13 : 0309487846
Total Pages : 69 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine

Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-03-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

Continuous Biomanufacturing in Microbial Systems

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Publisher : Frontiers Media SA
ISBN 13 : 288971120X
Total Pages : 126 pages
Book Rating : 4.8/5 (897 download)

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Book Synopsis Continuous Biomanufacturing in Microbial Systems by : Christoph Slouka

Download or read book Continuous Biomanufacturing in Microbial Systems written by Christoph Slouka and published by Frontiers Media SA. This book was released on 2021-07-29 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: Christoph Herwig is founder of Exputec GmbH.

Continuous Manufacturing of Pharmaceuticals

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Publisher : John Wiley & Sons
ISBN 13 : 1119001323
Total Pages : 645 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Continuous Manufacturing of Pharmaceuticals by : Peter Kleinebudde

Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-09-05 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Sustainable Dairy Production

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Publisher : John Wiley & Sons
ISBN 13 : 1118489470
Total Pages : 197 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis Sustainable Dairy Production by : Peter de Jong

Download or read book Sustainable Dairy Production written by Peter de Jong and published by John Wiley & Sons. This book was released on 2013-01-16 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a comprehensive overview of the state of the art in sustainable dairy production, helping the industry to develop more sustainable dairy products, through new technologies, implementing life cycle analysis, and upgrading and optimization of their current production lines. It aims to stimulate process innovations, taking into account environmental, economic and public relations benefits for companies. Topics covered include: How to set up a sustainable production line How to quantify the carbon foot print of a dairy product by using life cycle analysis Current technologies to improve the carbon foot print What measures can be taken to reduce the global warming potential of the farm Reduction of water use in dairy production Marketing sustainable dairy products Bench marking of dairy products against other food products Potential future technological developments to improve the carbon foot print for the following decades

Continuous Processing in Pharmaceutical Manufacturing

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Publisher : John Wiley & Sons
ISBN 13 : 3527335951
Total Pages : 528 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Continuous Processing in Pharmaceutical Manufacturing by : Ganapathy Subramanian

Download or read book Continuous Processing in Pharmaceutical Manufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2015-02-09 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Bioprocess and Analytics Development for Virus-based Advanced Therapeutics and Medicinal Products (ATMPs)

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Author :
Publisher : Springer Nature
ISBN 13 : 3031284895
Total Pages : 448 pages
Book Rating : 4.0/5 (312 download)

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Book Synopsis Bioprocess and Analytics Development for Virus-based Advanced Therapeutics and Medicinal Products (ATMPs) by : Saurabh Gautam

Download or read book Bioprocess and Analytics Development for Virus-based Advanced Therapeutics and Medicinal Products (ATMPs) written by Saurabh Gautam and published by Springer Nature. This book was released on 2023-08-10 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book reviews the knowledge, methods and available techniques in the rapidly advancing field of virus based vaccines and gene therapeutics. It also highlights new innovative tools and interdisciplinary techniques for bioprocess development and analytics of viruses and viral vectors. As such, it provides a timely and highly relevant resource, since current advances in pharmaceutical research have seen the rise of vaccines and advanced therapeutics and medicinal products (ATMPs), that rely on the power of viruses. However, developing bioprocesses and analytics required to create this often called “magic bullet” (i.e. gene therapy) remains an extremely challenging and costly task. This book offers strategies for overcoming hurdles and difficulties within in all the necessary steps of viral vector development - from scalability to purification methods and quality control. The book is intended for researchers working in academia or industry, as well as graduate students pursuing a career in virology.

Intensification of Biobased Processes

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Author :
Publisher : Royal Society of Chemistry
ISBN 13 : 178801457X
Total Pages : 482 pages
Book Rating : 4.7/5 (88 download)

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Book Synopsis Intensification of Biobased Processes by : Andrzej Górak

Download or read book Intensification of Biobased Processes written by Andrzej Górak and published by Royal Society of Chemistry. This book was released on 2018-06-18 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years bioprocessing has increased in popularity and importance, however, bioprocessing still poses various important techno-economic and environmental challenges, such as product yields, excessive energy consumption for separations in highly watery systems, batch operation or the downstream processing bottlenecks in the production of biopharmaceutical products. Many of those challenges can be addressed by application of different process intensification technologies discussed in the present book. The first book dedicated entirely to this area, Intensification of Biobased Processes provides a comprehensive overview of modern process intensification technologies used in bioprocessing. The book focusses on four different categories of biobased products: bio-fuels and platform chemicals; cosmeceuticals; food products; and polymers and advanced materials. It will cover various intensification aspects of the processes concerned, including (bio)reactor intensification; intensification of separation, recovery and formulation operations; and process integration. This is an invaluable source of information for researchers and industrialists working in chemical engineering, biotechnology and process engineering.