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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.
Christoph Herwig is founder of Exputec GmbH.
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.
3D Printing in Medicine and Surgery: Applications in Healthcare is an advanced book on surgical and enhanced medical applications that can be achieved with 3D printing. It is an essential handbook for medical practitioners, giving access to a range of practical methods, while also focusing on applied knowledge. This comprehensive resource features practical experiments and processes for preparing 3D printable materials. Early chapters cover foundational knowledge and background reading, while later chapters discuss and review the current technologies used to engineer specific tissue types, experiments and methods, medical approaches and the challenges that lie ahead for future research. The book is an indispensable reference guide to the various methods used by current medical practitioners working at the forefront of 3D printing applications in medicine. - Provides a detailed introduction and narrative on how 3-D printing can be used towards developing future medicine-based therapies - Covers up-to-date methods across a range of application areas for the first time in book form - Presents the only book on all current areas of 3D printing in medicine that is catered to a medical rather than engineering audience
The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.
Microbial Cell Factories Engineering for Production of Biomolecules presents a compilation of chapters written by eminent scientists worldwide. Sections cover major tools and technologies for DNA synthesis, design of biosynthetic pathways, synthetic biology tools, biosensors, cell-free systems, computer-aided design, OMICS tools, CRISPR/Cas systems, and many more. Although it is not easy to find relevant information collated in a single volume, the book covers the production of a wide range of biomolecules from several MCFs, including Escherichia coli, Bacillus subtilis, Pseudomonas putida, Streptomyces, Corynebacterium, Cyanobacteria, Saccharomyces cerevisiae, Pichia pastoris and Yarrowia lipolytica, and algae, among many others. This will be an excellent platform from which scientific knowledge can grow and widen in MCF engineering research for the production of biomolecules. Needless to say, the book is a valuable source of information not only for researchers designing cell factories, but also for students, metabolic engineers, synthetic biologists, genome engineers, industrialists, stakeholders and policymakers interested in harnessing the potential of MCFs in several fields. - Offers basic understanding and a clear picture of various MCFs - Explains several tools and technologies, including DNA synthesis, synthetic biology tools, genome editing, biosensors, computer-aided design, and OMICS tools, among others - Harnesses the potential of engineered MCFs to produce a wide range of biomolecules for industrial, therapeutic, pharmaceutical, nutraceutical and biotechnological applications - Highlights the advances, challenges, and future opportunities in designing MCFs
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.
The ability of the United States to sustain a dominant global position in biotechnology lies in maintaining its primacy in basic life-science research and developing a strong resource base for bioprocess engineering and bioproduct manufacturing. This book examines the status of bioprocessing and biotechnology in the United States; current bioprocess technology, products, and opportunities; and challenges of the future and what must be done to meet those challenges. It gives recommendations for action to provide suitable incentives to establish a national program in bioprocess-engineering research, development, education, and technology transfer.
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.
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.