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Author: Ralf Pörtner Publisher: ISBN: 9783036552095 Category : Languages : en Pages : 0
Book Description
Biopharmaceutical and pharmaceutical manufacturing are strongly influenced by the process analytical technology initiative (PAT) and quality by design (QbD) methodologies, which are designed to enhance the understanding of more integrated processes. The major aim of this effort can be summarized as developing a mechanistic understanding of a wide range of process steps, including the development of technologies to perform online measurements and real-time control and optimization. Furthermore, minimization of the number of empirical experiments and the model-assisted exploration of the process design space are targeted. Even if tremendous progress has been achieved so far, there is still work to be carried out in order to realize the full potential of the process systems engineering toolbox. Within this reprint, an overview of cutting-edge developments of process systems engineering for biopharmaceutical and pharmaceutical manufacturing processes is given, including model-based process design, Digital Twins, computer-aided process understanding, process development and optimization, and monitoring and control of bioprocesses. The biopharmaceutical processes addressed focus on the manufacturing of biopharmaceuticals, mainly by Chinese hamster ovary (CHO) cells, as well as adeno-associated virus production and generation of cell spheroids for cell therapies.
Author: Ralf Pörtner Publisher: ISBN: 9783036552095 Category : Languages : en Pages : 0
Book Description
Biopharmaceutical and pharmaceutical manufacturing are strongly influenced by the process analytical technology initiative (PAT) and quality by design (QbD) methodologies, which are designed to enhance the understanding of more integrated processes. The major aim of this effort can be summarized as developing a mechanistic understanding of a wide range of process steps, including the development of technologies to perform online measurements and real-time control and optimization. Furthermore, minimization of the number of empirical experiments and the model-assisted exploration of the process design space are targeted. Even if tremendous progress has been achieved so far, there is still work to be carried out in order to realize the full potential of the process systems engineering toolbox. Within this reprint, an overview of cutting-edge developments of process systems engineering for biopharmaceutical and pharmaceutical manufacturing processes is given, including model-based process design, Digital Twins, computer-aided process understanding, process development and optimization, and monitoring and control of bioprocesses. The biopharmaceutical processes addressed focus on the manufacturing of biopharmaceuticals, mainly by Chinese hamster ovary (CHO) cells, as well as adeno-associated virus production and generation of cell spheroids for cell therapies.
Author: Ravendra Singh Publisher: Elsevier ISBN: 0444639667 Category : Technology & Engineering Languages : en Pages : 698
Book Description
Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing
Author: KennethE. Avis Publisher: Routledge ISBN: 1351413864 Category : Medical Languages : en Pages : 286
Book Description
Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.
Author: Sarfaraz K. Niazi Publisher: CRC Press ISBN: 1466585749 Category : Medical Languages : en Pages : 746
Book Description
Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to healthcare product manufacturing and expands on areas of opportunity for qualified bioprocess engineers and students. The book is divided into two sections: the first half centers on the engineering fundamentals of bioprocessing; while the second half serves as a handbook offering advice and practical applications. Focused on the fundamental principles at the core of this discipline, this work outlines every facet of design, component selection, and regulatory concerns. It discusses the purpose of bioprocessing (to produce products suitable for human use), describes the manufacturing technologies related to bioprocessing, and explores the rapid expansion of bioprocess engineering applications relevant to health care product manufacturing. It also considers the future of bioprocessing—the use of disposable components (which is the fastest growing area in the field of bioprocessing) to replace traditional stainless steel. In addition, this text: Discusses the many types of genetically modified organisms Outlines laboratory techniques Includes the most recent developments Serves as a reference and contains an extensive bibliography Emphasizes biological manufacturing using recombinant processing, which begins with creating a genetically modified organism using recombinant techniques Fundamentals of Modern Bioprocessing outlines both the principles and applications of bioprocessing engineering related to healthcare product manufacturing. It lays out the basic concepts, definitions, methods and applications of bioprocessing. A single volume comprehensive reference developed to meet the needs of students with a bioprocessing background; it can also be used as a source for professionals in the field.
Author: National Research Council Publisher: National Academies Press ISBN: 0309047854 Category : Science Languages : en Pages : 133
Book Description
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.
Author: George Buckbee (P.E.) Publisher: ISA ISBN: 9781934394250 Category : Biopharmaceutics Languages : en Pages : 324
Book Description
A guide for engineers and designers new to the field of bio-pharmaceutical process control. For the experienced automation professional, it outlines the unique design and application issues for the bio-pharmaceutical industry. For those already familiar with this industry, it provides specific advice for automating these processes.
Author: Shijie Liu Publisher: Newnes ISBN: 0444595228 Category : Technology & Engineering Languages : en Pages : 1000
Book Description
Bioprocess Engineering involves the design and development of equipment and processes for the manufacturing of products such as food, feed, pharmaceuticals, nutraceuticals, chemicals, and polymers and paper from biological materials. It also deals with studying various biotechnological processes. "Bioprocess Kinetics and Systems Engineering" first of its kind contains systematic and comprehensive content on bioprocess kinetics, bioprocess systems, sustainability and reaction engineering. Dr. Shijie Liu reviews the relevant fundamentals of chemical kinetics-including batch and continuous reactors, biochemistry, microbiology, molecular biology, reaction engineering, and bioprocess systems engineering- introducing key principles that enable bioprocess engineers to engage in the analysis, optimization, design and consistent control over biological and chemical transformations. The quantitative treatment of bioprocesses is the central theme of this book, while more advanced techniques and applications are covered with some depth. Many theoretical derivations and simplifications are used to demonstrate how empirical kinetic models are applicable to complicated bioprocess systems. Contains extensive illustrative drawings which make the understanding of the subject easy Contains worked examples of the various process parameters, their significance and their specific practical use Provides the theory of bioprocess kinetics from simple concepts to complex metabolic pathways Incorporates sustainability concepts into the various bioprocesses
Author: Regine Eibl Publisher: John Wiley & Sons ISBN: 1119477832 Category : Medical Languages : en Pages : 368
Book Description
Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Author: Bjorn K. Lydersen Publisher: John Wiley & Sons ISBN: 0471035440 Category : Science Languages : en Pages : 837
Book Description
Divided into four sections, the first and third reflect the fact that there are two types of equipment required in the plant--one in which the actual product is synthesized or processed such as the fermentor, centrifuge and chromatographic columns; and the other that supplies support for the facility or process including air conditioning, water and waste systems. Part two describes such components as pumps, filters and valves not limited to a certain type of equipment. Lastly, it covers planning and designing the entire facility along with requirements for containment and validation of the process.
Author: Cenk Undey Publisher: CRC Press ISBN: 1439829454 Category : Medical Languages : en Pages : 330
Book Description
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Author: Ralf Pörtner
Author: Ralf Pörtner
Author: Ravendra Singh
Author: KennethE. Avis
Author: Sarfaraz K. Niazi
Author: National Research Council
Author: George Buckbee (P.E.)
Author: Shijie Liu
Author: Regine Eibl
Author: Bjorn K. Lydersen
Author: Cenk Undey