Author: Carl-Fredrik Mandenius
Publisher: MDPI
ISBN: 3036511504
Category : Science
Languages : en
Pages : 160
Book Description
This book is devoted to new developments in measurement technologies for upstream and downstream bioprocessing. The recent advances in biotechnology and bioprocessing have generated a number of new biological products that require more qualified analytical technologies for diverse process analytical needs. These includes especially fast and sensitive measurement technology that, early in the process train, can inform on critical process parameters related to process economy and product quality and that can facilitate ambitions of designing efficient integrated end-to-end bioprocesses. This book covers these topics as well as analytical monitoring methods based either on real-time or in-line sensor technology, on simple and compact bioanalytical devices, or on the use of advanced data prediction methods.
Computational Intelligence Techniques for Bioprocess Modelling, Supervision and Control
Author: Maria Carmo Nicoletti
Publisher: Springer Science & Business Media
ISBN: 3642018874
Category : Mathematics
Languages : en
Pages : 349
Book Description
Computational Intelligence (CI) and Bioprocess are well-established research areas which have much to offer each other. Under the perspective of the CI area, Biop- cess can be considered a vast application area with a growing number of complex and challenging tasks to be dealt with, whose solutions can contribute to boosting the development of new intelligent techniques as well as to help the refinement and s- cialization of many of the already existing techniques. Under the perspective of the Bioprocess area, CI can be considered a useful repertoire of theories, methods and techniques that can contribute and offer interesting alternative approaches for solving many of its problems, particularly those hard to solve using conventional techniques. Although throughout the past years CI and Bioprocess areas have accumulated substantial specific knowledge and progress has been quick and with a high degree of success, we believe there is still a long way to go in order to use the potentialities of the available CI techniques and knowledge at their full extent, as tools for supporting problem solving in bioprocesses. One of the reasons is the fact that both areas have progressed steadily and have been continuously accumulating and refining specific knowledge; another reason is the high level of technical expertise demanded by each of them. The acquisition of technical skills, experience and good insights in either of the two areas is very demanding and a hard task to be accomplished by any professional.
Publisher: Springer Science & Business Media
ISBN: 3642018874
Category : Mathematics
Languages : en
Pages : 349
Book Description
Computational Intelligence (CI) and Bioprocess are well-established research areas which have much to offer each other. Under the perspective of the CI area, Biop- cess can be considered a vast application area with a growing number of complex and challenging tasks to be dealt with, whose solutions can contribute to boosting the development of new intelligent techniques as well as to help the refinement and s- cialization of many of the already existing techniques. Under the perspective of the Bioprocess area, CI can be considered a useful repertoire of theories, methods and techniques that can contribute and offer interesting alternative approaches for solving many of its problems, particularly those hard to solve using conventional techniques. Although throughout the past years CI and Bioprocess areas have accumulated substantial specific knowledge and progress has been quick and with a high degree of success, we believe there is still a long way to go in order to use the potentialities of the available CI techniques and knowledge at their full extent, as tools for supporting problem solving in bioprocesses. One of the reasons is the fact that both areas have progressed steadily and have been continuously accumulating and refining specific knowledge; another reason is the high level of technical expertise demanded by each of them. The acquisition of technical skills, experience and good insights in either of the two areas is very demanding and a hard task to be accomplished by any professional.
Measurement, Monitoring, Modelling and Control of Bioprocesses
Author: Carl-Fredrik Mandenius
Publisher: Springer
ISBN: 3642368387
Category : Science
Languages : en
Pages : 288
Book Description
Automated Measurement and Monitoring of Bioprocesses: Key Elements of the M3C Strategy, by Bernhard Sonnleitner Automatic Control of Bioprocesses, by Marc Stanke, Bernd Hitzmann An Advanced Monitoring Platform for Rational Design of Recombinant Processes, by G. Striedner, K. Bayer Modelling Approaches for Bio-Manufacturing Operations, by Sunil Chhatre Extreme Scale-Down Approaches for Rapid Chromatography Column Design and Scale-Up During Bioprocess Development, by Sunil Chhatre Applying Mechanistic Models in Bioprocess Development, by Rita Lencastre Fernandes, Vijaya Krishna Bodla, Magnus Carlquist, Anna-Lena Heins, Anna Eliasson Lantz, Gürkan Sin and Krist V. Gernaey Multivariate Data Analysis for Advancing the Interpretation of Bioprocess Measurement and Monitoring Data, by Jarka Glassey Design of Pathway-Level Bioprocess Monitoring and Control Strategies Supported by Metabolic Networks, by Inês A. Isidro, Ana R. Ferreira, João J. Clemente, António E. Cunha, João M. L. Dias, Rui Oliveira Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm, by Anurag S Rathore, Anshuman Bansal, Jaspinder Hans The Choice of Suitable Online Analytical Techniques and Data Processing for Monitoring of Bioprocesses, by Ian Marison, Siobhán Hennessy, Róisín Foley, Moira Schuler, Senthilkumar Sivaprakasam, Brian Freeland
Publisher: Springer
ISBN: 3642368387
Category : Science
Languages : en
Pages : 288
Book Description
Automated Measurement and Monitoring of Bioprocesses: Key Elements of the M3C Strategy, by Bernhard Sonnleitner Automatic Control of Bioprocesses, by Marc Stanke, Bernd Hitzmann An Advanced Monitoring Platform for Rational Design of Recombinant Processes, by G. Striedner, K. Bayer Modelling Approaches for Bio-Manufacturing Operations, by Sunil Chhatre Extreme Scale-Down Approaches for Rapid Chromatography Column Design and Scale-Up During Bioprocess Development, by Sunil Chhatre Applying Mechanistic Models in Bioprocess Development, by Rita Lencastre Fernandes, Vijaya Krishna Bodla, Magnus Carlquist, Anna-Lena Heins, Anna Eliasson Lantz, Gürkan Sin and Krist V. Gernaey Multivariate Data Analysis for Advancing the Interpretation of Bioprocess Measurement and Monitoring Data, by Jarka Glassey Design of Pathway-Level Bioprocess Monitoring and Control Strategies Supported by Metabolic Networks, by Inês A. Isidro, Ana R. Ferreira, João J. Clemente, António E. Cunha, João M. L. Dias, Rui Oliveira Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm, by Anurag S Rathore, Anshuman Bansal, Jaspinder Hans The Choice of Suitable Online Analytical Techniques and Data Processing for Monitoring of Bioprocesses, by Ian Marison, Siobhán Hennessy, Róisín Foley, Moira Schuler, Senthilkumar Sivaprakasam, Brian Freeland
Measurement Technologies for up- and Downstream Bioprocessing
Author: Carl-Fredrik Mandenius
Publisher: MDPI
ISBN: 3036511504
Category : Science
Languages : en
Pages : 160
Book Description
This book is devoted to new developments in measurement technologies for upstream and downstream bioprocessing. The recent advances in biotechnology and bioprocessing have generated a number of new biological products that require more qualified analytical technologies for diverse process analytical needs. These includes especially fast and sensitive measurement technology that, early in the process train, can inform on critical process parameters related to process economy and product quality and that can facilitate ambitions of designing efficient integrated end-to-end bioprocesses. This book covers these topics as well as analytical monitoring methods based either on real-time or in-line sensor technology, on simple and compact bioanalytical devices, or on the use of advanced data prediction methods.
Publisher: MDPI
ISBN: 3036511504
Category : Science
Languages : en
Pages : 160
Book Description
This book is devoted to new developments in measurement technologies for upstream and downstream bioprocessing. The recent advances in biotechnology and bioprocessing have generated a number of new biological products that require more qualified analytical technologies for diverse process analytical needs. These includes especially fast and sensitive measurement technology that, early in the process train, can inform on critical process parameters related to process economy and product quality and that can facilitate ambitions of designing efficient integrated end-to-end bioprocesses. This book covers these topics as well as analytical monitoring methods based either on real-time or in-line sensor technology, on simple and compact bioanalytical devices, or on the use of advanced data prediction methods.
Bioprocess Engineering Principles
Author: Pauline M. Doran
Publisher: Elsevier
ISBN: 0080528120
Category : Science
Languages : en
Pages : 455
Book Description
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.
Publisher: Elsevier
ISBN: 0080528120
Category : Science
Languages : en
Pages : 455
Book Description
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.
Bioprocess Monitoring and Control
Author: Bernd Hitzmann
Publisher:
ISBN: 9783039369324
Category :
Languages : en
Pages : 234
Book Description
Process monitoring and control are fundamental to all processes; this holds especially for bioprocesses, due to their complex nature. Usually, bioprocesses deal with living cells, which have their own regulatory systems. It helps to adjust the cell to its environmental condition. This must not be the optimal condition that the cell needs to produce whatever is desired. Therefore, a close monitoring of the cell and its environment is essential to provide optimal conditions for production. Without measurement, no information of the current process state is obtained. In this book, methods and techniques are provided for the monitoring and control of bioprocesses. From new developments for sensors, the application of spectroscopy and modelling approaches, the estimation and observer implementation for ethanol production and the development and scale-up of various bioprocesses and their closed loop control information are presented. The processes discussed here are very diverse. The major applications are cultivation processes, where microorganisms were grown, but also an incubation process of bird's eggs, as well as an indoor climate control for humans, will be discussed. Altogether, in 12 chapters, nine original research papers and three reviews are presented.
Publisher:
ISBN: 9783039369324
Category :
Languages : en
Pages : 234
Book Description
Process monitoring and control are fundamental to all processes; this holds especially for bioprocesses, due to their complex nature. Usually, bioprocesses deal with living cells, which have their own regulatory systems. It helps to adjust the cell to its environmental condition. This must not be the optimal condition that the cell needs to produce whatever is desired. Therefore, a close monitoring of the cell and its environment is essential to provide optimal conditions for production. Without measurement, no information of the current process state is obtained. In this book, methods and techniques are provided for the monitoring and control of bioprocesses. From new developments for sensors, the application of spectroscopy and modelling approaches, the estimation and observer implementation for ethanol production and the development and scale-up of various bioprocesses and their closed loop control information are presented. The processes discussed here are very diverse. The major applications are cultivation processes, where microorganisms were grown, but also an incubation process of bird's eggs, as well as an indoor climate control for humans, will be discussed. Altogether, in 12 chapters, nine original research papers and three reviews are presented.
Biochemical Engineering and Biotechnology
Author: Ghasem Najafpour
Publisher: Elsevier
ISBN: 0444633774
Category : Technology & Engineering
Languages : en
Pages : 669
Book Description
Biochemical Engineering and Biotechnology, 2nd Edition, outlines the principles of biochemical processes and explains their use in the manufacturing of every day products. The author uses a diirect approach that should be very useful for students in following the concepts and practical applications. This book is unique in having many solved problems, case studies, examples and demonstrations of detailed experiments, with simple design equations and required calculations. - Covers major concepts of biochemical engineering and biotechnology, including applications in bioprocesses, fermentation technologies, enzymatic processes, and membrane separations, amongst others - Accessible to chemical engineering students who need to both learn, and apply, biological knowledge in engineering principals - Includes solved problems, examples, and demonstrations of detailed experiments with simple design equations and all required calculations - Offers many graphs that present actual experimental data, figures, and tables, along with explanations
Publisher: Elsevier
ISBN: 0444633774
Category : Technology & Engineering
Languages : en
Pages : 669
Book Description
Biochemical Engineering and Biotechnology, 2nd Edition, outlines the principles of biochemical processes and explains their use in the manufacturing of every day products. The author uses a diirect approach that should be very useful for students in following the concepts and practical applications. This book is unique in having many solved problems, case studies, examples and demonstrations of detailed experiments, with simple design equations and required calculations. - Covers major concepts of biochemical engineering and biotechnology, including applications in bioprocesses, fermentation technologies, enzymatic processes, and membrane separations, amongst others - Accessible to chemical engineering students who need to both learn, and apply, biological knowledge in engineering principals - Includes solved problems, examples, and demonstrations of detailed experiments with simple design equations and all required calculations - Offers many graphs that present actual experimental data, figures, and tables, along with explanations
Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts
Author: Claire Komives
Publisher: John Wiley & Sons
ISBN: 1118361989
Category : Science
Languages : en
Pages : 288
Book Description
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies
Publisher: John Wiley & Sons
ISBN: 1118361989
Category : Science
Languages : en
Pages : 288
Book Description
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies
Biochemical Engineering
Author: Shigeo Katoh
Publisher: John Wiley & Sons
ISBN: 3527684999
Category : Technology & Engineering
Languages : en
Pages : 328
Book Description
Completely revised, updated, and enlarged, this second edition now contains a subchapter on biorecognition assays, plus a chapter on bioprocess control added by the new co-author Jun-ichi Horiuchi, who is one of the leading experts in the field. The central theme of the textbook remains the application of chemical engineering principles to biological processes in general, demonstrating how a chemical engineer would address and solve problems. To create a logical and clear structure, the book is divided into three parts. The first deals with the basic concepts and principles of chemical engineering and can be read by those students with no prior knowledge of chemical engineering. The second part focuses on process aspects, such as heat and mass transfer, bioreactors, and separation methods. Finally, the third section describes practical aspects, including medical device production, downstream operations, and fermenter engineering. More than 40 exemplary solved exercises facilitate understanding of the complex engineering background, while self-study is supported by the inclusion of over 80 exercises at the end of each chapter, which are supplemented by the corresponding solutions. An excellent, comprehensive introduction to the principles of biochemical engineering.
Publisher: John Wiley & Sons
ISBN: 3527684999
Category : Technology & Engineering
Languages : en
Pages : 328
Book Description
Completely revised, updated, and enlarged, this second edition now contains a subchapter on biorecognition assays, plus a chapter on bioprocess control added by the new co-author Jun-ichi Horiuchi, who is one of the leading experts in the field. The central theme of the textbook remains the application of chemical engineering principles to biological processes in general, demonstrating how a chemical engineer would address and solve problems. To create a logical and clear structure, the book is divided into three parts. The first deals with the basic concepts and principles of chemical engineering and can be read by those students with no prior knowledge of chemical engineering. The second part focuses on process aspects, such as heat and mass transfer, bioreactors, and separation methods. Finally, the third section describes practical aspects, including medical device production, downstream operations, and fermenter engineering. More than 40 exemplary solved exercises facilitate understanding of the complex engineering background, while self-study is supported by the inclusion of over 80 exercises at the end of each chapter, which are supplemented by the corresponding solutions. An excellent, comprehensive introduction to the principles of biochemical engineering.
Control in Bioprocessing
Author: Pablo A. López Pérez
Publisher: John Wiley & Sons
ISBN: 1119296080
Category : Technology & Engineering
Languages : en
Pages : 297
Book Description
Closes the gap between bioscience and mathematics-based process engineering This book presents the most commonly employed approaches in the control of bioprocesses. It discusses the role that control theory plays in understanding the mechanisms of cellular and metabolic processes, and presents key results in various fields such as dynamic modeling, dynamic properties of bioprocess models, software sensors designed for the online estimation of parameters and state variables, and control and supervision of bioprocesses Control in Bioengineering and Bioprocessing: Modeling, Estimation and the Use of Sensors is divided into three sections. Part I, Mathematical preliminaries and overview of the control and monitoring of bioprocess, provides a general overview of the control and monitoring of bioprocesses, and introduces the mathematical framework necessary for the analysis and characterization of bioprocess dynamics. Part II, Observability and control concepts, presents the observability concepts which form the basis of design online estimation algorithms (software sensor) for bioprocesses, and reviews controllability of these concepts, including automatic feedback control systems. Part III, Software sensors and observer-based control schemes for bioprocesses, features six application cases including dynamic behavior of 3-dimensional continuous bioreactors; observability analysis applied to 2D and 3D bioreactors with inhibitory and non-inhibitory models; and regulation of a continuously stirred bioreactor via modeling error compensation. Applicable across all areas of bioprocess engineering, including food and beverages, biofuels and renewable energy, pharmaceuticals and nutraceuticals, fermentation systems, product separation technologies, wastewater and solid-waste treatment technology, and bioremediation Provides a clear explanation of the mass-balance–based mathematical modelling of bioprocesses and the main tools for its dynamic analysis Offers industry-based applications on: myco-diesel for implementing "quality" of observability; developing a virtual sensor based on the Just-In-Time Model to monitor biological control systems; and virtual sensor design for state estimation in a photocatalytic bioreactor for hydrogen production Control in Bioengineering and Bioprocessing is intended as a foundational text for graduate level students in bioengineering, as well as a reference text for researchers, engineers, and other practitioners interested in the field of estimation and control of bioprocesses.
Publisher: John Wiley & Sons
ISBN: 1119296080
Category : Technology & Engineering
Languages : en
Pages : 297
Book Description
Closes the gap between bioscience and mathematics-based process engineering This book presents the most commonly employed approaches in the control of bioprocesses. It discusses the role that control theory plays in understanding the mechanisms of cellular and metabolic processes, and presents key results in various fields such as dynamic modeling, dynamic properties of bioprocess models, software sensors designed for the online estimation of parameters and state variables, and control and supervision of bioprocesses Control in Bioengineering and Bioprocessing: Modeling, Estimation and the Use of Sensors is divided into three sections. Part I, Mathematical preliminaries and overview of the control and monitoring of bioprocess, provides a general overview of the control and monitoring of bioprocesses, and introduces the mathematical framework necessary for the analysis and characterization of bioprocess dynamics. Part II, Observability and control concepts, presents the observability concepts which form the basis of design online estimation algorithms (software sensor) for bioprocesses, and reviews controllability of these concepts, including automatic feedback control systems. Part III, Software sensors and observer-based control schemes for bioprocesses, features six application cases including dynamic behavior of 3-dimensional continuous bioreactors; observability analysis applied to 2D and 3D bioreactors with inhibitory and non-inhibitory models; and regulation of a continuously stirred bioreactor via modeling error compensation. Applicable across all areas of bioprocess engineering, including food and beverages, biofuels and renewable energy, pharmaceuticals and nutraceuticals, fermentation systems, product separation technologies, wastewater and solid-waste treatment technology, and bioremediation Provides a clear explanation of the mass-balance–based mathematical modelling of bioprocesses and the main tools for its dynamic analysis Offers industry-based applications on: myco-diesel for implementing "quality" of observability; developing a virtual sensor based on the Just-In-Time Model to monitor biological control systems; and virtual sensor design for state estimation in a photocatalytic bioreactor for hydrogen production Control in Bioengineering and Bioprocessing is intended as a foundational text for graduate level students in bioengineering, as well as a reference text for researchers, engineers, and other practitioners interested in the field of estimation and control of bioprocesses.
PAT Applied in Biopharmaceutical Process Development And Manufacturing
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.
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.