Download or read book Process Monitoring and Quality by Design for Biotechnology Products written by Neslihan Delacruz and published by Biota Publishing. This book was released on 2010-09-01 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use. Table of Contents: Abbreviations / Introduction / From the Traditional Development Path to Quality by Design / Continuous Process Verification and Process Monitoring / Process Monitoring and Statistical Control Limits / Multivariate Analysis: A Mature State of Statistical Process Monitoring / Conclusion / Bibliography

Download or read book Measurement Monitoring Modelling and Control of Bioprocesses written by Carl-Fredrik Mandenius and published by Springer. This book was released on 2014-07-08 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Sampling Sample Treatment Assay and Real Time Monitoring of Biotechnological Processes Using an Integrated Flow injection System written by and published by . This book was released on 2011 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Mass Spectrometry in Biotechnological Process Analysis and Control written by E. Heinzle and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is based on the contributions to the IFAC-Workshop "Mass Spectro metry in Biotechnological Process Analysis and Control" held in Graz, Austria from 23 to 24 October 1986. The idea to organize this workshop and further to prepare these proceedings was stimulated by the following facts. Biotechnological processes urgently need better on-line instrumentation. Mass spectrometry (MS) offers a great potential to especially analyse gases and volatile compounds. It is, however, considered that this potential by far is not exhausted. The main reason for this is that MS often still is considered to be a very expensive technique requiring the permanent attention of a MS expert. In addition methods have not yet been developed to a user friendly state. On-line MS-methods are available to a certain extent, but need further development. To stimulate such development an interdisciplinary effort is necessary. Needs of industrial and university users and experience of physicists and instrument manufacturers have to be brought into a hopefully fruitful discussion. An introductory article describes the bioprocess background including a brief summary of the state of the art in bioprocess sensor and parameter estimation development, and the potential MS offers for bioprocess monitoring. In the first chapter on "Instrumentation and Gas Analysis" a general overview on some developments in MS-instrumentation is given initially by Schmid. Then the presently available instrumentation for bioprocess monitoring is discussed by instrument manufacturers (Winter; Schaefer and Schultis; Bartman).

Download or read book Modelling and Control of Biotechnological Processes written by A. Johnson and published by Elsevier. This book was released on 2014-05-17 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modelling and Control of Biotechnological Processes contains the proceedings of the International Federation of Automatic Control's First Symposium on Modeling and Control of Biotechnological Processes held in Noordwijkerhout, The Netherlands, on December 11-13, 1985. The papers explore modeling and control of biotechnological processes such as fermentation and biological wastewater treatment. This book consists of 37 chapters divided into 11 sections and begins with a discussion on the control of fermentation processes; modeling of biotechnical processes; and application of measurement and estimation techniques to biotechnology. The following sections focus on adaptive control theory, applications of adaptive control, and control and modeling of bioreactors. The reader is also introduced to measurement techniques and sensors, with emphasis on pyrolysis mass spectrometry; rapid bioelectrochemical methods; and a self-tuning controller for multiloop controlled fed-batch fermentation. The remaining sections deal with parameter identification and estimation; Kalman filtering techniques; optimization of production processes; modeling of microkinetics; and optimization theory. This monograph will be of interest to researchers and practitioners in the field of biotechnology.

Download or read book Sensors in Bioprocess Control written by John Twork and published by CRC Press. This book was released on 1990-05-25 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume presents the reader with an overview of current chemical sensor technology and outlines a framework relating industrial bioprocess monitoring to modern process control technology. It deals with conventional multivariable control technology, focusing on bioprocess applications.

Download or read book Advanced Instrumentation Data Interpretation and Control of Biotechnological Processes written by J.F. van Impe and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the outgrowth of the COMETT II Course on Advanced Instru mentation, Data Interpretation, and Control of Biotechnological Processes organized by the Katholieke Universiteit Leuven and the Universiteit Gent, and held at Gent, Belgium, October 1994. The editors of the present volume were very fortunate to find all invited speakers prepared to write state-of-the-art expositions based on their lec tures. Special thanks are due to all of them. The result is an account of recent advances in instrumentation, data interpretation, and model based op timization and control of bioprocesses. For anyone interested in this emerg ing field, this text is of value and provides comprehensive reviews as well as new and important trends and directions for the future, motivated and illustrated by a wealth of applications. The typesetting of all this material represented a tremendous amount of work. I am most grateful to my wife, Myriam Uyttendaele, and to Kurt Gheys, who did most of the proof-reading. Their efforts have increased a lot the uniformity in style and presentation of the different manuscripts. Many thanks also to the co-editors, for their continued support. Kluwer Academic Publishers is gratefully acknowledged for publishing this book, thus contributing to the transfer of the latest research results into large scale industrial applications.

Download or read book Computational Intelligence Techniques for Bioprocess Modelling Supervision and Control written by Maria Carmo Nicoletti and published by Springer. This book was released on 2009-07-09 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Computer Applications in Fermentation Technology Modelling and Control of Biotechnological Processes written by N. M. Fish and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: Richard Fox Chairman, Scientific Programme Committee Between 25th and 29th September, 1988, 243 people who either apply or research the use of computers in fermentation gathered together at Robinson College, Cambridge, UK. They came from 30 countries. The conference brought together two traditions. Firstly, it continued the series on Computer Applications in Fermentation Technology (ICCAFT) inaugurated by Henri Blanchere in Dijon in 1973 and carried forward in Philadelphia and Manchester. Secondly, it brought the expertise of the many members of the International Federation of Automatic Control (IFAC), who focused their attention on biotechnology at Noordwijkerhout in the Netherlands in December, 1985. I am happy to say that the tradition carries on and a successor meeting will hopefully take place in the USA in 1991. If you find these proceedings useful or stimulating, then we hope to see you there. We set out to make ICCAFT4 a close-knit friendly conference. We housed all who cared to in Robinson College itself and organised no parallel sessions. Because we, the organisers, experience difficulty with the jargon of our colleagues from other disciplines, we asked Bruce Beck to present a breakfast tutorial on modern control and modelling techniques, and we set up informal panel discussions after dinner on two evenings. Neville Fish chaired a forum on the microbiological principles behind models, while Professors Derek Linkens and Ron Leigh led a discussion on expert systems in control.

Download or read book A Physiological Process Monitoring for Microalgal Biotechnology Based on the Detection of Variable Chlorophyll Fluorescence written by Sebastian Lippemeier and published by . This book was released on 2002 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book PAT Applied in Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and published by CRC Press. This book was released on 2011-12-07 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Process Monitoring and Quality by Design for Biotechnology Products written by Neslihan Delacruz and published by Morgan & Claypool Publishers. This book was released on 2010-12-31 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use.

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Download or read book Biotechnology Measuring modelling and control written by Hans-Jürgen Rehm and published by . This book was released on 1991 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biochemical Engineering and Biotechnology written by Ghasem Najafpour and published by Elsevier. This book was released on 2015-02-24 with total page 669 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Biosensors in Analytical Biotechnology written by Ruth Freitag and published by Academic Press. This book was released on 1996 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Looking at biosensors from a biotechnologist's viewpoint, this volume provides information on how to interface the sensor bioprocess, how to automate the entire analytical procedure, and how to use computers for enhanced data evaluation. There are chapters on biosensor-based monitoring in microbial and mammalian cell cultures, and chapter examples are all taken fron actual application rather than theoretical discussion.

Download or read book Engineering Aspects of Food Biotechnology written by Jose A. Teixeira and published by CRC Press. This book was released on 2013-08-29 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food biotechnology’s typical developments and applications have occurred in the fields of genetics and in enzyme- and cell-based biological processes, with the goal of producing and improving food ingredients and foods themselves. While these developments and applications are usually well reported in terms of the underlying science, there is a clear lack of information on the engineering aspects of such biotechnology-based food processes. Filling this gap, Engineering Aspects of Food Biotechnology provides a comprehensive review of those aspects, from the development of food processes and products to the most important unit operations implied in food biotechnological processes, also including food quality control and waste management. The book focuses on the use of biotechnology for the production of ingredients to be used in the food industry. It addresses two relevant issues—consumer’s awareness of the relation between nutrition and good health and the importance of environmental sustainability in the food chain (i.e. production of polymers and in vitro meat). A chapter on the application of process analytical technology highlights the importance of this tool for satisfying the increasingly sophisticated and strict polices for quality control and monitoring of specific process phases. The book includes a detailed presentation of relevant unit operations developed to extract/purify the ingredients of biotechnological origin intended for food applications. In addition to examining the contributions of biotechnology to producing and improving food ingredients, the book provides a concise description of the role biotechnology plays in adding value to food processing by-products, including post-harvest losses, in relevant industries of the food sector. It builds a foundation for further research and development in the food processing industry.