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Book Process Monitoring and Quality by Design for Biotechnology Products

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

Book Measurement  Monitoring  Modelling and Control of Bioprocesses

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

Book Advanced Instrumentation  Data Interpretation  and Control of Biotechnological Processes

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.

Book Sensors in Bioprocess Control

Download or read book Sensors in Bioprocess Control written by John Twork and published by CRC Press. This book was released on 2020-07-24 with total page 342 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.

Book Mass Spectrometry in Biotechnological Process Analysis and Control

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).

Book Sampling  Sample Treatment  Assay and Real Time Monitoring of Biotechnological Processes Using an Integrated Flow injection System

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:

Book Biosensors in Analytical Biotechnology

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.

Book Computer Applications in Fermentation Technology  Modelling and Control of Biotechnological Processes

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.

Book A Physiological Process Monitoring for Microalgal Biotechnology Based on the Detection of Variable Chlorophyll Fluorescence

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:

Book Biotechnology  Measuring  modelling  and control

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:

Book Bioprocess Monitoring and Control

Download or read book Bioprocess Monitoring and Control written by Marie-Noelle Pons and published by Oxford University Press, USA. This book was released on 1992 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first comprehensive volume on bioprocess automation and control. It addresses bioprocess engineers and biotechnologists seeking information about new devices and advanced control techniques, including those who are not be specialists in process control. It also offers guidance for control engineers who are used to classical problems in mechanical, electrical, or chemical engineering but who may not be familiar with the specifics of nonlinear, time-dependent bioprocesses and the instrumentation required to monitor them. The book begins with the development and analysis of control structures and describes available biosensors. Underlying soft sensor estimation techniques are outlined along with methods for using derived information. The coverage of industrial applications treats both low-level control loops (temperature, pH, etc.) and high-level control strategies (setpoint optimization, optimal trajectories, adaptive control, etc.). The international team of authors detail each topic in a thorough and complete manner, and provide an important source of information for both experienced users and those new to computer controlled fermentation systems. The intended readership includes chemical, control and bioprocess engineers; biochemists and biologists; and graduate students in biotechnology.

Book Bioprocess Monitoring and Control

Download or read book Bioprocess Monitoring and Control written by Marie-Noelle A. Pons and published by . This book was released on 1992 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive, contributed work concerned with bioprocess automation & control. Commences with generation & analysis of control structure, emphasizing biosensors with a penetrating look at available devices. Profiles underlying soft sensor estimation techniques as well as those for use in derived information. Illustrated applications treat either low level control loops or high level control strategies. Introduces new trends in process automation such as expert systems & neural networks, discussing their future in biotechnology.

Book Biotechnology  Measuring  Modelling  and Control

Download or read book Biotechnology Measuring Modelling and Control written by Karl Schügerl and published by Wiley-Blackwell. This book was released on 1996-12-16 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume covers monitoring of the biotechnological process with sophisticated analytical techniques, use of the resulting data by means of mathematical models, and computer-aided control for improvement of the productivity of biotechnological processes. The book consists of four main parts: instruments for analysis and biosensoring, measuring techniques, process models and their automation and control. The use of different cell types, recombinant microorganisms, and reactor conditions are presented and all present strategies of monitoring and optimizing cell growth and product formation are discussed with regard to improved productivity. Topics included are: Methods and Instruments/ Biosensors/ Characterization of Bioreactors/ Determination of Cell Concentration/ Cell Models/ Stirred Tank Models/ Tower Reactor Models/ Process Models/ Control of Bioreactor Systems/ Automation/ Control of Downstream Processing

Book Modelling And Control of Biotechnological Process

Download or read book Modelling And Control of Biotechnological Process written by Johnson A [Ed.] and published by . This book was released on 1974 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Biotechnology  Measuring  Modelling  and Control

Download or read book Biotechnology Measuring Modelling and Control written by Karl Schügerl and published by Wiley-Blackwell. This book was released on 1996-12-16 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume covers monitoring of the biotechnological process with sophisticated analytical techniques, use of the resulting data by means of mathematical models, and computer-aided control for improvement of the productivity of biotechnological processes. The book consists of four main parts: instruments for analysis and biosensoring, measuring techniques, process models and their automation and control. The use of different cell types, recombinant microorganisms, and reactor conditions are presented and all present strategies of monitoring and optimizing cell growth and product formation are discussed with regard to improved productivity. Topics included are: Methods and Instruments/ Biosensors/ Characterization of Bioreactors/ Determination of Cell Concentration/ Cell Models/ Stirred Tank Models/ Tower Reactor Models/ Process Models/ Control of Bioreactor Systems/ Automation/ Control of Downstream Processing