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Bio-mechatronics integrates mechanical parts with a human being. Illustrating how the general engineering design science theory can be applied when designing a technical system where biological species or components are integrated, Mechatronic Design for Biotechnology provides the fundamentals, theory, and applications of bio-mechatronic design principles. This cutting-edge book present professionals in the industrial biotech sector with a unifying approach to the many fields of engineering sciences and biotechnology used in the product development of protein purification systems, artificial human organs, and stem-cell technology.…mehr
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Bio-mechatronics integrates mechanical parts with a human being. Illustrating how the general engineering design science theory can be applied when designing a technical system where biological species or components are integrated, Mechatronic Design for Biotechnology provides the fundamentals, theory, and applications of bio-mechatronic design principles. This cutting-edge book present professionals in the industrial biotech sector with a unifying approach to the many fields of engineering sciences and biotechnology used in the product development of protein purification systems, artificial human organs, and stem-cell technology.
Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Produktdetails
- Produktdetails
- Verlag: Wiley & Sons
- Artikelnr. des Verlages: 14557334000
- 1. Auflage
- Seitenzahl: 304
- Erscheinungstermin: 6. September 2011
- Englisch
- Abmessung: 240mm x 161mm x 21mm
- Gewicht: 588g
- ISBN-13: 9780470573341
- ISBN-10: 0470573341
- Artikelnr.: 33260291
- Verlag: Wiley & Sons
- Artikelnr. des Verlages: 14557334000
- 1. Auflage
- Seitenzahl: 304
- Erscheinungstermin: 6. September 2011
- Englisch
- Abmessung: 240mm x 161mm x 21mm
- Gewicht: 588g
- ISBN-13: 9780470573341
- ISBN-10: 0470573341
- Artikelnr.: 33260291
Professor Carl-Fredrik Mandenius is head of the Division of Biotechnology at Linkoping University in Sweden. His main research interests include biochemical and bio-production engineering, bioprocess monitoring and control, stem cell technology, and biosensor technology. He was a director for process R&D at Pharmacia AB and has coordinated several EU networks on hESC-derived models for drug testing. Professor Mats Björkman is head of the Division of Assembly Technology at Linkoping University in Sweden. His main research interests include design and operation of flexible manufacturing systems and equipment. He has also been involved in research that has developed from traditional mechanical industries to include areas such as electronic manufacturing and manufacturing of biotech equipment, as well as pharmaceutical products.
PREFACE xiii 1 Introduction 1 1.1 Scope of Design
1 1.2 Definition of Biomechatronic Products
3 1.3 Principles of Biomechatronics
4 1.4 Brief History of the Development of Biomechatronic Products and Engineering
7 1.5 Aim of This Book
9 References
10 PART I FUNDAMENTALS 13 2 Conceptual Design Theory 15 2.1 Systematic Design
15 2.1.1 Design for Products
15 2.1.2 Origin of the Design Task
18 2.1.3 Development of Design Thinking
18 2.1.4 Recent Methods
20 2.2 Basics of Technical Systems
21 2.2.1 Energy, Material, and Signals and Their Conversion
22 2.2.2 Interrelationships of Functions
22 2.2.3 Interrelationship of Constructions
25 2.2.4 Interrelationship of Systems
25 2.3 Psychology in the Systematic Approach
25 2.4 A General Working Methodology
26 2.4.1 Analysis for Resolving Technical Problems
27 2.4.2 Abstraction of Interrelationships of Systems
28 2.4.3 Synthesis of the Technical System
28 2.5 Conceptual Design
28 2.6 Abstraction inOrder to Identify Essential Problems
29 2.7 Developing the Concepts
31 2.7.1 Organizing the Development Process
33 2.8 Concluding Remarks
34 References
35 3 Biotechnology and Mechatronic Design 37 3.1 Transduction of the Biological Science into Biotechnology
37 3.2 Biological Sciences and Their Applications
39 3.3 Biotechnology and Bioengineering
42 3.4 Applying Mechatronic Theory to Biotechnology: Biomechatronics
44 3.5 Conclusions
47 References
48 4 Methodology for Utilization of Mechatronic Design Tools 49 4.1 Idea of Applying the Mechatronic Design Tools
49 4.2 Table of User Needs
51 4.3 List of Target Specifications
52 4.4 Concept Generation Chart
52 4.4.1 Basic Concept Component Chart
53 4.4.2 Permutation Chart
54 4.5 Concept Screening Matrix
55 4.6 Concept Scoring Matrix
56 4.7 Hubka-Eder Mapping
57 4.7.1 Overview Hubka-Eder Map
57 4.7.2 Zoom-in Hubka-Eder Mapping
59 4.8 Functions Interaction Matrix
60 4.8.1 Functions Interaction Matrix for Systems and Subsystems
60 4.8.2 Functions Interaction Matrix for Systems and Transformation Process
61 4.8.3 Design Structure Matrix
61 4.9 Anatomical Blueprint
62 4.10 Conclusions
63 References
63 PART II APPLICATIONS 65 5 Blood Glucose Sensors 67 5.1 Background of Blood Glucose Analysis
67 5.2 Specification of Needs for Blood Glucose Analysis
70 5.3 Design of Blood Glucose Sensors
71 5.3.1 Generation of Sensor Concepts
71 5.4 Description of the Systems Involved in the Design Concepts for Glucose Blood Sensors
76 5.4.1 Biological Systems
77 5.4.2 Technical Systems
77 5.4.3 Information Systems
78 5.4.4 Management and Goal Systems
78 5.4.5 Human Systems
79 5.4.6 Active Environment
79 5.4.7 Interactions Between the Systems and Functions of the Design
79 5.4.8 Anatomical Blueprints from the Functions Interaction Matrix Analysis
81 5.5 Conclusions
82 References
82 6 Surface Plasmon Resonance Biosensor Devices 85 6.1 Introduction
85 6.2 Design Requirements on SPR Systems
88 6.2.1 Needs and Specifications of an SPR Design
88 6.3 Mechatronic Design Approach of SPR Systems
89 6.3.1 Generation of Design Alternatives
89 6.3.2 Hubka-Eder Mapping of the Design Alternatives
92 6.4 Detailed Design of Critical SPR Subsystems
99 6.4.1 Design of the Sensor Surface
100 6.4.2 Design of the Fluidic System
103 6.5 Conclusions
109 References
109 7 A Diagnostic Device for Helicobacter pylori Infection 113 7.1 Diagnostic Principle of Helicobacter Infection
113 7.2 Mechatronic Analysis of Urea Breath Test Systems
117 7.2.1 Mission and Specification for a Urea Breath Tests
117 7.2.2 Generation of UBT Design Concepts
118 7.2.3 Screening and Scoring of UBT Design Concepts
119 7.3 Description of the Systems Involved in the Design Concepts for the Urea Breath Tests
124 7.3.1 Biological Systems Involved
124 7.3.2 Technical Systems Alternatives
126 7.3.3 Information Systems (SIS) Required
127 7.3.4 Management and Goal Systems Required
127 7.3.5 Human Systems Involved in the Testing
127 7.3.6 Active Environment That Can Influence
128 7.4 Aspects of the Design for Efficient Manufacture
128 7.5 Conclusions
131 References
131 8 Microarray Devices 135 8.1 Principles, Methods, and Applications of Microarrays
135 8.1.1 Principles and Technology
135 8.1.2 Fabrication Methods
136 8.1.3 Companies Developing Microarrays
138 8.1.4 Applications of DNA Microarrays
139 8.2 Specification of Needs
141 8.3 Design of Microarrays
142 8.3.1 Generation of cDNA Microarray Concepts
142 8.4 Description of the Systems Involved in the Design Concepts
145 8.4.1 Biological Systems
146 8.4.2 Technical Systems
147 8.4.3 Information System
147 8.4.4 Management and Goal Systems and the Human Systems
147 8.4.5 Active Environment
147 8.4.6 Interaction Analysis
148 8.5 Conclusions
149 References
149 9 Microbial and Cellular Bioreactors 153 9.1 Bioreactor Development During the 1970s-1990s
153 9.2 Missions, User Needs, and Specifications for Bioreactors
158 9.2.1 Design Mission and User Needs
158 9.2.2 Target Specifications
158 9.3 Analysis of Systems for Conventional Bioreactors
161 9.3.1 Biological Systems in the Bioreactor
161 9.3.2 Technical Systems
164 9.3.3 Studying the Interactions of the Systems
166 9.3.4 Penicillin Production in a Metabolically Engineered Penicillium strain (Case 1)
168 9.3.5 A Bioreactor System Producing a Recombinant Protein in CHO Cell Culture (Case 2)
171 9.3.6 Information Systems
173 9.3.7 Management and Goal Systems
177 9.3.8 Human Systems
179 9.3.9 Active Environment
179 9.4 Novel Bioreactor Designs
180 9.4.1 Microbioreactors
180 9.4.2 Bioreactors with Immobilized Cells
183 9.4.3 Bioreactors for Tissue and Stem Cell Cultures
185 9.4.4 Bioreactors for Plant Cell Cultures
186 9.5 Conclusions
187 References
187 10 Chromatographic Protein Purification 193 10.1 Background of Chromatographic Protein Purification
193 10.2 Specification of Needs for Protein Purification Systems
197 10.3 Design of Purification Systems
199 10.3.1 Generation of Design Alternatives
199 10.3.2 Screening the Design Alternatives
201 10.3.3 Analysis of the Generated Alternatives for a Chromatography System
202 10.3.4 Interactions Between Key Systems and the Transformation Process
206 10.4 Unit Operation Purification in a FVIII Production Process (Case 1)
208 10.5 Micropurification System Based on a Multichip Device (Case 2)
209 10.6 Conclusions
211 References
212 11 Stem Cell Manufacturing 215 11.1 State of the Art of Stem Cell Manufacturing
215 11.2 Needs and Target Specifications for Scaled-Up Stem Cell Manufacturing
218 11.3 Setting Up an Efficient Manufacturing System by Using Biomechatronic Conceptual Design
220 11.3.1 Generating Process Alternatives
220 11.3.2 Hubka-Eder Map for a Human Embryonic Stem Cell Process
220 11.4 Conclusions
225 References
226 12 Bioartificial Organ-Simulating Devices 229 12.1 Introduction
229 12.2 Design of Bioartificial Organ-Simulation Devices
232 12.2.1 Needs and Specifications
232 12.2.2 Evaluation of the Design Concepts
236 12.3 Analysis of Bioartificial Liver Systems
239 12.3.1 Biological Systems
239 12.3.2 Technical Systems
241 12.3.3 Information Systems
242 12.3.4 Management and Goals Systems
243 12.3.5 Human Systems
243 12.4 Conclusions
244 References
244 13 Applications to Process Analytical Technology and Quality by Design 249 13.1 PAT and QbD Concepts
249 13.2 Needs of the PAT
QbD Players and Resulting Specifications
253 13.3 Application of Design Methodology to PAT
QbD
255 13.3.1 Concept Generation for a PAT
QbD System Structure
255 13.3.2 Hubka-Eder Mapping of the PAT
QbD Transformation Process for a Pharmaceutical Process
257 13.3.3 Analysis of Effects
259 13.4 Applying Mechatronic Design on a PAT System for Online Software Sensing in a Bioprocess (Case)
260 13.5 Conclusions
263 References
263 GLOSSARY 267 INDEX 275
1 1.2 Definition of Biomechatronic Products
3 1.3 Principles of Biomechatronics
4 1.4 Brief History of the Development of Biomechatronic Products and Engineering
7 1.5 Aim of This Book
9 References
10 PART I FUNDAMENTALS 13 2 Conceptual Design Theory 15 2.1 Systematic Design
15 2.1.1 Design for Products
15 2.1.2 Origin of the Design Task
18 2.1.3 Development of Design Thinking
18 2.1.4 Recent Methods
20 2.2 Basics of Technical Systems
21 2.2.1 Energy, Material, and Signals and Their Conversion
22 2.2.2 Interrelationships of Functions
22 2.2.3 Interrelationship of Constructions
25 2.2.4 Interrelationship of Systems
25 2.3 Psychology in the Systematic Approach
25 2.4 A General Working Methodology
26 2.4.1 Analysis for Resolving Technical Problems
27 2.4.2 Abstraction of Interrelationships of Systems
28 2.4.3 Synthesis of the Technical System
28 2.5 Conceptual Design
28 2.6 Abstraction inOrder to Identify Essential Problems
29 2.7 Developing the Concepts
31 2.7.1 Organizing the Development Process
33 2.8 Concluding Remarks
34 References
35 3 Biotechnology and Mechatronic Design 37 3.1 Transduction of the Biological Science into Biotechnology
37 3.2 Biological Sciences and Their Applications
39 3.3 Biotechnology and Bioengineering
42 3.4 Applying Mechatronic Theory to Biotechnology: Biomechatronics
44 3.5 Conclusions
47 References
48 4 Methodology for Utilization of Mechatronic Design Tools 49 4.1 Idea of Applying the Mechatronic Design Tools
49 4.2 Table of User Needs
51 4.3 List of Target Specifications
52 4.4 Concept Generation Chart
52 4.4.1 Basic Concept Component Chart
53 4.4.2 Permutation Chart
54 4.5 Concept Screening Matrix
55 4.6 Concept Scoring Matrix
56 4.7 Hubka-Eder Mapping
57 4.7.1 Overview Hubka-Eder Map
57 4.7.2 Zoom-in Hubka-Eder Mapping
59 4.8 Functions Interaction Matrix
60 4.8.1 Functions Interaction Matrix for Systems and Subsystems
60 4.8.2 Functions Interaction Matrix for Systems and Transformation Process
61 4.8.3 Design Structure Matrix
61 4.9 Anatomical Blueprint
62 4.10 Conclusions
63 References
63 PART II APPLICATIONS 65 5 Blood Glucose Sensors 67 5.1 Background of Blood Glucose Analysis
67 5.2 Specification of Needs for Blood Glucose Analysis
70 5.3 Design of Blood Glucose Sensors
71 5.3.1 Generation of Sensor Concepts
71 5.4 Description of the Systems Involved in the Design Concepts for Glucose Blood Sensors
76 5.4.1 Biological Systems
77 5.4.2 Technical Systems
77 5.4.3 Information Systems
78 5.4.4 Management and Goal Systems
78 5.4.5 Human Systems
79 5.4.6 Active Environment
79 5.4.7 Interactions Between the Systems and Functions of the Design
79 5.4.8 Anatomical Blueprints from the Functions Interaction Matrix Analysis
81 5.5 Conclusions
82 References
82 6 Surface Plasmon Resonance Biosensor Devices 85 6.1 Introduction
85 6.2 Design Requirements on SPR Systems
88 6.2.1 Needs and Specifications of an SPR Design
88 6.3 Mechatronic Design Approach of SPR Systems
89 6.3.1 Generation of Design Alternatives
89 6.3.2 Hubka-Eder Mapping of the Design Alternatives
92 6.4 Detailed Design of Critical SPR Subsystems
99 6.4.1 Design of the Sensor Surface
100 6.4.2 Design of the Fluidic System
103 6.5 Conclusions
109 References
109 7 A Diagnostic Device for Helicobacter pylori Infection 113 7.1 Diagnostic Principle of Helicobacter Infection
113 7.2 Mechatronic Analysis of Urea Breath Test Systems
117 7.2.1 Mission and Specification for a Urea Breath Tests
117 7.2.2 Generation of UBT Design Concepts
118 7.2.3 Screening and Scoring of UBT Design Concepts
119 7.3 Description of the Systems Involved in the Design Concepts for the Urea Breath Tests
124 7.3.1 Biological Systems Involved
124 7.3.2 Technical Systems Alternatives
126 7.3.3 Information Systems (SIS) Required
127 7.3.4 Management and Goal Systems Required
127 7.3.5 Human Systems Involved in the Testing
127 7.3.6 Active Environment That Can Influence
128 7.4 Aspects of the Design for Efficient Manufacture
128 7.5 Conclusions
131 References
131 8 Microarray Devices 135 8.1 Principles, Methods, and Applications of Microarrays
135 8.1.1 Principles and Technology
135 8.1.2 Fabrication Methods
136 8.1.3 Companies Developing Microarrays
138 8.1.4 Applications of DNA Microarrays
139 8.2 Specification of Needs
141 8.3 Design of Microarrays
142 8.3.1 Generation of cDNA Microarray Concepts
142 8.4 Description of the Systems Involved in the Design Concepts
145 8.4.1 Biological Systems
146 8.4.2 Technical Systems
147 8.4.3 Information System
147 8.4.4 Management and Goal Systems and the Human Systems
147 8.4.5 Active Environment
147 8.4.6 Interaction Analysis
148 8.5 Conclusions
149 References
149 9 Microbial and Cellular Bioreactors 153 9.1 Bioreactor Development During the 1970s-1990s
153 9.2 Missions, User Needs, and Specifications for Bioreactors
158 9.2.1 Design Mission and User Needs
158 9.2.2 Target Specifications
158 9.3 Analysis of Systems for Conventional Bioreactors
161 9.3.1 Biological Systems in the Bioreactor
161 9.3.2 Technical Systems
164 9.3.3 Studying the Interactions of the Systems
166 9.3.4 Penicillin Production in a Metabolically Engineered Penicillium strain (Case 1)
168 9.3.5 A Bioreactor System Producing a Recombinant Protein in CHO Cell Culture (Case 2)
171 9.3.6 Information Systems
173 9.3.7 Management and Goal Systems
177 9.3.8 Human Systems
179 9.3.9 Active Environment
179 9.4 Novel Bioreactor Designs
180 9.4.1 Microbioreactors
180 9.4.2 Bioreactors with Immobilized Cells
183 9.4.3 Bioreactors for Tissue and Stem Cell Cultures
185 9.4.4 Bioreactors for Plant Cell Cultures
186 9.5 Conclusions
187 References
187 10 Chromatographic Protein Purification 193 10.1 Background of Chromatographic Protein Purification
193 10.2 Specification of Needs for Protein Purification Systems
197 10.3 Design of Purification Systems
199 10.3.1 Generation of Design Alternatives
199 10.3.2 Screening the Design Alternatives
201 10.3.3 Analysis of the Generated Alternatives for a Chromatography System
202 10.3.4 Interactions Between Key Systems and the Transformation Process
206 10.4 Unit Operation Purification in a FVIII Production Process (Case 1)
208 10.5 Micropurification System Based on a Multichip Device (Case 2)
209 10.6 Conclusions
211 References
212 11 Stem Cell Manufacturing 215 11.1 State of the Art of Stem Cell Manufacturing
215 11.2 Needs and Target Specifications for Scaled-Up Stem Cell Manufacturing
218 11.3 Setting Up an Efficient Manufacturing System by Using Biomechatronic Conceptual Design
220 11.3.1 Generating Process Alternatives
220 11.3.2 Hubka-Eder Map for a Human Embryonic Stem Cell Process
220 11.4 Conclusions
225 References
226 12 Bioartificial Organ-Simulating Devices 229 12.1 Introduction
229 12.2 Design of Bioartificial Organ-Simulation Devices
232 12.2.1 Needs and Specifications
232 12.2.2 Evaluation of the Design Concepts
236 12.3 Analysis of Bioartificial Liver Systems
239 12.3.1 Biological Systems
239 12.3.2 Technical Systems
241 12.3.3 Information Systems
242 12.3.4 Management and Goals Systems
243 12.3.5 Human Systems
243 12.4 Conclusions
244 References
244 13 Applications to Process Analytical Technology and Quality by Design 249 13.1 PAT and QbD Concepts
249 13.2 Needs of the PAT
QbD Players and Resulting Specifications
253 13.3 Application of Design Methodology to PAT
QbD
255 13.3.1 Concept Generation for a PAT
QbD System Structure
255 13.3.2 Hubka-Eder Mapping of the PAT
QbD Transformation Process for a Pharmaceutical Process
257 13.3.3 Analysis of Effects
259 13.4 Applying Mechatronic Design on a PAT System for Online Software Sensing in a Bioprocess (Case)
260 13.5 Conclusions
263 References
263 GLOSSARY 267 INDEX 275
PREFACE xiii 1 Introduction 1 1.1 Scope of Design
1 1.2 Definition of Biomechatronic Products
3 1.3 Principles of Biomechatronics
4 1.4 Brief History of the Development of Biomechatronic Products and Engineering
7 1.5 Aim of This Book
9 References
10 PART I FUNDAMENTALS 13 2 Conceptual Design Theory 15 2.1 Systematic Design
15 2.1.1 Design for Products
15 2.1.2 Origin of the Design Task
18 2.1.3 Development of Design Thinking
18 2.1.4 Recent Methods
20 2.2 Basics of Technical Systems
21 2.2.1 Energy, Material, and Signals and Their Conversion
22 2.2.2 Interrelationships of Functions
22 2.2.3 Interrelationship of Constructions
25 2.2.4 Interrelationship of Systems
25 2.3 Psychology in the Systematic Approach
25 2.4 A General Working Methodology
26 2.4.1 Analysis for Resolving Technical Problems
27 2.4.2 Abstraction of Interrelationships of Systems
28 2.4.3 Synthesis of the Technical System
28 2.5 Conceptual Design
28 2.6 Abstraction inOrder to Identify Essential Problems
29 2.7 Developing the Concepts
31 2.7.1 Organizing the Development Process
33 2.8 Concluding Remarks
34 References
35 3 Biotechnology and Mechatronic Design 37 3.1 Transduction of the Biological Science into Biotechnology
37 3.2 Biological Sciences and Their Applications
39 3.3 Biotechnology and Bioengineering
42 3.4 Applying Mechatronic Theory to Biotechnology: Biomechatronics
44 3.5 Conclusions
47 References
48 4 Methodology for Utilization of Mechatronic Design Tools 49 4.1 Idea of Applying the Mechatronic Design Tools
49 4.2 Table of User Needs
51 4.3 List of Target Specifications
52 4.4 Concept Generation Chart
52 4.4.1 Basic Concept Component Chart
53 4.4.2 Permutation Chart
54 4.5 Concept Screening Matrix
55 4.6 Concept Scoring Matrix
56 4.7 Hubka-Eder Mapping
57 4.7.1 Overview Hubka-Eder Map
57 4.7.2 Zoom-in Hubka-Eder Mapping
59 4.8 Functions Interaction Matrix
60 4.8.1 Functions Interaction Matrix for Systems and Subsystems
60 4.8.2 Functions Interaction Matrix for Systems and Transformation Process
61 4.8.3 Design Structure Matrix
61 4.9 Anatomical Blueprint
62 4.10 Conclusions
63 References
63 PART II APPLICATIONS 65 5 Blood Glucose Sensors 67 5.1 Background of Blood Glucose Analysis
67 5.2 Specification of Needs for Blood Glucose Analysis
70 5.3 Design of Blood Glucose Sensors
71 5.3.1 Generation of Sensor Concepts
71 5.4 Description of the Systems Involved in the Design Concepts for Glucose Blood Sensors
76 5.4.1 Biological Systems
77 5.4.2 Technical Systems
77 5.4.3 Information Systems
78 5.4.4 Management and Goal Systems
78 5.4.5 Human Systems
79 5.4.6 Active Environment
79 5.4.7 Interactions Between the Systems and Functions of the Design
79 5.4.8 Anatomical Blueprints from the Functions Interaction Matrix Analysis
81 5.5 Conclusions
82 References
82 6 Surface Plasmon Resonance Biosensor Devices 85 6.1 Introduction
85 6.2 Design Requirements on SPR Systems
88 6.2.1 Needs and Specifications of an SPR Design
88 6.3 Mechatronic Design Approach of SPR Systems
89 6.3.1 Generation of Design Alternatives
89 6.3.2 Hubka-Eder Mapping of the Design Alternatives
92 6.4 Detailed Design of Critical SPR Subsystems
99 6.4.1 Design of the Sensor Surface
100 6.4.2 Design of the Fluidic System
103 6.5 Conclusions
109 References
109 7 A Diagnostic Device for Helicobacter pylori Infection 113 7.1 Diagnostic Principle of Helicobacter Infection
113 7.2 Mechatronic Analysis of Urea Breath Test Systems
117 7.2.1 Mission and Specification for a Urea Breath Tests
117 7.2.2 Generation of UBT Design Concepts
118 7.2.3 Screening and Scoring of UBT Design Concepts
119 7.3 Description of the Systems Involved in the Design Concepts for the Urea Breath Tests
124 7.3.1 Biological Systems Involved
124 7.3.2 Technical Systems Alternatives
126 7.3.3 Information Systems (SIS) Required
127 7.3.4 Management and Goal Systems Required
127 7.3.5 Human Systems Involved in the Testing
127 7.3.6 Active Environment That Can Influence
128 7.4 Aspects of the Design for Efficient Manufacture
128 7.5 Conclusions
131 References
131 8 Microarray Devices 135 8.1 Principles, Methods, and Applications of Microarrays
135 8.1.1 Principles and Technology
135 8.1.2 Fabrication Methods
136 8.1.3 Companies Developing Microarrays
138 8.1.4 Applications of DNA Microarrays
139 8.2 Specification of Needs
141 8.3 Design of Microarrays
142 8.3.1 Generation of cDNA Microarray Concepts
142 8.4 Description of the Systems Involved in the Design Concepts
145 8.4.1 Biological Systems
146 8.4.2 Technical Systems
147 8.4.3 Information System
147 8.4.4 Management and Goal Systems and the Human Systems
147 8.4.5 Active Environment
147 8.4.6 Interaction Analysis
148 8.5 Conclusions
149 References
149 9 Microbial and Cellular Bioreactors 153 9.1 Bioreactor Development During the 1970s-1990s
153 9.2 Missions, User Needs, and Specifications for Bioreactors
158 9.2.1 Design Mission and User Needs
158 9.2.2 Target Specifications
158 9.3 Analysis of Systems for Conventional Bioreactors
161 9.3.1 Biological Systems in the Bioreactor
161 9.3.2 Technical Systems
164 9.3.3 Studying the Interactions of the Systems
166 9.3.4 Penicillin Production in a Metabolically Engineered Penicillium strain (Case 1)
168 9.3.5 A Bioreactor System Producing a Recombinant Protein in CHO Cell Culture (Case 2)
171 9.3.6 Information Systems
173 9.3.7 Management and Goal Systems
177 9.3.8 Human Systems
179 9.3.9 Active Environment
179 9.4 Novel Bioreactor Designs
180 9.4.1 Microbioreactors
180 9.4.2 Bioreactors with Immobilized Cells
183 9.4.3 Bioreactors for Tissue and Stem Cell Cultures
185 9.4.4 Bioreactors for Plant Cell Cultures
186 9.5 Conclusions
187 References
187 10 Chromatographic Protein Purification 193 10.1 Background of Chromatographic Protein Purification
193 10.2 Specification of Needs for Protein Purification Systems
197 10.3 Design of Purification Systems
199 10.3.1 Generation of Design Alternatives
199 10.3.2 Screening the Design Alternatives
201 10.3.3 Analysis of the Generated Alternatives for a Chromatography System
202 10.3.4 Interactions Between Key Systems and the Transformation Process
206 10.4 Unit Operation Purification in a FVIII Production Process (Case 1)
208 10.5 Micropurification System Based on a Multichip Device (Case 2)
209 10.6 Conclusions
211 References
212 11 Stem Cell Manufacturing 215 11.1 State of the Art of Stem Cell Manufacturing
215 11.2 Needs and Target Specifications for Scaled-Up Stem Cell Manufacturing
218 11.3 Setting Up an Efficient Manufacturing System by Using Biomechatronic Conceptual Design
220 11.3.1 Generating Process Alternatives
220 11.3.2 Hubka-Eder Map for a Human Embryonic Stem Cell Process
220 11.4 Conclusions
225 References
226 12 Bioartificial Organ-Simulating Devices 229 12.1 Introduction
229 12.2 Design of Bioartificial Organ-Simulation Devices
232 12.2.1 Needs and Specifications
232 12.2.2 Evaluation of the Design Concepts
236 12.3 Analysis of Bioartificial Liver Systems
239 12.3.1 Biological Systems
239 12.3.2 Technical Systems
241 12.3.3 Information Systems
242 12.3.4 Management and Goals Systems
243 12.3.5 Human Systems
243 12.4 Conclusions
244 References
244 13 Applications to Process Analytical Technology and Quality by Design 249 13.1 PAT and QbD Concepts
249 13.2 Needs of the PAT
QbD Players and Resulting Specifications
253 13.3 Application of Design Methodology to PAT
QbD
255 13.3.1 Concept Generation for a PAT
QbD System Structure
255 13.3.2 Hubka-Eder Mapping of the PAT
QbD Transformation Process for a Pharmaceutical Process
257 13.3.3 Analysis of Effects
259 13.4 Applying Mechatronic Design on a PAT System for Online Software Sensing in a Bioprocess (Case)
260 13.5 Conclusions
263 References
263 GLOSSARY 267 INDEX 275
1 1.2 Definition of Biomechatronic Products
3 1.3 Principles of Biomechatronics
4 1.4 Brief History of the Development of Biomechatronic Products and Engineering
7 1.5 Aim of This Book
9 References
10 PART I FUNDAMENTALS 13 2 Conceptual Design Theory 15 2.1 Systematic Design
15 2.1.1 Design for Products
15 2.1.2 Origin of the Design Task
18 2.1.3 Development of Design Thinking
18 2.1.4 Recent Methods
20 2.2 Basics of Technical Systems
21 2.2.1 Energy, Material, and Signals and Their Conversion
22 2.2.2 Interrelationships of Functions
22 2.2.3 Interrelationship of Constructions
25 2.2.4 Interrelationship of Systems
25 2.3 Psychology in the Systematic Approach
25 2.4 A General Working Methodology
26 2.4.1 Analysis for Resolving Technical Problems
27 2.4.2 Abstraction of Interrelationships of Systems
28 2.4.3 Synthesis of the Technical System
28 2.5 Conceptual Design
28 2.6 Abstraction inOrder to Identify Essential Problems
29 2.7 Developing the Concepts
31 2.7.1 Organizing the Development Process
33 2.8 Concluding Remarks
34 References
35 3 Biotechnology and Mechatronic Design 37 3.1 Transduction of the Biological Science into Biotechnology
37 3.2 Biological Sciences and Their Applications
39 3.3 Biotechnology and Bioengineering
42 3.4 Applying Mechatronic Theory to Biotechnology: Biomechatronics
44 3.5 Conclusions
47 References
48 4 Methodology for Utilization of Mechatronic Design Tools 49 4.1 Idea of Applying the Mechatronic Design Tools
49 4.2 Table of User Needs
51 4.3 List of Target Specifications
52 4.4 Concept Generation Chart
52 4.4.1 Basic Concept Component Chart
53 4.4.2 Permutation Chart
54 4.5 Concept Screening Matrix
55 4.6 Concept Scoring Matrix
56 4.7 Hubka-Eder Mapping
57 4.7.1 Overview Hubka-Eder Map
57 4.7.2 Zoom-in Hubka-Eder Mapping
59 4.8 Functions Interaction Matrix
60 4.8.1 Functions Interaction Matrix for Systems and Subsystems
60 4.8.2 Functions Interaction Matrix for Systems and Transformation Process
61 4.8.3 Design Structure Matrix
61 4.9 Anatomical Blueprint
62 4.10 Conclusions
63 References
63 PART II APPLICATIONS 65 5 Blood Glucose Sensors 67 5.1 Background of Blood Glucose Analysis
67 5.2 Specification of Needs for Blood Glucose Analysis
70 5.3 Design of Blood Glucose Sensors
71 5.3.1 Generation of Sensor Concepts
71 5.4 Description of the Systems Involved in the Design Concepts for Glucose Blood Sensors
76 5.4.1 Biological Systems
77 5.4.2 Technical Systems
77 5.4.3 Information Systems
78 5.4.4 Management and Goal Systems
78 5.4.5 Human Systems
79 5.4.6 Active Environment
79 5.4.7 Interactions Between the Systems and Functions of the Design
79 5.4.8 Anatomical Blueprints from the Functions Interaction Matrix Analysis
81 5.5 Conclusions
82 References
82 6 Surface Plasmon Resonance Biosensor Devices 85 6.1 Introduction
85 6.2 Design Requirements on SPR Systems
88 6.2.1 Needs and Specifications of an SPR Design
88 6.3 Mechatronic Design Approach of SPR Systems
89 6.3.1 Generation of Design Alternatives
89 6.3.2 Hubka-Eder Mapping of the Design Alternatives
92 6.4 Detailed Design of Critical SPR Subsystems
99 6.4.1 Design of the Sensor Surface
100 6.4.2 Design of the Fluidic System
103 6.5 Conclusions
109 References
109 7 A Diagnostic Device for Helicobacter pylori Infection 113 7.1 Diagnostic Principle of Helicobacter Infection
113 7.2 Mechatronic Analysis of Urea Breath Test Systems
117 7.2.1 Mission and Specification for a Urea Breath Tests
117 7.2.2 Generation of UBT Design Concepts
118 7.2.3 Screening and Scoring of UBT Design Concepts
119 7.3 Description of the Systems Involved in the Design Concepts for the Urea Breath Tests
124 7.3.1 Biological Systems Involved
124 7.3.2 Technical Systems Alternatives
126 7.3.3 Information Systems (SIS) Required
127 7.3.4 Management and Goal Systems Required
127 7.3.5 Human Systems Involved in the Testing
127 7.3.6 Active Environment That Can Influence
128 7.4 Aspects of the Design for Efficient Manufacture
128 7.5 Conclusions
131 References
131 8 Microarray Devices 135 8.1 Principles, Methods, and Applications of Microarrays
135 8.1.1 Principles and Technology
135 8.1.2 Fabrication Methods
136 8.1.3 Companies Developing Microarrays
138 8.1.4 Applications of DNA Microarrays
139 8.2 Specification of Needs
141 8.3 Design of Microarrays
142 8.3.1 Generation of cDNA Microarray Concepts
142 8.4 Description of the Systems Involved in the Design Concepts
145 8.4.1 Biological Systems
146 8.4.2 Technical Systems
147 8.4.3 Information System
147 8.4.4 Management and Goal Systems and the Human Systems
147 8.4.5 Active Environment
147 8.4.6 Interaction Analysis
148 8.5 Conclusions
149 References
149 9 Microbial and Cellular Bioreactors 153 9.1 Bioreactor Development During the 1970s-1990s
153 9.2 Missions, User Needs, and Specifications for Bioreactors
158 9.2.1 Design Mission and User Needs
158 9.2.2 Target Specifications
158 9.3 Analysis of Systems for Conventional Bioreactors
161 9.3.1 Biological Systems in the Bioreactor
161 9.3.2 Technical Systems
164 9.3.3 Studying the Interactions of the Systems
166 9.3.4 Penicillin Production in a Metabolically Engineered Penicillium strain (Case 1)
168 9.3.5 A Bioreactor System Producing a Recombinant Protein in CHO Cell Culture (Case 2)
171 9.3.6 Information Systems
173 9.3.7 Management and Goal Systems
177 9.3.8 Human Systems
179 9.3.9 Active Environment
179 9.4 Novel Bioreactor Designs
180 9.4.1 Microbioreactors
180 9.4.2 Bioreactors with Immobilized Cells
183 9.4.3 Bioreactors for Tissue and Stem Cell Cultures
185 9.4.4 Bioreactors for Plant Cell Cultures
186 9.5 Conclusions
187 References
187 10 Chromatographic Protein Purification 193 10.1 Background of Chromatographic Protein Purification
193 10.2 Specification of Needs for Protein Purification Systems
197 10.3 Design of Purification Systems
199 10.3.1 Generation of Design Alternatives
199 10.3.2 Screening the Design Alternatives
201 10.3.3 Analysis of the Generated Alternatives for a Chromatography System
202 10.3.4 Interactions Between Key Systems and the Transformation Process
206 10.4 Unit Operation Purification in a FVIII Production Process (Case 1)
208 10.5 Micropurification System Based on a Multichip Device (Case 2)
209 10.6 Conclusions
211 References
212 11 Stem Cell Manufacturing 215 11.1 State of the Art of Stem Cell Manufacturing
215 11.2 Needs and Target Specifications for Scaled-Up Stem Cell Manufacturing
218 11.3 Setting Up an Efficient Manufacturing System by Using Biomechatronic Conceptual Design
220 11.3.1 Generating Process Alternatives
220 11.3.2 Hubka-Eder Map for a Human Embryonic Stem Cell Process
220 11.4 Conclusions
225 References
226 12 Bioartificial Organ-Simulating Devices 229 12.1 Introduction
229 12.2 Design of Bioartificial Organ-Simulation Devices
232 12.2.1 Needs and Specifications
232 12.2.2 Evaluation of the Design Concepts
236 12.3 Analysis of Bioartificial Liver Systems
239 12.3.1 Biological Systems
239 12.3.2 Technical Systems
241 12.3.3 Information Systems
242 12.3.4 Management and Goals Systems
243 12.3.5 Human Systems
243 12.4 Conclusions
244 References
244 13 Applications to Process Analytical Technology and Quality by Design 249 13.1 PAT and QbD Concepts
249 13.2 Needs of the PAT
QbD Players and Resulting Specifications
253 13.3 Application of Design Methodology to PAT
QbD
255 13.3.1 Concept Generation for a PAT
QbD System Structure
255 13.3.2 Hubka-Eder Mapping of the PAT
QbD Transformation Process for a Pharmaceutical Process
257 13.3.3 Analysis of Effects
259 13.4 Applying Mechatronic Design on a PAT System for Online Software Sensing in a Bioprocess (Case)
260 13.5 Conclusions
263 References
263 GLOSSARY 267 INDEX 275
?This book effectively presents the methodology and most of the necessary tools for a design process in biotechnology... I thus recommend this book to students who want to learn the fundamentals and basic applications of a product design process quickly. It is also a good read for professors, researchers and professionals from both engineering and biology... In conclusion, this book is a must-read for all modern bio-scientists and engineers working in the field of biotechnology.? ? Biotechnology Journal, 2012, 7