Biomechatronic Design in Biotechnology

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