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Handbook of Biophotonics, Volume 3: Photonics in Pharmaceutics, Bioanalysis and Environmental Research

Jurgen Popp (Editor), Valery V. Tuchin (Editor), Arthur Chiou (Editor), Stefan H. Heinemann (Editor)
ISBN: 978-3-527-41049-1
320 pages
May 2012
Handbook of Biophotonics, Volume 3: Photonics in Pharmaceutics, Bioanalysis and Environmental Research (352741049X) cover image
This new handbook covers the world of biophotonics not only geographically -- with the editors coming from different continents -- but also in terms of content, since the authors come from the whole spectrum of biophotonic basic and applied research. Designed to set the standard for the scientific community, these three volumes break new ground by providing readers with the physics basics as well as the biological and medical background, together with detailed reports on recent technical advances. The Handbook also adopts an application-related approach, starting with the application and then citing the various tools to solve the scientific task, making it of particular value to medical doctors.
Divided into several sections, the first part offers introductory chapters on the different fields of research, with subsequent parts focusing on the applications and techniques in various fields of industry and research. The result is a handy source for scientists seeking the basics in a condensed form, and equally a reference for quickly gathering the knowledge from neighboring disciplines.
Absolutely invaluable for biophotonic scientists in their daily work.
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Preface XIII

List of Contributors XV

Part One Process Control and Quality Assurance 1

1 Industrial Perspectives 3
Andreas Kandelbauer, Manfred Rahe, and Rudolf W. Kessler

1.1 Introduction and Definitions 3

1.1.1 Introduction 3

1.1.2 Historical Aspects 3

1.1.3 Definition of Quality: Product Functionality 4

1.1.4 Quality Control 8

1.1.5 Quality Assurance 9

1.2 Management and Strategy 9

1.2.1 PAT Initiative 9

1.2.2 PAT Toolbox 11

1.2.3 The Concept of Quality by Design (QbD) 12

1.2.4 ICH 13

1.2.5 The Concept of a Design Space 16

1.2.6 Implications for Other Branches of the Life Sciences 18

1.2.6.1 General Remarks 18

1.2.6.2 Biotechnology 19

1.2.6.3 Food Industry 19

1.2.6.4 Summary and Outlook 20

1.3 Toolboxes for Process Control and Understanding 21

1.3.1 Introduction: Causality 21

1.3.2 Sampling 22

1.3.3 Process Validation 25

1.3.3.1 Role of Design of Experiments (DoE) 25

1.3.3.2 Role of Failure Mode and Effects Analysis (FMEA) 26

1.3.4 Measurement Technologies (How to Measure) 27

1.3.4.1 Selection of the Appropriate Technique 27

1.3.4.2 Working in Aqueous Systems 28

1.3.4.3 Trace Analysis 29

1.3.4.4 Qualification of a Spectrometer 29

1.3.5 Data Analysis and Calibration (How to Process Data and How to Calibrate) 30

1.3.5.1 Introduction 30

1.3.5.2 Spectral Data Pretreatments and Data Cleaning 31

1.3.5.3 Chemometrics 32

1.3.5.4 Regression Analysis 33

1.3.6 Process Control (How to Control a Process) 34

1.4 Specific Problems Encountered in Industrial Process Analytics 37

1.4.1 Moisture Measurements (NIR, MW) 37

1.4.1.1 NIR Spectroscopy 37

1.4.1.2 Microwave Resonance Technique (MWR) 38

1.4.2 Process Analytics of Solids and Surfaces: Specular and Diffuse Reflectance 39

1.4.3 Working in Multiple Scattering Systems: Separating Scatter from Absorbance 41

1.4.3.1 Basics in the Measurement of Opaque Systems 41

1.4.3.2 Separation of Scatter from Absorption 43

1.4.3.3 Optical Penetration Depth 45

1.4.4 Spectral Imaging and Multipoint Spectroscopy 46

1.5 Survey Through Industrial Applications 49

1.5.1 Selection of Applications 49

1.5.2 Pharmaceutical Industry 50

1.5.2.1 UV/Vis Spectroscopy 50

1.5.2.2 NIR Spectroscopy 50

1.5.2.3 Raman Spectroscopy 51

1.5.2.4 Imaging Techniques 51

1.5.3 Food and Agriculture 52

1.5.3.1 UV/Vis Spectroscopy 53

1.5.3.2 NIR Spectroscopy 53

1.5.3.3 Raman Spectroscopy 53

1.5.3.4 Imaging Techniques 54

1.5.4 Polymers 55

1.5.4.1 UV/Vis Spectroscopy 55

1.5.4.2 NIR Spectroscopy 55

1.5.4.3 Raman Spectroscopy 56

1.5.4.4 Imaging Techniques 56

1.6 Perspectives 56

1.6.1 Technology Roadmap 2015þ 56

1.6.2 Medical Applications and Tomographic Imaging 58

1.6.3 Multi- Point-Information Systems in Manufacturing 59

1.6.4 Multimodal Spatially Resolved Spectroscopy 60

1.6.5 Microreactor Control and Reaction Tomography 61

References 63

2 Applications of Spectroscopy and Chemical Imaging in Pharmaceutics 71
Aoife A. Gowen and José M. Amigo

2.1 The New Paradigm of Process Control 71

2.2 Overview of Spectroscopic Techniques Commonly Used 72

2.3 The Need for Multivariate Data Analysis 75

2.3.1 Pre-Processing 75

2.3.2 Exploration Techniques 76

2.3.3 Regression, Resolution and Classification Techniques 77

2.3.4 Image Processing Techniques 77

2.4 Applications in Pharmaceutical Process Monitoring and Quality Control 78

2.4.1 Spray Formulations 78

2.4.2 Powders 79

2.4.3 Polymorphism 79

2.4.4 Solid Dosage Forms 80

2.4.5 Root Cause Analysis 80

2.4.6 API Distribution 80

2.4.7 Coatings 81

2.4.8 Counterfeit Identification 81

2.4.9 High Throughput Analysis 81

2.5 Issues Facing the Implementation of Spectroscopic Techniques in the Pharmaceutical Industry 82

2.5.1 Sampling 82

2.5.2 Spatial Resolution 83

2.5.3 Representativeness of the Measured Surface 84

2.5.4 Irregularities in the Measured Surface 85

2.6 Conclusions 85

References 86

3 Quality Control in Food Processing 89
Colette C. Fagan

3.1 Introduction 89

3.2 Quality Applications 91

3.3 Safety Applications 94

3.4 Authenticity Application 96

3.5 Process Control 102

3.6 Conclusions 104

3.7 Glossary 104

References 105


4 Application of Optical Methods for Quality and Process Control of Topically Applied Actives in Cosmetics and Dermatology 111
Juergen Lademann, Martina C. Meinke, Maxim E. Darvin, and Joachim W. Fluhr

4.1 Introduction 111

4.2 Laser Scanning Microscopy 112

4.2.1 Fluorescence Measurements 112

4.2.2 Remission Measurements 119

4.2.3 Multiphoton Measurements 119

4.3 Raman Spectroscopic Measurements 121

4.4 Resonance Raman Spectroscopy 123

4.5 Conclusions 123

References 124

Part Two On-Site Analysis 127

5 Agricultural Applications: Animal Epidemics and Plant Pathogen Detection 129
Robert Möller

5.1 Introduction 129

5.2 Diagnosis Under Field Conditions 130

5.3 Immunological Based-Techniques 131

5.3.1 Flow Through Format 132

5.3.2 Lateral Flow Assays 133

5.4 Nucleic Acid-Based Testing 134

5.5 Emerging Technologies 135

5.6 Conclusion 137

References 138

6 On-Site Analysis 141
Günther Proll and Günter Gauglitz

6.1 Introduction 141

6.2 Substances to be Monitored 143

6.3 Optical Methods for Monitoring 144

6.4 Assays 154

6.5 Applications 158

6.5.1 Chemical Contaminants, EDCs, Pharmaceuticals and Toxins 158

6.5.2 Pathogens 161

6.6 Perspectives and Visions 162

References 163

Part Three Security Applications 173

7 Body Scanner 175
Torsten May and Hans-Georg Meyer

7.1 Introduction 175

7.2 X-Ray Techniques 176

7.2.1 Overview 176

7.2.2 Physical and Technical Background 176

7.2.3 Backscatter Imaging 177

7.2.4 Transmission Imaging 179

7.3 Millimeter Wave Electronic Techniques 180

7.3.1 Overview 180

7.3.2 Physical and Technical Background 180

7.3.3 Active Imaging 182

7.3.4 Passive Imaging 184

7.4 Sub-Millimeter Wave (Terahertz) Photonic Techniques 186

7.4.1 Overview 186

7.4.2 Physical and Technical Background 187

7.4.3 Active Imaging 188

7.4.4 Passive Imaging 189

7.5 Conclusion and Outlook 191

References 191

8 Detection of Explosives 195
Wolfgang Schade, Rozalia Orghici, Mario Mordmüller, and Ulrike Willer

8.1 Introduction 195

8.2 Optical Methods for the Detection of Explosives – Overview 196

8.2.1 State of the Art Spectroscopic Methods 199

8.2.1.1 Absorption Spectroscopy 199

8.2.1.2 Detection of Decomposition Products and Fragments 200

8.2.1.3 Laser Induced Breakdown Spectroscopy (LIBS) 201

8.2.1.4 Raman Spectroscopy 202

8.2.1.5 Photoacoustic Spectroscopy of Explosives 204

8.2.1.6 Cavity Ring Down Spectroscopy 206

8.2.2 Novel Approaches 207

8.2.2.1 Femtosecond Coherent Control 207

8.2.2.2 THz-Spectroscopy 208

8.2.2.3 Photonic Ring Resonator Sensors 209

8.3 Summary 213

References 213

Part Four High Throughput and Content Screeming 219

9 High-Throughput and -Content Screening/Screening for New Pharmaceutics 221
Astrid Tannert and Michael Schaefer

9.1 Introduction 222

9.2 Targets 223

9.3 Substance Libraries 224

9.4 Biomarkers and Labels 226

9.4.1 Labels for Cell-Free Assays 227

9.4.2 Labeling of Cells 227

9.4.2.1 Synthetic Fluorophores 227

9.4.2.2 Genetically-Encoded Marker Proteins 228

9.5 Instrumentation 229

9.6 Assays 230

9.6.1 Fluorescence Polarization 231

9.6.2 Time-Resolved Fluorescence 234

9.6.3 Proximity Assay 235

9.6.4 Protein Complementation Assays 236

9.6.5 Resonance Energy Transfer 236

9.6.6 Fluorescence Fluctuation Approaches 237

9.6.7 Reporter Gene Expression 238

9.6.8 Measurement of Intracellular Calcium 238

9.6.9 Indicators for Ion Channel Activity 241

9.6.10 Flow Cytometry 242

9.6.11 Automated Microscopy 243

9.6.11.1 Image Analysis 245

9.7 Data Mining and Quality Control 246

9.7.1 Quality Control 246

9.7.1.1 Random and Systematic Errors 247

9.7.1.2 Compound Interferences 248

9.7.2 Identification of Hits 249

9.8 Conclusions 249

References 250

10 Optical Measurements for the Rational Screening of Protein Crystallization Conditions 257
Christoph Janzen and Kurt Hoffmann

10.1 Introduction 257

10.2 State of the Art of Protein Crystallization Techniques 258

10.3 A New Crystallization Method that Enables the Use of Optical Measurement Technologies 262

10.4 Optical Measurements for a Rational Crystallization Process 263

10.4.1 Static Light Scattering for the Analysis of the Pre-Nucleation Phase 264

10.4.2 Dynamic Light Scattering for the Analysis of the Nucleation Phase 266

10.4.3 Quantitative Polarization Microscopy for the Analysis of the Post-Nucleation Phase 268

10.5 Development of a New Optical Instrument 271

10.5.1 Measurement of Static and Dynamic Light Scattering in Small Volumes 271

10.5.2 Quantitative Polarization Microscopy 274

10.5.3 System Integration, Automation and Data Processing 274

10.6 Optical Measurements 275

10.6.1 Static Light Scattering 276

10.6.1.1 Instrument Performance 276

10.6.1.2 Measuring the Virial Coefficient of Proteins 277

10.6.1.3 Development of the Virial Coefficient with Different Solvent Parameters 280

10.6.2 Dynamic Light Scattering 281

10.6.3 Quantitative Polarization Microscopy 284

10.7 Outlook – An Iterative Optimization Process Based on Optical

Measurements 285

References 288

Index 291

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Jürgen Popp holds a full Professor at the Friedrich-Schiller-University Jena. He is Director of the Institute of Physical Chemistry at the university as well as Director of the Institute of Physical High Technology (IPHT) Jena. In the German Main Research Topic 'Biophotonik' (National Network financed by the BMBF) he serves as the speaker.

Associate Editors:
Arthur Chiou (National Yang-Ming University, Taipei, Taiwan)
Valery V. Tuchin (Saratov State University, Russia)
Stefan Heinemann (Friedrich-Schiller-University Jena, Germany)
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