Industrial pharmaceutical biotechnology

1 Introduction to Functional Biotechnology 1 1.1 Scientific and Technological Foundations 1 1.2 Genomics 2 1.3 Proteomics 14 1.4 Cytomics 30 1.5 Micro- and Nanotechnology 32 1.6 Cellular Cloning 42 1.7 Tissue Engineering (Organ Cultivation) 50 1.8 Micro- and Nanotechnologies for Medicine 62 1.9 Structural Genomics 66 2 Organizational Structures 73 2.1 Virtual and Real Enterprises 73 2.2 R & D Networks 74 2.3 Outsourcing 75 2.4 Registrations/Permissions 76 3 Markets and Factors 77 3.1 Products and Services 77 3.2 Economies 77 3.3 Manpower 78 3.4 Resources 78 4 Biotechnology and Medicine 79 4.1 Diagnostics 80 4.2 Therapeutics 80 4.3 Gene Therapy 82 4.4 Implantates 92 4.5 Medical Devices and Technology 93 4.6 Complex Traits 96 Industrial Pharmaceutical Biotechnology. Heinrich Klefenz Copyright © 2002 Wiley-VCH Verlag GmbH ISBNs: 3-527-29995-5 (Hardcover); 3-527-60012-4 (Electronic) VIII Contents 5 Drug Discovery 117 5.1 Substances Derived from Bacteria, Plants, Insects, and Animals 134 5.2 Sources of Active Principles 135 5.3 Assay Systems and Models (e.g., Knock-out Mice) 140 6 Molecular Pharma-Biotechnology 145 6.1 Bioinformatics 146 6.2 Biological Systems and Models 162 6.3 Assay Systems 167 6.4 High-throughput Screening 170 6.5 Automation 172 6.6 Combinatorial Synthesis: Chemistry, Biology, and Biotechnology 173 6.7 Genotyping: Genetic Pre-Disposition, and Heterogeneity 177 6.8 Sequencing 181 6.9 Pharmaco-Genomics 184 7 Research and Development 195 7.1 Biology, Medicine, and Genetics 195 7.2 Pre-clinical and Clinical Development 195 7.3 Processes 195 7.4 Pilot Plants 196 7.5 Engineering 196 7.6 Fermentation Process Development 196 8 Pharmaceutical Production 201 8.1 GenePharming (Animals and Plants) 203 8.2 Vitamins 208 8.3 Amino Acids 208 8.4 Proteins 209 8.5 Antibiotics 212 8.6 Biocatalysis 219 8.7 Natural Compounds 229 8.8 Recovery/(Bio-) Processing 229 8.9 Chemical–Biotechnological Syntheses 231 8.10 Gene Therapy Vectors/Systems 235 8.11 Production: Safety, Efficacy, Consistency, and Specificity 235 8.12 Registration 238 Contents IX 9 Safety 239 9.1 Medical Safety 239 9.2 Biological Safety 239 9.3 Chemical Safety 239 9.4 Equipment Safety 240 10 Environment 241 10.1 Pharmaceuticals and the Environment 241 10.2 Biological Containment 241 10.3 Physical/Chemical Containment 242 10.4 Process-Integrated Environmental Protection 242 10.5 Waste/Effluent Treatment and Recycling 242 11 Ethics 245 12 Companies, Institutes, Networks, and Organizations 247 References 263 Index 303