Pharmaceutical Biotechnology

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1 Textbook of Pharmaceutical Biotechnology Prof. Chandrakant Kokate PhD, FGAES (Germany) University, Karnataka Former Vice-Chancellor, Kakatiya University, Warangal, AP Former President, Pharmacy Council of India Prof. S. Jalalpure MPharm, PhD Professor Department of Pharmacognosy College of Pharmacy, KLE University Belgaum, Karnataka Dr J. Hurakadle MPharm, PhD Associate Professor and Head Department of Pharmaceutical Biotechnology College of Pharmacy, KLE University Belgaum, Karnataka A division Elsevier India Private Limited

2 Contents CHAPTER 1: Historical Perspectives and Milestones 1 Introduction 1 Discovery of Cell and Chromosome Theory of 1 Major Branches of Biotechnology 2 Advances in Biotechnology 4 Significant Milestones in Biotechnological Research 4 Historical Contributions of Some Leading Scientists 4 Genetic Evaluation 10 Historical Perspectives of Plant Tissue Culture CHAPTER 2: Immunology and Immunological Preparations Introduction 15 the Immune System Works 16 Principles 19 Types of Immunity 21 Immune Tolerance 22 Hypersensitivity 23 Antigen-Antibody Reactions and Their Applications Applications of 29 Vaccines CHAPTER 3: Environmental Biotechnology 35 Introduction Management of Environmental Pollution 36 Management of Air, Waste Gases and Water Pollution 40

3 CHAPTER 4: Proteins and 43 Introduction Proteins Proteomics CHAPTER 5: Animal Cell and Tissue Biotechnology Introduction 55 Primary and Established Cell Lines Kinetics of Cell Growth Animal Tissue Culture: Media Requirements CHAPTER 6: Medicinal Plant Biotechnology Genetics as Applied to Medicinal Herbs Mutation Polyploidy Hybridization (Chemical Races) Genetic Engineering and Recombinant DNA Technology in Plants Plant Tissue Cultures as Sources of Historical Development Types of Cultures Compounds Culture Medium 90 Surface Sterilization of Explants 91 Establishment of Cultures in Plant Tissue Cultures Bioproduction of Useful Metabolites in Hairy Root and Multiple Shoot Cultures CHAPTER 7: Microbial Culture and Fermentation Process Introduction Microorganisms 100 Microbial Culture 100 Quality Control of Microbial Culture Media 109 CHAPTER 8: Genetics and Molecular Biotechnology Introduction 111 DNA as Segment of Molecular Heredity 113 Genes 116 Mutations. 123

4 Molecular Biotechnology CHAPTER 9: Recombinant DNA Technology Introduction 129 Outline of Recombinant Technology 130 Introduction of the Recombinant DNAs into a Suitable Host Cell and Their Identification Applications of Recombinant Technology 134 Production of Human Follicle-Stimulating Hormone 139 Disease Diagnosis by Recombinant DNA Methods 139 Recombinant DNA Technology for Improving Milk Production 140 Applications in the Pulp and Paper Industry 140 Applications in Antibiotic-Producing Microorganisms 140 Genetic Engineering as a Part of Recombinant DNA Technology CHAPTER 10: Microbial Transformation 143 Introduction 143 Types of Reactions Mediated by Microorganisms 145 Design for Biotransformation 149 Biotransformation Process and Improvement with Special Reference to Steroids CHAPTER 11: Technology and Monoclonal Antibodies Introduction 155 Principle for Creation of Hybridoma Cells 156 Large-Scale Production of Monoclonal Antibodies 158 Applications of Monoclonal Antibodies CHAPTER Antibiotics Historical Development of Antibiotics 167 Antimicrobial Spectrum 171 Standardization of Antibiotics 172 Screening of Soil for Organisms Producing Antibiotics 174 or Bioreactor 176 Design of Industrial Fermentation Process 178 Fermenter Design and Control 180 Isolation of Mutants 181 Factors Influencing Rate of Mutation 182 Isolation of Fermentation Products 187

5 CHAPTER 13: Genetic Recombination 189 Introduction 189 Methods of Gene Transfer in Plants 190 Horizontal Gene Transfer Technology 200 Protoplast Fusion 205 Gene Cloning 207 Development of Hybridoma by Monoclonal Antibodies 208 Some Important Medicines Produced by Biotechnology 211 Gene Transfer in Humans 213 Applications of Gene Transfer CHAPTER 14: Medicine and Edible Vaccines 217 Introduction 217 Edible Vaccines CHAPTER 15: Broad Applications of Pharmaceutical Biotechnology 227 Introduction 227 Applications of Biotechnology in the Production of 228 Applications of Biotechnology in the Diagnosis of Diseases 231 Applications of Biotechnology in Agriculture 231 Applications of Ultrasound in Biotechnology 232 Testing of Pharmaceuticals CHAPTER 16: Biotechnology in Drug Discovery 233 Introduction 233 Current Trends in Modern Pharmaceutical Analysis for Drug Discovery 235 Recent Pharmacokinetic Advances Drug Discovery and Development 235 Natural Product Drug Discovery CHAPTER Immobilization of Enzymes 239 Introduction 239 History of Enzymes 240 Enzyme Structure Enzyme Kinetic Bioproduction of Enzymes Enzyme Production Enzyme Immobilization Immobilization of Plant Cells

6 Enzyme Engineering 259 Applications of Enzymes 260 Biosensors CHAPTER Nanobiotechnology 269 Introduction 269 Computational Gene 270 Nanolithography 272 and 274 Medical Applications of Molecular Nanotechnology CHAPTER Recent Advances in Biopharmaceuticals 287 Introduction 287 Advantages of DNA Technology in the Production of Biopharmaceuticals 288 Produced Through Recombinant DNA Technology 289 Biopharmaceuticals of Animal Origin 290 Biopharmaceuticals of Plant Origin 292 Pharmaceutical Substances of Microbial Origin 293 Recent Advances in Biopharmaceuticals Appendix 305 Glossary 313 Bibliography