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Hugo and Russell's Pharmaceutical Microbiology Table of contents : Cover Title Page Copyright Page Contents Notes on Contributors Preface to the First Edition Prefaceto the Ninth Edition About the Companion Website Part 1 Introducing Pharmaceutical Microbiology Chapter 1 Introduction to Pharmaceutical Microbiology 1.1 Pharmaceutical Microbiology: Microorganisms and Medicines 1.1.1 The Discipline of Pharmaceutical Microbiology 1.1.2 Microorganisms and Medicines 1.2 Scope and Content of the Book Part 2 Biology of Microorganisms Chapter 2 Fundamental Features of Microbiology 2.1 Introduction 2.1.1 Viruses, Viroids and Prions 2.1.2 Prokaryotes and Eukaryotes 2.2 Naming of Microorganisms 2.3 Microbial Metabolism 2.4 Microbial Cultivation 2.4.1 Culture Media 2.4.2 Cultivation Methods 2.4.3 Planktonic and Sessile (Biofilm) Growth 2.5 Enumeration of Microorganisms 2.6 Microbial Genetics 2.6.1 Bacteria 2.6.2 Eukaryotes 2.6.3 Genetic Variation and Gene Expression 2.7 Pharmaceutical Importance of the Major Categories of Microorganisms 2.8 Preservation of Microorganisms Chapter 3 Bacteria 3.1 Introduction 3.1.1 Bacterial Diversity and Ubiquity 3.2 Bacterial Ultrastructure 3.2.1 Cell Size and Shape 3.2.2 Cellular Components 3.2.3 Cell Surface Components 3.3 Biofilms 3.4 Bacterial Sporulation 3.4.1 Endospore Structure 3.4.2 Endospore Formation 3.4.3 Endospore Germination 3.5 Bacterial Toxins 3.6 Bacterial Reproduction and Growth Kinetics 3.6.1 Multiplication and Division Cycle 3.6.2 Population Growth 3.6.3 Growth and Genetic Exchange 3.7 Environmental Factors that Influence Growth and Survival 3.7.1 Physicochemical Factors that Affect Growth and Survival of Bacteria 3.7.2 Nutrition and Growth 3.8 Detection, Identification and Characterisation of Organisms of Pharmaceutical and Medical Significance 3.8.1 Culture Techniques 3.8.2 Microscopy 3.8.3 Biochemical Testing and Rapid Identification 3.8.4 Molecular Approaches to Identification 3.8.5 Pharmaceutically and Medically Relevant Microorganisms References Further Reading Chapter 4 Fungi 4.1 What Are Fungi? 4.2 Structure of the Fungal Cell 4.3 Medical Significance of Fungi 4.4 Antifungal Therapy 4.4.1 Polyene Antifungals 4.4.2 Azole Antifungals 4.4.3 Echinocandins 4.4.4 Synthetic Antifungal Agents 4.5 Medically Important Fungal Pathogens of Humans 4.5.1 Candida albicans 4.5.2 Aspergillus fumigatus 4.5.3 Histoplasma capsulatum 4.5.4 Cryptococcus neoformans 4.5.5 Dermatophytes 4.6 Emerging Fungal Pathogens 4.6.1 Saccharomyces cerevisiae 4.6.2 Non-albicans Candida Species 4.6.3 Penicillium marneffei 4.7 Antibiotic Production by Fungi Further Reading Chapter 5 Viruses and Other Acellular Infectious Agents: Characteristics and Control 5.1 Introduction 5.2 General Structure of Viruses 5.2.1 Viral Nucleic Acid 5.2.2 Viral Capsid 5.2.3 Viral Envelope 5.2.4 Viral Envelope-associated Proteins 5.3 Virus–Host Cell Interactions 5.3.1 Coronaviruses 5.3.2 Human Immunodeficiency Virus (HIV) 5.3.3 Oncogenic Viruses 5.4 Multiplication of Human Viruses 5.4.1 Attachment to the Host Cell 5.4.2 Penetration of the Viral Particle 5.4.3 Uncoating of the Viral Particle 5.4.4 Replication of Viral Nucleic Acids and Translation of the Genome 5.4.5 Maturation or Assembly of Virions 5.4.6 Release of Virions into the Surrounding Environment 5.5 Cultivation of Human Viruses 5.5.1 Cell Culture 5.5.2 The Chick Embryo 5.5.3 Animal Inoculation 5.6 Viral Epidemics and Pandemics 5.7 Control of Viruses 5.7.1 Antiviral Chemotherapy 5.7.2 Vaccination 5.7.3 Viricidal Effects of Chemical and Physical Agents on Viruses 5.7.4 Control of Viruses in Pharmaceutical Products 5.8 Biotechnological Applications of Viruses 5.9 Bacterial Viruses 5.9.1 Overview 5.9.2 Bacteriophages and Their Products as Antibacterial Agents 5.9.3 Other Applications of Bacteriophages 5.10 Subviral Infectious Agents and Prions Further Reading Chapter 6 Protozoa 6.1 Introduction 6.1.1 Protozoa 6.1.2 Parasitism 6.1.3 Habitats 6.1.4 Physiology of Parasitic Protozoa 6.2 Blood and Tissue Parasites 6.2.1 Malaria 6.2.2 Trypanosomatids 6.2.3 Toxoplasma gondii 6.3 Intestinal Parasites 6.3.1 Giardia lamblia (syn. intestinalis, duodenalis) 6.3.2 Entamoeba histolytica 6.3.3 Cryptosporidium parvum 6.4 Trichomonas and Free-living Amoebae 6.4.1 Trichomonas Vaginalis 6.4.2 Free-living Opportunist Amoebae 6.5 Host Response to Infection 6.5.1 Immune Response 6.5.2 Immune Pathology 6.5.3 Immune Evasion 6.6 Detection of Parasites 6.6.1 Methods of Detection 6.6.2 Analysis of Samples 6.7 Control of Protozoan Parasites 6.7.1 Chemotherapy 6.7.2 Other Approaches to Control Acknowledgement References Further Reading Part 3 Pathogens and Host Response Chapter 7 Principles of Microbial Pathogenicity and Epidemiology 7.1 Introduction 7.2 The Human Microbiome 7.3 Portals of Entry 7.3.1 Skin 7.3.2 Respiratory Tract 7.3.3 Intestinal Tract 7.3.4 Urogenital Tract 7.3.5 Conjunctiva 7.4 Consolidation 7.4.1 Nutrient Acquisition 7.4.2 Biofilms 7.4.3 Resistance to Host Defences 7.5 Manifestation of Disease 7.5.1 Non-invasive Pathogens 7.5.2 Partially Invasive Pathogens 7.5.3 Fully Invasive Pathogens 7.6 Damage to Tissues 7.6.1 Direct Damage 7.6.2 Indirect Damage 7.7 Recovery from Infection: the Exit of Microorganisms 7.8 Epidemiology of Infectious Disease Further Reading Chapter 8 Microbial Biofilms: Consequences for Health 8.1 Introduction 8.2 Biofilms 8.2.1 Biofilms in Nature and the Consequences for Health 8.2.2 Biofilms in the Food Industry 8.2.3 Biofilms in the Pharmaceutical Industry 8.2.4 Biofilms in Healthcare Facilities 8.2.5 Biofilms and Medical Devices 8.3 Tolerance of Biofilms to Antimicrobials 8.4 Mechanisms of Biofilm Tolerance 8.4.1 Biofilm Structure 8.4.2 Biofilm Physiology 8.4.3 Cellular Signalling and Biofilm Resistance 8.4.4 Plasticity of Biofilms 8.5 Treatment of Chronic Biofilm Infections 8.5.1 New Biofilm Assays 8.5.2 Better Use of Existing Antimicrobials 8.5.3 Next-generation Antimicrobials Acknowledgements References Further Reading Chapter 9 Immunology 9.1 Introduction 9.1.1 Historical Perspective and Scope of Immunology 9.1.2 Definitions and Outline Structure of the Immune System 9.1.3 Cells of the Immune System 9.2 The Innate Immune System 9.2.1 Innate Barriers at Epidermal and Mucosal Surfaces 9.2.2 Innate Defence Once Epidermal or Mucosal Barriers Have Been Compromised 9.2.2.1 Mononuclear Phagocytic Cells 9.3 The Humoral Adaptive Immune System 9.3.1 B-Lymphocyte Antigens 9.3.2 Basic Structure of Antibody Molecules 9.3.3 Clonal Selection and Expansion 9.3.4 Humoral Immune Effector Functions 9.4 Cell-mediated Adaptive Immune System 9.4.1 T-Lymphocyte Antigen Recognition and MHC Proteins 9.4.2 Processing of Proteins to Allow Peptide Presentation by MHC Molecules 9.4.3 More on T-lymphocyte Subpopulations 9.5 Some Clinical Perspectives 9.5.1 Transplantation Rejection 9.5.2 Hypersensitivity 9.5.3 Autoimmunity 9.5.4 Therapeutic Monoclonal Antibodies 9.5.5 Immunosuppressants 9.6 Summary Dedication Reference Further Reading Chapter 10 Vaccination and Immunisation 10.1 Introduction 10.2 Spread of Infection 10.2.1 Common-source Infections 10.2.2 Propagated-source Infections 10.3 Objectives of a Vaccine/Immunisation Programme 10.3.1 Disease Severity 10.3.2 Vaccine Effectiveness 10.3.3 Safety 10.3.4 Public Perception 10.3.5 Cost 10.3.6 Longevity of Immunity 10.4 Classes of Immunity 10.4.1 Passive Immunity 10.4.2 Active Immunity 10.5 Types of Vaccine 10.5.1 Live Vaccines 10.5.2 Inactivated (Killed) and Component Vaccines 10.5.3 DNA Vaccines 10.5.4 mRNA Vaccines 10.5.5 Viral Vector Vaccines 10.6 Routine Immunisation against Infectious Disease 10.6.1 Poliomyelitis Vaccination 10.6.2 Measles, Mumps and Rubella Vaccination 10.6.3 Tuberculosis 10.6.4 Diphtheria, Tetanus and Acellular Pertussis (DTaP) Immunisation 10.6.5 Immunisation against Bacteria Associated with Meningitis 10.6.6 Human Papillomavirus Vaccination 10.6.7 COVID-19 Vaccination 10.7 The UK Routine Childhood Immunisation Programme 10.8 Immunisation of the Over 65s and Other Risk Groups Acknowledgements Further Reading Part 4 Prescribing Therapeutics and Infection Control Chapter 11 Antibiotics and Synthetic Antimicrobial Agents: Their Properties and Uses 11.1 Antibiotic Development, Past and Present 11.1.1 Antibiotic Usage 11.2 β-Lactam Antibiotics 11.2.1 Penicillins 11.2.2 Cephalosporins 11.2.3 β-Lactamase Inhibitors 11.2.4 Carbapenems and Monobactams 11.2.5 Hypersensitivity 11.3 Tetracyclines 11.4 Macrolides 11.5 Sulphonamides and Trimethoprim 11.6 Quinolones 11.7 Aminoglycosides 11.8 Glycopeptides 11.9 Antitubercular Drugs 11.10 Newer Antibiotics for MRSA and Other Gram-positive Cocci Infections 11.11 Miscellaneous Antibacterial Antibiotics 11.11.1 Clindamycin 11.11.2 Fusidic Acid 11.11.3 Mupirocin 11.11.4 Colistin 11.11.5 Chloramphenicol 11.11.6 Metronidazole and Other Nitroimidazoles 11.11.7 Nitrofurantoin 11.12 Antifungal antibiotics 11.12.1 Azoles 11.12.2 Polyenes 11.12.3 Echinocandins 11.12.4 Other Antifungal Agents 11.13 Antiviral Drugs 11.13.1 Human Immunodeficiency Virus 11.13.2 Herpes and Cytomegalovirus Infections 11.13.3 Viral Hepatitis 11.13.4 Influenza and Respiratory Syncytial Virus Acknowledgements References Further Reading Chapter 12 Mechanisms of Action of Antibiotics and Synthetic Anti-infective Agents 12.1 Introduction 12.2 The Microbial Cell Wall 12.2.1 Peptidoglycan Biosynthesis in Bacteria and Its Inhibition 12.2.2 Mycolic acid and Arabinogalactan Biosynthesis in Mycobacteria 12.2.3 Echinocandins – Caspofungin, Anidulafungin and Micafungin 12.3 Protein Synthesis 12.3.1 Protein Synthesis and Its Selective Inhibition 12.3.2 Aminoglycoside–Aminocyclitol Antibiotics 12.3.3 Tetracyclines 12.3.4 Chloramphenicol 12.3.5 Macrolides and Azalides 12.3.6 Clindamycin 12.3.7 Streptogramins – Quinupristin and Dalfopristin 12.3.8 Oxazolidinones – Linezolid and Tedizolid Phosphate 12.3.9 Mupirocin 12.3.10 Fusidic Acid 12.3.11 Pleuromutilins – Retapamulin and Lefamulin 12.4 Chromosome Function and Replication 12.4.1 Basis for the Selective Inhibition of Chromosome Replication and Function 12.4.2 Fluoroquinolones 12.4.3 Nitroimidazoles (Metronidazole, Tinidazole) and Nitrofurans (Nitrofurantoin) 12.4.4 Semi-synthetic Rifamycins (Rifampicin, Rifabutin, Rifaximin, Rifapentine) and Fidaxomicin 12.4.5 5-Fluorocytosine 12.5 Folate Antagonists 12.5.1 Folate Metabolism in Microbial and Mammalian Cells 12.5.2 Sulphonamides 12.5.3 DHFR Inhibitors – Trimethoprim, Pyrimethamine, Proguanil and Trimetrexate 12.6 The Cytoplasmic Membrane 12.6.1 Composition and Susceptibility of Membranes to Selective Disruption 12.6.2 Polymyxins 12.6.3 Daptomycin 12.6.4 Polyenes 12.6.5 Imidazoles and Triazoles 12.6.6 Terbinafine and Amorolfine Further Reading Chapter 13 Bacterial Resistance to Antibiotics 13.1 Introduction 13.2 The Origins of Resistance 13.3 Mechanisms of Resistance 13.4 Resistance to β-Lactam Antibiotics 13.4.1 β-Lactamases 13.4.2 β-Lactamase Inhibitors 13.4.3 Altered Penicillin-binding Proteins and Methicillin-resistant Staphylococcus aureus 13.5 Resistance to Glycopeptide Antibiotics 13.5.1 MRSA and Reduced Glycopeptide Susceptibility 13.6 Resistance to Aminoglycoside Antibiotics 13.7 Resistance to Tetracycline Antibiotics 13.8 Resistance to Fluoroquinolone Antibiotics 13.9 Resistance to Macrolide, Lincosamide and Streptogramin Antibiotics 13.10 Resistance to Chloramphenicol 13.11 Resistance to Oxazolidinone Antibiotics 13.12 Resistance to Trimethoprim 13.13 Resistance to Mupirocin 13.14 Resistance to the Polymyxin Antibiotic Colistin (Polymyxin E) 13.15 Resistance to the Lipopeptide Antibiotic Daptomycin 13.16 Resistance to Antimycobacterial Therapy 13.17 Multiple Drug Resistance 13.17.1 R-Plasmids 13.17.2 Mobile Gene Cassettes and Integrons 13.17.3 Chromosomal Multiple Antibiotic Resistance (mar) Locus 13.17.4 Multidrug Efflux Pumps 13.18 Clinical Resistance, MICs, Breakpoints, Phenotypic Resistance and Outcome 13.19 Conclusion Acknowledgement References Further Reading Chapter 14 Clinical Uses of Antimicrobial Drugs 14.1 Introduction 14.2 Principles of Use of Antimicrobial Drugs 14.2.1 Susceptibility of Infecting Organisms 14.2.2 Host Factors 14.2.3 Pharmacological Factors 14.2.4 Drug Resistance 14.2.5 Drug Combinations 14.2.6 Adverse Reactions 14.2.7 Superinfection 14.2.8 Chemoprophylaxis 14.3 Clinical Use 14.3.1 Respiratory Tract Infections 14.3.2 Urinary Tract Infections 14.3.3 Gastrointestinal Infections 14.3.4 Skin and Soft Tissue Infections 14.3.5 Central Nervous System Infections 14.3.6 Fungal Infections 14.3.7 Medical device-associated Infections 14.4 Antibiotic Policies 14.4.1 Rationale 14.4.2 Types of Antibiotic Policies Acknowledgements References Further Reading Chapter 15 Antibiotic Prescribing and Antimicrobial Stewardship 15.1 The Need for Antimicrobial Stewardship 15.1.1 The Problem of Antibiotic Resistance 15.1.2 The Challenge of New Antibiotic Development 15.1.3 The Need for Alternative Approaches to Antibiotic Use 15.2 Antibiotic Consumption 15.2.1 Relationship between Antibiotic Consumption and Bacterial Resistance 15.2.2 Global Antibiotic Consumption 15.2.3 Non-prescription Access to Antibiotics 15.2.4 Non-human Antibiotic Use 15.3 Antimicrobial Stewardship Programmes 15.3.1 Definition and Aims of Antimicrobial Stewardship 15.3.2 Components of an ASP 15.3.3 ASP Interventions and their Evidence 15.3.4 Antimicrobial Stewardship in Primary and Community Care 15.3.5 ASPs and Infection Prevention and Control Strategies 15.3.6 The Experience of ASPs during a Pandemic 15.4 Monitoring Antimicrobial Stewardship Programmes 15.4.1 Electronic Surveillance of Antibiotic Use and Resistance References Further Reading Chapter 16 Infection Prevention and Control: Healthcare-associated Infection 16.1 Introduction 16.2 Defining Healthcare-associated Infections 16.2.1 Surgical Site Infections 16.2.2 Bloodstream Infections 16.2.3 Urinary Tract Infections 16.2.4 Ventilator-associated Pneumonia 16.3 Microorganisms Implicated in Healthcare-associated Infection 16.3.1 Gram-positive Bacteria 16.3.2 Gram-negative Bacteria 16.3.3 Viruses 16.3.4 Clinically Relevant Fungi 16.4 Standard IPC Interventions for the Management and Prevention of HCAI 16.4.1 Standard Precautions 16.4.2 Hand Hygiene 16.4.3 Infection Precautions (Contact Precaution and Droplet Precautions) 16.4.4 Isolation Precautions 16.4.5 Cohorting 16.4.6 Cleaning and Disinfection 16.4.7 Active Surveillance 16.4.8 Clinical Protocol-driven Responses 16.4.9 Antimicrobial Stewardship 16.5 Impact of the Clinical Setting on Infection Prevention and Control 16.5.1 Outbreaks and IPC Interventions 16.6 Measuring Impact and Success 16.7 Professional Support for Infection Prevention and Control References Further Reading Part 5 Contamination and Contamination Control Chapter 17 Microbial Spoilage, Infection Risk and Contamination Control 17.1 Introduction 17.2 Spoilage: Chemical and Physicochemical Deterioration of Pharmaceuticals 17.2.1 Pharmaceutical Ingredients Susceptible to Microbial Attack 17.2.2 Observable Effects of Microbial Attack on Pharmaceutical Products 17.2.3 Factors Affecting Microbial Spoilage of Pharmaceutical Products 17.3 Hazard to Health 17.3.1 Microbial Toxins 17.4 Sources and Control of Contamination 17.4.1 In Manufacture 17.4.2 In Use 17.5 The Extent of Microbial Contamination 17.5.1 In Manufacture 17.5.2 In Use 17.6 Factors Determining the Outcome of a Medicament-borne Infection 17.6.1 Type and Degree of Microbial Contamination 17.6.2 Route of Administration 17.6.3 Resistance of the Patient 17.7 Preservation of Medicines Using Antimicrobial Agents: Basic Principles 17.7.1 Introduction 17.7.2 Effect of Preservative Concentration, Temperature and Size of Inoculum 17.7.3 Factors Affecting the ‘Availability’ of Preservatives 17.8 Quality Assurance and the Control of Microbial Risk in Medicines 17.8.1 Introduction 17.8.2 Quality Assurance in Formulation Design and Development 17.8.3 Good Pharmaceutical Manufacturing Practice 17.8.4 Quality Control Procedures 17.8.5 Post-market Surveillance 17.9 Overview References Further Reading Chapter 18 Chemical Disinfectants, Antiseptics and Preservatives 18.1 Introduction 18.1.1 European Union Regulation 18.1.2 Definitions 18.1.3 Economic Aspects 18.2 Factors Affecting Choice of Antimicrobial Agent 18.2.1 Properties of the Chemical Agent 18.2.2 Microbiological Challenge 18.2.3 Intended Application 18.2.4 Environmental Factors 18.2.5 Toxicity of the Agent 18.3 Types of Compound 18.3.1 Acids and Esters 18.3.2 Alcohols 18.3.3 Aldehydes 18.3.4 Biguanides 18.3.5 Halogens 18.3.6 Heavy Metals 18.3.7 Hydrogen Peroxide and Peroxygen Compounds 18.3.8 Phenols 18.3.9 Surface-active Agents 18.3.10 Other Antimicrobials 18.3.11 Antimicrobial Combinations and Systems 18.4 Disinfection Policies References Further Reading Chapter 19 Laboratory Evaluation of Antimicrobial Agents 19.1 Introduction 19.1.1 Definitions 19.2 Factors Affecting the Antimicrobial Activity of Disinfectants 19.2.1 Innate (Natural) Resistance of Microorganisms 19.2.2 Microbial Density 19.2.3 Disinfectant Concentration and Exposure Time 19.2.4 Physical and Chemical Factors 19.2.5 Presence of Extraneous Organic Material 19.3 Evaluation of Liquid Disinfectants 19.3.1 General 19.3.2 Antibacterial Disinfectant Efficacy Tests 19.3.3 Other Microbe Disinfectant Tests 19.4 Evaluation of Solid Disinfectants 19.5 Evaluation of Air Disinfectants 19.6 Evaluation of Preservatives 19.7 Rapid Evaluation Procedures 19.8 Evaluation of Potential Chemotherapeutic Antimicrobials 19.8.1 Tests for Bacteriostatic Activity 19.8.2 Tests for Bactericidal Activity 19.8.3 Tests for Fungistatic and Fungicidal Activities 19.8.4 Evaluation of Possible Synergistic Antimicrobial Combinations 19.9 Tests for Biofilm Susceptibility 19.9.1 Synergy Biofilm Assays Acknowledgement References Further Reading Chapter 20 Microbicides: Mode of Action and Resistance 20.1 Introduction 20.2 Mechanisms of Interaction 20.3 Antimicrobial Effects 20.4 Mechanisms of Action 20.4.1 Oxidation Reactions 20.4.2 Cross-linking Reactions 20.4.3 Coagulation 20.4.4 Disruption of Functional Structures 20.5 Enhancing Activity 20.6 Mechanisms of Resistance to Microbicides 20.6.1 General Mechanisms 20.6.2 Induction of Resistance 20.6.3 Dissemination of Resistance 20.6.4 Bacterial Endospores 20.6.5 Bacterial Biofilms 20.6.6 Misuse and Abuse of Microbicides 20.7 Viricidal Activity of Microbicides 20.8 Microbicides and Protozoa 20.9 Microbicides and Fungi 20.10 Inactivation of Prions 20.11 Conclusion References Further Reading Chapter 21 Sterilisation Procedures and Sterility Assurance 21.1 Introduction 21.2 Sensitivity of Microorganisms 21.2.1 Survivor Curves 21.2.2 Expressions of Resistance 21.2.3 Sterility Assurance 21.3 Sterilisation Methods 21.4 Heat Sterilisation 21.4.1 Sterilisation Processes 21.4.2 Moist Heat Sterilisation 21.4.3 Dry Heat Sterilisation 21.5 Gaseous Sterilisation 21.5.1 Ethylene Oxide 21.5.2 Formaldehyde 21.5.3 Peroxygen Compounds 21.6 Radiation Sterilisation 21.6.1 Steriliser Design and Operation 21.7 Filtration Sterilisation 21.7.1 Filtration Sterilisation of Liquids 21.7.2 Filtration Sterilisation of Gases 21.8 Newer Sterilisation Technologies 21.8.1 High-intensity Light 21.8.2 Low-temperature Plasma 21.9 Sterilisation Control and Sterility Assurance 21.10 Bioburden Determinations 21.11 Environmental Monitoring 21.12 Validation and In-process Monitoring of Sterilisation Procedures 21.12.1 Physical Indicators 21.12.2 Chemical Indicators 21.12.3 Biological Indicators 21.13 Sterility Testing 21.13.1 Sterility Testing Methods 21.13.2 Antimicrobial Agents 21.13.3 Positive Controls 21.13.4 Specific Cases 21.13.5 Sampling 21.13.6 Retests 21.13.7 The Role of Sterility Testing References Further Reading Part 6 Pharmaceutical Production Chapter 22 Sterile Pharmaceutical Products and Principles of Good Manufacturing Practice 22.1 Introduction 22.2 Defining Sterility 22.3 Sterilisation Methods 22.3.1 Factors Affecting Sterilisation 22.4 Demonstrating Sterility 22.5 Types of Sterile Product 22.5.1 Injections 22.5.2 Non-injectable Sterile Fluids 22.5.3 Ophthalmic Preparations 22.5.4 Dressings 22.5.5 Implants 22.5.6 Absorbable Haemostats 22.5.7 Surgical Ligatures and Sutures 22.5.8 Instruments and Equipment 22.5.9 General Considerations 22.6 Good Manufacturing Practices for Sterile Products 22.6.1 Regulatory Framework 22.6.2 In-process Controls and Quality Control (QC) 22.7 Sterility Assurance and the Manufacture of Sterile Products 22.8 Terminal Sterilisation and Aseptic Processing 22.9 Cleanrooms and Facility Design 22.9.1 Design of Premises 22.9.2 Internal Surfaces, Fittings and Floors 22.9.3 Services 22.9.4 Air Supply 22.10 Operating Principles for Aseptic Processing 22.10.1 Sterile Filtration 22.10.2 Managing Aseptic Assembly, Connections and Interventions 22.10.3 Transfer of Materials into and out of Aseptic Processing Areas 22.11 Minimising Human Intervention 22.11.1 Blow–Fill–Seal Technology 22.11.2 Restricted Access Barrier Systems 22.11.3 Isolators 22.11.4 Single-use Sterile Disposable Technology 22.12 Personnel 22.13 Media Simulation Trials 22.14 Quality Risk Management 22.15 Environmental Monitoring 22.16 Release of Sterile Products 22.16.1 Assessments of Sterility 22.16.2 Assessments of Pyrogenicity 22.16.3 Visible Particulates 22.17 Summary Acknowledgements Reference Further Reading Chapter 23 The Manufacture and Quality Control of Immunological Products 23.1 Introduction 23.2 Vaccines 23.2.1 Types of Vaccines 23.2.2 The Seed Lot System 23.2.3 Production of the Bacteria and the Cellular Components of Bacterial Vaccines 23.2.4 Fermentation 23.2.5 Production of the Viruses and the Components of Viral Vaccines 23.2.6 Blending 23.2.7 Filling and Drying 23.2.8 Quality Control 23.3 In Vivo Diagnostics 23.3.1 Preparation 23.3.2 Quality Control 23.4 Immune Sera 23.4.1 Preparation 23.4.2 Quality Control 23.5 Human Immunoglobulins 23.5.1 Source Material 23.5.2 Fractionation 23.5.3 Quality Control 23.6 Monoclonal Antibodies 23.6.1 Preparation 23.6.2 Quality Control 23.7 Acknowledgements References Further Reading Chapter 24 Recombinant DNA Technology 24.1 Introduction: Biotechnology in the Pharmaceutical Sciences 24.2 Enabling Techniques 24.2.1 Cutting and Joining DNA Molecules 24.2.2 Cloning Vectors 24.2.3 Introduction of Vector into Hosts 24.2.4 Construction of Genomic Libraries 24.2.5 Screening of Genomic Libraries 24.2.6 Optimising Expression of Recombinant Genes 24.2.7 Amplifying DNA: the Polymerase Chain Reaction 24.2.8 Genome Editing Using CRISPR–Cas9 Endonuclease 24.3 Biotechnology in the Pharmaceutical Industry 24.3.1 Recombinant Human Insulin 24.3.2 Recombinant Somatostatin 24.3.3 Recombinant Somatotropin 24.3.4 Recombinant Hepatitis B Vaccine 24.3.5 Recombinant Influenza and Coronavirus Vaccines 24.3.6 Production of Recombinant Antibiotics 24.4 New Diagnostics Using Recombinant DNA Technology 24.4.1 Diagnosis of Infectious Diseases 24.4.2 Diagnosis of Genetic Disorders Further Reading Part 7 Current Trends and New Directions Chapter 25 The Wider Contribution of Microbiology to the Pharmaceutical Sciences 25.1 Introduction 25.1.1 Early Treatment of Human Disease 25.1.2 Present-day Exploitation 25.2 Pharmaceuticals Produced by Microorganisms 25.2.1 Dextrans 25.2.2 Vitamins, Amino Acids and Organic Acids 25.2.3 Iron-chelating Agents 25.2.4 Enzymes 25.3 Applications of Microorganisms in the Partial Synthesis of Pharmaceuticals 25.3.1 Production of Antibiotics 25.3.2 Steroid Biotransformations 25.3.3 Chiral Inversion 25.4 Applications of Microorganisms in the Discovery of Pharmaceuticals 25.4.1 Phage Display 25.5 Use of Microorganisms and Their Products in Assays 25.5.1 Antibiotic Bioassays 25.5.2 Vitamin and Amino Acid Bioassays 25.5.3 Phenylketonuria Testing 25.5.4 Carcinogen and Mutagen Testing 25.5.5 Use of Microbial Enzymes in Sterility Testing 25.5.6 Immobilised Enzyme Technology 25.6 Use of Microorganisms as Models of Mammalian Drug Metabolism 25.7 Microorganisms as Therapy 25.7.1 Bacteriophages 25.7.2 Probiotics 25.7.3 Toxins 25.8 Insecticides 25.9 Bioterrorism 25.10 Concluding Remarks Further Reading Chapter 26 Alternative Strategies to Antibiotics: Priorities for Development 26.1 Introduction 26.2 Bacteriophage Therapy 26.3 Bacteriophage Lysins 26.4 Vaccines and Immunotherapies 26.4.1 Vaccines for Bacterial Infections 26.4.2 Immunotherapies 26.5 Probiotics 26.5.1 Gastrointestinal Conditions 26.5.2 Recurrent Vaginitis 26.6 Antimicrobial Peptides 26.7 Conclusion Acknowledgements References Further Reading Index EULA
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Hugo and Russell's Pharmaceutical Microb
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