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| Preface | |
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| Acronyms | |
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| Pharmaceuticals, biologics and biopharmaceuticals | |
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| Introduction to pharmaceutical products | |
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| Biopharmaceuticals and pharmaceutical biotechnology | |
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| History of the pharmaceutical industry | |
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| The age of biopharmaceuticals | |
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| Biopharmaceuticals: current status and future prospects | |
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| Protein structure | |
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| Introduction | |
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| Overview of protein structure | |
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| Higher level structure | |
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| Protein stability and folding | |
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| Protein post-translational modifi cation | |
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| Gene manipulation and recombinant DNA technology | |
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| Introduction | |
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| Nucleic acids: function and structure | |
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| Recombinant production of therapeutic proteins | |
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| Classical gene cloning and identifi cation | |
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| The drug development process | |
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| Introduction | |
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| Discovery of biopharmaceuticals | |
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| The impact of genomics and related technologies upon drug discovery | |
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| Gene chips | |
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| Proteomics | |
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| Structural genomics | |
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| Pharmacogenetics | |
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| Initial product characterization | |
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| Patenting | |
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| Delivery of biopharmaceuticals | |
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| Nasal, transmucosal and transdermal delivery systems | |
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| Preclinical studies | |
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| Pharmacokinetics and pharmacodynamics | |
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| Toxicity studies | |
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| The role and remit of regulatory authorities | |
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| Conclusion | |
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| Sources and upstream processing | |
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| Introduction | |
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| Sources of biopharmaceuticals | |
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| Upstream processing | |
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| Downstream processing | |
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| Introduction | |
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| Initial product recovery | |
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| Cell disruption | |
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| Removal of nucleic acid | |
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| Initial product concentration | |
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| Chromatographic purifi cation | |
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| High-performance liquid chromatography of proteins | |
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| Purifi cation of recombinant proteins | |
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| Final product formulation | |
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| Product analysis | |
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| Introduction | |
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| Protein-based contaminants | |
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| Removal of altered forms of the protein of interest from the product stream | |
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| Detection of protein-based product impurities | |
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| Immunological approaches to detection of contaminants | |
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| Endotoxin and other pyrogenic contaminants | |
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| The cytokines: The interferon family | |
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| Cytokines | |
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| Cytokine receptors | |
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| Cytokines as biopharmaceuticals | |
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| The interferons | |
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| Interferon biotechnology | |
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| Conclusion | |
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| Cytokines: Interleukins and tumour necrosis factor | |
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| Introduction | |
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| Interleukin-2 | |
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| Interleukin-1 | |
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| Interleukin-11 | |
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| Tumour necrosis factors | |
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| Growth factors | |
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| Introduction | |
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| Haematopoietic growth factors | |
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| Growth factors and wound healing | |
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| Therapeutic hormones | |
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| Introduction | |
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| Insulin | |
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| Glucagon | |
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| Human growth hormone | |
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| The gonadotrophins | |
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| Medical and veterinary applications of gonadotrophins | |
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| Additional recombinant hormones now approved | |
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| Conclusion | |
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| Recombinant blood products and therapeutic enzymes | |
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| Introduction | |
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| Haemostasis | |
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| Anticoagulants | |
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| Thrombolytic agents | |
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| Enzymes of therapeutic value | |
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| Antibodies, vaccines and adjuvants | |
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| Introduction | |
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| Traditional polyclonal antibody preparations | |
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| Monoclonal antibodies | |
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| Vaccine technology | |
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| Adjuvant technology | |
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| Nucleic-acid- and cell-based therapeutics | |
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| Introduction | |
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| Gene therapy | |
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| Vectors used in gene therapy | |
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| Gene therapy and genetic disease | |
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| Gene therapy and cancer | |
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