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