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Contents
Chapter 1: Biopharmaceuticals, an Introductory Overview
1.1 Introduction to pharmaceutical products
1.2 Genetic engineering and the advent of biopharmaceuticals
1.3 Biopharmaceuticals: current status and future prospects
Chapter 2: Biopharmaceuticals: Discovery, Development and Regulation
2.1 Introduction
2.2 Discovery of biopharmaceuticals
2.3 The impact of �omics� and related technologies upon drug discovery
2.4 Lead discovery
2.5 Pharmacogenetics
2.6 The influence of artificial intelligence upon drug discovery
2.7 Lead characterization, CMC development and QbD
2.8 Delivery of biopharmaceuticals
2.9 Preclinical studies
2.10 Pharmacokinetics and pharmacodynamics
2.11 Toxicity studies
2.12 Clinical trials
2.13 The role and remit of regulatory authorities
2.14 The Food and Drug Administration (FDA)
2.15 European pharmaceutical law
2.16 Pharmacovigilance
2.17 World harmonization of drug regulations and the ICH
2.18 The naming of biopharmaceuticals
2.19 Patenting
2.20 Biosimilar regulation
Chapter 3: Good Manufacturing Practice
3.1 Introduction
3.2 Guides to Good Manufacturing Practice (GMP)
3.3 Pharmacopoeia
3.4 The manufacturing facility
3.5 Documentation
3.6 Validation
Chapter 4: Protein Structure
4.1 Introduction
4.2 Primary Structure
4.3 Higher level structure
4.4 Protein folding and stability
4.5 Protein structure prediction
4.6 Protein post translational modification
Chapter 5: Production of Therapeutic Proteins by Recombinant Means
5.1 Introduction
5.2 Nucleic acids; structure and function
5.3 The principles of genetic engineering
5.4 Cell types in which recombinant therapeutic proteins are produced
5.5 Engineered therapeutic proteins
Chapter 6: Therapeutic protein manufacture: upstream processing
6.1 Introduction
6.2 Cell banking systems
6.3 Bioreactors
6.4 Microbial cell fermentation
6.5 Mammalian cell culture
Chapter 7: Therapeutic protein manufacture: downstream processing
7.1 Initial product recovery
7.2 Initial product concentration
7.3 Chromatographic purification
7.4 Viral clearance
7.5 Some influences which can alter the biological activity of proteins
7.6 Final product formulation
7.7 Sterilization and final product fill
7.8 Trends in downstream processing
Chapter 8: Product analysis
8.1 Introduction and regulatory context
8.2 Potency determination
8.3 Protein content
8.4 Purity determination and API characterization
8.5 Key analytical methodologies
8.6 Product purity determination
8.7 API characterization
8.8 Non-protein impurity characterization: DNA
8.9 Contaminant testing
8.10 Additional tests
Chapter 9: Antibodies
9.1 Antibody structure and function
9.2 Polyclonal antibody preparations used therapeutically
9.3 Hybridoma technology and first generation monoclonal antibodies
9.4 Chimeric and humanized antibodies
9.5 Fully human mAbs
9.6 Routine manufacture of mAbs
9.7 mAb therapeutic applications in overview
9.8 mAb therapeutics treating inflammation
9.9 mAbs therapeutic treating cancer
9.10 Some additional therapeutic mAbs
9.11 Additional engineered antibody formats
9.12 The mAb market and the advent of mAb biosimilars
Chapter 10: Vaccines
10.1 Introduction
10.2 Traditional vaccine preparations
10.3 The impact of recombinant DNA technology on vaccines
10.4 Adjuvant technology
Chapter 11: The cytokines - the interferon family
11.1 Introduction to the cytokines
11.2 The Interferons
11.3 Interferon biotechnology
Chapter 12: The cytokines - Interleukins and Tumour Necrosis Factor
12.1 Introduction to the interleukins
12.2 Interleukin-2
12.3 IL-2 biotechnology
12.4 Interleukin 11
12.5 Inhibition of interleukin activity
12.6 Tumour Necrosis Factor
Chapter 13: Growth Factors
13.1 Introduction
13.2 Haematopoietic growth factors
13.3 Granulocyte colony stimulating factor (G-CSF)
13.4 Macrophage colony-stimulating factor (M-CSF)
13.5 Granulocyte macrophage colony-stimulating factor (GM-CSF)
13.6 Clinical application of CSFs
13.7 Erythropoietin
13.8 Therapeutic applications of EPO
13.9 Thrombopoietin
13.10 Insulin-like growth factors
13.10.1 IGF biological effects
13.11 Neurotrophic factors
13.12 Fibroblast growth factors
13.13 Platelet-derived growth factor
13.14 Bone morphogenetic proteins
13.15 Inhibition of growth factor activity
Chapter 14: Hormones
14.1 Introduction
14.2 Insulin
14.3 The Insulin Molecule
14.4 The Insulin Receptor and signal transduction
14.5 Insulin manufacture by traditional means
14.6 Production of human insulin by recombinant DNA technology
14.7 Formulation of insulin products
14.8 Engineered insulins
14.9 Glucagon-like peptide-1 (GLP-1) related products
14.10 GLP-1 receptor agonists
14.11 Human Growth Hormone
14.12 The Gonadotrophins
14.13 Medical applications of gonadotrophins
14.14 Additional recombinant hormones now approved
Chapter 15: Recombinant blood products and therapeutic enzymes
15.1 Introduction
15.2 Haemostasis
15.3 The coagulation pathway
15.4 Clotting disorders
15.5 Factor VIII and hemophilia A
15.6 Additional recombinant blood factors
15.7 Anticoagulants
15.8 Thrombolytic agents
15.9 Enzymes of therapeutic value
Chapter 16: Nucleic acid based products
16.1 Introduction
16.2 Classical Gene Therapy
16.3 Basic approach to gene delivery
16.4 Vectors used in gene therapy
16.5 Manufacture of viral vectors
16.6 CAR-T based gene therapy
16.7 Non-viral vectors
16.8 The impact of CRISPR technology on gene therapy
16.9 Antisense technology, including siRNA
