Biopharmaceuticals

Nyhet

Biochemistry and Biotechnology

Häftad, Engelska, 2026

Av Gary Walsh, Ireland) Walsh, Gary (University of Limerick

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Produktinformation

Utgivningsdatum2026-04-09
FormatHäftad
SpråkEngelska
Antal sidor560
Upplaga3
FörlagJohn Wiley & Sons Inc
ISBN9781394211128

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Chapter 1: Biopharmaceuticals, an Introductory Overview1.1 Introduction to pharmaceutical products1.2 Genetic engineering and the advent of biopharmaceuticals1.3 Biopharmaceuticals: current status and future prospectsChapter 2: Biopharmaceuticals: Discovery, Development and Regulation2.1 Introduction2.2 Discovery of biopharmaceuticals2.3 The impact of �omics� and related technologies upon drug discovery2.4 Lead discovery2.5 Pharmacogenetics2.6 The influence of artificial intelligence upon drug discovery2.7 Lead characterization, CMC development and QbD 2.8 Delivery of biopharmaceuticals2.9 Preclinical studies2.10 Pharmacokinetics and pharmacodynamics2.11 Toxicity studies2.12 Clinical trials2.13 The role and remit of regulatory authorities2.14 The Food and Drug Administration (FDA)2.15 European pharmaceutical law2.16 Pharmacovigilance2.17 World harmonization of drug regulations and the ICH2.18 The naming of biopharmaceuticals2.19 Patenting2.20 Biosimilar regulation Chapter 3: Good Manufacturing Practice3.1 Introduction3.2 Guides to Good Manufacturing Practice (GMP)3.3 Pharmacopoeia3.4 The manufacturing facility3.5 Documentation3.6 ValidationChapter 4: Protein Structure4.1 Introduction4.2 Primary Structure4.3 Higher level structure4.4 Protein folding and stability 4.5 Protein structure prediction 4.6 Protein post translational modificationChapter 5: Production of Therapeutic Proteins by Recombinant Means5.1 Introduction5.2 Nucleic acids; structure and function5.3 The principles of genetic engineering5.4 Cell types in which recombinant therapeutic proteins are produced5.5 Engineered therapeutic proteinsChapter 6: Therapeutic protein manufacture: upstream processing6.1 Introduction6.2 Cell banking systems6.3 Bioreactors6.4 Microbial cell fermentation6.5 Mammalian cell culture Chapter 7: Therapeutic protein manufacture: downstream processing7.1 Initial product recovery7.2 Initial product concentration7.3 Chromatographic purification7.4 Viral clearance7.5 Some influences which can alter the biological activity of proteins7.6 Final product formulation7.7 Sterilization and final product fill7.8 Trends in downstream processingChapter 8: Product analysis 8.1 Introduction and regulatory context8.2 Potency determination8.3 Protein content8.4 Purity determination and API characterization8.5 Key analytical methodologies8.6 Product purity determination8.7 API characterization8.8 Non-protein impurity characterization: DNA8.9 Contaminant testing8.10 Additional testsChapter 9: Antibodies 9.1 Antibody structure and function9.2 Polyclonal antibody preparations used therapeutically9.3 Hybridoma technology and first generation monoclonal antibodies9.4 Chimeric and humanized antibodies9.5 Fully human mAbs9.6 Routine manufacture of mAbs9.7 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 formats9.12 The mAb market and the advent of mAb biosimilarsChapter 10: Vaccines 10.1 Introduction10.2 Traditional vaccine preparations10.3 The impact of recombinant DNA technology on vaccines10.4 Adjuvant technologyChapter 11: The cytokines - the interferon family 11.1 Introduction to the cytokines11.2 The Interferons11.3 Interferon biotechnologyChapter 12: The cytokines - Interleukins and Tumour Necrosis Factor12.1 Introduction to the interleukins12.2 Interleukin-212.3 IL-2 biotechnology12.4 Interleukin 1112.5 Inhibition of interleukin activity12.6 Tumour Necrosis FactorChapter 13: Growth Factors13.1 Introduction13.2 Haematopoietic growth factors13.3 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 CSFs13.7 Erythropoietin13.8 Therapeutic applications of EPO13.9 Thrombopoietin13.10 Insulin-like growth factors13.10.1 IGF biological effects13.11 Neurotrophic factors13.12 Fibroblast growth factors13.13 Platelet-derived growth factor13.14 Bone morphogenetic proteins 13.15 Inhibition of growth factor activityChapter 14: Hormones14.1 Introduction14.2 Insulin14.3 The Insulin Molecule14.4 The Insulin Receptor and signal transduction14.5 Insulin manufacture by traditional means14.6 Production of human insulin by recombinant DNA technology14.7 Formulation of insulin products14.8 Engineered insulins14.9 Glucagon-like peptide-1 (GLP-1) related products14.10 GLP-1 receptor agonists14.11 Human Growth Hormone14.12 The Gonadotrophins14.13 Medical applications of gonadotrophins14.14 Additional recombinant hormones now approvedChapter 15: Recombinant blood products and therapeutic enzymes15.1 Introduction15.2 Haemostasis15.3 The coagulation pathway15.4 Clotting disorders15.5 Factor VIII and hemophilia A15.6 Additional recombinant blood factors 15.7 Anticoagulants15.8 Thrombolytic agents15.9 Enzymes of therapeutic valueChapter 16: Nucleic acid based products16.1 Introduction16.2 Classical Gene Therapy16.3 Basic approach to gene delivery16.4 Vectors used in gene therapy16.5 Manufacture of viral vectors16.6 CAR-T based gene therapy16.7 Non-viral vectors16.8 The impact of CRISPR technology on gene therapy16.9 Antisense technology, including siRNA