Overview

Updated all-in-one guide to understanding the science, development and manufacture of bio-based therapeutics Biopharmaceuticals: Biochemistry and Biotechnology is a unique resource on biopharmaceuticals that serves as a comprehensive introduction to both the biopharmaceutical industry and its role within the global pharmaceutical industry. This new edition incorporates all major advances from the past 20 years, including the development of biosimilars, bispecific and other engineered antibody formats, engineered cell-based therapies, RNA-based vaccines, and genome editing techniques. Case studies and application examples demonstrate the entire value chain, from development to approval and manufacturing of all types of biopharmaceuticals, covering antibodies (mAbs), cytokines, nucleic acid therapeutics as well as cell-based and other biotherapeutics. Written by an accomplished instructor and textbook writer who has been working with small and large biotech companies for more than 25 years, Biopharmaceuticals: Biochemistry and Biotechnology covers: Protein structure (covering protein folding, stability, engineering and structure prediction, post-translational modifications) and recombinant production Discovery, development and biopharmaceutical regulation mAb-based therapeutics and vaccines Cytokines and growth factors, including interferons, interleukins, haematopoietic growth factors, and colony stimulating factors (CSFs) Recombinant blood products and therapeutic enzymes, covering clotting disorders, anticoagulants, thrombolytic agents, and enzymes of therapeutic value Hormones, including insulins, GLP-1 related products, human growth hormone and gonadotropins Product manufacture (upstream and downstream processing) and analysis, covering API characterization, purity and potency determinations, analytical methodologies, protein content, and contaminant testing Delivering comprehensive coverage of the field, Biopharmaceuticals: Biochemistry and Biotechnology is an essential reference for students and professionals in biotechnology, medical biochemistry, medicinal chemistry, and pharmaceutical technology.

Full Product Details

Author:   Gary Walsh (University of Limerick, Ireland)
Publisher:   John Wiley & Sons Inc
Imprint:   John Wiley & Sons Inc
Edition:   3rd edition
Dimensions:   Width: 17.30cm , Height: 3.10cm , Length: 24.90cm
Weight:   1.089kg
ISBN:  

9781394211128

ISBN 10:   1394211120
Pages:   560
Publication Date:   26 February 2026
Audience:   College/higher education ,  Tertiary & Higher Education
Format:   Paperback
Publisher's Status:   Active
Availability:   Awaiting stock  
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Table of 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

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Author Information

Gary Walsh is Chair of Industrial Biotechnology at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical and diagnostic industries, as well as extensive teaching and research interests in the pharmaceutical and biotechnology arena.

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