{"product_id":"biopharmaceuticals-biochemistry-and-biotechnology-paperback-softback-9781394211128","title":"Biopharmaceuticals; Biochemistry and Biotechnology (Paperback \/ softback) 9781394211128","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eBiopharmaceuticals\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eBiochemistry and Biotechnology\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eGary Walsh (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9781394211128, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePaperback \/ softback, published 26 February 2026\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e560 pages\u003cbr\u003e24.9 x 17.3 x 3 cm, 1.089 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003cb\u003eUpdated all-in-one guide to understanding the science, development and manufacture of bio-based therapeutics\u003c\/b\u003e \u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eBiopharmaceuticals: Biochemistry and Biotechnology\u003c\/i\u003e 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, \u003ci\u003eBiopharmaceuticals: Biochemistry and Biotechnology\u003c\/i\u003e covers: \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eProtein structure (covering protein folding, stability, engineering and structure prediction, post-translational modifications) and recombinant production\u003c\/li\u003e\n\u003cli\u003eDiscovery, development and biopharmaceutical regulation\u003c\/li\u003e\n\u003cli\u003emAb-based therapeutics and vaccines\u003c\/li\u003e\n\u003cli\u003eCytokines and growth factors, including interferons, interleukins, haematopoietic growth factors, and colony stimulating factors (CSFs)\u003c\/li\u003e\n\u003cli\u003eRecombinant blood products and therapeutic enzymes, covering clotting disorders, anticoagulants, thrombolytic agents, and enzymes of therapeutic value\u003c\/li\u003e\n\u003cli\u003eHormones, including insulins, GLP-1 related products, human growth hormone and gonadotropins\u003c\/li\u003e\n\u003cli\u003eProduct manufacture (upstream and downstream processing) and analysis, covering API characterization, purity and potency determinations, analytical methodologies, protein content, and contaminant testing\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eDelivering comprehensive coverage of the field, \u003ci\u003eBiopharmaceuticals: Biochemistry and Biotechnology\u003c\/i\u003e is an essential reference for students and professionals in biotechnology, medical biochemistry, medicinal chemistry, and pharmaceutical technology.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003ePreface xiv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Biopharmaceuticals, an Introductory Overview 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction to Pharmaceutical Products 1\u003c\/p\u003e \u003cp\u003e1.2 Genetic Engineering and the Advent of Biopharmaceuticals 7\u003c\/p\u003e \u003cp\u003e1.3 Biopharmaceuticals: Current Status and Future Prospects 12\u003c\/p\u003e \u003cp\u003eSources of Additional Information 20\u003c\/p\u003e \u003cp\u003eSome Journal Articles 21\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Biopharmaceuticals: Discovery, Development, and Regulation 23\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 23\u003c\/p\u003e \u003cp\u003e2.2 Discovery of Biopharmaceuticals 24\u003c\/p\u003e \u003cp\u003e2.3 The Impact of “Omics” and Related Technologies Upon Drug Discovery 26\u003c\/p\u003e \u003cp\u003e2.4 Lead Discovery 34\u003c\/p\u003e \u003cp\u003e2.5 Pharmacogenetics 34\u003c\/p\u003e \u003cp\u003e2.6 The Influence of Artificial Intelligence Upon Drug Discovery 35\u003c\/p\u003e \u003cp\u003e2.7 Lead Characterization, CMC Development, and QbD 36\u003c\/p\u003e \u003cp\u003e2.8 Delivery of Biopharmaceuticals 39\u003c\/p\u003e \u003cp\u003e2.9 Preclinical Studies 43\u003c\/p\u003e \u003cp\u003e2.10 Pharmacokinetics and Pharmacodynamics 43\u003c\/p\u003e \u003cp\u003e2.11 Toxicity Studies 50\u003c\/p\u003e \u003cp\u003e2.12 Clinical Trials 53\u003c\/p\u003e \u003cp\u003e2.13 The Role and Remit of Regulatory Authorities 57\u003c\/p\u003e \u003cp\u003e2.14 The Food and Drug Administration (FDA) 58\u003c\/p\u003e \u003cp\u003e2.15 European Pharmaceutical Law 61\u003c\/p\u003e \u003cp\u003e2.16 Pharmacovigilance 65\u003c\/p\u003e \u003cp\u003e2.17 World Harmonization of Drug Regulations and the ICH 66\u003c\/p\u003e \u003cp\u003e2.18 The Naming of Biopharmaceuticals 67\u003c\/p\u003e \u003cp\u003e2.19 Patenting 68\u003c\/p\u003e \u003cp\u003e2.20 Biosimilar Regulation 69\u003c\/p\u003e \u003cp\u003eSources of Additional Information 73\u003c\/p\u003e \u003cp\u003eSome Journal Articles 73\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Good Manufacturing Practice 75\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 75\u003c\/p\u003e \u003cp\u003e3.2 Guides to Good Manufacturing Practice (GMP) 75\u003c\/p\u003e \u003cp\u003e3.3 Pharmacopoeia 77\u003c\/p\u003e \u003cp\u003e3.4 The Manufacturing Facility 78\u003c\/p\u003e \u003cp\u003e3.5 Documentation 93\u003c\/p\u003e \u003cp\u003e3.6 Validation 95\u003c\/p\u003e \u003cp\u003eFurther Reading 97\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Protein Structure 99\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 99\u003c\/p\u003e \u003cp\u003e4.2 Primary Structure 99\u003c\/p\u003e \u003cp\u003e4.3 Higher-Level Structure 106\u003c\/p\u003e \u003cp\u003e4.4 Protein Folding and Stability 111\u003c\/p\u003e \u003cp\u003e4.5 Protein Structure Prediction 113\u003c\/p\u003e \u003cp\u003e4.6 Protein Post-translational Modification 115\u003c\/p\u003e \u003cp\u003eFurther Reading 123\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Production of Therapeutic Proteins by Recombinant Means 125\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 125\u003c\/p\u003e \u003cp\u003e5.2 Nucleic Acids: Structure and Function 125\u003c\/p\u003e \u003cp\u003e5.3 The Principles of Genetic Engineering 133\u003c\/p\u003e \u003cp\u003e5.4 Cell Types in Which Recombinant Therapeutic Proteins Are Produced 147\u003c\/p\u003e \u003cp\u003e5.5 Engineered Therapeutic Proteins 159\u003c\/p\u003e \u003cp\u003eFurther Reading 164\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Therapeutic Protein Manufacture: Upstream Processing 165\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 165\u003c\/p\u003e \u003cp\u003e6.2 Cell Banking Systems 166\u003c\/p\u003e \u003cp\u003e6.3 Bioreactors 168\u003c\/p\u003e \u003cp\u003e6.4 Microbial Cell Fermentation 174\u003c\/p\u003e \u003cp\u003e6.5 Mammalian Cell Culture 176\u003c\/p\u003e \u003cp\u003eFurther Reading 180\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Therapeutic Protein Manufacture: Downstream Processing 181\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Initial Product Recovery 181\u003c\/p\u003e \u003cp\u003e7.2 Initial Product Concentration 187\u003c\/p\u003e \u003cp\u003e7.3 Chromatographic Purification 190\u003c\/p\u003e \u003cp\u003e7.4 Viral Clearance 212\u003c\/p\u003e \u003cp\u003e7.5 Some Influences Which can Alter the Biological Activity of Proteins 213\u003c\/p\u003e \u003cp\u003e7.6 Final Product Formulation 217\u003c\/p\u003e \u003cp\u003e7.7 Sterilization and Final Product Fill 219\u003c\/p\u003e \u003cp\u003e7.8 Trends in Downstream Processing 224\u003c\/p\u003e \u003cp\u003eFurther Reading 225\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Product Analysis 227\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction and Regulatory Context 227\u003c\/p\u003e \u003cp\u003e8.2 Potency Determination 229\u003c\/p\u003e \u003cp\u003e8.3 Protein Content 232\u003c\/p\u003e \u003cp\u003e8.4 Purity Determination and API Characterization 233\u003c\/p\u003e \u003cp\u003e8.5 Key Analytical Methodologies 235\u003c\/p\u003e \u003cp\u003e8.6 Product Purity Determination 238\u003c\/p\u003e \u003cp\u003e8.7 API Characterization 240\u003c\/p\u003e \u003cp\u003e8.8 Non- protein Impurity Characterization: DNA 247\u003c\/p\u003e \u003cp\u003e8.9 Contaminant Testing 248\u003c\/p\u003e \u003cp\u003e8.10 Additional Tests 255\u003c\/p\u003e \u003cp\u003eFurther Reading 255\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Antibodies 257\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Antibody Structure and Function 257\u003c\/p\u003e \u003cp\u003e9.2 Polyclonal Antibody Preparations Used Therapeutically 262\u003c\/p\u003e \u003cp\u003e9.3 Hybridoma Technology and First- generation Monoclonal Antibodies 265\u003c\/p\u003e \u003cp\u003e9.4 Chimeric and Humanized Antibodies 268\u003c\/p\u003e \u003cp\u003e9.5 Fully Human mAbs 271\u003c\/p\u003e \u003cp\u003e9.6 Routine Manufacture of mAbs 274\u003c\/p\u003e \u003cp\u003e9.7 mAb Therapeutic Applications in Overview 275\u003c\/p\u003e \u003cp\u003e9.8 mAb Therapeutics Treating Inflammation 275\u003c\/p\u003e \u003cp\u003e9.9 mAbs Therapeutic Treating Cancer 277\u003c\/p\u003e \u003cp\u003e9.10 Some Additional Therapeutic mAbs 283\u003c\/p\u003e \u003cp\u003e9.11 Additional Engineered Antibody Formats 286\u003c\/p\u003e \u003cp\u003e9.12 The mAb Market and the Advent of mAb Biosimilars 302\u003c\/p\u003e \u003cp\u003eFurther Reading 305\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Vaccines 307\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 307\u003c\/p\u003e \u003cp\u003e10.2 Traditional Vaccine Preparations 309\u003c\/p\u003e \u003cp\u003e10.3 The Impact of Recombinant DNA Technology on Vaccines 313\u003c\/p\u003e \u003cp\u003e10.4 Adjuvant Technology 332\u003c\/p\u003e \u003cp\u003eFurther Reading 335\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 The Cytokines – The Interferon Family 337\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction to the Cytokines 337\u003c\/p\u003e \u003cp\u003e11.2 The Interferons 344\u003c\/p\u003e \u003cp\u003e11.3 Interferon Biotechnology 356\u003c\/p\u003e \u003cp\u003eFurther Reading 363\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 The Cytokines – Interleukins and Tumor Necrosis Factor 365\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction to the Interleukins 365\u003c\/p\u003e \u003cp\u003e12.2 Interleukin- 2 367\u003c\/p\u003e \u003cp\u003e12.3 IL- 2 Biotechnology 370\u003c\/p\u003e \u003cp\u003e12.4 Interleukin 11 373\u003c\/p\u003e \u003cp\u003e12.5 Inhibition of Interleukin Activity 374\u003c\/p\u003e \u003cp\u003e12.6 Tumor Necrosis Factor 379\u003c\/p\u003e \u003cp\u003eFurther Reading 389\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Growth Factors 391\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 391\u003c\/p\u003e \u003cp\u003e13.2 Hematopoietic Growth Factors 391\u003c\/p\u003e \u003cp\u003e13.3 Granulocyte Colony- Stimulating Factor (G- CSF) 394\u003c\/p\u003e \u003cp\u003e13.4 Macrophage colony- stimulating factor (M- CSF) 395\u003c\/p\u003e \u003cp\u003e13.5 Granulocyte Macrophage Colony- Stimulating Factor (GM- CSF) 395\u003c\/p\u003e \u003cp\u003e13.6 Clinical Application of CSFs 396\u003c\/p\u003e \u003cp\u003e13.7 Erythropoietin 400\u003c\/p\u003e \u003cp\u003e13.8 Therapeutic Applications of EPO 402\u003c\/p\u003e \u003cp\u003e13.9 Thrombopoietin 404\u003c\/p\u003e \u003cp\u003e13.10 Insulin- Like Growth Factors 407\u003c\/p\u003e \u003cp\u003e13.11 Neurotrophic Factors 408\u003c\/p\u003e \u003cp\u003e13.12 Fibroblast Growth Factors 410\u003c\/p\u003e \u003cp\u003e13.13 Platelet- Derived Growth Factor 411\u003c\/p\u003e \u003cp\u003e13.14 Bone Morphogenetic Proteins 412\u003c\/p\u003e \u003cp\u003e13.15 Inhibition of Growth Factor Activity 413\u003c\/p\u003e \u003cp\u003eFurther Reading 419\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Hormones 421\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 421\u003c\/p\u003e \u003cp\u003e14.2 Insulin 421\u003c\/p\u003e \u003cp\u003e14.3 The Insulin Molecule 423\u003c\/p\u003e \u003cp\u003e14.4 The Insulin Receptor and Signal Transduction 424\u003c\/p\u003e \u003cp\u003e14.5 Insulin Manufacture by Traditional Means 426\u003c\/p\u003e \u003cp\u003e14.6 Production of Human Insulin by Recombinant DNA Technology 427\u003c\/p\u003e \u003cp\u003e14.7 Formulation of Insulin Products 428\u003c\/p\u003e \u003cp\u003e14.8 Engineered Insulins 430\u003c\/p\u003e \u003cp\u003e14.9 Glucagon- Like Peptide- 1 (GLP- 1)- Related Products 434\u003c\/p\u003e \u003cp\u003e14.10 GLP- 1 Receptor Agonists 436\u003c\/p\u003e \u003cp\u003e14.11 Human Growth Hormone 440\u003c\/p\u003e \u003cp\u003e14.12 The Gonadotrophins 444\u003c\/p\u003e \u003cp\u003e14.13 Medical Applications of Gonadotrophins 451\u003c\/p\u003e \u003cp\u003e14.14 Additional Recombinant Hormones Now Approved 455\u003c\/p\u003e \u003cp\u003eFurther Reading 458\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Recombinant Blood Products and Therapeutic Enzymes 459\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 459\u003c\/p\u003e \u003cp\u003e15.2 Hemostasis 459\u003c\/p\u003e \u003cp\u003e15.3 The Coagulation Pathway 459\u003c\/p\u003e \u003cp\u003e15.4 Clotting Disorders 463\u003c\/p\u003e \u003cp\u003e15.5 Factor VIII and Hemophilia A 464\u003c\/p\u003e \u003cp\u003e15.6 Additional Recombinant Blood Factors 470\u003c\/p\u003e \u003cp\u003e15.7 Anticoagulants 473\u003c\/p\u003e \u003cp\u003e15.8 Thrombolytic Agents 475\u003c\/p\u003e \u003cp\u003e15.9 Enzymes of Therapeutic Value 480\u003c\/p\u003e \u003cp\u003eFurther Reading 492\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Nucleic- Acid- Based Products 493\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 493\u003c\/p\u003e \u003cp\u003e16.2 Classical Gene Therapy 494\u003c\/p\u003e \u003cp\u003e16.3 Basic Approach to Gene Delivery 495\u003c\/p\u003e \u003cp\u003e16.4 Vectors Used in Gene Therapy 499\u003c\/p\u003e \u003cp\u003e16.5 Manufacture of Viral Vectors 510\u003c\/p\u003e \u003cp\u003e16.6 CAR- T- Based Gene Therapy 518\u003c\/p\u003e \u003cp\u003e16.7 Non- viral Vectors 522\u003c\/p\u003e \u003cp\u003e16.8 The Impact of CRISPR Technology on Gene Therapy 524\u003c\/p\u003e \u003cp\u003e16.9 Antisense Technology, Including siRNA 527\u003c\/p\u003e \u003cp\u003eFurther Reading 533\u003c\/p\u003e \u003cp\u003eIndex 535\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52458244178200,"sku":"9781394211128","price":78.59,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9781394211128.jpg?v=1785370013","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/biopharmaceuticals-biochemistry-and-biotechnology-paperback-softback-9781394211128","provider":"Freshly Printed Books","version":"1.0","type":"link"}