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Biopharmaceuticals
Biochemistry and Biotechnology
Gary Walsh (Author)
9781394211128, Wiley
Paperback / softback, published 26 February 2026
560 pages
24.9 x 17.3 x 3 cm, 1.089 kg
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: 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.
Preface xiv 1 Biopharmaceuticals, an Introductory Overview 1 1.1 Introduction to Pharmaceutical Products 1 1.2 Genetic Engineering and the Advent of Biopharmaceuticals 7 1.3 Biopharmaceuticals: Current Status and Future Prospects 12 Sources of Additional Information 20 Some Journal Articles 21 2 Biopharmaceuticals: Discovery, Development, and Regulation 23 2.1 Introduction 23 2.2 Discovery of Biopharmaceuticals 24 2.3 The Impact of “Omics” and Related Technologies Upon Drug Discovery 26 2.4 Lead Discovery 34 2.5 Pharmacogenetics 34 2.6 The Influence of Artificial Intelligence Upon Drug Discovery 35 2.7 Lead Characterization, CMC Development, and QbD 36 2.8 Delivery of Biopharmaceuticals 39 2.9 Preclinical Studies 43 2.10 Pharmacokinetics and Pharmacodynamics 43 2.11 Toxicity Studies 50 2.12 Clinical Trials 53 2.13 The Role and Remit of Regulatory Authorities 57 2.14 The Food and Drug Administration (FDA) 58 2.15 European Pharmaceutical Law 61 2.16 Pharmacovigilance 65 2.17 World Harmonization of Drug Regulations and the ICH 66 2.18 The Naming of Biopharmaceuticals 67 2.19 Patenting 68 2.20 Biosimilar Regulation 69 Sources of Additional Information 73 Some Journal Articles 73 3 Good Manufacturing Practice 75 3.1 Introduction 75 3.2 Guides to Good Manufacturing Practice (GMP) 75 3.3 Pharmacopoeia 77 3.4 The Manufacturing Facility 78 3.5 Documentation 93 3.6 Validation 95 Further Reading 97 4 Protein Structure 99 4.1 Introduction 99 4.2 Primary Structure 99 4.3 Higher-Level Structure 106 4.4 Protein Folding and Stability 111 4.5 Protein Structure Prediction 113 4.6 Protein Post-translational Modification 115 Further Reading 123 5 Production of Therapeutic Proteins by Recombinant Means 125 5.1 Introduction 125 5.2 Nucleic Acids: Structure and Function 125 5.3 The Principles of Genetic Engineering 133 5.4 Cell Types in Which Recombinant Therapeutic Proteins Are Produced 147 5.5 Engineered Therapeutic Proteins 159 Further Reading 164 6 Therapeutic Protein Manufacture: Upstream Processing 165 6.1 Introduction 165 6.2 Cell Banking Systems 166 6.3 Bioreactors 168 6.4 Microbial Cell Fermentation 174 6.5 Mammalian Cell Culture 176 Further Reading 180 7 Therapeutic Protein Manufacture: Downstream Processing 181 7.1 Initial Product Recovery 181 7.2 Initial Product Concentration 187 7.3 Chromatographic Purification 190 7.4 Viral Clearance 212 7.5 Some Influences Which can Alter the Biological Activity of Proteins 213 7.6 Final Product Formulation 217 7.7 Sterilization and Final Product Fill 219 7.8 Trends in Downstream Processing 224 Further Reading 225 8 Product Analysis 227 8.1 Introduction and Regulatory Context 227 8.2 Potency Determination 229 8.3 Protein Content 232 8.4 Purity Determination and API Characterization 233 8.5 Key Analytical Methodologies 235 8.6 Product Purity Determination 238 8.7 API Characterization 240 8.8 Non- protein Impurity Characterization: DNA 247 8.9 Contaminant Testing 248 8.10 Additional Tests 255 Further Reading 255 9 Antibodies 257 9.1 Antibody Structure and Function 257 9.2 Polyclonal Antibody Preparations Used Therapeutically 262 9.3 Hybridoma Technology and First- generation Monoclonal Antibodies 265 9.4 Chimeric and Humanized Antibodies 268 9.5 Fully Human mAbs 271 9.6 Routine Manufacture of mAbs 274 9.7 mAb Therapeutic Applications in Overview 275 9.8 mAb Therapeutics Treating Inflammation 275 9.9 mAbs Therapeutic Treating Cancer 277 9.10 Some Additional Therapeutic mAbs 283 9.11 Additional Engineered Antibody Formats 286 9.12 The mAb Market and the Advent of mAb Biosimilars 302 Further Reading 305 10 Vaccines 307 10.1 Introduction 307 10.2 Traditional Vaccine Preparations 309 10.3 The Impact of Recombinant DNA Technology on Vaccines 313 10.4 Adjuvant Technology 332 Further Reading 335 11 The Cytokines – The Interferon Family 337 11.1 Introduction to the Cytokines 337 11.2 The Interferons 344 11.3 Interferon Biotechnology 356 Further Reading 363 12 The Cytokines – Interleukins and Tumor Necrosis Factor 365 12.1 Introduction to the Interleukins 365 12.2 Interleukin- 2 367 12.3 IL- 2 Biotechnology 370 12.4 Interleukin 11 373 12.5 Inhibition of Interleukin Activity 374 12.6 Tumor Necrosis Factor 379 Further Reading 389 13 Growth Factors 391 13.1 Introduction 391 13.2 Hematopoietic Growth Factors 391 13.3 Granulocyte Colony- Stimulating Factor (G- CSF) 394 13.4 Macrophage colony- stimulating factor (M- CSF) 395 13.5 Granulocyte Macrophage Colony- Stimulating Factor (GM- CSF) 395 13.6 Clinical Application of CSFs 396 13.7 Erythropoietin 400 13.8 Therapeutic Applications of EPO 402 13.9 Thrombopoietin 404 13.10 Insulin- Like Growth Factors 407 13.11 Neurotrophic Factors 408 13.12 Fibroblast Growth Factors 410 13.13 Platelet- Derived Growth Factor 411 13.14 Bone Morphogenetic Proteins 412 13.15 Inhibition of Growth Factor Activity 413 Further Reading 419 14 Hormones 421 14.1 Introduction 421 14.2 Insulin 421 14.3 The Insulin Molecule 423 14.4 The Insulin Receptor and Signal Transduction 424 14.5 Insulin Manufacture by Traditional Means 426 14.6 Production of Human Insulin by Recombinant DNA Technology 427 14.7 Formulation of Insulin Products 428 14.8 Engineered Insulins 430 14.9 Glucagon- Like Peptide- 1 (GLP- 1)- Related Products 434 14.10 GLP- 1 Receptor Agonists 436 14.11 Human Growth Hormone 440 14.12 The Gonadotrophins 444 14.13 Medical Applications of Gonadotrophins 451 14.14 Additional Recombinant Hormones Now Approved 455 Further Reading 458 15 Recombinant Blood Products and Therapeutic Enzymes 459 15.1 Introduction 459 15.2 Hemostasis 459 15.3 The Coagulation Pathway 459 15.4 Clotting Disorders 463 15.5 Factor VIII and Hemophilia A 464 15.6 Additional Recombinant Blood Factors 470 15.7 Anticoagulants 473 15.8 Thrombolytic Agents 475 15.9 Enzymes of Therapeutic Value 480 Further Reading 492 16 Nucleic- Acid- Based Products 493 16.1 Introduction 493 16.2 Classical Gene Therapy 494 16.3 Basic Approach to Gene Delivery 495 16.4 Vectors Used in Gene Therapy 499 16.5 Manufacture of Viral Vectors 510 16.6 CAR- T- Based Gene Therapy 518 16.7 Non- viral Vectors 522 16.8 The Impact of CRISPR Technology on Gene Therapy 524 16.9 Antisense Technology, Including siRNA 527 Further Reading 533 Index 535
Subject Areas: Chemistry [PN]
