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

Tillhör följande kategorier

Kemi inom Naturvetenskap och teknik
Farmakologi inom Medicin

PrefaceChapter 1 Biopharmaceuticals, an introductory overview1.1 Introduction to pharmaceutical products1.2 Genetic engineering and the advent of biopharmaceuticals1.2.1 Manufacture of recombinant therapeutic proteins1.3 Biopharmaceuticals: current status and future prospects1.3.1 Monoclonal antibodies1.3.2 Nucleic acid and engineered cell-based products1.3.3 Biosimilars1.3.4 Market value1.3.5 Future prospectsSources of additional informationSome journal articlesChapter 2 Biopharmaceuticals: Discovery, Development and Regulation2.1 Introduction2.2 Discovery of biopharmaceuticals2.3 The impact of ‘omics’ and related technologies upon drug discovery2.3.1 Genomics2.3.2 Proteomics2.3.3. Bioinformatics2.3.4 Omics influence upon target or drug discovery2.4 Lead discovery2.5 Pharmacogenetics2.6 The influence of artificial intelligence upon drug discovery2.7 Lead characterization, CMC development and QbD2.8 Delivery of biopharmaceuticals2.8.1 Oral delivery systems2.8.2 Pulmonary delivery2.8.3 Nasal, transmucosal and transdermal delivery systems2.9 Preclinical studies2.10 Pharmacokinetics and pharmacodynamics2.10.1 Protein pharmacokinetics2.10.2 Tailoring of pharmacokinetic profile2.10.3 Protein mode of action and pharmacodynamics2.11 Toxicity studies2.11.1 Reproductive toxicity and teratogenicity2.11.2 Mutagenicity, carcinogenicity and other tests2.12 Clinical trials2.12.1 Clinical trial design2.12.2 Trial size design and study population2.13 The role and remit of regulatory authorities2.14 The Food and Drug Administration (FDA)2.15 European pharmaceutical law2.15.1 National regulatory authorities and the EMA2.15.2 Drug approval pathways in the EU2.16 Pharmacovigilance2.17 World harmonization of drug regulations and the ICH2.18 The naming of biopharmaceuticals2.19 Patenting2.19.1 What is a patent and what is patentable?2.19.2 Patenting in biotechnology2.20 Biosimilar regulationSources of additional informationSome journal articlesChapter 3 Good Manufacturing Practice3.1 Introduction3.2 Guides to Good Manufacturing Practice (GMP)3.3 Pharmacopoeia3.4 The manufacturing facility3.4.1. Clean rooms3.4.2. Product flow through the facility3.4.3 Cleaning, decontamination and sanitation.3.4.4 Water for (bio)pharmaceutical processing.3.4.5 Generation of purified water and WFI3.4.6 Distribution system for WFI3.5 Documentation3.5.1 Standard Operating Procedures3.5.2 Specifications3.5.3. Manufacturing formulae, processing and packaging instructions.3.5.4 Records3.6 Validation3.7 Further reading:Chapter 4 Protein structure4.1 Introduction4.2 Primary Structure4.2.1 The peptide bond4.2.2 Amino acid sequence determination4.3 Higher level structure4.3.1. Secondary structure4.3.2. Tertiary structure4.3.3. Experimental determination of a protein’s three-dimensional structure4.4 Protein folding and stability4.5 Protein structure prediction4.6 Protein post translational modification4.6.1. Glycosylation4.6.2 Carboxylation and Hydroxylation4.6.3 Sulfation and amidationFurther readingChapter 5 Production of therapeutic proteins by recombinant means5.1 Introduction5.2 Nucleic acids; structure and function5.2.1 Genome and gene organization5.2.2 Nucleic acid purification and quantification5.3 The principles of genetic engineering5.3.1 Identification and isolation of the target DNA sequence5.3.2 Cloning the target sequence5.3.3. Expression vectors5.3.4 Engineering of recombinant host cells5.4 Cell types in which recombinant therapeutic proteins are produced5.4.1 E coli as a source of recombinant, therapeutic proteins5.4.2 Expression of recombinant proteins in animal cell culture systems5.4.3 Yeast-based expression5.4.4 Insect cell-based systems5.4.5 Transgenic animals5.4.6 Plant-based expression systems5.5 Engineered therapeutic proteins5.5.1 Engineering via altering amino acid sequence.5.5.2 Engineering via chemical modification5.5.3 Engineering of producer cell linesFurther readingChapter 6 Therapeutic protein manufacture: upstream processing6.1 Introduction6.2 Cell banking systems6.3 Bioreactors6.3.1 Stirred tank bioreactors6.3.2 Bioreactor operation: batch v feed batch v continuous6.3.3 Single use (disposable) bioreactors.6.4 Microbial cell fermentation6.5 Mammalian cell culture6.5.1 Cell culture media6.5.2 Adherent versus non-adherent cells6.5.3 Bioprocess scale culture of adherent and non-adherent cells.Additional readingChapter 7 Therapeutic protein manufacture: downstream processing7.1 Initial product recovery7.1.1 Centrifugation7.1.2 Filtration7.1.3 Cell disruption7.2.4 Removal of nucleic acid7.2 Initial product concentration7.2.1 Ultrafiltration7.2.2 Diafiltration7.3 Chromatographic purification7.3.1 Engineering proteins for purification7.3.3 Size exclusion chromatography (Gel filtration)7.3.3 Ion exchange chromatography7.3.4 Hydrophobic interaction chromatography7.3.5 Affinity chromatography7.3.6 Chromatography on hydroxyapatite7.3.7 Chromatofocusing7.3.8 Multimodal chromatography7.3.9 Flow through chromatography7.3.10 HPLC of proteins7.4 Viral clearance7.5 Some influences which can alter the biological activity of proteins7.5.1 Proteolytic degradation and alteration of sugar side chains.7.5.2 Protein deamidation7.5.3 Oxidation and disulphide exchange7.6 Final product formulation7.6.1 Excipients used in final product formulations7.7 Sterilization and final product fill7.7.1 Freeze drying7.7.2 Labelling and packing7.8 Trends in downstream processingFurther readingChapter 8 Product analysis8.1 Introduction and regulatory context8.2 Potency determination8.3 Protein content8.4 Purity determination and API characterization8.5 Key analytical methodologies8.5.1 High-performance liquid chromatography (HPLC)8.5.2 Mass spectrometry8.6 Product purity determination8.7 API characterization8.7.1 Compositional analysis8.7.2. Peptide mapping8.7.3. Partial sequencing8.7.4. Detection of aggregates and chemically modified variants8.7.5. PTM analysis.8.7.6. Analysis of higher order structure.8.8 Non-protein impurity characterization: DNA8.9 Contaminant testing8.9.1 Microbial contaminants, including mycoplasma8.9.2 Viral contaminants8.9.3 Endotoxin and other pyrogenic contaminants.8.10 Additional testsFurther readingChapter 9 Antibodies9.1.1 Antibody structure and function9.1.2 Antibody structure9.1.2 Antigen, epitopes and polyclonal antibodies9.1.3 Antibody-antigen binding9.1.4 Antibody function9.1.3 Polyclonal antibody preparations used therapeutically9.1.4 Hybridoma technology and first generation monoclonal antibodies9.1.5 Limitations of hybridoma-derived mAbs9.4 Chimeric and humanized antibodies9.5 Fully human mAbs9.6 Routine manufacture of mAbs9.7 mAb therapeutic applications in overview9.8 mAb therapeutics treating inflammation9.9 mAbs therapeutic treating cancer9.9.1 Antibodies targeting immune checkpoint inhibitors9.9.2 Additional antibodies that inactivate molecules or pathways important in fueling cancer cell growth and division9.9.3 Antibodies triggering cancer cell destruction9.10 Some additional therapeutic mAbs9.11 Additional engineered antibody formats9.11.1 mAb fragments9.11.2 Bispecific antibodies9.11.3 Antibody drug conjugates9.11.4 Glycoengineered mAbs9.11.5 mAbs generated by multiple engineering9.11.6 Antibody-based fusion products9.12 The mAb market and the advent of mAb biosimilarsFurther readingChapter 10 Vaccines10.1 Introduction10.2 Traditional vaccine preparations10.2.1 Attenuated, dead or inactivated bacteria10.2.2 Attenuated and inactivated viral vaccines10.2.3 Toxoids and antigen-based vaccines10.3 The impact of recombinant DNA technology on vaccines10.3.1 Recombinant subunit vaccines10.3.2 Vaccine vectors10.3.3 mRNA vaccines10.4 Adjuvant technology10.4.1 Adjuvant mode of action10.4.2 Mineral-based adjuvants10.4.3 Emulsion-based adjuvantsFurther information & reading:Chapter 11 The cytokines - the interferon family11.1 Introduction to the cytokines 11.1.1 Cytokine receptors11.1.2 Cytokines as biopharmaceuticals11.2 The Interferons11.2.1 The biochemistry of Interferon-*9.2.2 Interferon-*11.2.3 Interferon-*11.2.4 Interferon signal transduction11.2.5 The interferon receptors11.2.6 The JAK-STAT pathway11.2.7 The interferon JAK-STAT pathway11.2.8 The biological effects of interferons11.2.9 The eIF - 2* protein kinase system11.3 Interferon biotechnology11.3.1 Medical uses of IFN-β11.3.2 Medical applications of IFN-γFurther readingChapter 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 Factor12.6.1 TNF biochemistry12.6.2 Biological activities of TNF12.6.3 Tumour necrosis factor receptors12.6.4 TNF as a therapeutic agent12.6.5 Inhibition of TNF activityFurther readingChapter 13 Growth Factors13.1 Introduction13.2 Haematopoietic growth factors13.2.1 The interleukins as haemopoietic 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 proteins13.15 Inhibition of growth factor activity13.15.1 Inhibition of VEGF activity13.15.2 Inhibition of HER2-related signalingFurther readingChapter 14 Hormones14.1 Introduction14.2 Insulin14.2.1 Type 1 diabetes14.2.2 Type 2 diabetes14.3 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 insulins14.8.1 Fast-acting insulins14.8.2 Long-acting insulins14.9 Glucagon-like peptide-1 (GLP-1) related products14.10 GLP-1 receptor agonists14.10.1 GLP-1 receptor agonists; further uses14.11 Human Growth Hormone14.11.1 The GH receptor14.11.2 Biological effects of GH14.11.3 Therapeutic uses of GH14.12 The Gonadotrophins14.12.1 FSH, LH and hCG14.12.2 The inhibins and activins14.13 Medical applications of gonadotrophins14.13.1 Sources and medical uses of FSH, LH and hCG14.13.2 Recombinant Gonadotrophins14.14 Additional recombinant hormones now approvedFurther readingChapter 15 Recombinant blood products and therapeutic enzymes15.1 Introduction15.2 Haemostasis15.3 The coagulation pathway15.3.1 Terminal steps of coagulation pathway15.4 Clotting disorders15.5 Factor VIII and hemophilia A15.5.1 Production of factor VIII15.6 Additional recombinant blood factors15.7 Anticoagulants15.7.1 Antithrombin15.8 Thrombolytic agents15.8.1 Tissue plasminogen activator15.8.2 Streptokinase15.8.3 Urokinase15.9 Enzymes of therapeutic value15.9.1 Asparaginase15.9.2 DNase15.9.3 Enzymes used to treat genetic diseases.15.9.4 Glucocerebrosidase15.9.5 -Galactosidase15.9.6 Debriding agents15.9.7 Digestive aidsFurther readingChapter 16 Nucleic acid based products16.1 Introduction16.2 Classical Gene Therapy16.3 Basic approach to gene delivery16.3.1 Ex vivo versus in vivo targeted gene delivery16.4 Vectors used in gene therapy16.4.1 Retroviral vectors16.4.2 Adenoviral -based vectors16.4.3 Adeno-associated virus-based vectors16.4.4 Herpes simplex viral vectors16.5 Manufacture of viral vectors16.5.1 Initial production of plasmids16.5.2 Vector producer cell culture and subsequent plasmid transfection16.5.3 Vector recovery, purification and formulation16.5.4 Lentiviral vector downstream processing16.5.5 AAV vector downstream processing16.5.6 Variant approaches to viral vector production16.6 CAR-T based gene therapy16.6 Non-viral vectors16.7 The impact of CRISPR technology on gene therapy16.8 Antisense technology, including siRNA16.8.1 Antisense oligonucleotides (ASOs) and their mode of action16.8.2 Uses, advantages and disadvantages of ASOs16.8.3 Oligonucleotide pharmacokinetics and delivery16.8.4 ASO manufacture16.8.5 siRNA-based antisense productsFurther readingIndex