Biopharmaceuticals Biochemistry and Biotechnology 2nd by Gary Walsh 0470843276 9780470843277

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ISBN 10: 0470843276

ISBN 13: 9780470843277

Author: Gary Walsh

 

Biopharmaceuticals Biochemistry and Biotechnology 2nd Table of contents:

Chapter 1 Pharmaceuticals, biologics and biopharmaceuticals

Introduction to pharmaceutical products

Biopharmaceuticals and pharmaceutical biotechnology

History of the pharmaceutical industry

The age of biopharmaceuticals

Biopharmaceuticals: current status and future prospects

Traditional pharmaceuticals of biological origin

Pharmaceuticals of animal origin

The sex hormones

The androgens

Oestrogens

Progesterone and progestogens

Corticosteroids

Catecholamines

Prostaglandins

Pharmaceutical substances of plant origin

Alkaloids

Atropine and scopalamine

Morphine and cocaine

Additional plant alkaloids

Ergot alkaloids

Flavonoids, xanthines and terpenoids

Cardiac glycosides and coumarins

Aspirin

Pharmaceutical substances of microbial origin

The macrolides and ansamycins

Peptide and other antibiotics

Conclusion

Further reading

Chapter 2 The drug development process

Drug discovery

The impact of genomics and related technologies upon drug discovery

Gene chips

Proteomics

Structural genomics

Pharmacogenetics

Plants as a source of drugs

Microbial drugs

Rational drug design

Combinatorial approaches to drug discovery

Initial product characterization

Patenting

What is a patent and what is patentable?

Patent types

The patent application

Patenting in biotechnology

Delivery of biopharmaceuticals

Oral delivery systems

Pulmonary delivery

Nasal, transmucosal and transdermal delivery systems

Pre-clinical trials

Pharmacokinetics and pharmacodynamics

Toxicity studies

Reproductive toxicity and teratogenicity

Mutagenicity, carcinogenicity and other tests

Clinical trials

Clinical trial design

Trial size and study population

Randomized control studies

Additional trial designs

The role and remit of regulatory authorities

The Food and Drug Administration

The investigational new drug application

The new drug application

European regulations

National regulatory authorities

The EMEA and the new EU drug approval systems

The centralized procedure

Mutual recognition

Drug registration in Japan

World harmonization of drug approvals

Conclusion

Further reading

Chapter 3 The drug manufacturing process

International pharmacopoeia

Martindale, the Extra Pharmacopoeia

Guides to good manufacturing practice

The manufacturing facility

Clean rooms

Cleaning, decontamination and sanitation (CDS)

CDS of the general manufacturing area

CDS of process equipment

Water for biopharmaceutical processing

Generation of purified water and water for injections (WFI)

Distribution system for WFI

Documentation

Specifications

Manufacturing formulae, processing and packaging instructions

Records

Generation of manufacturing records

Sources of biopharmaceuticals

E. coli as a source of recombinant, therapeutic proteins

Expression of recombinant proteins in animal cell culture systems

Additional production systems: yeasts

Fungal production systems

Transgenic animals

Transgenic plants

Insect cell-based systems

Production of final product

Cell banking systems

Upstream processing

Microbial cell fermentation

Mammalian cell culture systems

Downstream processing

Final product formulation

Some influences that can alter the biological activity of proteins

Proteolytic degradation

Protein deamidation

Oxidation and disulphide exchange

Alteration of glycoprotein glycosylation patterns

Stabilizing excipients used in final product formulations

Final product fill

Freeze-drying

Labelling and packing

Analysis of the final product

Protein-based contaminants

Removal of altered forms of the protein of interest from the product stream

Product potency

Determination of protein concentration

Detection of protein-based product impurities

Capillary electrophoresis

High-pressure liquid chromatography (HPLC)

Mass spectrometry

Immunological approaches to detection of contaminants

Amino acid analysis

Peptide mapping

N-terminal sequencing

Analysis of secondary and tertiary structure

Endotoxin and other pyrogenic contaminants

Endotoxin, the molecule

Pyrogen detection

DNA

Microbial and viral contaminants

Viral assays

Miscellaneous contaminants

Validation studies

Further reading

Chapter 4 The cytokines—the interferon family

Cytokines

Cytokine receptors

Cytokines as biopharmaceuticals

The interferons

The biochemistry of interferon-a

Interferon-b

Interferon-g

Interferon signal transduction

The interferon receptors

The JAK–STAT pathway

The interferon JAK–STAT pathway

The biological effects of interferons

The eIF-2a protein kinase system

Interferon biotechnology

Production and medical uses of IFN-a

Medical uses of IFN-b

Medical applications of IFN-g

Interferon toxicity

Additional interferons

Conclusion

Further reading

Chapter 5 Cytokines: interleukins and tumour necrosis factor

Interleukin-2 (IL-2)

IL-2 production

IL-2 and cancer treatment

IL-2 and infectious diseases

Safety issues

Inhibition of IL-2 activity

Interleukin-1 (IL-1)

The biological activities of IL-1

IL-1 biotechnology

Interleukin-3: biochemistry and biotechnology

Interleukin-4

Interleukin-6

Interleukin-11

Interleukin-5

Interleukin-12

Tumour necrosis factors (TNFs)

TNF biochemistry

Biological activities of TNF-a

Immunity and inflammation

TNF receptors

TNF: therapeutic aspects

Further reading

Chapter 6 Haemopoietic growth factors

The interleukins as haemopoietic growth factors

Granulocyte colony stimulating factor (G-CSF)

Macrophage colony-stimulating factor (M-CSF)

Granulocyte-macrophage colony stimulating factor (GM-CSF)

Clinical application of CSFs

Leukaemia inhibitory factor (LIF)

Erythropoietin (EPO)

The EPO receptor and signal transduction

Regulation of EPO production

Therapeutic applications of EPO

Chronic disease and cancer chemotherapy

Additional non-renal applications

Tolerability

Thrombopoietin

Further reading

Chapter 7 Growth factors

Growth factors and wound healing

Insulin-like growth factors (IGFs)

IGF biochemistry

IGF receptors

IGF-binding proteins

Biological effects

IGF and fetal development

IGFs and growth

Renal and reproductive effects

Neuronal and other effects

Epidermal growth factor (EGF)

The EGF receptor

Platelet-derived growth factor (PDGF)

The PDGF receptor and signal transduction

PDGF and wound healing

Fibroblast growth factors (FGFs)

Transforming growth factors (TGFs)

TGF-a

TGF-b

Neurotrophic factors

The neurotrophins

Neurotrophin receptors

The neurotrophin low-affnity receptor

Ciliary neurotrophic factor and glial cell line-derived neurotrophic factor

Neurotrophic factors and neurodegenerative disease

Amyotrophic lateral sclerosis (ALS) and peripheral neuropathy

Neurotrophic factors and neurodegenerative diseases of the brain

Further reading

Chapter 8 Hormones of therapeutic interest

Insulin

Diabetes mellitus

The insulin molecule

The insulin receptor and signal transduction

Insulin production

Enzymatic conversion of porcine insulin

Production of human insulin by recombinant DNA technology

Formulation of insulin products

Engineered insulins

Additional means of insulin administration

Treating diabetics with insulin-producing cells

Glucagon

Human growth hormone (hGH)

Growth hormone releasing factor (GHRF) and inhibitory factor (GHRIF)

The GH receptor

Biological effects of GH

Therapeutic uses of GH

Recombinant hGH (rhGH) and pituitary dwarfism

Idiopathic short stature and Turner’s syndrome

Metabolic effects of hGH

GH, lactation and ovulation

The gonadotrophins

Follicle stimulating hormone (FSH), luteinizing hormone (LH) and human chorionic gonadotrophin (hCG)

Pregnant mare serum gonadotrophin (PMSG)

The inhibins and activins

LHRH and regulation of gonadotrophin production

Medical and veterinary applications of gonadotrophins

Sources and medical uses of FSH, LH and hCG

Recombinant gonadotrophins

Veterinary uses of gonadotrophins

Gonadotrophin releasing hormone (GnRH)

Additional recombinant hormones now approved

Conclusions

Further reading

Chapter 9 Blood products and therapeutic enzymes

Disease transmission

Whole blood

Platelets and red blood cells

Blood substitutes

Dextrans

Albumin

Gelatin

Oxygen-carrying blood substitutes

Haemostasis

The coagulation pathway

Terminal steps of coagulation pathway

Clotting disorders

Factor VIII and haemophilia

Production of factor VIII

Factors IX, VII(a) and XIII

Anticoagulants

Heparin

Vitamin K antimetabolites

Hirudin

Antithrombin

Thrombolytic agents

Tissue plasminogen activator (tPA)

First-generation tPA

Engineered tPA

Streptokinase

Urokinase

Staphylokinase

a(1)-Antitrypsin

Enzymes of therapeutic value

Asparaginase

DNase

Glucocerebrosidase

a-Galactosidase and urate oxidase

Superoxide dismutase

Debriding agents

Digestive aids

Lactase

Further reading

Chapter 10 Antibodies, vaccines and adjuvants

Polyclonal antibody preparations

Anti-D immunoglobulin

Normal immunoglobulins

Hepatitis B and tetanus immunoglobulin

Snake and spider antivenins

Monoclonal antibodies

Production of monoclonals via hybridoma technology

Antibody screening: phage display technology

Therapeutic application of monoclonal antibodies

Tumour immunology

Antibody-based strategies for tumour detection/destruction

Drug-based tumour immunotherapy

First-generation anti-tumour antibodies: clinical disappointment

Tumour-associated antigens

Antigenicity of murine monoclonals

Chimaeric and humanized antibodies

Antibody fragments

Additional therapeutic applications of monoclonal antibodies

Cardiovascular and related disease

Infectious diseases

Autoimmune disease

Transplantation

Vaccine technology

Traditional vaccine preparations

Attenuated, dead or inactivated bacteria

Attenuated and inactivated viral vaccines

Toxoids, antigen-based and other vaccine preparations

The impact of genetic engineering on vaccine technology

Peptide vaccines

Vaccine vectors

Development of an AIDS vaccine

Difficulties associated with vaccine development

AIDS vaccines in clinical trials

Cancer vaccines

Recombinant veterinary vaccines

Adjuvant technology

Adjuvant mode of action

Mineral-based adjuvants

Oil-based emulsion adjuvants

Bacteria/bacterial products as adjuvants

Additional adjuvants

Further reading

Chapter 11 Nucleic acid therapeutics

Gene therapy

Basic approach to gene therapy

Some additional questions

Vectors used in gene therapy

Retroviral vectors

Additional viral-based vectors

Manufacture of viral vectors

Non-viral vectors

Manufacture of plasmid DNA

Gene therapy and genetic disease

Gene therapy and cancer

Gene therapy and AIDS

Gene-based vaccines

Gene therapy: some additional considerations

Anti-sense technology

Anti-sense oligonucleotides

Uses, advantages and disadvantages of ‘oligos’

Delivery and cellular uptake of oligonucleotides

Manufacture of oligonucleotides

Vitravene, an approved antisense agent

Antigene sequences and ribozymes

Conclusion

Further reading

Appendix 1 Biopharmaceuticals thus far approved in the USA or European Union

Appendix 2 Some Internet addresses relevant to the biopharmaceutical sector

Appendix 3 Two selected monographs reproduced from the European Pharmacopoeia with permission from t

I. Products of recombinant DNA technology

II. Interferon a-2 concentrated solution

Appendix 4 Manufacture of biological medicinal products for human use. (Annex 2 from The Rules Gover

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