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Biopharmaceuticals Biochemistry and Biotechnology

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ISBN-10: 0470843276

ISBN-13: 9780470843277

Edition: 2nd 2003 (Revised)

Authors: Gary Walsh

List price: $149.95
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This work provides a comprehensive overview of biopharmaceutical products. It discusses the method of production of these drugs, and the biochemistry/molecular mechanisms of action and biotechnology of all the major biopharmaceutical types.
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Book details

List price: $149.95
Edition: 2nd
Copyright year: 2003
Publisher: John Wiley & Sons, Incorporated
Publication date: 8/29/2003
Binding: Paperback
Pages: 576
Size: 7.50" wide x 9.84" long x 1.28" tall
Weight: 2.640
Language: English

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
Progesterone and progestogens
Pharmaceutical substances of plant origin
Atropine and scopalamine
Morphine and cocaine
Additional plant alkaloids
Ergot alkaloids
Flavonoids, xanthines and terpenoids
Cardiac glycosides and coumarins
Pharmaceutical substances of microbial origin
The macrolides and ansamycins
Peptide and other antibiotics
Further reading
The drug development process
Drug discovery
The impact of genomics and related technologies upon drug discovery
Gene chips
Structural genomics
Plants as a source of drugs
Microbial drugs
Rational drug design
Combinatorial approaches to drug discovery
Initial product characterization
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
Further reading
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
Manufacturing formulae, processing and packaging instructions
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
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
Microbial and viral contaminants
Viral assays
Miscellaneous contaminants
Validation studies
Further reading
The cytokines--the interferon family
Cytokine receptors
Cytokines as biopharmaceuticals
The interferons
The biochemistry of interferon-[alpha]
Interferon signal transduction
The interferon receptors
The JAK-STAT pathway
The interferon JAK-STAT pathway
The biological effects of interferons
The eIF-2[alpha] protein kinase system
Interferon biotechnology
Production and medical uses of IFN-[alpha]
Medical uses of IFN-[beta]
Medical applications of IFN-[gamma]
Interferon toxicity
Additional interferons
Further reading
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
Tumour necrosis factors (TNFs)
TNF biochemistry
Biological activities of TNF-[alpha]
Immunity and inflammation
TNF receptors
TNF: therapeutic aspects
Further reading
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
Further reading
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)
Neurotrophic factors
The neurotrophins
Neurotrophin receptors
The neurotrophin low-affinity 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
Hormones of therapeutic interest
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
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
Further reading
Blood products and therapeutic enzymes
Disease transmission
Whole blood
Platelets and red blood cells
Blood substitutes
Oxygen-carrying blood substitutes
The coagulation pathway
Terminal steps of coagulation pathway
Clotting disorders
Factor VIII and haemophilia
Production of factor VIII
Factors IX, VII[subscript a] and XIII
Vitamin K antimetabolites
Thrombolytic agents
Tissue plasminogen activator (tPA)
First-generation tPA
Engineered tPA
[alpha subscript 1]-Antitrypsin
Enzymes of therapeutic value
[alpha]-Galactosidase and urate oxidase
Superoxide dismutase
Debriding agents
Digestive aids
Further reading
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
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
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
Further reading
Biopharmaceuticals thus far approved in the USA or European Union
Some Internet addresses relevant to the biopharmaceutical sector
Two selected monographs reproduced from the European Pharmacopoeia with permission from the European Commission
Products of recombinant DNA technology
Interferon [alpha]-2 concentrated solution
Manufacture of biological medicinal products for human use. (Annex 2 from The Rules Governing Medicinal Products in the European Community, Vol. 4, Good Manufacturing Practice for Medicinal Products)