Biopharmaceuticals Handbook from C.H.I.P.S.

Pharmaceutical Biotechnology
Concepts and Applications
by Gary Walsh

Pharmaceutical Biotechnology: Concepts and Applications is a comprehensive introduction to the fast-moving area of biopharmaceuticals. It provides a single comprehensive source of information with regard to pharmaceutical biotechnology.

With a particular focus on the subject taken from a pharmaceutical perspective, the book offers a broad introduction to protein science and recombinant DNA technology.

Pharmaceutical Biotechnology: Concepts and Applications:

  • Includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products
  • Features an entire chapter devoted to the principles of genetic engineering and how these drugs are developed
  • Includes numerous relevant case studies to enhance student understanding
  • Assumes no prior knowledge of protein structure


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

Protein structure

  • Overview of protein structure
  • Higher level structure
  • Protein stability and folding
  • Protein post-translational modifi cation

Gene manipulation and recombinant DNA technology

  • Nucleic acids: function and structure
  • Recombinant production of therapeutic proteins
  • Classical gene cloning and identifi cation

The drug development process

  • Discovery of biopharmaceuticals
  • The impact of genomics and related technologies upon drug discovery
  • Gene chips
  • Proteomics
  • Structural genomics
  • Pharmacogenetics
  • Initial product characterization
  • Patenting
  • Delivery of biopharmaceuticals
  • Preclinical studies
  • Pharmacokinetics and pharmacodynamics
  • Toxicity studies
  • The role and remit of regulatory authorities

Sources and upstream processing

  • Sources of biopharmaceuticals
  • Upstream processing

Downstream processing

  • Initial product recovery
  • Cell disruption
  • Removal of nucleic acid
  • Initial product concentration
  • Chromatographic purifi cation
  • High-performance liquid chromatography of proteins
  • Purifi cation of recombinant proteins
  • Final product formulation

Product analysis

  • Protein-based contaminants
  • Removal of altered forms of the protein of interest from the product stream
  • Detection of protein-based product impurities
  • Immunological approaches to detection of contaminants
  • Endotoxin and other pyrogenic contaminants

The cytokines: The interferon family

  • Cytokines
  • The interferons
  • Interferon biotechnology

Cytokines: Interleukins and tumour necrosis factor

  • Interleukin-2
  • Interleukin-1
  • Interleukin-11
  • Tumour necrosis factors

Growth factors

  • Haematopoietic growth factors
  • Growth factors and wound healing

Therapeutic hormones

  • Insulin
  • Glucagon
  • Human growth hormone
  • The gonadotrophins
  • Medical and veterinary applications of gonadotrophins
  • Additional recombinant hormones now approved

Recombinant blood products and therapeutic enzymes

  • Haemostasis
  • Anticoagulants
  • Thrombolytic agents
  • Enzymes of therapeutic value

Antibodies, vaccines and adjuvants

  • Traditional polyclonal antibody preparations
  • Monoclonal antibodies
  • Vaccine technology
  • Adjuvant technology

Nucleic-acid- and cell-based therapeutics

  • Gene therapy
  • Vectors used in gene therapy
  • Gene therapy and genetic disease
  • Gene therapy and cancer
  • Gene therapy and AIDS
  • Antisense technology
  • Oligonucleotide pharmacokinetics and delivery
  • Aptamers
  • Cell- and tissue-based therapies


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Pharmaceutical Biotechnology
Concepts and Applications
by Gary Walsh

2007 • 480 pages • $204.00 + shipping
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