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

Contents

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

Index

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