An advance in
our understanding of the molecular principles underlining both health and
disease has revealed the existence of many regulatory polypeptides of significant
medical potential. The fact that such polypeptides are produced naturally
within the body only in minute quantities initially precluded their large-scale
medical application. The development in the 1970s of the twin techniques of
genetic engineering and hybridoma technology marked the birth of the modern
biotech era. These techniques facilitate the large-scale production of
virtually any protein, and proteins of medical interest produced by these
methodologies have been coined ‘biopharmaceuticals’. More recent developments
in biomedical research highlight the clinical potential of nucleic acid-based
therapeutic agents. Gene therapy and anti-sense technology are likely to become
a medical reality within a decade. The term ‘biopharmaceutical’ now also incorporates
the polynucleotide sequences utilized for such purposes. This book attempts to
provide a balanced overview of the biopharmaceutical industry, not only in
terms of categorizing the products currently available, but also illustrating
how these drugs are produced and brought to market. Chapter 1 serves as an
introduction to the topic, and also focuses upon several ‘traditional’
pharmaceutical substances isolated (initially at least) from biological
sources. This serves as a backdrop for the remaining chapters, which focus
almost exclusively upon recently developed biopharmaceutical products. The
major emphasis is placed upon polypeptide-based therapeutic agents, while the
potential of nucleic acid-based drugs is discussed in the final chapter.
In preparing the
latest edition of this textbook, I highlight the latest developments within the
sector, provide a greater focus upon actual commercial products thus far
approved and how they are manufactured, and I include substantial new sections
detailing biopharmaceutical drug delivery and how advances in genomics and
proteomics will likely impact upon (bio)pharmaceutical drug development.
The major target
audience is that of advanced undergraduates or postgraduate students pursuing
courses in relevant aspects of the biological sciences. The book should prove particularly
interesting to students undertaking programmes in biotechnology, biochemistry,
the pharmaceutical sciences, medicine or any related biomedical subject. A
significant additional target audience are those already employed in the
(bio)pharmaceutical sector, who wish to gain a better overview of the industry
in which they work.
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