Pharmaceuticals, biologics and biopharmaceuticals - Pharmaceutical Biotechnology: Concepts and Aapplications - page 13

or in animal cell lines. Work continues on the production of such products in transgenic-based
production systems, specifi cally either transgenic plants or animals (Chapter 5).
Virtually all therapeutic proteins must enter the blood in order to promote a therapeutic effect.
Such products must usually be administered parenterally. However, research continues on the de-
velopment of non-parenteral routes which may prove more convenient, less costly and obtain im-
proved patient compliance. Alternative potential delivery routes include transdermal, nasal, oral
and bucal approaches, although most progress to date has been recorded with pulmonary-based
delivery systems (Chapter 4). An inhaled insulin product ('Exubera', Chapters 4 and 11) was ap-
proved in 2006 for the treatment of type I and II diabetes.
A small number of whole-cell-based therapeutic products have also been approved to date
(Chapter 14). All contain mature, fully differentiated cells extracted from a native biological
source. Improved techniques now allow the harvest of embryonic and, indeed, adult stem cells,
bringing the development of stem-cell-based drugs one step closer. However, the use of stem cells
to replace human cells or even entire tissues/organs remains a long term goal (Chapter 14). Over-
all, therefore, products of pharmaceutical biotechnology play an important role in the clinic and
are likely to assume an even greater relative importance in the future.
Further reading
Books
Crommelin, D. and Sindelar, R. 2002. Pharmaceutical Biotechnology , second edition. Taylor and Francis,
London, UK.
Goldberg, R. 2001. Pharmaceutical Medicine, Biotechnology and European Law . Cambridge University Press.
Grindley, J. and Ogden, J. 2000. Understanding Biopharmaceuticals. Manufacturing and Regulatory Issues .
Interpharm Press.
Kayser, O. and Muller, RH. 2004. Pharmaceutical Biotechnology . Wiley VCH, Weinheim, Germany.
Oxender, D. and Post, L. 1999. Novel Therapeutics from Modern Biotechnology . Springer Verlag.
Spada, S. and Walsh, G. 2005. Directory of Approved Biopharmaceutical Products . CRC Press, Florida, USA.
Articles
Mayhall, E., Paffett-Lugassy N., and Zon L.I. 2004. The clinical potential of stem cells. Current Opinion in Cell
Biology 16 , 713-720.
Reichert, J. and Paquette, C. 2003. Therapeutic recombinant proteins: trends in US approvals 1982-2002. Current
Opinion in Molecular Therapy 5 , 139-147.
Reichert, J. and Pavlov, A. 2004. Recombinant therapeutics - success rates, market trends and values to 2010.
Nature Biotechnology 22 , 1513-1519.
Walsh, G. 2005. Biopharmaceuticals: recent approvals and likely directions. Tren ds in Biotech nology 23 , 553-
558.
Walsh, G. 2006. Biopharmaceutical benchmarks 2006. Nature Biotechnology 24 , 769-776.
Weng, Z. and DeLisi, C. 2000. Protein therapeutics: promises and challenges of the 21st century. Tren ds in Bio -
technology 20 , 29-36.