Abstract
Monoclonal antibodies (MAbs) are one of the fastest growing classes of all pharmaceutical products. In 2007, a total of 26 therapeutic MAbs were approved in the U.S. market (Table 1-1), which was valued at more than $12,612 million (Frost & Sullivan 2008). Currently, more than 200 MAbs are in clinical study with more than 600 in preclinical development (Reuters 2008). They play a major role in treating a wide variety of diseases including cancer, infectious disease, allergy, autoimmune disease and inflammation. MAbs now belong to a well-established drug class, that has a high success rate from first in human studies to regulatory approval: Typically 25% (Reichert et al. 2005), which compares favorably with the 11% success rate for small molecule drugs (Kola and Landis 2004).
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© 2010 American Association of Pharmaceutical Scientists
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Gombotz, W.R., Shire, S.J. (2010). Introduction. In: Shire, S., Gombotz, W., Bechtold-Peters, K., Andya, J. (eds) Current Trends in Monoclonal Antibody Development and Manufacturing. Biotechnology: Pharmaceutical Aspects, vol XI. Springer, New York, NY. https://doi.org/10.1007/978-0-387-76643-0_1
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DOI: https://doi.org/10.1007/978-0-387-76643-0_1
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