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Monoclonal Antibodies as Innovative Therapeutics

The last decade has seen the rise to prominence in the Biotech and Pharmaceutical fields of the Monoclonal Antibody (mAb), due to its exquisite specificity.

The decrease in identification of traditional small molecule drugs by pharmaceutical companies has coincided with the emergence of alternative therapeutic agents such as monoclonal antibodies. Human monoclonal antibodies are now the fastest growing class of biological therapies under development. They captured eight of the top 20 spots for best selling biotechnology drugs in the U.S in 2007 and their sales growth rate of >35%, far exceeds the <8% sales for small-molecule drugs ¹.

Due to the versatile uses of monoclonal antibodies as therapeutics and their economical success, pharmaceutical and biotechnology firms are actively investing in programs dedicated to various aspects of mAb research and development (R&D), including cost-effective manufacturing processes ².

Although mAbs are a promising treatment for a variety of diseases, the current manufacturing and purification processes cause limitations in the production capacity of therapeutic antibodies leading to an increase in cost. As with traditional small molecules, some patients will fail to respond or become resistant to mAb therapy. The parallel development of biomarkers for identifying patient subpopulations most likely to respond to monoclonal antibody treatment may lead to a more cost effective and specific use of these drugs. The same qualities that make mAbs attractive therapeutic agents also make mAbs the key component of analytical platforms for biomarker identification.

References

¹ http://www.landesbioscience.com/journals/mabs/article/7736/

²http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm

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