Classes of Biopharmaceuticals

Therapeutic antibodies constitute the most studied and commercialized class of biopharmaceuticals nowadays. Their applications range from in vitro and in vivo diagnostics, to the treatment of cancer, cardiovascular diseases, asthma, and infectious and autoimmune diseases. 

However, the most promising class of biopharmaceuticals consists of the therapeutic mAbs. In 2004, total sales of therapeutic mAbs reached approximately US 11.2 billion, with an impressive annual growth rate of 42% in the period 2000-2004 (Research and Markets, 2005d). The forecast is that in 2010 this market will reach US 34 billion. 

In the following sections, an overview of the use of CE for the characterization of selected classes of biopharmaceuticals is presented. The emphasis is placed on the relationship between the test performed and its intended purpose, that is, in terms of its usefulness for product identity or product purity determination. 

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