ABSTRACT

Proteins and monoclonal antibodies (mABs) derived from recombinant DNA are of increasing economic importance for the pharmaceutical industry. More than 165 biopharmaceuticals are presently on the market, with an estimated market size of US$33 billion in 2004 (1). The projection for the end of the decade is ranging around US$70 billion (2). Presently about 2500 biotech drugs are in discovery, 900 in preclinical trials, and 1600 are under clinical investigation (1). Biopharmaceuticals are developed and applied for a broad spectrum of applications, such as tumor therapy and diagnostics, AIDS and other immunological disorders, infectious diseases, neurology, cardiovascular diseases, hematology, wound healing, ophthalmics, skin disorders, diabetes, and respiratory diseases. Besides therapeutic applications, protein-based biopharmaceuticals are applied as vaccines, as drug carriers, and as diagnostic tools (in vivo and in vitro).