Monoclonal antibody therapy considerations

VII. Monoclonal Antibody Therapy of Cancer A. General Considerations... 

The main opportunity for advanced drag delivery systems in this market is in the area of targeted drag delivery. Current research is focused on the development of carriers such as liposomes and on the use of monoclonal antibodies as targeting agents (see Sections 5.2 and 5.3). The eventual market opportunity is considerable—cancer is still one of the commonest fatal diseases, and some of the most deadly forms are resistant to available therapies. The potential market for effective targeting delivery systems may eventually exceed 5 billion. Whether, and how soon, it achieves this figure will depend on the speed with which successful products come to market. 

A particularly useful example for biopharmaceuticals is the FDA guidance entitled, Points to Consider (PTC) in the Manufacture and Testing of Monoclonal Antibody Products for Human Use [5]. This is a comprehensive document, which describes steps that should be taken in the manufacture, characterization, quahty control and product testing of rtiAbs. In addition, the 1997 mAb PTC document describes the types of pre-chnical studies that should be performed, as well as considerations for design of Phase 1 and Phase 2 clinical trials. Therapeutic rtiAbs, as well as those intended for in-vivo diagnostic use, for use ex-vivo with therapeutic devices, or for use in cell therapy protocols, should be developed according to the guidance in this document... 

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