Product design biopharmaceutic considerations

It should be noted that different species of field crops possess different biomass yields. For example, for every hectare of pea crop grown, only a third of a hectare of tomato crop would be required to produce the same amount of protein, even though the yield of protein per unit biomass is lower in tomato than in pea. Thus, consideration of which crop species to use becomes of paramount importance in the design of large-scale production of a particular biopharmaceutical. The relative biomass yields for a number of crops currently used for the production of biopharmaceuticals are listed in Table 6.2. 

Table 1 Biopharmaceutic considerations in drug product design...

Biopharmaceutic considerations in the design and manufacture of a drug product to deliver the active drug with the desired bioavailability characteristics include 1) the type of drug product (e.g., solution, suspension suppository) 2) the nature of the excipients in the drug product 3) the physicochemical properties of the drug molecule and 4) the route of drug administration. 

The considerable list in Table 6.3 illustrates some of the companies that are currently preparing plant-based biopharmaceutical technologies for commercialization. Steps have been taken toward the development and subsequent commercialization of one of these products, currently in Phase 2 clinical trials and known as CaroRx (licensed to Planet Biotechnology Inc., Hayward, CA) a monoclonal antibody designed for treatment of tooth decay by S. mutans is described in the following text. 

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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