ABSTRACT

Precipitation by PAA from Tobacco Extract . . . . . . . 383 12.3 Recombinant Protein Purification from Transgenic Animal Milk . . . . 384 12.4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 388 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389

Transgenic sources (plants and animals) for biopharmaceutical production offer numerous advantages over bioreactor-based production, and the most important ones are the ease and the associated low cost for large-scale production. It has been estimated that the cost of producing a recombinant drug from transgenic plants is only 10 to 20% of the cost of using fermentation [1]. For example, depending on the scale, the total production cost of monoclonal antibodies (MAbs) via mammalian cell culture ranges from $100/g to more than $300/g [2],

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of the protein the rest for its recovery and purification. In contrast, the estimated cost is for producing a drug in a transgenic crop 12 to $15/g [1]. Transgenic plants offer additional advantages, such as plants do not carry human pathogens; this is an advantage not only from the process economy point of view but also from a regulatory and safety perspective. Processes for protein purification from expression systems such as cell culture and transgenic animal product usually include extra steps for clearance of pathogens, such as chromatographic or membrane separation methods [3-5], which add to the total process cost. Many proteins have been targeted for production in transgenic sources; these proteins range from monoclonal antibodies (MAbs), enzymes, blood proteins, to various subunit vaccines.