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Once the genetic manipulation of tobacco has occurred and levels of protein expression are sufficient for commercial application, the protein must be extracted from plant material and purified to meet FDA requirements. Compared with technologies such as mammalian cell culture, which are capital and operation intensive, the manufacture of tobacco produced proteins can be very cost effective due to the low cost of field production and upstream processing. The primary manufacturing development model for producing human recombinant proteins in tobacco is based on green tissue (leaf) biomass processing. The major steps in green tissue processing are illustrated below:  Bioprocessing To facilitate scale-up and cGMP production of proteins, Chlorogen has established a strategic manufacturing alliance with Kentucky Bioprocessing, LLC (KBP). KBP is a contract research and manufacturing company, which recently purchased the Owensboro, Kentucky-based assets of the former Large Scale Biology Corporation (LSBC). KBP is not engaged in product discovery, but instead is focused on using its facilities and experience to work with and add value to products developed by others. Through the alliance, KBP is engaged in extracting Chlorogen's lead pipeline product from tobacco biomass and purifying it for clinical trials as a potential therapy for ovarian and other reproductive cancers. KBP's experienced team already has demonstrated success in scale-up and commercial scale manufacturing of proteins from tobacco in compliance with cGMP. Members of the KBP team produced two cGMP proteins at LSBC that were used in successful Phase I clinical trials.
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