Mathematical modeling in recombinant plant systems: The challenge to produce heterologous proteins under GLP/GMP

MARCONI PL, KLYKOV SS

Plant Biotechnology for Health: from secondary metabolites to molecular farming

Springer

Año: 2014; p. 145 - 155

In the last time and in the near future, the markets are demanding large recombinant proteins production capacity, due to the production levels of traditional platforms will be certainly not suffice to make available these demands (Huang and McDonald 2012). The explore of alternative tools to assure adequate supplies for a growing demand constitutes a challenge of present times being the ?bioengineered pharmaceutical plant? a promising strategy to respond to this require at affordable costs. According to FDA/USDA (2002) ?bioengineered pharmaceutical plant? is a plant manipulated by recombinant DNA technology to express a gene encoding a biological or drug product. Plants expressing transiently o constituently recombinant proteins are considered competitive systems for producing high-value recombinant proteins for medical and industrial purposes. This technology (molecular pharming® or biopharming or agropharming) has advanced greatly as a secure technology, capable of rendering valuable recombinant proteins free of toxins and animal pathogens in a relatively short time and cost-effective (Ma et al. 2005; Franconi et al. 2010, De Muynck et al. 2010; Paul and Ma. 2011; Yuan et al. 2011). This scenario opens up promising horizons to produce recombinant proteins with attractive prospects for commercial exploitation. Many proofs of principles studies just to commercialization have been obtained in the last 25 years (Twyman et al., 2003, Arcalis et al., 2013). Sigma-Aldrich commercializes plant-made recombinant avidin and bovine trypsin, Dow AgroSciences LLC produces plant-made recombinant veterinary vaccines and it has recently been approved by FDA the enzyme Taliglucerase alfa, a carrot-expressed recombinant glucocerebrosidase for the treatment of Gaucher disease, to be commercialized by Pfizer (FDA application Nº (NDA) 022458, 2012). Furthermore, Heber Biotec (Havana, Cuba) has produced the first whole antibody in tobacco plants. It was also demonstrated that most of the recombinant antibodies produced in plants maintains the functional properties as the ones produced in mammalian cell cultures (Kaiser 2008; Zimran et al. 2011; Zeitlin et al. 2011).