Bulk production of the antiviral lectin griffithsin

Fuqua, Joshua L.; Hamorsky, Krystal; Khalsa, Guruatma; Matoba, Nobuyuki; Palmer, Kenneth E.

As an HIV microbicide, GRFT is targeted for use by individuals at high-risk for HIV exposure. Some of the most at-risk HIV populations are found in resource-poor countries, and in poor communities in developed countries. Therefore, cost of goods with GRFT-based microbicides will be a very sensitive issue. Reducing the production costs and in turn reducing the price per dose of GRFT will expand the availability of GRFT in areas with the highest HIV burden. To this end, we need a better understanding of the production costs of GRFT. Many theoretical studies have been performed examining the cost of goods of multiple products to demonstrate the economic feasibility of PMPs, all of which show that the economics is product, process and scale dependent (Tuse et al., 2014; Walwyn et al., 2015) . Success of GRFT-based commercial products is dependent on its performance in preclinical and clinical trials (safety and efficacy); however, practical issues regarding its availability as a sexual health product to a substantial population of potential users is contingent on the cost, which is driven in part by the production process. Therefore, continued optimization of the production process may be necessary. Certainly, the purification process has been improved tremendously by our group (Fuqua et al., 2015) . Further optimization of these technologies will need to be undertaken with economics as a primary concern. We put forth, in this review, potential expression systems to be tested, and our opinions of the economic impact process changes may have on the cost of goods. We acknowledge that successful development of GRFT as an HIV microbicide will depend solely on its clinical performance as long as hurdles related to bulk PMP production are overcome with proper foresight.