Clearant, Inc. proposes to develop methods of utilizing gamma-irradiation to inactivate prions in plasma-derived protein products while preserving their integrity and functions. The primary goal is to achieve at least 2xlog10 reduction in prion infectivity while retaining >80 percent of protein structure and activity. Clearant's proprietary process minimizes protein damage at doses up to 50 kGy or more in purified proteins and has demonstrated viral inactivation. This process is applicable to solutions, liquid or frozen, powders, and pastes, making it amenable to incorporation into manufacturing processes. Preliminary data also indicates reductions in prion infectivity may occur. Two different plasma proteins, IGIV and PPF, will be irradiated as manufacturing process intermediates. They will be spiked with scrapie and irradiated at several dosages under varying conditions. Prion inactivation will be measured in an in vivo infectivity assay. Protein recovery will be measured using biochemical techniques. Achieving these goals will profoundly impact the safety of plasma-derived therapeutics, which represent a $1.5B market in the U.S. Plasma fractionators, several of which are interested in using this technology on their process intermediates, would license the technology from Clearant, providing a significant commercial opportunity while preventing the possible spread of prion diseases from plasma products.
