This work will examine the feasibility of a novel technique for inactivating viral contaminants in fresh-frozen plasma, with retention of the activities of labile therapeutic proteins. The method comprises applying pulses of greatly elevated hydrostatic pressures at sub-zero temperatures and has many potential advantages including effectiveness, ease of validation, and speed. Preliminary results suggest that a 7 orders of magnitude decrease in titers of a model virus can be achieved in 15 minutes, with retention of activity indicators for two model proteins. Optimal parameters will be determined for inactivation of a stable model virus in human plasma with concurrent retention of factor VIII. The optimized process will then be validated against a wider selection of viruses and therapeutic proteins.
The cryobaric technology is potentially a potent, rapid, and easily validated treatment that inactivates encapsulated and non-encapsulated viruses in human plasma for the production of therapeutic blood proteins. If the optimized process is sufficiently gentle, it may be used for processing of plasma for transfusion. We plan to develop and manufacture equipment designed to the specifications of plasma derivative manufacturers, gain FDA approval for the technology, then commercialize and license the technique to producers of therapeutic blood products.
