SANARIA INC. — Department of Defense SBIR Phase II: DHP163-003

Description

A cryovial suitable for vaccine storage below -150 C, containing a septum to facilitate syringe preparation in the field does not exist, but is urgently needed for eukaryotic whole cell products. Sanaria PfSPZ Vaccine, consisting of radiation-attenuated whole Plasmodium falciparum sporozoites (PfSPZ), has protected >90% of recipients against malaria in 5 clinical trials in the US, Europe and Africa, but is stored in traditional screwcap cryovials, necessitating the sterile environment of a biosafety cabinet for syringe preparation. During our Phase I SBIR, we designed and prototyped a cryovial containing a foil-protected septum allowing access by needle and syringe in the field. This breakthrough cryovial will support licensure of PfSPZ Vaccine for travelers and military personnel deployed to malaria-endemic areas, and mass vaccination programs for malaria elimination. In Phase II the cryovial will be optimized for usein manufacture of PfSPZ Vaccine for phase 3 clinical trials and commercialization. This will include developing ancillary components (rack, lid, cap carrier) and automating manufacturing and fill-finish operations. We will pilot cryogenic cold chain distribution to military installations for immunization of deploying personnel. FDA licensure of PfSPZ Vaccine using this first-in-class cryovial will support broad application to other eukaryotic whole cell products.