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

Description

Sanaria has designed a cryovial for cryopreserving eukaryotic cells that can be used for distribution of cryopreserved eukaryotic cell-based vaccines and is suitable for direct vaccine administration to patients. The cryovials can be stored in liquid nitrogen vapor phase (LNVP) and are currently undergoing testing for suitability as the FDA-registered container for Sanarias Plasmodium falciparum (Pf) sporozoite (SPZ) eukaryotic cell products (PfSPZ Vaccine, PfSPZ Challenge). This new cryovial is unique, having an in-cap septum that allows diluent addition and withdrawal of diluted vaccine by needle and syringe. The vial is compatible with automated filling and cryopreservation and has a tamper-evident closure and final heat-sealed film protecting the septum. In this application, we propose to demonstrate compatibility of the new cryovial with PfSPZ products by comparing the product characteristics within lots of PfSPZ Vaccine or PfSPZ Challenge, when subjected to GMP Quality Control assays used in release of GMP-manufactured PfSPZ. Additionally, we will develop a new leak test protocol for the new cryovials and demonstrate maintenance of product sterility when the cryovials are used in a non-controlled environment (i.e. outside a Biological Safety Cabinet). In parallel, we will generate a plan for distribution of the product in the LNVP cold chain.