Cryoport has expanded its partnership with Sanaria for the design and implementation of the cryogenic cold chain for Sanaria’s investigational malaria vaccines. This work is supported by grants to Sanaria from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) (phase II Commercialization Readiness Pilot Program) and U.S. Department of Defense (DoD) (phase I Small Business Innovation Research).

Cryoport’s cryogenic logistics solutions will be applied to distribution models for Sanaria PfSPZ Vaccine for travel clinics (NIAID, NIH grant) and the U.S. military (DoD grant). This work will assist in the implementation of Phase 3 clinical trials of the vaccine and the development of cryogenic logistics distribution in support of the anticipated commercial launch of PfSPZ Vaccine, which is cryopreserved. Initially, vaccine distribution will be aimed at filling the needs of the U.S. DoD, State Department, and Peace Corps, travel medicine companies, and extraction industries. The Cryoport designs will incorporate distribution models enabling “just in time” delivery by providing logistics support incorporating novel packaging designs, inventory management, liquid nitrogen (LN2) replenishment and will test transport to specific clinics. Cryoport’s SmartPak II monitoring system will be utilized to manage in real time the “chain of custody” distribution logistics as well as the “chain of condition” environmental conditions. The SmartPak II works alongside Cryoport’s Cryoportal software system to provide logistics monitoring, including GPS tracking, which locates dry shippers and payloads and proactively tracks potential adverse events which may occur due to weather, logistics handling, or other delays.

“We are thrilled to have been selected to develop models for the distribution of Sanaria’s groundbreaking malaria vaccine as part of these two projects,” said Jerrell Shelton, chief executive officer, Cryoport. “This selection, we believe, is a testament to the quality and reliability of our cryogenic logistics solutions. We are proud to support Sanaria’s work developing and eventually bringing to market a vaccine to prevent malaria.”

Stephen Hoffman, chief executive and scientific officer, Sanaria said, “Cryoport’s expertise in cryogenic logistics management, track record and reputation were important in helping to secure funding from the U.S. DoD and NIAID, NIH. Cryoport has reliably supported our research efforts over the past five years and they were the natural partner for these new projects.”

Sanaria’s malaria vaccines have achieved more than 90% protection in multiple clinical trials to date. Current clinical studies aim to finalize the regimen—dose strength, number of doses, and interval between doses—for the traveler’s indication. Future Phase 3 clinical trials are intended to lead to licensure of the vaccine for prevention of malaria in travelers and subsequently for use in mass vaccination programs in the countries most affected by malaria.