Cryoport developing cold chain logistic models for malaria vaccine

Cryoport will design and implement the cryogenic cold chain to support Phase III clinical trials of Sanaria’s investigational malaria vaccines.

The cold chain logistics solution provider has expanded its agreement with Sanaria through which it will also support the anticipated commercial launch of the cryopreserved PfSPZ (Plasmodium falciparum sporozoite) Vaccine.

Cryoport will be working with Sanaria to design and implement the global distribution strategies for the Department of Defense as well as World Health Organization for military vaccinations against malaria and for the travelers Malaria market,” Mark Sawicki, Chief Commercial Officer of Cryoport told Outsourcing-Pharma.com.

According to Sawicki, the biggest challenge will be designing and scaling a repeatable process to support cryogenic distribution and storage in remote third world locations.

Temperature compliance is critical to maintaining vaccine integrity,” he said. “Effective distribution of these clinical and commercial vaccines will require extremely challenging logistics support to reach and address the patient population.”

Previous clinical trials of the vaccine have protected more than 80% of recipients, according to the biotechnology company. This data is supporting finalization of Phase III clinical trials in Africa, Europe, and the US, which are expected to lead to the vaccine’s licensure.

According to the World Health Organization (WHO), nearly half of the world’s population is at risk of malaria, though Sub-Saharan Africa suffers a disproportionate amount of the disease burden.

The trials are supported in part by funding from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and from others involved in the International PfSPZ Consortium.