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*Canadian EnWave Corporation believes to be a step closer to developing a new industry standard technology for dehydrating vaccines and antibodies, as it has received positive results from the company’s first room temperature shelf-life study of dehydrated rotavirus vaccine conducted by its collaboration partner Aridis Pharmaceuticals of San Jose, California. *
Aridis is testing the new bioREV technology under a Collaboration Agreement to determine the feasibility of dehydrating vaccines and antibodies to produce room temperature stable products as a cost-effective alternative to the industry standard of lyophilization (freeze drying).
If dried vaccines and antibodies could be stored at room temperature this could lead to an industry breakthrough as it would make it possible to ship and store these pharmaceuticals worldwide, without the need for expensive refrigeration. It would also mean that the drugs could be stockpiled to protect against pandemic diseases and bio terrorism threats.
Early stage data are indicative of positive results for EnWave’s technology because the stability results are comparable to that of freeze dried vaccines with moisture contents of 1-2% which require three days to dehydrate, compared to bioREV’s 10 minute processing time. * Test data better than expected*
“The results from this preliminary stability study are better than we expected, given that vaccines such as rotavirus are not generally room temperature stable at such high moisture content,” said Aridis R&D Vice President Dr Vu Truong.
“Developing a stable vaccine for this childhood disease is particularly important for developing countries where constant product refrigeration is a major challenge.”
“This promising post-dehydration shelf-life data brings EnWave one major step forward in providing the vaccine manufacturing industry with the technology to reduce processing time, along with the elimination of the need for constant refrigeration during shipment and storage,” said EnWave Corporation Chairman and Co-CEO Dr Tim Durance.
EnWave and Aridis will now work together to optimize a modified form of the bioREV technology with new rotavirus vaccine formulations to allow for further reductions in vaccine moisture content. The project team will also undertake a longer term shelf-life study. EnWave expects to receive results from this testing in September 2008. In addition, the two companies are collaborating on the development of a dried salmonella typhoid vaccine (“Ty21a”) as well as a vaccine for shigellosis.