The development of a safe, efficacious vaccine to protect against the seven known naturally occurring serotypes of botulinum neurotoxins would effectively eliminate them as weapons of mass destruction. It is essential that any vaccine include all antigens to protect against all seven serotypes. This is a significant challenge that requires the naturally unstable properties of proteins to be overcome.
The aim of this project is to develop ultrastable heptavalent botulinum vaccines. DynPort Vaccine Company, LLC proposes to achieve this by formulating botulinum vaccine antigens in water soluble sugar glasses that entrap proteins, minimizing protein interactions with themselves and their environment, as well as shielding them from the effects of thermal and chemical stresses. Individually formulated antigens will be combined and prepared as monodisperse suspensions in a Perfluorcarbon. Approved by the FDA for use in humans, these inert chemicals enhance stability and provide a suitable delivery vehicle for human immunization, because of its low viscosity, high lubricity and simple respiratory elimination from the body. Their inclusion ensures that the delivery vehicle and vaccine are in the same vial, further enhancing the utility and management of the vaccine. The resulting ultrastable formulations will effectively eliminate the cold chain of vaccine management, constraining vaccine replacement to use rather than stability. We believe that we are uniquely placed to meet the aim of this program. We are funded through the DoD and NIAID to develop multivalent recombinant botulinum vaccine formulations, and the scientific and technical knowledge at DVC will be leveraged to facilitate vaccine formulation design intended for potential future CGMP production. DVC is partnering with Cambridge Biostability Ltd, which has developed and demonstrated this formulation technology for several vaccines. Finally, DVC is also partnering with Battelle Memorial Institute, which has a proven track record in the performance of assays to assess the potency of the botulinum neurotoxin related vaccines and therapeutics.
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