The Promise of Therapeutic Vaccines
Vaccines are well known effective tools for controlling infectious diseases. Recently, the first therapeutic virus has been approved and more are being evaluated in the clinic. In addition, recent progress has been made with gene-modified cell and gene therapies which require viral vectors to introduce exogenous genes.
Viral Structures are Fragile
Vaccines, therapeutic viruses, and viral vectors share the highly ordered complex structure and characteristics of viruses. Even at refrigerated temperatures, it is challenging to maintain their biological activity and often requires frozen storage at very low temperature. Commercially available products require either refrigeration or frozen storage and transport. This cold chain requirement limits distribution and patient access.
Manufacturing & Distribution Issues
Therapeutic viruses, viral vectors, and vaccines are often produced in mammalian cells then purified, concentrated, formulated, and stored until their use. It is known that these pharmaceuticals are fragile and easily inactivated during the manufacturing cycle thereby losing biological activity.
Due to the fragility of viruses, viral vectors, and vaccines, stabilization is needed during manufacturing. A stable form increases production yield, improves efficiency during manufacturing, maintains biological activity, and helps generate high quality materials. A stable formulation at ambient temperature greatly facilitates cost effective distribution and storage around the globe.
Vaccine Stabilization Institute (VSI) has developed a proprietary formulation technology using blended amino acids. The technology is applied to an enveloped virus and stabilizes the virus in liquid and freeze-dried states.