By Aphios Corp.
Consisting of polymer nanospheres using proprietary and patented PNS technology for HIV, influenza and anthrax vaccines Vaccination is the most cost-effective tool for the control and prevention of infectious diseases. However, multiple inoculations are often required to achieve desirable protection even with potent antigens. In order to increase the therapeutic efficiency of such vaccines, adjuvants are used with vaccines to augment the immune response. There are several types of adjuvants with different modes of action. Adjuvants form a depot of antigen at the site of inoculation with slow release of antigens. Adjuvants can improve the performance of vaccines by targeting the antigen to antigen-presenting cells, eliciting specific cytokines that direct Th1 or Th2 immune responses. Most of the adjuvants increase the production of specific antibodies. Adjuvants that enhance cell-mediated immunity for vaccines against bioterrorist agents are desirable since many of these agents are intracellular pathogens. Several vaccines are under development and testing for HIV, influenza and bioterrorism agents. Most of these vaccines are recombinant or purified subunit vaccines. These subunit vaccines are being developed because they are safer than whole-cell vaccines. However, these subunit vaccines often result in weaker immune responses. The use of adjuvants capable of enhancing and directing the immune response to subunit vaccines is a critical component of rational vaccine design. To circumvent these problems, Aphios has developed a novel process for making biodegradable polymer nanospheres (PNS) that avoids the use of organic solvents (US Patents, Castor, 2006, 2010 and 2011). - This technology encompasses nanotechnology. - The process is enabled by the use of supercritical, critical or near-critical fluids with or without polar cosolvents such as ethanol [referred to as SuperFluids™ or SFS]. - Biodegradable biopolymers are dissolved in SuperFluids™ and mixed with the subunit vaccine in aqueous solution or as a slurry of nanoparticles. - The mixture is decompressed into an aqueous solution, liquid nitrogen or an empty vessel (spray dryer). - As a result of decompression, polymer nanospheres are formed, encapsulating the subunit vaccine. Advantages and Benefits - The use of SuperFluids™, instead of organic solvents such as ethyl acetate and methylene chloride, reduces exposure of encapsulated therapeutic proteins and vaccine antigens to potentially denaturing organic solvents. - The use of SuperFluids™ also eliminates the need to remove any residual organic solvents in the final drug product. - SuperFluids™ biodegradable polymer nanospheres have the potential for the scaled-up production of nanospheres vaccine formulations protective against anthrax. - Use of SFS greatly reduces the processing time and the cost associated with the preparation of biodegradable polymer microspheres containing therapeutic products while maintaining the uniformity and integrity of the vaccine antigens. - In addition to reduction or elimination of organic solvent usage, utilizing supercritical fluids for microspheres may impart advantages of product sterility; there are a number of reports demonstrating the microbicidal and virucidal effects of supercritical fluids (Fischer et al., 1991; Lin et al., 1992; Castor et al., 1995, 1999, 2002). Partnering Opportunity We are seeking strategic corporate partners as well as partnerships with government and research institutions interested in developing a stable, effective anthrax vaccine adjuvant for anthrax vaccination.
