The Nanoparticle Vaccine Production Core (Core B) will use the proprietary PRINT process to produce nanoparticles which will be provided to the all three research programs for in vitro and vivo usage throughout the project period. The particles will fall into two main categories. First, nanoparticles made from poly(lacticco- glycolic acid) (PLGA), a material used in FDA approved drug carriers and therapeutic devices. An influenza vaccine based on PLGA PRINT particles have previously been evaluated in a clinical study that demonstrated their functionality and showed no safety concerns. Second, particles made from PEG hydrogel materials. The two materials were chosen not only based on safety but because they complement each other in how they can be utilized for vaccine design. PLGA particles will have the vaccine antigen electrostatically adsorbed and adjuvant components associate by either adsorption or encapsulation. The chemical composition of hydrogel particles will allow for antigens and adjuvants to be linked by conjugation either inside or outside of the particles. The Core will initially produce PLGA particles of 12 different sizes and shapes during the first three months of the project, then devote 6 months for developing process methods for manufacture of at least 10 hydrogel particles. For the duration of the project, we will work closely with the research projects to produce particles formulated with antigens, adjuvants and fluorescent molecules for experiments defined in respective project's research plans.
The Nanoparticle Vaccine Production Core will produce nanoparticles based on the novel technology, PRINT, which produces particles of controllable size, shape, ratio, antigen density and chemical composition. These particles will be the basis of the U19 application, and will be used by all three projects. Hence this Core is highly relevant to the Program.