The primary goal of the BARDA-funded project is for IDRI to partner with developing country vaccine manufacturers (DCVMs) to develop adjuvanted influenza vaccine capabilities. IDRI will supply sufficient oil-in-water emulsion adjuvant and partner with up to two DCVMs to enhance their pandemic influenza vaccine programs.
“Apart from large pharmaceutical companies, vaccine adjuvant manufacturing capability is not widely available,” Christopher Fox, PhD, principal investigator for the project, told BioPharma-Reporter.com. “Vaccine adjuvants are complex particulate formulations that require specialized manufacturing and characterization equipment. Since adjuvants enhance the biological activity of vaccine antigens, it is essential that adjuvant manufacturing quality controls are met. A major challenge of adjuvant manufacturing is to ensure that the final large scale manufacturing process results in material with similar physicochemical, stability, and biological activity characteristics as the material currently manufactured at small scale in IDRI’s manufacturing facility.”
IDRI plans to demonstrate the capacity to manufacture adjuvant at large scale before the end of the BARDA-sponsored cooperative agreement in September 2017, he added.
These adjuvants will be evaluated with antigen through preclinical and clinical studies. As part of this project, IDRI will establish the capacity to manufacture 50 million doses of adjuvant within a three-month timeframe, to provide adjuvants to eligible DCVMs supported through the World Health Organization (WHO) Global Action Plan for Influenza Vaccines.
IDRI has previously shown its ability to develop adjuvants, which can enhance the ability of antigens to stimulate the body's immune response, and transfer that technology to enable manufacturing in several countries, including Romania and India.
“In order to facilitate a rapid global response to a pandemic, BARDA and WHO have identified institutes in developing countries that are able to make influenza vaccines. Dose-sparing strategies such as adjuvants will be critical in order to have sufficient coverage in the event of an influenza pandemic,” explained Fox. “This project will represent a new approach in making the vaccine technology available to developing countries so there can be a rapid response where it’s needed most.”