BOULDER COLORADO (1/29/19) -- InDevR Inc. announced publication of "A Neuraminidase Potency Assay for Quantitative Assessment of Neuraminidase in Influenza Vaccines" in npj Vaccines. The manuscript focuses on accuracy and precision for the VaxArray Influenza Seasonal Neuraminidase assay as tested to ICH guidelines. The new VaxArray kit is poised to help improve influenza vaccines by empowering manufacturers with a standardized method to meet current regulatory requirements and to prepare for future trends. The VaxArray NA kit is also expected to serve as an important new tool in the push for a more broadly protective or "universal" flu vaccine.
For example, PATH is a non-profit organization working toward sustainable production of high-quality, affordable seasonal and pandemic influenza vaccines in developing countries - including innovative broadly protective influenza vaccines. According to Dr. Francesco Berlanda Scorza, Director of Vaccine Development at PATH:
"Improving our understanding the role of neuraminidase is an important component of this effort of improving influenza vaccines. Together with studying the immune response elicited by influenza vaccines against HA, we are interested in understanding the potential contribution of NA, as we believe this might lead to more effective seasonal and pandemic influenza vaccines. The latest publication on the VaxArray NA assay demonstrates its potential to greatly accelerate our ability to track NA. Indeed, we are currently exploiting this platform to characterize the NA content in a pre-pandemic whole virion H5N1 vaccine candidate."
For today's seasonal influenza vaccines, the level of neuraminidase (NA) in flu vaccines is not currently regulated but its "presence and type must be confirmed by suitable enzymatic or immunological methods" during vaccine manufacturing. Since no standardized method exists, vaccine producers each implement their own approach and many use non-influenza specific enzymatic activity assays. The VaxArray Influenza Seasonal NA kit is based on N1, N2, and B-NA subtype-specific monoclonal antibodies arrayed for use in a simple, multiplexed immunoassay. The assay is quantitative, highly correlated with enzymatic activity, stability indicating, and has been demonstrated to serve as a proxy for immunogenicity for a monovalent H3N2 vaccine (see Vaccine 36 (2018) 2937-2945).
InDevR also offers VaxArray potency assays for influenza hemagglutinin and nucleoprotein. Find more information about the entire VaxArray product line at: https:/
InDevR has a demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing vaccines and other biotherapeutics, InDevR is a leader in progressive new analytical technologies that enable accelerated development and manufacturing of these life-saving products. For more information about the company and products, please visit http://www.