INDEVR, INC — Department of Health and Human Services SBIR Phase II: NIAID

Description

DESCRIPTION provided by applicant It is widely acknowledged that for split vaccines potency determination is often a rate limiting step The FDA approved andquot gold standardandquot potency assay for influenza hemagglutinin HA protein based vaccines is single radial immunodiffusion SRID SRID is a time and labor intensive assay often requiring days to complete and a minimum of hours hands on time by well trained analysts Costs for SRID analysis for both pre licensure and post licensure testing can be more than $ million per year for each production facility In terms of impact on the seasonal influenza vaccine development process perhaps even more important are the development and production delays imposed by the time required for new reference antisera Even with reference materials in hand the wait for results can be days for each round of clone assessment prior to moving forward in development Overall the result is a recognized inefficient step in the vaccine development process If funded this project will result in an innovative off the shelf product that eliminates the need for referece antisera The Flu Titer on Chip product will enable vaccine producers to dramatically reduce costs standardize results and deliver flu vaccines to market faster by streamlining quantification of hemagglutinin at all stages of vaccine development from in process to bulk drug substances through to tri or quadrivalent vaccine formulations PUBLIC HEALTH RELEVANCE InDevR will develop a product Flu TOC that will enable vaccine producers to dramatically reduce costs standardize results and deliver flu vaccines to market faster by streamlining quantification of hemagglutinin at all stages of vaccine development from in process to bulk drug substances through to tri or quadrivalent vaccine formulations