APTITUDE MEDICAL SYSTEMS INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Every yearnearlymillion people in the US receive flu vaccinesaccounting for a $billion marketDue to antigenic driftnew flu vaccines need to be produced every year under an extremely tight timelineDelays in manufacturing have severe healthcare consequencesA major rate limiting step in the flu vaccine manufacturing process is the assessment of vaccine potencyThe single radial immunodiffusionSRDassay is the current gold standard methodbut suffers from several limitationsthe SRD reagents need to be freshly prepared every year by immunizing sheepwhich takes multiple months and presents a bottleneck when the vaccine is most neededSRD is labor intensive and requires trained personneland takes several days to completeSRD was originally validated against inactivated vaccinegrowing evidence suggests it may not be suitable for novel vaccinesIn resultboth recent EMA guidelines and a joint workshop by FDA and WHO concluded that alternative methods should be developed to address these limitationsand that an ideal assay should below costnot labor intensivehigh throughputhigh specificitystability indicatingand indicative of antigenic structure and vaccine efficacyWe propose to solve this problem by developing an aptamer based multiplex electrochemical biosensorSimilar to SRDour sensor is low costhighly specificand can assess vaccine stability and efficacyIt also has two key advantages that make it an ideal assay for flu vaccine potencyIt uses aptamersnucleic acid ligandsto overcome the limitation of antibodiesBecause aptamers are developed in vitrowe can create a highly robust and rapid process that yields new strain specific aptamers inweeksAptamers are more stable and consistent than antibodiesand have a well defined compositionand thus support standardization and broad dissemination within the Randamp D communityThe device utilizes a microfluidic multiplex electrochemical sensor design which enables rapid and accurate assaysminimal hands on timeand ease of manufactureIf successfulour product has the potential to provide life saving benefits by overcoming a critical risk in flu vaccine production!Every yearnearlymillion people in the US receive flu vaccinesaccounting for a $billion marketDue to antigenic driftnew flu vaccines need to be produced every year under an extremely tight timelineDelays in manufacturing have severe healthcare consequencesA major rate limiting step in the flu vaccine manufacturing process is the assessment of vaccine potencyWe propose to overcome this problem by developing an aptamer based multiplex electrochemical biosensor that can enable rapidIf successfulour product has the potential to provide life saving benefits by overcoming a critical risk in flu vaccine production