Transitioning the Multiplexed Bactericidal Assay for Shigella Lipopolysaccharide Antibodies for Commercial Use

In response to DHA202-002, SunFire Biotechnologies (SFB) proposed to develop a 2-fold multiplexed serum bactericidal assay (mSBA) for Shigella antibodies and to demonstrate its operational feasibility.  With that Phase I funding, SFB developed a 4-fold mSBA, based on antibiotic resistance, which allows the simultaneous testing of functional antibodies against S. flexneri serotypes 2a, 3a, and 6, as well as S. sonnei.  The mSBA was found to be reliable, with good reproducibility and repeatability.  SFB is now proposing to transition the mSBA to commercial use using two approaches.  The first is to refine the mSBA created in Phase I to create an assay that can be utilized in Shigella vaccine development.  To increase throughput, reduce testing turn-around times, and decrease cost, the assay will be optimized.  With analytical qualification of the assay and application of our current quality assurance systems to ensure regulatory compliance, SFB will be able to offer mSBA testing for pre-clinical as well as early-stage clinical trials of Shigella vaccines on a fee-for-service basis.  Additionally, SFB can improve the performance of mSBA further by developing an “in-house kit.” The mSBA is amenable to a kit since all critical mSBA reagents can be prepared in large amounts, stored in aliquots until needed, and characterized ahead of time. SFB will explore other options, such as automation, to further improve assay performance. The second approach to commercial transition is to produce and market mSBA kits, which were originally developed for an in-house use. The key to this approach is to demonstrate that the “in-house kit” allows an external laboratory to reliably perform the mSBA. For this purpose, we have identified an external laboratory to test the SFB in-house kits.  If the kits perform well for the outside laboratory, SFB will be able to produce and market Shigella mSBA kits on a larger scale.  The work will be performed in SFB under the direction of Mr. Burton, the Director of SFB and PI for the Phase I project. SFB has identified a subcontractor with experience in Shigella SBAs to test the kits, and several outstanding consultants that will help with this project. Furthermore, SFB is currently functioning as a contract research organization (CRO) for pneumococcal vaccine industry and can do the same for Shigella.  Therefore, SFB can easily transition the assay developed in Phase I to these commercial applications.