Topogen, Inc — Department of Health and Human Services SBIR Phase I: 300

Description

Project Summary TopoGENin a strategic partnership with Nanoly Bioscienceproposes to develop ambient condition stable Research Use OnlyRUOproductse genzymesantibodiesand Kitsthrough the use of a syntheticsafeand biocompatible polymer encapsulation technologyNanoShieldNanoShield uses a patent protected photodegradable polyethylene glycolPEGhydrogel network to encapsulate and shield sensitive biomolecules from thermal stress encountered during storage and transitThe enzymes highlighted in this proposal are important anti cancer and antibiotic targets in modern drug developmentThese enzymeslike RUO products from many other companieswhich are used in basic and translational researchare highly labile and require costly dry ice packaging for both domestic and international distributionDry ice packagingthough commonly usedpresents major problems including high cost and hazardous material classificationwith the additional risk of total product loss upon shipping delayThe US is currently a global leader in the RUO marketplacewhich is expected to grow to nearly US $B byand if the US is to maintain its position in this marketthese issues must be addressedThe technology developed herein will eliminate the requirement for expensive cold chain services for RUO product distribution and storageNanoShield s capability to eliminate the need for cold chain storage and distribution will lead to significant reductions in logistics costsand will provide a considerable market advantage to US companies that adopt the technologyNanoly will develop effective formulations for a number of TopoGEN s RUO productsfocusing on enzymese gTopTopandand bacterial gyrasesNanoShield s unique chemistry allows for the rational tuning of the polymer network to achieve maximal payload stabilityWe will test at leastNanoShield formulations to maintain protein function and stabilityas measured by assays developed by TopoGENfollowing stress at a number of temperaturesi eambientCCThese assessments will be carried out for shortseveral daysor longmany monthsterm storageTopoGEN will then conduct a limited fieldbetatest using the fully formulated enzymeTopAs one of TopoGEN s best selling productsHuman Topwill allow for sufficient prototype testing events to achieve sufficient statistical rigorand will test NanoShield s compatibility with other productsAdditionallyTopwill be shipped to a large global network of Company Distributors to field test the ability of NanoShield to maintain product stability over a wide range of storage conditions in real world situationsWe will rely heavily on e commerce and web portal based feedback to gauge product stability and robustness in the hands of end usersWe will leverage the findings from this proposal to develop a full line of NanoShield stabilized TopoGEN RUO productsTopoGEN and Nanolytogetherwill pursue SBIR Phase II funding for expanding field tests and full development of a line of NanoShield stabilized products in the RUO product industryPhase II will also examine translational functionality of NanoShieldThe potential for NanoShield in stabilizing labile bio products extends into a wide array of applicationsfrom vaccines in undeveloped countries to providing ambient stable yet critical medical supplies for our military in battle or other health care workers in harm s way Narrative Public health relevancewe are developing Nanotech based materialsNanoShieldthat will reduce cost and improve access to important biomolecules used as therapeutics and research reagentsNanoShield will inhibit aggregation of biomoleculespreventing loss of potency and avoiding severe side effectsThe potential is far reachingIn addition to public health benefitsincluding stabilizing vaccines for use in third world economiesproviding battlefield medical supplies for our troops and others in harmandapos s waythis work has immediate and significant potential to enhance the economic health of US Biotechnology companies who must ship labile products abroad on dry iceconsidered a dangerous goods shipmentBy eliminating dry ice shippingAmerican made biotechnology products will be far more competitively priced in global marketsthereby increasing US export activity into emerging marketssuch as Asia!