SBIR/STTR Award attributes
ABSTRACT BSTRACT In an effort to reduce the use of animals for toxicity testingcompanies have developed bioengineered in vitro skin models to replace the Draize skin irritation testThe development of tissue models has been further pushed by the European Union that prohibited the use of animals infor collecting toxicological data on cosmetic ingredientsSupply of bioengineered tissues is a significant issue that can be solved by development of effective cryopreservation methodsPresentlytissues or skin constructs are made to order and require a lead time of several weeks before they can be usedA cryopreserved product would be available upon demand eliminating the order lead time required to manufacture the productAdditionallyquality control checks can be performed pre shipmentnot post shipment as is the current practice due to the short product shelf lifeCryopreservation will permit economies of manufacturing scaleresulting in reduced bioengineered construct costs to both the manufacturers and the end usersThe availability of cryopreserved human bioengineered epithelial constructs would also provide the end user greater flexibility for scheduling of experiments without concern regarding availabilityFurtherit would be possible to order from the same batch of product in order to have better control of uniformity within research studiesWe have developed an ice free vitrification method for cryopreservation of bioengineered skin constructs used in toxicity testingIn preliminary studies using ice free vitrificationwe have consistently demonstrated andgtviability of several types of human bioengineered epithelial constructs using ice free vitrification that persists for several days post rewarmingHowevera limiting factor for preservation at larger scale in multiwell plates using current manual preservation methods is the inability to add and remove cryoprotectants fast enough to avoid cytotoxicity across an entirewell plateIn this Phase I proposal we plan to customize and integrate an automated liquid handling system to manage our current successful vitrification methods in one Specific AimAs a resultwe will demonstrate the ability to process fourwell plates simultaneously in the same time frame as we presently processconstructs manuallyThe outcome will be measured by assessment of tissue viability and functional assays required by tissue suppliers for quality controlWe will also track accuracy of the automated system by measuring volumes of solutionsplate and solution temperatureand plate processing timeThe outcome of this proposal will be inline with our Company goal of commercializing our vitrification process by storing ondemand human bioengineered tissues for distribution to customers for drug or chemical screening and research applications PROJECT NARRATIVE Bioengineered human tissue constructs are being developed to replace the use of more traditional animal toxicity testssuch as the Draize irritation and corrosivity testsand preclinical animal modelsAn effective preservation method for validated skin constructs and other tissues in development will create the opportunity for tissue bankingproviding anon demandsupply of tissues for research purposesVitreous preservation will provide a less expensiveconsistentbetter quality controlled productSuccess in this project will rely on automation to manage vitrification processes which in turn willreduce the cost of tissue equivalent constructs and increase the availability of human test models that will be more predictive of outcome for humans than currently employed live animal models
