CellGro Technologies, LLC — Department of Health and Human Services STTR Phase I: 400

Description

PROJECT SUMMARY ABSTRACT SignificanceCell therapy is expected to become an important method to treat chronic diseases such as diabetesrheumatoid arthritisretinal diseases like macular degeneration and certain types of cancersThe cell therapy market in general is projected to become a $billion industry byHuman pluripotent stem cellshPSCsare of particular importance since their utility as a source for a variety of cell types for therapeutic useextends to additional applications like tissue fabrication and drug screeningHoweverbroad patient access is limited by the cost and capacity of cell manufacturingCurrent technologyD suspension culture methodfor cell production processes are complicated and can only produce cells for small patient populations at high costAdditionallyculture conditions cause large variations of cell yieldcompositions and potencyConsequentlypatients receive highly varied cell productsThusthere is a critical need for new technologies that have the capability to easily scale outlower the cost of manufacturing and improve batch to batch repeatabilityCellGro TechnologiesLLC proposes a technology to address this critical needThe core technologyinvented by DrYuguo Leiis a novel cell culturing methodCells are cultured in hollow alginate tubesAlgTubesthat are suspended in constantly refreshed cell culture mediumThe alginate tubes create a protective micro environment that favors rapid cell growth to high densities and high viabilitySpecific AimsThe objective of this project is to develop the prototype of AlgTubes based personalized bioreactorPBRthat will generate optimized conditions for cell growthThe facilitating technology is a PBR which is loaded up tovolwith the alginate tubes The PBR will use an internal circulation airlift design that utilizes sparged oxygen to circulate the medium to assure that the nutrient and oxygen demands are met for the cells in the alginate tubesIn Specific Aimwe will design and build an AlgTube micro extruder that extrudes multipleup to sixtubes simultaneouslyThe extruder forms part of the disposable PBR systemThe manufacture of the extruder requires precision machining and prototypes will be tested for tube uniformity across all six nozzlesIn Specific Aimprototypes of the PBR will be builtFeatures includeapart from extruderan airlift design to promote nutrient transport between the bulk and tube phases and easy cell harvestingMost importantlythe PBR is a completely closed systemIn Specific Aimwe will evaluate the PBR prototypes performanceshPSCs will be cultured and cell densities and viability will be assessedOverall impactThis project will advance the technology of cell manufacture and make cell therapy more broadly accessible by manufacturing products that are more consistentreliableand affordable PROJECT NARRATIVE Our goal is to develop a low costdisposablepersonalized bioreactorPBRto automate production of consistent high quality human pluripotent stem cellshPSCsCell therapy is expected to become an important technology for the treatment of certain chronic diseases and hPSCs will play a major roledue to the ability to differentiate into many different cell typesHoweverscaling out manufacturing to large patient numbers with high consistency and at lower cost is still a challengeThe novel AlgTubes based PBR cell expansion technology has the potential to set standards for consistent cell manufacturing and it will make cell therapy more accessible and affordable