HOLLOW-FIBER BIOREACTOR WITH IMPROVED OXYGENATION

RECOMBINANT RESEARCH HAS FACILITATED THE IN VITRO PRODUCTIONOF MAMMALIAN CELL-SECRETED PRODUCTS. THESE PRODUCTS ARE USED IN THE IN VITRO AND IN VIVO DIAGNOSTIC AND THERAPEUTIC SETTING. PRODUCTS THAT HAVE BEEN APPROVED OR ARE IN THE APPROVAL PROCESS HAVE PROJECTED MARKET NEEDS ON THE ORDER OF100 KILOGRAMS PER YEAR, BUT LARGE QUANTITIES LIKE THIS WILL BE DIFFICULT TO PRODUCE USING TODAY'S STATE-OF-THE-ART CELL CULTURE METHODS. A NEW HOLLOW-FIBER BIOREACTOR HAS BEEN DEVELOPED THAT CAN MEET THESE PRODUCTION NEEDS IN A COST-EFFECTIVE MANNER. THE DEVICE HAS ALL OF THE ADVANTAGES OF HOLLOW-FIBER CELL CULTURE: HIGH CELL DENSITY, LOW CULTURE VOLUMES, HIGH PRODUCT CONCENTRATION AND PURITY, LOW SERUM/GROWTH FACTOR REQUIREMENT, AND COMPACT SIZE. THE BIOREACTOR IS A NOVEL DESIGN THAT IS EASILY MANUFACTURED WITHOUT LARGE INVESTMENTSIN CAPITAL EQUIPMENT AND IS LINEARLY SCALABLE. THE DEVICE CAN TRANSFER OXYGEN AT A RATE OF 196 MM/HOUR/LITER. THE PHASE I RESEARCH OBJECTIVE IS TO GENERATE THE DATA REQUIRED TO OPTIMIZE THE DESIGN OF THE COMMERCIAL BIOREACTOR. THIS BIOREACTOR WILL ALLOW VERY LARGE-SCALE MAMMALIAN CELL CULTURING WITH LESS SPACE AND REDUCED EQUIPMENT COSTS THAN CURRENT CELL CULTURE METHODS. THIS RESEARCH WILL LEAD TO PHASE II DEVELOPMENT OF THE BIOREACTORAND LAY THE GROUNDWORK FOR IMPROVED CELL-CULTURE INSTRUMENTATION DEVELOPMENT.