MAGNETICALLY STABILIZED CELL CULTURE SYSTEM

THE OVERALL OBJECTIVE OF THIS RESEARCH PROGRAM IS TO DEVELOP COST-EFFECTIVE CELL CULTURE TECHNOLOGY FOR THE MANUFACTURING OF PRODUCTS SUCH AS MONOCLONAL ANTIBODIES OR THERAPEUTIC PROTEINS. THE APPROACH INVOLVES GROWTH OF CELLS ON A MAGNETICALLY SENSITIZED MICROCARRIER BEAD SO THAT MUCH HIGHER MICROCARRIER DENSITY WHICH IN TURN MEANS HIGHER CELL DENSITY (>1.0 X 10(7) /ML) CAN BE USED IN A BIOREACTOR. OTHER ADVANTAGES OF THIS APPROACH INCLUDE COMPATIBILITY WITH EXISTING CULTURE HARDWARE AND PROCEDURES,EASE OF SCALE-UP, SIMPLIFIED CONTROL, AND NEW OPPORTUNITIES TO OPTIMIZE CELLULAR METABOLISM AND PRODUCT YIELD. PHASE I RESEARCH OBJECTIVE IS TO DEVELOP THIS MAGNETICALLY SENSITIZED MICROCARRIERS AND DEMONSTRATE ITS POTENTIAL UTILITY FOR CELL CULTURE OF ANCHORAGE DEPENDENT CELLS. THISRESEARCH WILL ALSO STUDY VARIOUS COATING MATERIALS AND THEIR INTERACTIONS WITH CELL ATTACHMENT AND DETACHMENT. IN THE ABSENCE OF OXYGEN LIMITATION OR MEDIUM EXHAUSTION, THE PHASE I RESEARCH WILL DEMONSTRATE THE MAXIMUM ACHIEVABLE CELL DENSITY IN A LABORATORY MAGNETICALLY STABILIZED BIOREACTOR SYSTEM. PHASE II RESEARCH WILL EXTEND AND SCALE UP THESE RESULTS TO COMMERCIALLY RELEVANT CELL CULTURE CONDITIONS.