(319c) Single-use Sensor Array for Monitoring Key Growth Medium Analytes During mAbs Biomanufacturing

Monoclonal antibodies (mAbs) are highly specific protein therapeutics that have revolutionized medicine. Their manufacture represents the largest sector of the U.S. biotechnology industry, with predicted revenues of $125 billion by year 2020. Surprisingly, mAbs biomanufacturing in the U.S. is archaic, relying upon batch bioreactors that employ a minimal number of process sensors. Hence the Process Analytical Technology (PAT) initiative introduced by the FDA emphasizes the need for developing new biomanufacturing techniques that employ advanced process monitoring and control techniques. In my talk, I will discuss how the goals of the FDA’s PAT initiative can be achieved through the use of single-use bioreactors that employ single-use sensors of growth medium conditions based upon smart hydrogels.