Multi-Analyte In-line Sensor for Biomanufacturing Applications Based on Analyte-Responsive Smart Hydrogels.

Performance Period: 9/1/2020 to 1/31/2022

Current process analytical techniques (PAT) in biomanufacturing are generally cost-prohibitive, inefficient, skill-intensive, and fail to support the growing demand for continuous manufacturing. Applied Biosensors LLC in collaboration with Merck & Co., Inc. and MilliporeSigma is addressing this unmet need by developing InSens4™, an in-line multi-analyte sensor that can simultaneously monitor Glucose, Lactate, Osmolality, and pH values during bioproduction. This technology is expandable to other analytes in the production of biologics including large-molecules. NIIMBL funding will enable further development needed to translate the technology into a commercial product. In particular, the project funds will focus on:

1) testing sensor prototypes and algorithms in different complex commercial media and environmental conditions;

2) Cell culture validation of the sensor-system by partner organizations in various conditions including different biomasses; and,

3) Development of transmitter prototypes and translation of InSens4™manufacturing to ISO certified contract manufacturers. The InSens4™ sensor will ensure the high quality and efficacy of biologic drugs by improving manufacturing outcomes while reducing development and production costs.