Current process analytical techniques (PAT) in biomanufacturing are generally cost-prohibitive, ineffective, skill-intensive, and fail to support the growing demand for continuous manufacturing.
The team will address the current PAT by developing InSens4™ The team will address the current PAT by developing InSens4™, an in-line multi-analyte sensor that can simultaneous monitor Glucose, Lactate, osmolality, and pH values during bioproduction., an in-line multi-analyte sensor that can simultaneous monitor Glucose, Lactate, osmolality, and pH values during bioproduction.
Inline monitoring of critical process parameters enables greater process understanding and control, reduced product development times, and faster scale-up for the biopharma R&D.
Implementing InSens4™, the first multi-analyte inline sensing platform, cuts manual sampling and offline testing costs while accelerating scale-up, tech transfer, and batch cycle times for faster biologics development and time-to-market. Delivering 1000X more data per culture run, it enables adaptive closed-loop control that improves yield by up to 30%, minimizes variability, and ensures consistent, compliant product quality.
Applied Biosensors (AB) has developed InSens4™, the world’s only multi-analyte, plug and play, inline sensing platform to simultaneously monitor the most critical process parameters (CPPs) Glucose, Lactate, Osmolality, and pH during bioproduction.
The project has demonstrated the responsiveness and integrity of the system (hydrogels, sensor housing, and reader electronics) through data and results from multiple CHO cell-culture runs. Data predictions show an accuracy of ± 5% accuracy compared to off-line measurements
InSens4™ provides 1000X more data per culture run. This enables advanced adaptive closed feedback control systems that result in higher process yield (up to 30%), reduces labor & time (eliminates the need for an operator to take a manual sample every 2-4 hours and manually adjust the controllers), reduces batch to batch variability, and faster time-to-market for new biologic products.
Tathireddy, P., Presenter, PC3.1-135 Multi-Analyte In-line Sensor for Biomanufacturing Applications Based on Analyte-Responsive Smart Hydrogels, NIIMBL National Meeting, Washington, D.C., July 26, 2022.
Sharma, R., Tathireddy, P., Kwan, B., Fournier, A., Smith, R., Robust, Multi-Analyte In-Line Sensor For Biomanufacturing, NIIMBL National Meeting, Jul 28, 2021.
Sharma, R., Tathireddy, P., Robust, Multi-Analyte In-Line Sensor for Biomanufacturing, Presented at BioProcess International Meeting, Sept 2021.
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Applied Biosensors
EMD Millipore Corporation
Merck Sharp & Dohme LLC
