Aug 6, 2020 | Atlanta, GA
BioFabUSA, a Department of Defense-funded Manufacturing Innovation Institute within the Manufacturing USA network, has awarded the Georgia Institute of Technology and industry partner Rockwell Automation a project entitled, “Wireless Electrochemical Sensor Capsules for Real-Time Monitoring of Cell Secretomes and Culture Media in Tissue Growth Bioreactors.” Real-time bioprocess monitoring and control is needed for the scalable production and deployment of efficacious tissue engineered medical products (TEMPs) at reasonable cost.
Billyde Brown, the project's principal investigator, explained, “we are addressing this challenge by working with BioFabUSA, our partners at the Georgia Tech School of Materials Science and Engineering, the Marcus Center for Therapeutic Cell Characterization and Manufacturing, as well as Rockwell Automation, to develop a fully integrated, wireless, 3D-printed sensor ‘capsule’ to be used for in-situ multiplexed monitoring of critical quality attributes (CQAs). The targeted CQAs include pH, glucose, lactate, and select secreted biomarker concentrations from human mesenchymal stem cells – one of the most common cell types used in tissue engineering.”
In both biopharmaceutical and regenerative medicine industries, an urgent need remains for in-line sensor technology for quantitative real-time bioprocess monitoring and control. Unfortunately, many key CQAs are still monitored off-line or at-line using destructive testing or technologies of significant complexity and cost. In at-line measurement, the sample is typically withdrawn from a single location in the bioreactor and analyzed in close proximity to the process stream, whereas in off-line measurements, the sample is taken to a laboratory and the results are usually not returned in a timely manner for process control.
The Georgia Tech team has previously developed potentiometric sensors based on an extended gate field-effect-transistor (FET) topology whereby a separate gold electrode surface is functionalized with an analyte-specific layer that selectively reacts or binds with the chemical or biomolecule of interest. The charge associated with the attached analyte results in a potential change of the gold electrode. These sensors have previously been used to detect chemicals such as pH and lactate, as well as specific proteins/antibodies in a laboratory environment with accuracy and dynamic range equivalent to Surface Plasmon Resonance (SPR) and Enzyme-Linked Immunosorbent Assay (ELISA). One of the unique aspects of this system is that each sensor surface can be individually functionalized permitting multiplexed (simultaneous) detection of almost any number of different chemicals/biomolecules of interest.
In this project, the Georgia Tech team will integrate these sensors into a “capsule” device smaller than the size of a golf-ball and packaged in a 3D-printed waterproof and biocompatible polymer. The capsule will contain a multiplexed sensor chip, with sealed opening to facilitate interaction between the sensor chip and tissue culture environment, Li-polymer battery, and electronics for micro-control, data acquisition and wireless transmission of sensor data to the smartphone of a technician in charge of monitoring the bioreactor process. In addition, Georgia Tech will work with Rockwell to develop an IoT platform such that other permitted internet-connected devices can securely access the data via a cloud server. Another unique aspect of this technology is that multiple “capsules” could be deployed within a stirred tank bioreactor during high volume production of medical products with the ability to move efficiently throughout the bioreactor due to the mechanical forces of the impellors. This would allow for unprecedented simultaneous measurements at various points within the bioreactor, giving accurate representations of the homogeneity of key parameters over time thus achieving in-situ monitoring of CQAs with high spatial and temporal resolution.
Georgia Tech project leads include Billyde Brown, Ph.D., Kan Wang, Ph.D., and Eric Vogel, Ph.D. Brown is research faculty and director of manufacturing education programs at the Georgia Tech Manufacturing Institute (GTMI). Wang is lead researcher of additive manufacturing in the Bio-Engineering Research Laboratory at GTMI. Vogel is a professor at the School of Materials Science and Engineering and deputy director for the Institute of Electronics and Nanotechnology at Georgia Tech. The Georgia Tech project leads will also receive support and assistance from Carolyn Yeago, Ph.D., and Krishnendu Roy, Ph.D. whom are directors of the Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M). Leading the project for Rockwell Automation is Wayne Charest, who also serves as a liaison between Rockwell and BioFabUSA.
“Being able to obtain real-time data on relevant biomarkers will be critical in advancing the field of tissue engineering,” said Stephanie Robichaud, technical project manager with the Advanced Regenerative Manufacturing Institute. “Getting this important information and being able to react to it quickly will result in more consistent manufacturing of a final product that meets its critical quality attributes.”
About the Georgia Institute of Technology
The Georgia Institute of Technology, also known as Georgia Tech, is one of the nation’s leading research universities — a university that embraces change while continually Creating the Next. The next generation of leaders. The next breakthrough startup company. The next lifesaving medical treatment.
Georgia Tech provides a focused, technologically based education to more than 36,000 undergraduate and graduate students. The Institute has many nationally recognized programs, all top-ranked by peers and publications alike, and is ranked among the nation’s top five public universities by U.S. News & World Report. It offers degrees through the Colleges of Computing, Design, Engineering, Sciences, the Scheller College of Business, and the Ivan Allen College of Liberal Arts. As a leading technological university, Georgia Tech has more than 100 centers focused on interdisciplinary research that consistently contribute vital research and innovation to American government, industry, and business. https://www.gatech.edu/
About Rockwell Automation
Rockwell Automation is the largest company in the world that is dedicated to industrial automation and information and is committed to enabling the next generation of smart manufacturing. Rockwell’s mission is to improve the quality of life by making the world more productive and sustainable.
BioFabUSA is a DOD-funded Manufacturing USA Innovation Institute (MII) sustained by the Advanced Regenerative Manufacturing Institute (ARMI), a non-profit organization located in Manchester, New Hampshire. ARMI's mission is make practical the scalable, consistent, cost-effective manufacturing of tissue engineered medical products and tissue-related technologies, to benefit existing industries and grow new ones. https://www.armiusa.org/
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