Measurement: the central nervous system of a quality manufacturing line for tissue engineering and regenerative medicine products

Cell & Gene Therapy Insights 2020; 6(10), 1477–1488


Published: 25 November 2020
Expert Insight
Mary Clare McCorry, Rebecca Robinson-Zeigler, Richard McFarland, Thomas Bollenbach

The field of tissue engineering and regenerative medicine have been making headlines for the last three decades heralding a new age of medicine. While the science behind guiding tissue regeneration and repair has advanced by leaps and bounds, these technologies rely on an artisanal manufacturing approach that leads to a rigid manufacturing control strategy as the technology scales up production. Cell and tissue developers need to embrace a Quality by Design approach in which the technology is thoroughly characterized along with a systematic analysis of how the final product attributes relate to the material attributes and process parameters input into the manufacturing process. This knowledge will drive targeted sensor and measurement development that can be integrated throughout the process supporting monitoring and feedback control. Using this approach, the cell and tissue manufacturing process will have increased flexibility, decreased cost, and reduced growing pains of manufacturing scale-up. Most importantly, implementation of sensors and measurement technologies is critical to moving toward adaptive process control and is the foundation for the application of process analytic technologies.