Current sensor technologies are constrained by single-parameter detection, large size, and the need for frequent sample extraction. These limitations complicate integration and prevent real-time, in-situ monitoring, especially in milliliter-scale systems critical for early-stage research. Existing systems also struggle to meet the demands of continuous manufacturing and modular production facilities, where flexibility, scalability, and integration are essential. Regular fibers can tolerate typical sterilization doses (25–50 kGy) without structural damage; however, optical losses may increase due to radiation-induced attenuation (RIA), particularly in the visible range where attenuation can become significant.
The proposed sensor has the ability to monitor multiple parameters in real time. Its small size allows it to function effectively in milliliter-scale flasks, enabling detailed online sensing for research and development. In large-scale bioreactors, the sensor's distributed sensing capability enables flexible and customizable monitoring without requiring probes or openings, simplifying system design and enhancing process control. Polyimide-coated fibers will be used in non-sensing regions to provide radiation resistance and mechanical durability, while fluorine-doped fibers will be employed in the sensing region to minimize RIA and maintain signal integrity. Furthermore, the sensor's compatibility with gamma radiation ensures sterility, meeting industry standards for biomanufacturing.
The sensor combines pH, DO, and temperature monitoring into a single, streamlined unit, simplifying biomanufacturing processes, reducing complexity, and lowering operational costs compared to bulky, costly multi-sensor setups
The sensor supports continuous manufacturing and QbD goals, offering cost savings, process efficiency, and accurate data critical for producing biologics such as cell and gene therapies. Its ultra-miniaturized design (125 µm) is ideal for milliliter-scale flasks, reducing material needs for early-stage development, while its robust, gamma-radiation-compatible construction suits large-scale bioreactors, ensuring sterility and scalability across applications.
Implementing the SENSILINE real-time multi-parameter sensor (pH/DO/temperature) replaces multiple probes and ports, reducing hardware, consumable, and labor costs. This integration accelerates scale-up and supports continuous manufacturing while improving aseptic assurance and aligning with QbD and PAT frameworks. By streamlining operations and ensuring regulatory compliance, it enables faster development timelines without compromising product quality.
The project aims to deliver 5 SENSILINE (sensor prototypes) ready for initial testing. Detailed design and prototype testing reports will document the sensor's performance against initial specifications, ensuring all requirements are met
The project will provide validation reports showing effectiveness of algorithms developed for the sensors
Login to the NIIMBL member portal to access additional project information, including presentations, progress updates, reports, and more.
Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.
University of Massachusetts Lowell
Lonza Biologics, Inc.
Sartorius Stedim
Xheme
