Invention could revolutionize production of future medicine

Pharmaceutical products, a swiftly developing area of medicine, involves treatments derived from biological (rather than chemical) origins, such as vaccines, gene therapies, cell therapy and protein therapies. Producing biopharmaceuticals is a complex procedure, involving living tissues, cells and materials. The production process, called bioprocessing, requires constant and detailed monitoring to ensure that products develop properly in bioreactors, the vessels that contain biological materials. This is where the PATsule comes in.

Previous sensors have been fixed in one position and could only monitor material that directly passed their surface. The PATsule sensor capsule will move around freely in the bioreactor during production, providing a stream of data to monitor factors that might affect product yield or quality. Used specifically for the production of protein therapies, the PATsule has the potential to revolutionise bioprocess monitoring and control. More informed process development will improve the ability to manufacture therapeutic proteins, enhance their quality, increase their speed to market and benefit medical professionals and patients by reducing the cost of therapies.

Dr. Karen Twomey, Staff Researcher at Tyndall, explained, "Current process monitoring is performed using fixed sensor probes. The PATsule, a wireless mobile sensing device, will freely move within the bioreactor, continuously monitoring and analysing the production vessel environment. This information will help biopharmaceutical manufacturers to visualise and control their process, making it uniform. PATsule involves a multi-disciplinary approach of micro- and nano-sensor technology, miniaturised instrumentation, data analytics and wireless communications."

Dr Jonathan Bones, NIBRT Principal Investigator, said, "The PATsule represents a new concept in process monitoring as it enables the measurement of critical process parameters in both time and space, which was not previously possible. We foresee it becoming must-have technology within the industry for all those engaged in process development and commercial manufacturing."

"We are delighted to be working with Tyndall on this exciting project," said Dr. Bones. "It blends a unique mix of Tyndall's expertise in sensing devices and microelectronics with NIBRT's excellence in biopharmaceutical manufacture."

PATsule is a joint venture between Tyndall and NIBRT and is funded by Enterprise Ireland's Commercialisation Fund, which has committed €347,870 to the project. The collaboration will be coordinated from Tyndall by Dr Karen Twomey and from NIBRT by Dr Jonathan Bones, employing research assistants and postdoctoral researchers across both institutions.