Lung cancer is leading cause of cancer death worldwide and lung biopsy is the gold standard method of diagnosis. Approximately, 1 in 3 patients undergoing a lung biopsy suffer from a collapsed lung, known as pneumothorax. Irish start-up Selio Medical has developed a new technology platform, the Selio Sealant System, which is a single use, prophylactic device, comprising a percutaneous delivery needle together with a novel biodegradable hydrogel sealant, which significantly reduces pneumothorax during transthoracic needle biopsy. As a start-up company, Selio Medical, faced challenges around access to resources and specialist expertise & infrastructure to identify its raw material and hydrogel critical quality attributes and to determine the impact of sterilization throughout the manufacturing process.
Challenge
The challenges faced by many start-up companies primarily centre around their limited resources in terms of expertise and infrastructure, in particular. Selio Medical, having identified the unique interdisciplinary expertise and extensive capabilities available within the Centre, became a member of the SSPC in 2022. At that time, the company required specific expertise to identify its raw material and hydrogel critical quality attributes and to determine the impact of sterilization throughout the manufacturing process.
SSPC, under the direction of Professor Sarah Hudson and Associate Professor Emmet O’Reilly (UL) led a research project collaboration that provided extensive analysis of pre and post crosslinked gelatin dry powders using TGA, Raman, SEM, DSC, FTIR, NMR and GPC, DVS and Mass Spec analysis. The outputs from this project provided expert insight on the characterisation of the Selio Medical material and the feedback and knowledge shared by the research team, impacted in real-time, the R&D decisions that the company was making on the hydrogels. Through this project SSPC directly informed the process parameters and contributed to the final product’s process development.
During the course of the collaboration, Selio Medical was at a critical juncture and preparing their product design verification in order to lock down the hydrogel manufacturing process. SSPC’s hands-on knowledge helped to expedite the research approach and facilitated a very effective collaboration. Furthermore, the student benefited from with a very valuable industry experience.
Professional Services Impact
Following extensive analysis of pre and post crosslinked gelatin dry powders using TGA, Raman, SEM, DSC, FTIR, NMR and GPC, DVS and Mass Spec analysis, the outputs from this project provided expert insight on the characterisation of the Selio Medical material. The feedback and knowledge shared by the research team, impacted in real-time, the R&D decisions that the company was making on the hydrogels. Through this project SSPC directly informed the process parameters and contributed to the final product’s process development.
The high calibre of polymer knowledge and expertise made available through their engagement with the SSPC played a critical role in contributing to the final process adjustments and ultimately resulted in Selio Medical adopting an improved process within their organisation. Through their Centre membership, Selio Medical also participated in the SSPC placement programme and embedded a PhD researcher into their product development team for 3 months. This allowed the researcher to be fully inducted and integrated into the Selio team, and experience the process development first hand.
“Our collaboration with SSPC began at a critical juncture in Selio Medical’s product development. By partnering with SSPC, we were able to formulate a project that tackled our core research questions and manufacturing obstacles. The high calibre of research results and consistent interaction with SSPC, coupled with the flexibility of their team, played a pivotal role in the positive outcomes from our collaboration. The project led to enhancements in our hydrogel product and manufacturing procedures.” Dr Sally Ryan, R&D Manager, Selio Medical
