Year: 2021-22

Company: SanBio

Liaison(s): Jigesha Dholakia, Lydia Lim, Andrew Norton, Dipali Patel, Kiran Umesh, Shalini Raj Unnikandam Veetil, Timothy Wong

The SanBio Group is a global leader in the regenerative cell medicine business spanning research, development, manufacture, and sales of regenerative cell medicines. Founded in 2001, SanBio has consistently worked to advance the development of regenerative medicines with the mission to create a new category of medicine, and to deliver breakthrough therapies to patients in need around the world. SanBio’s proprietary regenerative cell medicine product, SB623, is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury (TBI), ischemic stroke, and hemorrhagic stroke. SB623 is in Phase 3 clinical trials in Japan and is being considered for trials in the US, EU, and China, for treatment of TBI. The SanBio TMP team was asked to work with the process development and analytical development departments at SanBio to complete two projects within the 2021-2022 school year. In the Fall, students executed multiple experiments to optimize SanBio’s manufacturing process and to further cultivate their stem cell growth kinetics. Main points of interest include cell growth, morphology, and metabolite levels which were monitored daily throughout the experimental timeline. In the Spring, students ran experiments involving exosome analysis and cytokine quantification to better characterize SB623’s mechanism of action. Completion of these projects have provided SanBio further insight into reproducibility of their manufacturing process as well as a deeper understanding of their leading product.