Allele Biotechnology & Pharmaceuticals, Inc. (Allele), a San Diego-based technology development and cell manufacturing company,  announced its participation in an up to $25.8 million research project with the University of California, San Diego, funded by the Advanced Research Projects Agency for Health (ARPA-H). The project’s goal is to develop a fully functional, patient-specific, 3D bioprinted liver for transplantation. This project is under ARPA-H’s Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program which intends to use state-of-the-art bioprinting technology and a regenerative medicine approach to 3D print personalized, on demand organs that do not require immunosuppressive drugs. The PRINT program is led by ARPA-H Program Manager Ryan Spitler, Ph.D.

The objective of the project is to develop “made-to-order” livers grown from a patient’s own cells. This innovative approach offers a safe, scalable alternative to traditional transplantation, eliminating the need for donor organs and lifelong immunosuppressant drugs. Allele will produce induced pluripotent stem cells (iPSCs), a technology pioneered by Dr. Shinya Yamanaka and awarded the Nobel Prize in 2012, using its patented, highly efficient mRNA reprogramming method in Allele’s GMP facilities dedicated to stem cell–derived therapies. Led by Allele’s founder and CEO, Jiwu Wang, Ph.D., the Allele team will also apply its master gene mRNA platform to generate multiple liver-specific cell types, eventually manufacturing them in quantities reaching tens of billions per organ.

The joint liver regeneration team is led by Shaochen Chen, Ph.D., a professor in the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at the UC San Diego Jacobs School of Engineering and a world-renowned 3D bioprinting expert. The project unites specialists in liver biology, imaging, surgery, and artificial intelligence. Liver failure, a life-threatening condition, claims thousands of lives annually as patients await donor organs. If successful, the project could offer an on-demand source of functional liver tissue for transplantation, potentially saving over 12,000 U.S. patients each year on the waiting list. It could also cut healthcare costs and improve long-term outcomes for those with chronic liver disease.