Pluristyx and WFIRM Are Building a Hepatocyte Manufacturing Pipeline for Temporary Liver Support

Pluristyx and WFIRM Are Building a Hepatocyte Manufacturing Pipeline for Temporary Liver Support

On July 27, Pluristyx, the Wake Forest Institute for Regenerative Medicine (WFIRM), Innovian Space, and ReMDO announced a joint project. The team plans to establish cell manufacturing for a liver construct designed to support patients temporarily while they await transplantation.

The team's first stated objective is to establish the process and conduct an initial validation by December 2026. By April 2027, the project plans to be ready for the second phase of the InSPA program.

A hepatocyte is a cell that performs the liver's core functions. Producing cells labeled as hepatocytes is not enough for this construct. The cells must also demonstrate liver function. The team plans to measure albumin production, bilirubin clearance from the blood, urea synthesis, secretion of coagulation factors, and metabolic profile. These measurements are intended to serve as the criteria for accepting the cellular component into the liver construct.

Pluristyx is preparing a bank of induced pluripotent stem cells, or iPSC, and a protocol for differentiating them into hepatocytes. iPSC are produced by reprogramming adult cells and can be used to grow cells from different tissues. WFIRM is developing the liver construct and testing its function. ReMDO is preparing the documentation needed for regulatory review and commercial use, while Innovian Space connects the project with InSPA.

The participants have divided the successive stages of one process among themselves: Pluristyx produces the cells, WFIRM incorporates them into the construct and tests its functions, and ReMDO prepares the path toward clinical use. This arrangement is intended to ensure that the cells can be manufactured under consistent rules and evaluated using consistent measures, instead of requiring each laboratory to rebuild the process from the beginning.

The purpose of the project is to create a reproducible pipeline for temporary liver support. The December validation is intended to determine whether the team can integrate the cell bank, functional tests, and tissue construct into a single process. The April milestone will assess whether this process is ready for the next phase of InSPA.