Xcellerex and Humacyte to Develop Single-Use Manufacturing Technology to Grow Vascular Grafts

Humacyte, Inc. (Research Triangle Park, NC) and Xcellerex, Inc. (Marlborough, MA) have entered into an initial strategic collaboration for Xcellerex to develop a manufacturing process that will enable the production of Humacyte’s lead regenerative medicine product using Xcellerex’s XDR single-use bioreactor system in its FlexFactory. Humacyte’s product is a large-diameter vascular graft based on its proprietary platform technology for engineering human, extracellular, matrix-based tissues that have properties similar to native tissues.

Humacyte’s vascular grafts are designed to be used for arterio-venous access in patients on hemodialysis and will eventually be used as a replacement of diseased or damaged blood vessels. Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing development fees from Humacyte. Humacyte will use the initial grafts produced under this collaboration for preclinical development, and the parties may continue their collaboration for the development of large-scale manufacturing of vascular grafts for transplantation for clinical and commercial use.

The FlexFactory will allow Humacyte to later scale-up its production to meet late-stage clinical and worldwide commercial market demands. The technology for cultivation of vascular grafts was developed by Humacyte using small-scale bioreactors that produced one graft at a time. The grafts have successfully completed animal tests, allowing Humacyte to begin scale-up for manufacturing grafts for human clinical trials and eventually commercial production. The collaboration is partially funded by a small business innovation research grant awarded to the companies by the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases.

The goal of the collaboration is to transform the current small-scale, single-graft bioreactor manufacturing process into a robust process able to produce commercial supply of multiple vascular grafts in the XDR single-use bioreactor system. In the first proof-of-concept phase of the collaboration, grafts will be produced and subjected to physical and chemical testing to demonstrate equivalence to grafts produced to date using small-scale approaches.