Xcellerex and Humacyte have entered into an initial strategic collaboration for Xcellerex to develop a manufacturing process that will enable the production of Humacyte’s regenerative medicine product using Xcellerex’s XDR single use bioreactor system in its FlexFactory.
Under the terms of agreement, Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing development fees from Humacyte.
Humacyte will utilise the initial grafts produced under the 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 enable 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 completed animal tests, enabling Humacyte to begin scale up for manufacturing of grafts for human clinical trials and eventually commercial production. The collaboration is partially funded by a Small Business Innovation Research (SBIR) 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 more efficient and flexible XDR single use bioreactor system configured in the modular turnkey FlexFactory platform. 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.
The agreement follows collaborative design work by the two companies over a period of several months. Xcellerex is providing in-depth support in single use bioreactor design and FlexFactory configuration to help accelerate Humacyte’s deployment efforts. Humacyte is providing expert cell biology and vascular graft technology and know-how.
The FlexFactory line will be assembled, tested, and operated at Xcellerex for protocol development and proof of concept graft production. In subsequent project phases, Xcellerex may also complete engineering and/or GMP manufacturing runs for Humacyte before TransPlanting the modular FlexFactory line to Humacyte’s facility for rapid site validation and startup for commercial supply. Financial terms were not disclosed.
Joseph Zakrzewski, chairman, president and chief executive officer of Xcellerex, said: “We are pleased to utilise our manufacturing technology and development know-how to enable the rapid development of a potent single-use manufacturing platform for Humacyte. Our technology offers Humacyte a cost-effective and novel manufacturing solution for their full pre-clinical and clinical development needs through to commercial production, using our FlexFactory platform.”