NurExone Biologic, a Toronto and Haifa, Israel-based biotechnology company developing exosome-based regenerative therapies, has signed a binding memorandum of understanding (MOU) with Made Scientific to establish an exclusive U.S. manufacturing and commercial supply partnership.

Under the proposed agreement, Made Scientific will manufacture and provide aseptic fill-finish services for NurExone’s bone marrow-derived exosomes at its 60,000-square-foot facility in Princeton, New Jersey, which opened late last year. The facility operates under U.S. Food and Drug Administration and EU GMP Annex 1 requirements, according to the companies.

The companies plan to begin technology transfer immediately, with the first GMP exosome batches targeted for the first half of 2027. The agreement contemplates an initial five-year term for the definitive agreement, with options for successive five-year renewals.

The partnership is intended to support NurExone’s clinical pipeline, including its lead candidate ExoPTEN, as well as potential future commercial exosome production. Made Scientific will serve as NurExone’s exclusive U.S. manufacturing partner under the MOU.

The agreement builds on Made Scientific’s cell therapy manufacturing activities. In February, the CDMO announced a program with Streamline Bio to develop and validate AI-driven robotic manufacturing workflows for CAR T therapies in a GMP-ready environment.

NurExone’s manufacturing strategy also includes a July 30 collaboration with Novasign GmbH focused on bioprocess optimization. The company said the initiatives are intended to strengthen manufacturing infrastructure for its therapeutic pipeline and future commercial exosome activities.

NurExone also said its U.S. subsidiary, Exo-Top, and Florida-based BioXtek have mutually agreed not to proceed with a nonbinding letter of intent announced in April. The decision follows NurExone’s plan to consolidate its U.S. GMP exosome manufacturing strategy under the proposed Made Scientific collaboration.

The MOU will terminate if the parties do not execute a definitive agreement within six months, subject to specified surviving obligations.