Global biotechnology company NurExone Biologic Inc. recently announced that its wholly owned U.S. subsidiary, Exo-Top Inc., has signed a binding memorandum of understanding (MOU) with Princeton-based Made Scientific, Inc.
The partnership establishes an exclusive U.S. Good Manufacturing Practice (GMP) manufacturing and commercial supply agreement for NurExone’s exosome-based therapies, targeting initial GMP exosome batches in the first half of 2027.
Under the terms of the binding MOU, Made Scientific will serve as the exclusive U.S. partner for the manufacturing and aseptic fill-finish of NurExone’s bone marrow-derived exosomes. The collaboration is designed to support NurExone’s clinical pipeline—including its lead therapeutic candidate, ExoPTEN, targeting acute spinal cord and optic nerve damage—alongside future commercial production.
Understanding exosomes: nature’s tiny messengers
Exosomes are naturally occurring, microscopic extracellular vesicles (tiny fluid-filled sacs) released by almost all types of cells in the body. Ranging in size from about 30 to 150 nanometers, they were once thought to be little more than cellular “garbage bags” used to get rid of unwanted waste. Modern science has revealed, however, that exosomes are actually a sophisticated communication system used by cells to talk to one another.
Made Scientific operates a 60,000-square-foot, U.S. FDA and EU GMP Annex 1-compliant facility in Princeton. Backed by global pharmaceutical leader GC Corporation, the firm specializes in cell therapy contract development and manufacturing.
“Partnering with highly regarded organizations is essential to building world-class manufacturing around novel therapeutic approaches, including exosome-based therapies,” Dr. Lior Shaltiel, chief executive officer of NurExone said. “Made Scientific is an ideal strategic partner because of its manufacturing capabilities, operational expertise, and shared long-term vision.”
Syed Husain, chairman and CEO of Made Scientific, echoed the sentiment: “This collaboration combines NurExone’s innovative bone marrow-derived exosome platform with Made Scientific’s manufacturing and regulatory expertise, creating an integrated pathway to bring exosome-based therapies from development through commercial supply.”
Timeline: Technology transfer will begin immediately in parallel with final negotiations for a definitive agreement, which is contemplated to have an initial five-year term with five-year renewal options. Initial GMP batches are targeted for H1 2027.
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Broader strategy: This initiative follows NurExone’s bioprocess optimization partnership with Novasign GmbH announced in July 2026.
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BioXtek LOI update: Concurrently, NurExone announced that its subsidiary Exo-Top has mutually agreed with Florida-based BioXtek Inc. not to proceed with a previously announced non-binding LOI from April 2026, pivoting its U.S. manufacturing infrastructure entirely to the Made Scientific collaboration.
