- NurExone and its U.S. subsidiary Exo-Top have signed a binding memorandum of understanding with Made Scientific to establish an exclusive U.S. GMP manufacturing and commercial exosome supply partnership.
- The companies plan to begin technology transfer immediately, with the first GMP exosome batches targeted for the first half of 2027.
NurExone Biologic Inc. and its wholly owned U.S. subsidiary, Exo-Top Inc., have signed a binding memorandum of understanding (MOU) with Made Scientific to establish an exclusive U.S. Good Manufacturing Practice (GMP) manufacturing and commercial exosome supply partnership. Under the proposed agreement, Made Scientific will provide manufacturing and aseptic fill-finish services for NurExone’s bone marrow-derived exosomes, supporting the company’s clinical and commercial activities. The companies intend to begin technology transfer immediately, with the first GMP exosome batches targeted for the first half of 2027.
Made Scientific is a U.S.-based contract development and manufacturing organization (CDMO) operating a 60,000-square-foot FDA- and EU GMP Annex 1-compliant facility in Princeton, New Jersey. According to the companies, the partnership is intended to establish scalable U.S. manufacturing infrastructure for exosome-based therapeutics and commercial exosome products while supporting NurExone’s therapeutic pipeline, including its lead candidate, ExoPTEN.
“Partnering with highly regarded organizations is essential to building world-class manufacturing around novel therapeutic approaches, including exosome-based therapies. Made Scientific is an ideal strategic partner because of its manufacturing capabilities, operational expertise, and shared long-term vision.”
Dr. Lior Shaltiel, Chief Executive Officer of NurExone
The proposed collaboration builds on NurExone’s manufacturing strategy, including its previously announced bioprocess optimization initiative with Novasign GmbH. The companies said these efforts are intended to strengthen manufacturing infrastructure for both therapeutic development and future commercial exosome activities.
Under the MOU, Made Scientific will serve as NurExone’s exclusive U.S. partner for contract manufacturing and aseptic fill-finish of bone marrow-derived exosomes. The proposed definitive agreement would have an initial five-year term with options for successive five-year renewals. If a definitive agreement is not executed within six months of signing the MOU, the agreement and related exclusivity provisions will automatically terminate, subject to specified surviving obligations.
