NurExone Biologic Inc., and its US subsidiary, Exo-Top Inc., have signed a binding memorandum of understanding (MOU) with Made Scientific to establish an exclusive US 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 US-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.
