Israel and Canada-based NurExone Biologic and its US subsidiary, Exo-Top, have signed a binding memorandum of understanding (MOU) with US-based contract development and manufacturing organization (CDMO) Made Scientific to establish an exclusive US good manufacturing practice (GMP) manufacturing and commercial supply partnership for NurExone's exosome-based therapies. The partnership targets initiating first GMP exosome batches in the first half of 2027 to support NurExone's clinical pipeline and planned commercial production.¹
Key facts
- Companies: NurExone Biologic (via Exo-Top); Made Scientific
- Agreement type: Binding MOU for exclusive US GMP manufacturing and supply
- Key milestone: First GMP exosome batches targeted for 1H 2027
- Agreement terms: 5-year initial term (if executed); 6-month deadline to finalize
- Related development: BioXtek non-binding letter of intent discontinued (originally announced April 7, 2026)
- Related development: Novasign bioprocess optimization initiative (announced July 30, 2026)
- Lead program: ExoPTEN (FDA orphan drug designation; spinal cord/optic nerve injury)
- Backing: Made Scientific backed by GC Corporation
- Geography: US manufacturing infrastructure (Princeton, NJ)
"Partnering with highly regarded organizations is essential to building world-class manufacturing around novel therapeutic approaches, including exosome-based therapies," said Lior Shaltiel, PhD, CEO of NurExone, in a company press release.1 "Made Scientific is an ideal strategic partner because of its manufacturing capabilities, operational expertise, and shared long-term vision."
What does the MOU cover?
Under the binding MOU, Made Scientific will serve as NurExone's exclusive US partner for the manufacturing and aseptic fill/finish of NurExone's bone marrow-derived exosomes. The parties intend to begin technology transfer immediately while negotiating a definitive partnership agreement. If executed, that agreement would carry an initial 5-year term with options for successive 5-year renewals.¹ If the parties do not execute a definitive agreement within 6 months of signing, the MOU and its obligations, including exclusivity, will automatically terminate, subject to specified surviving obligations.¹
What is Made Scientific's role as manufacturing partner?
Made Scientific, a cell therapy CDMO, operates a 60,000-square-foot facility in Princeton, NJ. The facility is compliant with both FDA and European Union GMP Annex 1 standards.¹ The company is backed by GC Corporation, a global pharmaceutical and biotechnology company.¹
"NurExone has developed a differentiated exosome platform with significant clinical and commercial potential," said Syed T. Husain, chairman and CEO of Made Scientific, in the release.1 "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."
How does this fit into NurExone's broader manufacturing strategy?
The Made Scientific collaboration builds on NurExone's bioprocess optimization initiative with Austria-based Novasign, announced July 30, 2026, which applies Novasign's bioprocess modeling platform to NurExone's exosome production process to support technology transfer and manufacturing efficiency.² NurExone also said Exo-Top has mutually agreed with Florida-based BioXtek not to proceed with a non-binding letter of intent announced April 7, 2026, as the company consolidates its US GMP manufacturing infrastructure around the Made Scientific partnership.¹
