NurExone Partners with Made Scientific to Scale US GMP Exosome Manufacturing

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

"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

NurExone's lead candidate, ExoPTEN, has shown strong preclinical data supporting its potential in treating acute spinal cord and optic nerve damage and holds FDA orphan drug designation, supporting the company's roadmap toward clinical trials in the United States and Europe.¹^,³

What are the limitations?

The partnership remains a non-definitive MOU. The parties have not yet executed a binding, definitive manufacturing agreement, and the arrangement will automatically terminate if one is not signed within 6 months. Financial terms of the collaboration were not disclosed.

References

1. NurExone Biologic. NurExone announces binding MOU with Made Scientific for US GMP manufacturing and commercial supply partnership. News release. Published August 12, 2026. Accessed August 13, 2026. https://www.globenewswire.com/news-release/2026/08/12/3344133/0/en/nurexone-announces-binding-mou-with-made-scientific-for-u-s-gmp-manufacturing-and-commercial-supply-partnership.html
2. NurExone Biologic. NurExone launches bioprocess optimization initiative to support commercial and clinical readiness. News release. Published July 30, 2026. Accessed August 13, 2026. https://www.globenewswire.com/news-release/2026/07/30/3336036/0/en/NurExone-Launches-Bioprocess-Optimization-Initiative-to-Support-Commercial-and-Clinical-Readiness.html
3. NurExone Biologic. NurExone Biologic receives FDA Orphan-Drug Designation, accelerating development of ExoPTEN therapy for acute spinal cord injury treatment. News release. Published October 30, 2023. Accessed August 13, 2026. https://www.globenewswire.com/news-release/2023/10/30/2769335/0/en/NurExone-Biologic-Receives-FDA-Orphan-Drug-Designation-Accelerating-Development-of-ExoPTEN-therapy-for-Acute-Spinal-Cord-Injury-Treatment.html