NurExone Signs Exclusive U.S. GMP Manufacturing MOU with Made Scientific for Exosome Supply

With first GMP exosome batches targeted for H1 2027, NurExone Biologic's binding MOU with Made Scientific signals a concrete infrastructure commitment for a modality that has, until now, operated largely outside established CDMO frameworks. For QA directors and regulatory leads tracking emerging biologics, the arrangement introduces a dual FDA and EU GMP Annex 1 compliant manufacturing pathway for bone marrow-derived exosomes, a combination that remains rare at commercial scale.

Made Scientific operates a 60,000-square-foot facility in Princeton, New Jersey, certified under both U.S. FDA and EU GMP Annex 1 standards, positioning it to support aseptic fill-finish requirements that exosome therapeutics demand. Under the binding MOU, Made Scientific will serve as NurExone's exclusive U.S. partner for manufacturing and aseptic fill-finish of its exosome platform. Technology transfer is set to begin immediately, running in parallel with negotiation of a definitive agreement. The contemplated contract carries an initial five-year term with successive five-year renewal options.

The MOU includes a six-month window to execute a definitive agreement; if that deadline lapses without execution, exclusivity grants and ongoing MOU obligations terminate automatically, subject to specified surviving provisions. That clause introduces a measurable checkpoint for both parties and for any supply-chain teams monitoring NurExone's manufacturing readiness ahead of clinical progression of lead candidate ExoPTEN.

The arrangement also closes out a prior strategic path. NurExone confirmed that its U.S. subsidiary, Exo-Top Inc., has mutually agreed with Florida-based BioXtek Inc. not to proceed with the non-binding letter of intent announced on April 7, 2026. The company attributed the decision to a strategic consolidation of its U.S. GMP exosome manufacturing infrastructure under the Made Scientific collaboration. NurExone indicated it may explore separate, non-production collaborative opportunities with BioXtek.

Read alongside NurExone's bioprocess optimization agreement with Novasign GmbH, announced July 30, 2026, the Made Scientific MOU represents the second manufacturing-infrastructure move within roughly two weeks, suggesting an accelerating effort to build a validated, scalable supply chain before clinical-stage demand intensifies.

Execution of the definitive agreement within the six-month MOU window will serve as the next concrete indicator of whether this manufacturing platform advances from binding intent to operational GMP readiness.

Source: GlobeNewswire via NurExone Biologic Inc., August 12, 2026.