GBI Biomanufacturing Partners with NanoRetinal on IRD Therapy NAR-001

  • GBI Biomanufacturing has announced a partnership with NanoRetinal to develop and manufacture NAR-001, a therapy for Inherited Retinal Diseases.
  • The collaboration will focus on process development, cGMP manufacturing, and accelerated timelines while meeting regulatory standards.

GBI Biomanufacturing (GBI) has entered into an agreement with NanoRetinal, Inc. to develop and manufacture NAR-001, a nanoparticle-based therapy aimed at restoring or preserving vision in patients with Inherited Retinal Diseases (IRD), including Retinitis Pigmentosa.

Under the partnership, GBI will apply its expertise in mammalian cell culture systems to support NanoRetinal’s first-in-class programme. Its services will cover end-to-end process development as well as cGMP manufacturing of both drug substance and drug product. NAR-001 combines protein engineering and advanced bioprocessing with the goal of improving the durability of treatment and patient outcomes.

Both companies have committed to accelerating the development timeline for NAR-001. The collaboration is intended to advance the programme from concept to clinical trials and, eventually, commercialisation, while maintaining safety, efficacy, and regulatory compliance.

Karl Pinto, CEO at GBI, said: “This collaboration represents the best of science and manufacturing working together to bring transformative therapies to patients. By applying our integrated biomanufacturing expertise, we are proud to support NanoRetinal in advancing a therapy that directly addresses the urgent unmet needs of IRD patients in clinical trials and eventually we trust commercial markets.”

NanoRetinal CEO John Cullity added that the company had been “entirely impressed by [GBI’s] total commitment” to supporting its mission of preserving sight for IRD patients.

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