GBI Biomanufacturing (GBI), a US-based contract development and manufacturing organization (CDMO), has announced a partnership with NanoRetinal, Inc. to develop and manufacture NAR-001, NanoRetinal's proprietary nanoparticle technology designed to restore and/or preserve vision in patients with Inherited Retinal Diseases (IRD).

IRD, including Retinitis Pigmentosa (RP) is caused by gene mutations which impair the structure and function of visual pigment, an essential element for vision. NAR-001 is engineered to increase the supply, photostability and durability of visual pigment, so offering hope for patients living with RP.

Under this agreement, GBI will leverage its expertise in mammalian cell culture systems to support the development of NanoRetinal's first-in-class molecule. GBI's services encompass end-to-end process development and cGMP manufacturing of drug substance and drug product (fill and finish) of complex biologics.

NanoRetinal's NAR-001 program represents a next-generation therapeutic approach. Through this partnership, both organizations have committed to an accelerated developmental timeline, all while maintaining the highest standards of safety, efficacy, and regulatory compliance.

“This collaboration represents the best of science and manufacturing working together to bring transformative therapies to patients,” said Karl Pinto, CEO at GBI. “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.”

“Throughout our discussions with GBI we've been entirely impressed by their total commitment to our company and its mission of bringing our next generation solution to the clinic with a view to preserving sight for IRD patients,” said John Cullity, CEO at NanoRetinal. “We are confident in GBI's capacity will meet the exacting regulatory standards necessary for product manufacture.”

This collaboration marks an important milestone in the journey to bring NAR-001 from concept to commercialisation, reinforcing NanoRetinal's commitment to extend vision for IRD patients, and GBI's mission of empowering innovators with the expertise, infrastructure, and partnership needed to turn scientific breakthroughs into life-changing medicines.