Forge Biologics Partners with Restore Vision, Showcases Manufacturing at ASGCT, and Discusses AAV Expertise

Forge Biologics, a gene therapy contract development and manufacturing organization (CDMO) and member of Ajinomoto Bio-Pharma Services, announced a development and manufacturing partnership with Restore Vision Inc. to support the clinical supply of RV-001, an investigational gene therapy for retinitis pigmentosa. The company also detailed seven presentations at the American Society of Gene and Cell Therapy (ASGCT) 29th Annual Meeting, and its Chief Technology Officer participated in a podcast discussing the industrial-scale evolution of AAV gene therapy.

Through the collaboration, Forge is providing Restore Vision with AAV process development, current Good Manufacturing Practices (cGMP) manufacturing, analytical development, stability testing, and regulatory consultation services. The work takes place at the Hearth, Forge’s 200,000-square-foot facility in Columbus, Ohio, and the drug product is transported to Japan for a Phase 1/2 clinical trial. RV-001 is an optogenetic AAV gene therapy that uses a proprietary gene encoding Chimeric Rhodopsin, delivered via intravitreal injection, designed to restore vision in patients with retinitis pigmentosa. The trial is being conducted in Japan and is the world’s first clinical trial of an optogenetic gene therapy using Chimeric Rhodopsin. "Providing a new visual restoration treatment option for patients living with retinitis pigmentosa is central to our mission," said the CEO of Restore Vision. "We are pleased to collaborate with Forge Biologics and value their expertise in AAV development, manufacturing, and regulatory support."

At the ASGCT 29th Annual Meeting, taking place May 11–15, 2026, in Boston, Forge will present seven sessions, including a sponsored symposium on process innovation and late-phase manufacturing frameworks, featuring participants from Forge and Ascidian Therapeutics. A Tools & Technology Forum presentation will cover validation of an AUC assay for characterizing AAV empty-to-full capsid ratios. Additionally, Forge co-chairs an oral abstract session on AAV cell line development and engineering, and presents four scientific posters. The posters address topics such as the role of a Drug Master File in data sharing, advancing purification technologies for high rAAV productivity, late-stage process characterization, and high-yield suspension HEK293 manufacturing in single-use bioreactors. The CEO of Forge stated, "As the gene therapy field enters a critical phase of maturation, manufacturing must evolve to support both larger patient populations and the growing number of programs advancing into late-stage development. At ASGCT, we’re proud to showcase how our FUEL™ platform is enabling more doses per batch, improving scalability for broader indications."

Separately, a LinkedIn post from Forge Biologics highlighted the participation of its Chief Technology Officer on The Genetics Podcast, where he discussed the evolution of AAV gene therapy from academic settings to industrial-scale manufacturing. Topics included vector design, capsid engineering, improved central nervous system delivery, manufacturing innovation, and next-generation delivery technologies.

Forge Biologics, a member of Ajinomoto Bio-Pharma Services, operates a 200,000-square-foot facility, the Hearth, housing 20 cGMP suites and 20,000L of bioreactor capacity. The company provides end-to-end plasmid and AAV manufacturing services, from research-grade to cGMP, fill and finish, and regulatory support.