Restore Vision and Forge Biologics, a manufacturer of gene therapies and member of Ajinomoto Bio-Pharma Services, announced a development and manufacturing partnership to support RV-001, Restore Vision’s investigational GPCR-based optogenetic AAV gene therapy for patients with retinitis pigmentosa.
Through this 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 AAV development and manufacturing activities performed by Forge under this collaboration take place at the Hearth, Forge’s 200,000-square-foot facility in Columbus, Ohio, and the drug product is transported to Japan for clinical trial supply.
“Forge is proud to support gene therapy developers around the world with integrated development, manufacturing, and regulatory expertise,” said John Maslowski, Chief Executive Officer of Forge Biologics. “Our partnership with Restore Vision reflects our commitment to helping developers navigate the complexities of gene therapy manufacturing, with the shared goal of enabling treatment options for patients.”
Material manufactured at Forge for Restore Vision is being used to evaluate RV-001 in a Phase 1/2 clinical trial in Japan, further expanding Forge's experience supporting clinical-stage gene therapy programs in the Asia-Pacific (APAC) region.
“Providing a new visual restoration treatment option for patients living with retinitis pigmentosa is central to our mission,” said Yusaku Katada, M.D., Ph.D., Chief Executive Officer of Restore Vision. “We are pleased to collaborate with Forge Biologics and value their expertise in AAV development, manufacturing, and regulatory support as we advance RV-001 through Phase 1/2 clinical evaluation in Japan.”