Epicrispr taps Forge for AAV manufacturing of gene therapy candidate

Epicrispr Biotechnologies, a biotechnology company headquartered in San Francisco, has entered a manufacturing partnership with Forge Biologics, based in Columbus, Ohio, to support development and production of an investigational gene therapy.

Under the agreement, Forge will provide adeno-associated virus (AAV) process development, analytical development, and current Good Manufacturing Practice (cGMP) manufacturing services for EPI-321, a gene therapy candidate for facioscapulohumeral muscular dystrophy. Manufacturing activities are being conducted at Forge’s Columbus facility, according to the company.

Epicrispr said material produced through the partnership is being used in an ongoing first-in-human clinical trial across the United States, New Zealand, and Australia. The collaboration is intended to support scalable manufacturing and consistent product quality as the program advances through clinical development.

Forge said the work leverages its AAV production platform to improve manufacturing efficiency and increase output per production run, supporting broader patient access if the therapy advances toward commercialization.

The agreement reflects continued demand for integrated development and manufacturing services to support gene therapy programs from early-stage development through clinical supply, according to the announcement.