- Epicrispr Biotechnologies and Forge Biologics have entered a strategic partnership to support development and manufacturing of the investigational gene therapy EPI-321 for facioscapulohumeral muscular dystrophy (FSHD).
- Forge is providing AAV process development, cGMP manufacturing, and analytical services at its Ohio facility using its proprietary FUEL™ platform.
Epicrispr Biotechnologies and Forge Biologics have announced a strategic partnership to support the development and manufacturing of EPI-321, an investigational adeno-associated virus (AAV) gene therapy for facioscapulohumeral muscular dystrophy (FSHD).
Under the agreement, Forge will provide AAV process development, current Good Manufacturing Practices (cGMP) manufacturing, and analytical development services. The work is being carried out at Forge’s 200,000-square-foot Hearth facility in Columbus, Ohio. Epicrispr is also using Forge’s proprietary FUEL™ platform, including HEK293 suspension Ignition Cells™, pEMBR™ 2.0 adenovirus helper plasmid, and AAVrh74 rep/cap plasmid technology.
Material manufactured through the partnership is being used in Epicrispr’s first-in-human clinical trial evaluating EPI-321 across the United States, New Zealand, and Australia. The therapy is designed as a single-dose gene-modulating treatment intended to suppress DUX4 expression in skeletal muscle associated with FSHD.
“FUEL™ was designed to enable more efficient manufacturing, delivering more doses per run so partners like Epicrispr can reach more patients.”
David Dismuke, Ph.D., Chief Technical Officer at Forge Biologics
The partnership expands Forge’s role in supporting gene therapy clinical programs and highlights continued demand for CDMO and contract manufacturing capabilities in AAV-based therapies. Epicrispr stated that early clinical data from the ongoing study indicate EPI-321 has been well tolerated, with no serious adverse events reported to date.
