Forge Biologics to provide CDMO support for Solid Biosciences' preclinical gene therapy

By providing AAV process development, scale up and cGMP manufacturing services, Forge hopes to bolster Solid's gene therapy pipeline

Forge Biologics, a cell and gene therapy-focused CDMO, has agreed to advance the development and manufacturing of Solid Biosciences' next-generation gene therapy programme for Duchenne muscular dystrophy.

As part of the agreement, Forge will provide an adeno-associated viral (AAV) vector process, scale-up engineering and cGMP manufacturing services for SGT-003 — Solid Biosciences' preclinical candidate — from its 175,000-sq. ft gene therapy production facility in Columbus, Ohio.

The facility, which is known as The Hearth, is dedicated to AAV vector manufacturing and host end-to-end manufacturing services to accelerate gene therapy programmes from preclinical through clinical and commercial stage manufacturing.

To support Solid’s clinical development, Forge will use its Blaze Vector production platform, as well as its proprietary HEK293 suspension Ignition Cells and pEMBR adenovirus helper plasmid.

Joel Schneider, Chief Operating Officer of Solid Biosciences, said: "Uniting Forge’s integrated platforms and cGMP gene therapy manufacturing capabilities with our in-depth knowledge in high dose gene therapy development and manufacturing will introduce an additional method to produce AAV gene therapy at Solid, and help to accelerate human proof of concept for SGT-003."