Forge Biologics is a hybrid gene therapy CDMO and clinical-stage therapeutics developer focused on AAV viral vector manufacturing. It operates a 200,000 square foot cGMP facility in Columbus, Ohio called the Hearth with 20 cGMP suites and operational 50L, 500L, 1,000L and 5,000L bioreactors. The company provides end-to-end manufacturing services to scale gene therapy programs from research through clinical and commercial manufacturing. Recent technology milestones include scaling a proprietary HEK 293 suspension platform from 50L to 1,000L and integrating single-use chromatography and automated fill-finish. Forge has expanded hiring for key technical roles and formed a Scientific and Manufacturing Advisory Board to advise on manufacturing offerings and pipeline development. The company plans to use new funds to expand client offerings, proprietary technologies, manufacturing systems, cell lines, and additional services to bolster its end-to-end manufacturing platform. Forge Biologics is a hybrid gene therapy CDMO and clinical-stage therapeutics development company focused on AAV vector manufacturing. The company operates The Hearth, a custom-designed cGMP facility in Columbus, Ohio, and is expanding its footprint to over 200,000 square feet with 20 cGMP manufacturing suites. Planned upgrades include installation of 5,000L cGMP bioreactors and automated cGMP fill-finish capabilities, designed to meet EMA cleanroom requirements and support late-stage clinical and commercial needs. Forge will deploy its proprietary suspension HEK 293 Ignition cell line at larger bioreactor scale and expects the 5,000L bioreactors and automated filling systems to be available in the second half of 2022. The company is accelerating hiring toward roughly 400 employees, aided by a grant from the State of Ohio. Financially, Forge has continued investment support to enable the expansion and new client offerings. Forge Biologics is a hybrid gene therapy contract development and therapeutic development company focused on AAV viral vector manufacturing. It operates a 175,000 square foot cGMP facility in Columbus, Ohio called "The Hearth," dedicated to end-to-end AAV production from research and toxicology grade through clinical and commercial stages. Forge offers end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial manufacturing. The company also operates subsidiaries advancing a proprietary pipeline, including its lead program FBX-101, a first-in-human AAV therapy for Krabbe disease delivering a functioning GALC gene. Forge will use the Series B proceeds to accelerate expansion of its AAV manufacturing CDMO capabilities with additional cGMP production capacity and to support its subsidiaries advancing novel AAV programs. The company frames its work as a patients-first approach aimed at addressing industry-wide AAV manufacturing capacity shortages. Forge Biologics operates a state-of-the-art, 175,000 ft2 facility (The Hearth) dedicated to AAV viral vector production and offers end-to-end CDMO capabilities from preclinical through clinical and commercial manufacturing. The facility currently supports up to 50L research and toxicology grade AAV manufacturing and is being expanded to provide cGMP AAV production at 500L scale by mid-2021. Forge combines AAV manufacturing capacity with an internal pipeline of proprietary AAV-based therapeutics, including a lead program using a combined AAV and umbilical cord blood transplant approach for infantile Krabbe disease. The company appointed Maria Escolar, M.D., a University of Pittsburgh rare disease and clinical gene therapy expert, as Chief Medical Officer and she holds equity in Forge. Forge closed a $40 million Series A financing to fund manufacturing expansion and pipeline development. The management team includes gene therapy veterans with prior roles at Abeona Therapeutics, Nationwide Children’s Hospital gene therapy manufacturing, and Myonexus Therapeutics.

Total raised

$330M

Funding rounds

4

Latest round

Series C

Latest activity

Sep 2022