Forge Biologics
Forge Biologics provides comprehensive manufacturing services for gene therapy programs, operating a 200,000+ square foot cGMP facility known as the Hearth. The company specializes in AAV and plasmid DNA manufacturing and focuses on developing gene therapies for rare diseases.
Services
Forge Biologics provides end-to-end manufacturing services to accelerate gene therapy programs from preclinical stages through to clinical and commercial manufacturing. They specialize in the production of AAV and plasmid DNA and offer proprietary solutions like HEK293 suspension Ignition Cells™ and pEMBR™ Ad helper plasmid. The company supplies Research-Grade, GMP-Pathway, and cGMP plasmid DNA manufacturing, ensuring a comprehensive suite of offerings for gene therapy developers.
The Hearth Facility
Forge Biologics operates the Hearth, a custom-designed, 200,000+ square foot facility dedicated to cGMP manufacturing. The facility includes 20 cGMP suites with bioreactors ranging from 50L to 5,000L, allowing for scalable manufacturing solutions. The Hearth complies with European Union Good Manufacturing Practices (EU GMP) standards, which is crucial for clients looking to distribute products in Europe. This extensive infrastructure supports both current and future manufacturing needs.
Gene Therapy Development for Rare Diseases
Forge Biologics is focused on developing innovative gene therapies aimed at treating patients with rare genetic diseases. One such therapy is FBX-101, an adeno-associated viral gene therapy developed to treat children with Krabbe disease. FBX-101 has received several designations from regulatory agencies, including Fast Track, Orphan Drug, and Rare Pediatric Disease Designations from the FDA, as well as Orphan Drug Designation and PRIME Designation from the EMA. The REKLAIM trial is a Phase 1b clinical trial currently enrolling children with various forms of Krabbe disease.
Company History
Forge Biologics was founded in 2020 with a mission to accelerate the development and manufacturing of gene therapies. In 2023, the company joined the Ajinomoto Group, a global business committed to investing in Forge Biologics' long-term growth. The company’s proprietary platform technology and focus on rare genetic diseases underscore its dedication to innovative treatments and solutions in the gene therapy arena.
Proprietary Technologies
Forge Biologics employs proprietary technologies to enhance gene therapy development. These include the HEK293 suspension Ignition Cells™ and the pEMBR™ Ad helper plasmid, which help gene therapy developers accelerate their programs safely and efficiently. This suite of technologies allows the company to offer customized and scalable solutions to meet the diverse needs of its clients in the gene therapy sector.