Forge Biologics is focused on the development and manufacturing of gene therapies, particularly utilizing adeno-associated virus (AAV) technology. Their custom-designed, 200,000+ square foot cGMP facility, known as the Hearth, is dedicated to the end-to-end manufacturing of AAV gene therapies, supporting programs from preclinical stages through to clinical and commercial production. The company offers a comprehensive suite of services, including continuous AAV manufacturing, plasmid DNA production, and advanced process development, all aimed at accelerating the delivery of innovative therapies to patients. Their proprietary FUEL™ platform enhances AAV development by integrating advanced technologies and optimization packages, which aim to improve efficiency and safety in the manufacturing process.

One of Forge's key therapeutic developments is FBX-101, a gene therapy designed to treat Krabbe disease, a rare neurodegenerative condition. FBX-101 employs an AAVrh10 vector to deliver a functional copy of the GALC gene, which is crucial for myelination in the nervous system. This therapy has shown promise in preclinical models by correcting neuropathy and improving motor function, with the potential to significantly extend lifespan. The ongoing REKLAIM clinical trial is investigating the safety and efficacy of FBX-101 in children with Krabbe disease, highlighting Forge's commitment to addressing the needs of patients with devastating genetic disorders through innovative gene therapy solutions.

United States

Forge is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping champion teams that are navigating the long road from the lab bench to the bedside. With a patients-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them most.

Forge Biologics

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