GentiBio, an emerging biotherapeutics company developing best-in-class engineered regulatory T cells programmed to treat autoimmune, alloimmune, autoinflammatory, and allergic diseases, and Forge Biologics, a cell and gene therapy-focused contract development and manufacturing organization (CDMO), have entered a development and manufacturing partnership to advance GentiBio’s immune tolerance platform.

Forge will provide adeno-associated viral (AAV) vector process and analytical development, scale-up engineering and GMP manufacturing services for GentiBio’s engineered Tregs therapeutic candidates. The program will employ both Forge’s Blaze Vector? production platform and HEK 293 Suspension Ignition Cells to facilitate GentiBio’s development process. All development and GMP activities will occur at The Hearth, Forge’s 175,000 square foot gene therapy GMP production facility in Columbus, OH.

“We are thrilled to partner with Forge Biologics and their experienced team to further develop our lead engineered Treg program and take a critical step in advancing our therapies to patients in need,” said Andy Walker, co-founder and chief technology officer, GentiBio. “Forge offers a broad array of services ranging from process development to GMP manufacturing, making them a strong partner for GentiBio’s cell therapies with capacity to support GentiBio as we advance programs through clinical development.”

Forge’s Hearth is the home of a state-of-the-art cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate cell and gene therapy programs from preclinical through clinical and commercial stage manufacturing. Forge offers product and analytical development services, cGMP manufacturing and regulatory support services.

Timothy J. Miller, CEO, president, and co-founder of Forge, said, “Our team is excited to embark on this partnership with GentiBio to meet their viral vector manufacturing needs and help them advance to clinical trials. Forge is committed to providing quality AAV manufacturing to all stages of program development, and this partnership highlights the Forge team’s capabilities to help innovators such as the GentiBio team on their path to success.”