RARE Daily

GentiBio and Forge Biologics Form GMP Manufacturing Partnership

July 19, 2021

Cell therapy developer GentiBio has entered into a partnership with the contract manufacturing and development organization Forge Biologics to advance GentiBio’s immune tolerance platform.

Photo: Timothy Miller, CEO of Forge

Under the agreement, Forge will provide adeno-associated viral 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 gene therapy GMP production facility in Columbus, Ohio.

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.

“This partnership highlights the Forge team’s capabilities to help innovators such as the GentiBio team on their path to success,” said Timothy Miller, CEO of Forge.

Author: Rare Daily Staff

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