Policy & Regulation
Forge Biologics Launches Plasmid DNA Manufacturing Services to Support AAV Clients
27 September 2022 - - US-based gene therapy-focused contract development and manufacturing organization Forge Biologics has added plasmid DNA manufacturing to its suite of scalable manufacturing services for gene therapy programs, complementing Forge's existing AAV process development, analytical development, cGMP manufacturing, and automated final fill capabilities, the company said.

Forge's plasmid manufacturing services encompass three grades to accommodate a phase-appropriate approach: Research-Grade, suitable for discovery, research and development; GMP-Pathway, suitable for early-stage clinical trial cGMP AAV manufacturing, and cGMP, suitable for late-stage clinical and commercial cGMP manufacturing.

Forge's plasmid production services utilize single-use systems that seamlessly integrate into the company's platform AAV manufacturing process, allowing continuity of manufacturing for clients and streamlined vendor management.

Research-Grade and GMP-Pathway plasmid grades are currently available, with cGMP plasmid production available in 2023.

All plasmid production will occur at Forge's manufacturing facility, the Hearth, in Columbus, OH, and is available exclusively to clients performing their AAV manufacturing at Forge.

The company will deliver data presentations highlighting plasmid production in up to 50L fermenters and AAV manufacturing up to 1,000L at the BioProcess International Conference and Exhibition, taking place in Boston, MA, September 27-30, 2022.

Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company.

Forge's mission is to enable access to life changing gene therapies and help bring them from idea to reality.

Forge's 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters.

The Hearth is a custom-designed cGMP facility focused on AAV manufacturing and can host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.

By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.
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