Forge Biologics Fuels Gene Therapy Manufacturing Engine with Launch of Plasmid DNA Manufacturing Services to Support AAV Clients

• Enables gene therapy clients to accelerate AAV manufacturing with seamless incorporation into the Company’s HEK 293 platform suspension process with access to end-to-end capabilities
• New offerings of Research-Grade and GMP-Pathway expedite Phase 1/2 clinical trial timelines, with GMP-Grade available in 2023
• Data to support Company’s plasmid production is being presented at BioProcess International East this week

COLUMBUS, Ohio--(BUSINESS WIRE)--Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced the new availability of 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.

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 launch of plasmid DNA manufacturing enables clients to better streamline the production of their AAV programs by vertically integrating plasmids into our manufacturing process,” said John Maslowski, Chief Commercial Officer of Forge. “The ability to streamline vendor management, better control timeline risks, and accelerate end-to-end AAV manufacturing are important differentiators when upscaling to our 5,000L cGMP bioreactors for clients and patients. We are excited to present the data supporting our now-available services at BioProcess International East this week.”

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 & Exhibition, taking place in Boston, MA, September 27-30, 2022.

Poster Presentations

Title: Process Development and Scale-Up of Plasmid DNA Production in 1-50L Single Use Fermenters for Accelerating AAV Manufacturing
Presenter: Frank Agbogbo, Ph.D., Vice President, Process Development

Title: Development of a Platform Process for AAV Production
Presenter: Frank Agbogbo, Ph.D., Vice President, Process Development

Title: Development of a Scalable Purification Process for High Grade Plasmid DNA
Presenter: Donald Belcher, Ph.D., Senior Scientist, Process Development

Title: Purification of AAV from 1L to 1,000L Batch Sizes
Presenter: Ganesh Krishnamoorthy, Ph.D., Associate Director, Process Development

Title: Production and the Scale-Up of rAAV from 1L to 1,000L in Bioreactors
Presenter: Steven Wesel, Associate Director, Process Development

Posters will be displayed—and participants can also access them—on the BPI conference website.

About Forge Biologics

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. To learn more, visit www.forgebiologics.com.