Oct 11, 2023   SOURCE: BusinessWire

Forge Biologics Selected as an AAV Manufacturing Partner for California Institute for Regenerative Medicine to Help Accelerate Gene Therapy Programs

Forge Biologics (Forge), a leading manufacturer of genetic medicines, announced today that it has joined the California Institute for Regenerative Medicine’s (CIRM) Industry Resource Partner Program to help advance the manufacturing of adeno-associated adenovirus (AAV) gene therapy programs from the state of California.

With $5.5 billion in funding from the state of California, CIRM is a recognized leader in the development and funding of regenerative medicine clinical trials focused on cell-based and gene therapies.

Forge joins the CIRM Industry Resource Partner Program and will enable accelerated research and cGMP AAV manufacturing to CIRM-funded programs. As a leader in AAV and plasmid manufacturing, Forge will assist CIRM’s partners—which range from industry to academic investigators—in accelerating gene therapy development and manufacturing. Forge’s bespoke platform process and end-to-end CDMO services, including fill-finish, will enable CIRM programs to receive more efficient services and save time getting through the clinical phases of development to reach commercial potential.

“We are enthusiastic about collaborating with the California Institute for Regenerative Medicine to help advance gene therapy programs through our clinically-proven manufacturing processes, which may help CIRM programs more quickly reach clinical trials in a state fulfilling the promise of gene therapy to help patients in need,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge.

Forge specializes in accelerating AAV gene therapy programs at any stage, from preclinical to clinical and commercial manufacturing. All manufacturing is done at the Hearth, Forge’s 200,000 square foot custom-designed cGMP facility in Columbus, Ohio.

“CIRM’s Industry Resource Partner Program aims to create a force-multiplier effect by bringing in industry partners who possess resources, experience and expertise to accelerate CIRM-funded regenerative medicine research projects,” said Shyam Patel, Ph.D., Senior Director of Business Development and Alliance Management at CIRM. “By agreeing to provide access to its AAV manufacturing services, Forge Biologics joins our collaborative network of partners who share our unwavering commitment to advancing transformative regenerative medicine therapies for patients.”

About the California Institute for Regenerative Medicine (CIRM)

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $5.5 billion in funding and more than 161 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to www.cirm.ca.gov.

About Forge Biologics

Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company focused on enabling access to life-changing gene therapies. Forge was founded in 2020 and is headquartered in the cell and gene therapy hub of Columbus, Ohio. Its 200,000 square foot facility, the Hearth, is dedicated to AAV manufacturing with 20 custom-designed cGMP suites. Offerings include scalable, end-to-end manufacturing services including, process and analytical development, cGMP viral vector manufacturing, final fill, plasmid DNA manufacturing, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. Forge aims to accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.