Forge Biologics joins CIRM to manufacture AAV gene therapies

Forge Biologics and the California Institute for Regenerative Medicine (CIRM) have collaborated to advance gene therapy programs in California. 

The Ohio-based contract development and manufacturing organization (CDMO) has joined CIRM’s Industry Resource Partner Program, under which the firm will manufacture adeno-associated adenovirus (AAV) vectors to accelerate gene therapy programs.  

c/o Forge Biologics

“Our partnership aims to provide direct resources, experience, and expertise in AAV manufacturing to help accelerate CIRM-funded gene therapy programs. By working with CIRM programs at the earliest stages of their research, we aim to support developers in understanding critical manufacturing decisions at pivotal moments in development,” John Maslowski, CCO for Forge told BioProcess Insider. 

Under the alliance, the CDMO will aid CIRM’s partners to accelerate gene therapy development and manufacturing to efficiently and effectively accelerate progression through clinical phases of development and commercialization. Manufacturing will take place at Forge’s 200,000 square-foot facility in Columbus, Ohio. 

An AAV vector is the delivery mechanism used for transporting gene therapies to patients. It is used to deliver copies of a normal/unaffected gene to the right tissues or organs in the body and is a preferred viral vector choice for gene therapy developers.  

However, some of the biggest challenges associated with AAV programs include access to high quality materials, the ability to successfully scale-up a therapy while maintaining consistent yields and titers, robust downstream purification for ideal empty-full ratios, access to robust analytics, ability to maintain high quality standards, and comply with the regulatory frameworks needed to provide the therapies to the patients.  

“We are enthusiastic about the opportunity to potentially work with the full breadth of CIRM-funded AAV programs to advance their gene therapy programs for the more than 10,000 rare diseases out there, and hope the future includes many collaborations as we deliver on our shared commitment to advance transformative regenerative medicines for patients,” said Maslowski 

Forge Biologics specializes in manufacturing AAV gene therapies for clients and works alongside developers to help take their programs from the research-stage to the clinical stage, and onto commercial production.  The firm has been involved in raising funds to expand its AAV capacity in the past raising $120 million, led by RA Capital Management, Octagon Capital, Surveyor Capital (a Citadel company), and Marshall Wace.