Forge Bio launches pDNA production to support gene therapy clients

Forge Biologics has launched plasmid DNA (pDNA) manufacturing services to support its AAV clients after closing a $90 million Series C funding round.

Gene therapy contract development manufacturing organization (CDMO) Forge Bio completed a $90 million Series C financing round last month, which it said would be used to expand its technologies, manufacturing systems, and cell lines.

Now, the firm has said that on the back of the Series C funding round and the US government’s investment of over $2 billion in September to launch its biomanufacturing initiative, it is accelerating its presence in the gene  therapy space by adding pDNA production to its scalable manufacturing services.

Forge Biologics’ booth at BWB 2022. Image c/o Forge Bio

The addition of this service “provides end-to-end vertically integrated plasmid production, which then helps adeno associated virus (AAV) production because it is made inhouse and the process is fully integrated, so we are able to check everything from the very beginning. It also gives our clients a one stop shop, they come to one place where they can get their plasmids made and their AAV’s made as well,” Frank Agbogbo told BioProcess Insider at Boston Biotech Week.

Production of the plasmids will take place at Forge’s manufacturing plant located in Columbus, Ohio and the CDMO claims that its plasmid production services will take a three-grade phased approach.

The firm dubs the first phase as “Research-Grade”, which it says is most suitable for research and development, and discovery. Another phase is entitled the “GMP-Pathway”, used for early-stage clinical trial drug production, and the third phase is “cGMP” appropriate for late-stage clinical and commercial manufacturing.

“We’re offering this only to our [current and incoming] AAV clients, we are not just selling plasmids on their own. We are producing the plasmids that our clients are going to need, we are not planning to just produce plasmids for [anybody],” said Agbogbo.

Forge says that its plasmid production services use single-use systems that can integrate into its AAV manufacturing process platform. In turn, the firm claims that this provides a streamlined vendor management system for its clients.

Research and GMP-Pathway grades are available, and the CDMO anticipates cGMP plasmid to be available at some point next year.