The company, which combines contract manufacturing with the development of an internal pipeline of gene therapies, already offered adeno-associated viruses (AAV) production services. However, a lack of in-house plasmid DNA manufacturing capacity left customers reliant on third parties for a key material in the gene therapy production process.
Forge is producing plasmids using single-use systems to integrate the new service into its existing AAV manufacturing process. The integration is intended to facilitate continuity of manufacturing for clients and streamlined vendor management, as John Maslowski, chief commercial officer at Forge, explained in a statement.
“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. 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,” said Maslowski.
Forge will offer three grades of plasmid DNA, from research-grade material suitable for early-stage work through to cGMP material designed for late-stage clinical and commercial manufacturing. The first two grades are already available, with Forge aiming to make cGMP materials available next year.
The company released news of the expansion into plasmid DNA production shortly before disclosing a deal with clinical-stage gene therapy company Myrtelle. Forge will provide Myrtelle with manufacturing services covering its first two grades of plasmids, plus GMP AAV process development and scale-up services, to support the monogenic hearing loss gene therapy candidate Myr-201.
All development and cGMP manufacturing activities will take place at Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio. Forge will apply its HEK 293 suspension Ignition Cells and pEMBR adenovirus helper plasmid to the project.