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Forge Biologics will offer three grades of plasmid manufacturing services at its Columbus, Ohio, location.
Forge Biologics, a contract development and manufacturing organization focused on gene therapies, announced the addition of plasmid DNA manufacturing to its Columbus, Ohio, facility on Sept. 27, 2022. The addition is designed to complement the company’s existing manufacturing services for gene therapy programs, including anti-adeno-virus process development, analytic development, current good manufacturing practice (CGMP) manufacturing, and automated final fill capabilities.
According to a company press release, the plasmid manufacturing services encompass three grades: research-grade, for discovery, research, and development; GMP-pathway, for early stage clinical trial CGMP adeno-associated virus (AAV) manufacturing; and CGMP, for late-stage clinical and commercial CGMP manufacturing. Research-grade and GMP-pathway plasmid grade manufacting is currently available, and CGMP plasmid production is expected to come online in 2023.
“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, Forge Therapeutics, in the release. “The ability to streamline vendor management, better control timeline risks, and accelerate end-to-end AAV manufacturing are important differentiators when upscaling to our 5000-L [C]GMP bioreactors for clients and patients.”
Source: Forge Biologics