AGC Biologics, a global CDMO for biopharmaceuticals, is significantly expanding its plasmid DNA (pDNA) service offerings from its Heidelberg site in Germany. The expansion has been in response to increased demand for pDNA, growing at 20% CAGR for many different applications.
pDNA have been used for many years in the manufacturing of DNA adjuvants and vaccines and as a starting material for RNA drugs and cell-free protein expression platforms. However, in more recent years, pDNA has been key for gene therapy applications for the creation of Lentivirus and AAAVs as well as direct gene therapy.
“By expanding this plasmid DNA supply commercially, we’re meeting the growing demand,” says AGC Biologics CEO Patricio Massera. “Our globally aligned network is equipped and experienced to take on this expansion.”
AGC Biologics facility in Heidelberg, Germany has been manufacturing pDNA for 10 years. Now, the site has completed a pDNA manufacturing process improvement project that enables the extension of the service in hosts and plasmids (low and high copy pDNA expression systems) via a large toolbox in process development with scales of 1 L to 10 L for pDNA. These processes can easily be scaled up to fit into the established 50 L, 100 L, 500 L or 1000 L GMP manufacturing.
AGC has microbial facilities in Heidelberg (Germany), Copenhagen (Denmark) and Chiba (Japan), and soon an additional microbial facility in Seattle (US).