AGC Biologics expands plasmid DNA capacity as gene therapies move front and center

AGC Biologics has completed manufacturing improvements at its site in Heidelberg, Germany. With it comes the expansion of its plasmid DNA (pDNA) capacity. The Seattle-based CDMO says that it can now produce hosts and plasmids with scales of 1L to 10L for high-quality pDNA. The processes, it says, can be scaled to fit into 50L, 100L, 500L or 1000L GMP manufacturing. “By expanding this plasmid DNA supply commercially, we’re meeting the growing demand,” AGC Biologics CEO Patricio Massera said in a statement. Quality pDNA are used to manufacture DNA adjuvants and vaccines and as a starting material for RNA drugs and cell-free protein expression platforms. More recently, they have become central to gene therapies for the creation of lentivirus and adeno-associated viruses, even in direct gene therapies. The announcement comes shortly after the contractor said next year it will invest about $18 million to expand its facilities in Seattle and in Copenhagen. AGC Biologics was formed after Japan’s AGC Asahi Glass first acquired Heidelberg-based clinical supply producer Biomeva in 2016 and then followed that up with the $511 buyout of Denmark-based CMC Biologics in 2017. It designated CMC’s Bothell, Washington, operation the drug business headquarters because of its intent to focus on the U.S.

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