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The plant— dedicated to cell and gene therapy development—welcomes additional warehouse space, and aims to meet commercial needs.
AGC Biologics, a contract development and manufacturing organization (CDMO), has completed the expansion of its manufacturing space at its Milan Cell & Gene Center of Excellence production site, which it originally acquired in July 2020.
The expansion adds 1 x 50L 2 x 200L and 2 x 1,000L suspension single-use bioreactors, and allows for the addition of up to four iCellis500 adherent single-use bioreactors to meet demands for current good manufacturing practice (cGMP) viral vector manufacturing projects. Further, the project includs the build-out of more process development lab space and a new automated filling line, along with the addition of a new fully dedicated 10,764 square-foot warehouse space.
“This is another important milestone for our site and for the AGC Biologics global cell and gene network as we prepare to serve more developers,” says Luca Alberici, general manager, AGC Biologics Milan. “Thanks to this expansion, we have the flexibility to support companies from clinical to commercial stages for in–vivo end ex-vivo gene therapy applications, and can manufacture adeno-associated and lentiviral vectors from medium 50L scales to as large as 2,000L. When you combine this with our development, analytical and fill/finish services, this site can offer cell and gene developers any type of support they need throughout their product’s lifecycle.”