AGC Biologics has concluded expansion of its manufacturing area at its Cell & Gene Center of Excellence production site in Milan, Italy.
The expansion involved addition of one 50L, two 200L, and two 1,000L suspension single-use bioreactors.
It also offers the flexibility to accommodate up to four iCellis500 adherent single-use bioreactors for meeting the demands of cGMP viral vector manufacturing projects.
The project also included the build-out of extra process development lab area, installation of a new automated filling line, and construction of a dedicated warehouse space spanning 1,000m².
AGC Biologics Milan general manager Luca Alberici said: “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.”
In July 2020, AGC Biologics purchased the site to establish its cell and gene business.
The site’s team has brought several products from pre-clinical to commercial stages and designed custom plug-and-play systems for vector manufacturing, including the BravoAAV and ProntoLVV platforms of AGC.
The company operates one more cell and gene facility in Longmont, Colorado, US.
Leveraging advanced technology platforms and scientific methods, the company provides end-to-end global viral vector and cell therapy development, manufacturing, and quality/regulatory services at each site.