As part of the expansion of the Milan site, AGC Biologics has added five suspension single-use bioreactors, including one with a capacity of 50l, and two with capacities of 200l and 1,000l each
AGC Biologics has expanded its cell and gene manufacturing site in Italy. (Credit: AGC Biologics)
AGC Biologics, a contract development and manufacturing organisation (CDMO), has wrapped up the expansion of the production space of its Milan Cell & Gene Center of Excellence site in Milan, Italy.
The site was acquired by the company in 2020 for launching its cell and gene business.
As part of the expansion of the Milan site, AGC Biologics has added five suspension single-use bioreactors, including one with a capacity of 50l, and two with capacities of 200l and 1,000l each.
The increased space will also have the potential to add up to four iCellis500 adherent single-use bioreactors to address the needs of cGMP viral vector manufacturing projects.
The expansion project, which was announced in March 2021, also involved the construction of a new automated filling line, a new 1,000m² warehouse, and more space for the process development lab.
AGC Biologics Milan general manager Luca Alberici said: “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.
“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.”
The location in Milan was the first cell and gene therapy manufacturing facility in Europe to receive GMP certification for both clinical and commercial supply.
The team at the location has built proprietary plug-and-play systems for vector manufacturing, including AGC Biologics’ BravoAAV and ProntoLVV platforms, and brought various products from the pre-clinical through commercial phases.
Within its global network, AGC Biologics runs two cell and gene facilities, one in Milan and the other in Longmont, Colorado, in the US.
AGC Biologics provides end-to-end viral vector and cell therapy development, production, and quality/regulatory services at each location.