The expansion, first announced in 2021, adds 1x50L, 2x200L, 2x1,000L suspension single-use bioreactors, and allows for up to 4 iCellis500 adherent single-use bioreactors to meet demands for upcoming GMP viral vector manufacturing projects.
The project also included the build-out of more process development lab space, a new automated filling line and the addition of a new fully dedicated 1,000m2 warehouse space.
AGC Biologics acquired the Milan site to launch its cell and gene business in July of 2020, and it has since become the global hub for the company’s cell and gene therapy services.
The location was the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies. AGC Biologics also operates a second cell and gene facility in Longmont, CO, offering global viral vector and cell therapy development, manufacturing, as well as quality and regulatory services.
The AGC’s global cell and gene network has supported four commercial viral vector products, three commercial cell therapies and more than 30 cell and gene therapy clinical trials across Europe and the U.S.
Luca Alberici, general manager, AGC Biologics Milan, 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.”