Business Strategy AGC Biologics Expands Cell & Gene Therapy Production Site in Italy
AGC Biologics’ expanded development and production site includes single-use bioreactors which will help to meet the rising demands for GMP viral vector manufacturing projects. With this, the firm can also assist companies for in–vivo end ex-vivo gene therapy applications as well as manufacture adeno-associated and lentiviral vectors.
Bresso MI/Italy – AGC Biologics has recently completed the expansion of its manufacturing space at the Milan Cell & Gene Center of Excellence production site. The expansion added 1 x 50L, 2 x 200L and 2x 1,000L 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. In addition, the project 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.
“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,” said 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.”
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 our cell and gene therapy services. The core scientific team has 30 years of expertise in the field and the location was the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies. The team at the site has brought multiple products from pre-clinical through commercial phases and developed custom plug-and-play systems for vector manufacturing, including AGC’s Bravoaav and Prontolvv Platforms.