AGC Biologics Completes Expansion at CGT Manufacturing Site in Milan

AGC Biologics announced on Aug. 9, 2023 the completed expansion of its manufacturing space at the Milan Cell & Gene Center of Excellence production. The expansion offers the addition of 1 x 50L, 2 x 200L, and 2x 1000L suspension single-use bioreactors and allows for up to four iCellis500 adherent single-use bioreactors to meet demands for upcoming good manufacturing practice (GMP) viral vector manufacturing projects, according to the company press release.

Additionally, 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 1000-square-meter 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, in a press release. “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 2000L. 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 site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies, according to the press release. Further, the site has brought multiple products from the pre-clinical stage through commercial phases, such as developing a custom plug-and-play systems for vector manufacturing.

The two cell and gene facilities from AGC Biologics, in Milan and Longmont, US, receive support from the Biologics Heidelberg site, which produces proprietary plasmid starting materials for advanced therapies in high-quality and GMP grades, according to the press release.

Source: AGC Biologics