Over 2,500m2 expansion for Adeno-Associated and Lentiviral Vector development and manufacturing built for large-scale and Late-Phase Clinical and Commercial Demands.
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced the company completed the expansion of its manufacturing space at its Milan Cell & Gene Center of Excellence production site. The expansion added 1 x 50L 2 x 200L and 2 x 1,000L suspension single-use bioreactors, and allows for the addition of up to four iCellis500 adherent single-use bioreactors to meet demands for cGMP 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.”
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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 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.
AGC Biologics operates two cell and gene facilities within its global network, one in Milan and one in Longmont, Col, USA. At each site AGC Biologics offers end-to-end global viral vector and cell therapy development, manufacturing, and quality/regulatory services, using the latest technology platforms and scientific methods. These sites also receive support from the AGC Biologics Heidelberg site, which produces proprietary plasmid starting materials for advanced therapies in high-quality and GMP grades.
The CDMO’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 United States.
SOURCE: BusinessWire