The expansion of the CGT manufacturing site in Milan, Italy, will support viral vector development and manufacturing for late-stage clinical and commercial projects.
Contract development and manufacturing organisation AGC Biologics has completed expansion of its cell and gene therapy (CGT) development and manufacturing site in Milan, Italy.
The site was acquired in July 2020 and was the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies. It has since become the ‘global hub’ of the company’s cell and gene therapy business
At over 2,500 square meters, the expansion added several single-use suspension bioreactors (1 x 50L x 200L and 2 x 1,000L) and allows for the addition of up to four adherent single-use bioreactors to meet demands for cGMP viral vector manufacturing projects. The facility also includes extra process development lab space, a new automated filling line and a new 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,” commented Luca Alberici, General Manager, AGC Biologics Milan.
He added: “Thanks to this expansion we have the flexibility to support companies from clinical to commercial stages for in–vivo and ex-vivo gene therapy applications and can manufacture adeno-associated and lentiviral vectors from medium 50L scales to as large as 2,000L.”
In addition to the site in Milan, AGC Biologics operates a cell and gene therapy facility in Longmont, Colorado, USA. Both sites receive support from a facility in Heidelberg, Germany, which produces plasmid starting materials for advanced therapies. The CDMO operates further sites in Denmark, the US and Japan.
The CDMO’s global CGT manufacturing 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 USA.
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