In short order, Seattle-based contract manufacturer AGC Biologics has gone hard into the development and production of cell and gene therapies.
In 2020, it acquired Italian cell and gene therapy specialist MolMed. A year later, it purchased a Colorado cell and gene therapy production facility from Novartis.
Wednesday, the company said it has completed of a 2,500-square-meter (27,000-square-foot) expansion of its site in Milan, which it gained in the MolMed purchase. Two new floors were added to the site in the expansion, which was first announced in 2021.
The beefed-up facility enhances AGC’s ability to develop and manufacture adeno-associated and lentiviral vectors. It will allow the company to meet the growing demand for large-scale and late-phase commercial products.
The project added five single-use bioreactors, including two with 1,000-liter capacity. Other additions to the facility include more process development lab space, a new automated filling line and a new 1,000-square-meter (10,760-square-foot) warehouse.
In a release, Luca Alberici, AGC’s general manager of the Milan Cell & Gene Center of Excellence, called the upgrade an “important milestone” as it prepares to serve more developers.
“We have the flexibility to support companies from clinical to commercial stages for in–vivo end ex-vivo gene therapy applications,” Alberici added.
Under MolMed, the site was the first in Europe to gain regulatory manufacturing authorization for cell and gene therapies.
AGC’s other cell and gene therapy production site, in Longmont, Colorado, covers 622,000 square feet over six buildings.
AGC’s cell and gene therapy network has supported four commercial viral vector products, three commercial cell therapies and more than 30 cell and gene therapy clinical trials in the U.S. and Europe, the company said.
Early this year, AGC revealed that it had been tapped to produce Provention Bio’s Type 1 diabetes treatment Tzield at its Seattle protein biologics facility. The company was instrumental in the early development of the long-awaited medicine.