“I’m very pleased that we’ll be able to offer our current and future cell and gene therapy customers even more of what they need from our Milan facility,” said chief business officer Mark Womack. “This is but one of the important steps we are taking to ensure we keep pace with the evolving needs of the market.”

This latest investment is part of AGC Biologics’ global cell and gene therapy expansion plan and comes less than a year after its acquisition of the former MolMed facilities in Milan. 

AGC Biologics said the Milan site was the first GMP facility approved in Europe for ex-vivo gene therapy manufacturing and has unique commercial manufacturing experience, with two cell and gene therapy products. The company added that it is now one of the very few CDMOs worldwide to offer both plasmid production and end-to-end cell and gene therapy services.

Last November, AGC Biologics revealed plans to expand production in Copenhagen, Denmark. The investment of about €160 million will more than double its single-use bioreactor mammalian cell-culture capacity, enabling AGC Biologics to meet the needs of the market. Operations are scheduled to start in 2023.

The biopharmaceutical CDMO market continues to grow at about 10% annually, and the accumulation of contracts awarded to AGC Biologics is outpacing the market, the company said. AGC Biologics’ network comprises cGMP-compliant facilities in Seattle, Washington and Boulder, Colorado in the US; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan.

Last June, the CDMO announced it was partnering with Novavax on large-scale production of Matrix-M, the adjuvant component of Novavax’s coronavirus vaccine candidate. Two months later, in the midst of preparations to start production at Copenhagen, AGC Biologics said it was extending the partnership to expand supply of the adjuvant from its Seattle plant in order to ensure availability for the US.

Novavax is currently in two pivotal Phase 3 studies on its Covid-19 vaccine, NVX-CoV2373, and expects to announce initial interim data this quarter.

Author: Elaine Burridge, Freelance Journalist