CDMO AGC Biologics has formed a nove Cell and Gene Technologies Division.
The offshoot aims to provide the industry with resources in the emerging cell and gene therapy market which currently lacks technical CDMO expertise, according to the company.
As many other CDMOs in this space close sites and downsize their operations, AGC Biologics has backed the potential of this industry, offering industry players the support and technical knowledge that will allow them to increase their speed to GMP phases while controlling costs.
Operating in three continents — the US, Europe and Asia — AGC Biologics will also offer its proprietary cell therapy and viral vector platforms, ProntoLVV and BravoAAV, to customers.
The company's Centre of Excellence based in Milan will house the team for this new division, which have played a key role in the approval of 9 therapeutics, as well as the efficient manufacture of hundreds of GMP batches.
AGC Biologics currently holds commercial manufacturing authorisations from the FDA and the EMA for viral vectors and cell therapies.
The new Cell and Gene Technologies Division features expanded global capabilities, including AGC Biologics' Longmont facility and the new Yokohama facility, which will begin cell therapy operations in July 2025.
The new Division aims to "Bring Hope to Life Together" with developers in the global cell and gene industry and inspire progress for these promising treatments. The Cell and Gene Technologies Division offers support for R&D initiatives, solves complexities in clinical stages, builds scalable manufacturing processes, and addresses the unique needs of developers based on the geographical regions they operate in.
Luca Alberici has been appointed Executive VP of the Cell and Gene Technologies Division. Reporting directly to the President and CEO, Alberto Santagostino, he will join the executive leadership team to oversee the new division's global strategy, operations and commercial development.
"Luca is a veteran in this space, with a proven track record of success in launching CGT products in the market, and he has extensive leadership experience at our flagship Milan site," said Alberto Santagostino. "With 20 years in the industry, his expertise will be invaluable as we expand our capabilities and customer pipeline in this vital therapeutic area."
"AGC Biologics has invested significant resources to make manufacturing of cell and gene therapies economically sustainable for the market," added Alberici.
"With our newest scales, we are focused on making life-saving treatments more cost-effective and aim to be able to offer lentiviral vectors for commercial applications at a cost as low as USD $1,000 per patient. Thanks to automation in cell therapy manufacturing, full quality control testing in-house, and a wide facility footprint in each global region, we believe we can now be the partner of choice for most late-stage CGT customers from CAR-T to viral vectors and new trailblazing modalities like exosomes," he concluded.