AGC completes Italy CGT plant expansion

AGC Biologics said the completed expansion of its cell and gene therapy site in Milan, Italy will support industry demand.

Contract development manufacturing organization (CDMO) AGC launched a voluntary tender offer to acquire Italian cell and gene therapy (CGT) developer and manufacturer MolMed for €240 million ($284 million). In July 2020, the deal closed.

The CDMO has now completed a 2,500m² expansion at its Milan site for adeno-associated and lentiviral vector development and production has been built to accommodate large-scale and late-phase clinical and commercial needs.

Yoshinori Hirai, representative director, president and CEO of AGC inc at the opening. Image c/o AGC Bio

The expansion added 1×50 L, 2×200 L, 2×1,000 L suspension single-use bioreactors and allows for four of Pall Corporation’s ICellis500 single-use bioreactors in order to meet demands for viral vector manufacturing projects. Furthermore, included in the project was a process development lab, an automated filling line, and warehouse space.

“Single-use bioreactors give our customers flexibility of supply as they progress through clinical phases, from early clinical stage when future demand is not well understood, to commercial stage which needs larger capacity,” a spokesperson for AGC told BioProcess Insider.

“Through this single-use flexibility, AGC helps customers scale based on need and demand (even after regulatory approvals). With this approach, developers in the cell and gene space – where budgets and resources can be tight – can save internal resources, time, and money.”

Ability to scale

According to AGC, the decision to expand derived from the increasing number of clinical trials in the CGT space and demand from its clients. The firm referenced the Clinicaltrials.gov website and said that there are over 18,000 combined active early Phase I clinical trials for CGTs to date.

With this in mind, the company stated if “even a fraction” of these players do not have the capacity to scale vector production in-house to support their project, these develops will need CDMOs like AGC to advance their treatments through the clinic through to commercialization.

“We are seeing demand from our customers who have started from the early phases and are advancing into the later clinical stages. Also, there is market opportunity. Viral vectors are not only gene therapies, but the critical raw material used in the manufacturing of most gene-modified cell therapies in ongoing clinical trials. Developers value partners that can assure the supply of viral vectors from small clinical stages to large commercial scales,” the spokesperson said.

No financial details have been disclosed.