CDMO AGC places CO plant on ice amid turbulent CGT economy

As a direct result of the COVID-19 pandemic, the cell and gene therapy space (CGT)is lurching towards recovery. Yet, the industry still struggles with lackluster sales and dwindling demand. Despite positive signs, experts have said that disruption in CGT investment will likely continue.

Citing such shifts in the biopharmaceutical landscape, contract development and manufacturing organization (CDMO) AGC Biologics announced a restructuring effort under which it is laying off 95 employees, effective November 22, 2024.

According to a Worker Adjustment and Retraining Notification (WARN) alert, the CDMO will lay off 68 employees at its CGT facility in Longmont, Colorado. Additionally, 17 employees will be let go from its mammalian plant in Boulder, Colorado, along with 10 employees in Bothell, Washington.

“Our industry has seen fluctuation over the last 12-18 months as the global biopharmaceutical business environment has changed,” a spokesperson for AGC Biologics told BioProcess Insider.

“This includes developers slowing their investment in R&D and timelines for advancing treatments into their next phase, which has had a negative impact on CDMOs and other manufacturers. With that, AGC Biologics has evaluated our resources and made the difficult decision to idle most operations at one of our global sites, the AGC Biologics’ CGT plant in Longmont, and restructure some US and global support functions.”

The spokesperson for AGC confirmed that “Longmont is idled,” but not up for sale.

The 622,000 square-foot cell therapy and viral vector site is located 110 miles north of Denver. The facility has undergone two expansions. The first occurred in May 2022 when the CDMO added viral vector suspension technology, and the second in August 2023 when 30,000 square feet of space was added to accommodate two process suites and one flex suite.

Over the years, the plant has changed hands several times. The site was being used to produce drug substance (DS) for Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) before being sold to AstraZeneca (AZ) in October 2016 for an undisclosed amount.

At the time of acquisition, AZ was going to use the facility alongside another plant in Boulder for its biomanufacturing ambitions. However, citing operational restructuring, the firm sold both plants in 2019.

AGC bought the Boulder site for $100 million in June 2020, while Novartis purchased the Longmont facility. But in March 2021, Novartis unexpectedly wound down the plant highlighting a change in its gene-therapy capacity needs.

In August 2021, AGC purchased the Longmont facility for an undisclosed fee.