Manufacturing shift to Ireland frees up US capacity for Regeneron’s COVID antibodies

Regeneron is shifting production of non-COVID therapies from its US facilities to its site in Limerick, Ireland to make space for a potential antibody cocktail against COVID-19.

Regeneron’s efforts to combat COVID-19, caused by the novel coronavirus (SARS-CoV-2), is a monoclonal antibody (mAb) cocktail treatment based on potency and binding ability to the SARS-CoV-2 spike protein. The prospective therapy, REGN-COV2, developed using technology and experience demonstrated by the firm’s investigational triple antibody cocktail treatment for Ebola REGN-EB3, is is in late-stage clinical trials for the treatment and prevention of COVID-19 infection.

A such, Regeneron has been preparing to supply commercial quantities by manufacturing at risk from its 130-acre site in Rensselaer, New York. Speaking in May, the firm talked of clearing capacity at the site to make way for large-scale production of the antibody cocktail.

Image: iStock/chrisdorney

Some of the products made at Rensselaer – which according to an EMA assessment report includes the active substance for blockbuster dermatitis mAb Dupixent (dupilumab) – need a new home, and according to Neil Stahl, executive vice president of R&D, that will be Ireland.

“We’re actually actively moving some of our products that are manufactured here in Rensselaer at our manufacturing facility, we’re moving them to Ireland, so that we can have even more capacity here,” he told investors at Citi’s 15th Annual BioPharma Virtual Conference this week.

Regeneron acquired the site in Ireland from Dell Computer Corporation in 2014 and swiftly converted it into its Industrial Operations and Product Supply (IOPS) bioprocessing campus. Since then, the firm has invested heavily in the site and continues to do so.

To support the expansion and shift of manufacturing to the site, Regeneron recently announced plans to hire an extra 400 staff.

By making space for COVID-19 antibodies, Regeneron is committing itself to producing prospective therapies in the US, for the US. According to Stahl, the Biomedical Advanced Research and Development Authority (BARDA) “is ethically supporting us to use all of our existing American manufacturing capacity for the COVID antibodies.” In July, the Agency awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2 as part of Operation Warp Speed.

International supply

While Regeneron is preparing its Rensselaer facility for US supply, the firm is also looking at the international market. Last month, Regeneron inked a manufacturing collaboration with Switzerland’s Roche for the distribution of REGN-COV2 internationally.

“What the Roche deal does is it allows us to expand by about three and a half fold the amount that we can make,” said Stahl. “We will be focusing on supplying the US and Roche will be focusing on supplying the ex-US.”

Under the terms of the agreement, each company has committed to dedicate a certain manufacturing capacity to REGN-COV2 each year, and the collaborators have already begun the technology transfer process.

However, Stahl hinted at the possibility of adding further production partners going forward.

“Depending on how robust the data is, if there’s a lot of demand, then we will look for other ways to try to increase the supply through other potential partners.”